Miriam E. Tucker

WASHINGTON — Once-daily saxagliptin added to metformin resulted in statistically significant reductions in hemoglobin A1c, fasting plasma glucose, and postprandial glucose levels for up to 24 weeks in a placebo-controlled trial involving 743 patients with type 2 diabetes who were inadequately controlled with metformin alone.

Results of the multicenter phase III study were reported in a poster at the annual meeting of the American Association of Diabetes Educators by Dr. Shoba Ravichandran, an endocrinologist with Bristol-Myers Squibb, and Laureen MacEachern, director of scientific communications for the company. Saxagliptin is a dipeptidyl peptidase-4 (DPP-4) inhibitor jointly developed by Bristol-Myers Squibb and AstraZeneca PLC, which cosponsored the study.

At baseline, the patients had a mean diabetes duration of 6.5 years, mean hemoglobin A1c of 8.0%, fasting plasma glucose of 176 mg/dL, and 2-hour postprandial glucose of 286 mg/dL.

All of the patients were on stable doses of metformin—between 1,500 and 2,550 mg/day—for at least 8 weeks prior to the study, and remained on the same dosage during the study. They were randomized to one of four groups: saxagliptin in daily doses of 2.5, 5, or 10 mg, or placebo.

The investigators found statistically significant reductions in both HbA1c and fasting plasma glucose (FPG) were seen with all the saxagliptin doses, but the maximal benefit occurred with the 5.0- mg/day dose.

At week 24, placebo-corrected mean reductions from baseline in HbA1c were 0.73, 0.83, and 0.72 percentage points for the 2.5-, 5-, and 10-mg/day doses, respectively. Placebo-corrected FPG was reduced from baseline by 16, 23, and 22 mg/dL, respectively.

Reductions in FPG were observed as early as week 2, Dr. Ravichandran and Ms. MacEachern said.

The investigators also reported significant placebo-adjusted reductions in 2-hour postprandial glucose levels from baseline—44, 40, and 32 mg/dL, for the 2.5- 5-, and 10-mg doses, respectively. Saxagliptin did not have a significant impact on body weight, with mean reductions from baseline at week 24 of 1.4, 0.9, and 0.5 kg, respectively, and of 0.9 kg in the placebo group.

Saxagliptin was generally well-tolerated. A total of 74% of patients in the three treatment groups and 65% of the placebo group reported at least one adverse event, including nasopharyngitis in 9% of the saxagliptin patients and 8% of the placebo group, headache in 8% vs. 7%, and diarrhea in 7% vs. 11%, respectively.

The incidence of hypoglycemia was similar in the saxagliptin plus metformin-treated patients (5.7%) and the placebo plus metformin patients (5.0%).

Events of hypoglycemia that were confirmed by a fingerstick glucose value of 50 mg/dL or less were 0.5% for the saxagliptin groups and 0.6% with placebo, the investigators reported.

In July, Bristol-Myers Squibb and AstraZeneca announced the submission of a New Drug Application to the U.S. Food and Drug Administration and validation of a Marketing Authorization Application to the European Medicines Agency for saxagliptin under the proposed trade name Onglyza.

WASHINGTON — Once-daily saxagliptin added to metformin resulted in statistically significant reductions in hemoglobin A1c, fasting plasma glucose, and postprandial glucose levels for up to 24 weeks in a placebo-controlled trial involving 743 patients with type 2 diabetes who were inadequately controlled with metformin alone.

Results of the multicenter phase III study were reported in a poster at the annual meeting of the American Association of Diabetes Educators by Dr. Shoba Ravichandran, an endocrinologist with Bristol-Myers Squibb, and Laureen MacEachern, director of scientific communications for the company. Saxagliptin is a dipeptidyl peptidase-4 (DPP-4) inhibitor jointly developed by Bristol-Myers Squibb and AstraZeneca PLC, which cosponsored the study.

At baseline, the patients had a mean diabetes duration of 6.5 years, mean hemoglobin A1c of 8.0%, fasting plasma glucose of 176 mg/dL, and 2-hour postprandial glucose of 286 mg/dL.

All of the patients were on stable doses of metformin—between 1,500 and 2,550 mg/day—for at least 8 weeks prior to the study, and remained on the same dosage during the study. They were randomized to one of four groups: saxagliptin in daily doses of 2.5, 5, or 10 mg, or placebo.

The investigators found statistically significant reductions in both HbA1c and fasting plasma glucose (FPG) were seen with all the saxagliptin doses, but the maximal benefit occurred with the 5.0- mg/day dose.

At week 24, placebo-corrected mean reductions from baseline in HbA1c were 0.73, 0.83, and 0.72 percentage points for the 2.5-, 5-, and 10-mg/day doses, respectively. Placebo-corrected FPG was reduced from baseline by 16, 23, and 22 mg/dL, respectively.

Reductions in FPG were observed as early as week 2, Dr. Ravichandran and Ms. MacEachern said.

The investigators also reported significant placebo-adjusted reductions in 2-hour postprandial glucose levels from baseline—44, 40, and 32 mg/dL, for the 2.5- 5-, and 10-mg doses, respectively. Saxagliptin did not have a significant impact on body weight, with mean reductions from baseline at week 24 of 1.4, 0.9, and 0.5 kg, respectively, and of 0.9 kg in the placebo group.

Saxagliptin was generally well-tolerated. A total of 74% of patients in the three treatment groups and 65% of the placebo group reported at least one adverse event, including nasopharyngitis in 9% of the saxagliptin patients and 8% of the placebo group, headache in 8% vs. 7%, and diarrhea in 7% vs. 11%, respectively.

The incidence of hypoglycemia was similar in the saxagliptin plus metformin-treated patients (5.7%) and the placebo plus metformin patients (5.0%).

Events of hypoglycemia that were confirmed by a fingerstick glucose value of 50 mg/dL or less were 0.5% for the saxagliptin groups and 0.6% with placebo, the investigators reported.

In July, Bristol-Myers Squibb and AstraZeneca announced the submission of a New Drug Application to the U.S. Food and Drug Administration and validation of a Marketing Authorization Application to the European Medicines Agency for saxagliptin under the proposed trade name Onglyza.

WASHINGTON — Once-daily saxagliptin added to metformin resulted in statistically significant reductions in hemoglobin A1c, fasting plasma glucose, and postprandial glucose levels for up to 24 weeks in a placebo-controlled trial involving 743 patients with type 2 diabetes who were inadequately controlled with metformin alone.

Results of the multicenter phase III study were reported in a poster at the annual meeting of the American Association of Diabetes Educators by Dr. Shoba Ravichandran, an endocrinologist with Bristol-Myers Squibb, and Laureen MacEachern, director of scientific communications for the company. Saxagliptin is a dipeptidyl peptidase-4 (DPP-4) inhibitor jointly developed by Bristol-Myers Squibb and AstraZeneca PLC, which cosponsored the study.

At baseline, the patients had a mean diabetes duration of 6.5 years, mean hemoglobin A1c of 8.0%, fasting plasma glucose of 176 mg/dL, and 2-hour postprandial glucose of 286 mg/dL.

All of the patients were on stable doses of metformin—between 1,500 and 2,550 mg/day—for at least 8 weeks prior to the study, and remained on the same dosage during the study. They were randomized to one of four groups: saxagliptin in daily doses of 2.5, 5, or 10 mg, or placebo.

The investigators found statistically significant reductions in both HbA1c and fasting plasma glucose (FPG) were seen with all the saxagliptin doses, but the maximal benefit occurred with the 5.0- mg/day dose.

At week 24, placebo-corrected mean reductions from baseline in HbA1c were 0.73, 0.83, and 0.72 percentage points for the 2.5-, 5-, and 10-mg/day doses, respectively. Placebo-corrected FPG was reduced from baseline by 16, 23, and 22 mg/dL, respectively.

Reductions in FPG were observed as early as week 2, Dr. Ravichandran and Ms. MacEachern said.

The investigators also reported significant placebo-adjusted reductions in 2-hour postprandial glucose levels from baseline—44, 40, and 32 mg/dL, for the 2.5- 5-, and 10-mg doses, respectively. Saxagliptin did not have a significant impact on body weight, with mean reductions from baseline at week 24 of 1.4, 0.9, and 0.5 kg, respectively, and of 0.9 kg in the placebo group.

Saxagliptin was generally well-tolerated. A total of 74% of patients in the three treatment groups and 65% of the placebo group reported at least one adverse event, including nasopharyngitis in 9% of the saxagliptin patients and 8% of the placebo group, headache in 8% vs. 7%, and diarrhea in 7% vs. 11%, respectively.

The incidence of hypoglycemia was similar in the saxagliptin plus metformin-treated patients (5.7%) and the placebo plus metformin patients (5.0%).

Events of hypoglycemia that were confirmed by a fingerstick glucose value of 50 mg/dL or less were 0.5% for the saxagliptin groups and 0.6% with placebo, the investigators reported.

In July, Bristol-Myers Squibb and AstraZeneca announced the submission of a New Drug Application to the U.S. Food and Drug Administration and validation of a Marketing Authorization Application to the European Medicines Agency for saxagliptin under the proposed trade name Onglyza.

The Food and Drug Administration will no longer issue “approvable” or “not approvable” letters when a drug application is not approved, but will instead issue a “complete response” letter at the end of the review period, the agency has announced.

The change went into effect on Aug. 11 for all drug applications, regardless of when they were submitted.

“These new regulations will help the FDA adopt a more consistent and neutral way of conveying information to a company when we cannot approve a drug application in its present form,” Dr. Janet Woodcock, director of the agency's Center for Drug Evaluation and Research, said in a statement.

Currently, when assessing new drug and generic drug applications, the FDA can respond to a sponsor in one of three types of letters: an “approval” letter, meaning the drug has met agency standards for safety and efficacy and can be marketed for sale in the United States; an “approvable” letter, which generally indicates that the drug can probably be approved at a later date provided that the applicant provides certain additional information or makes specified changes (such as to the labeling); or a “not approvable” letter, meaning the application has deficiencies generally requiring the submission of substantial additional data before approval.

A “complete response” letter, which will replace options 2 and 3, will be issued to inform the company that the review period for a drug is complete and that the application is not yet ready for approval, the statement said. The letter will describe specific deficiencies and, when possible, will outline recommended actions the applicant might take to prepare the application for approval. The way that the FDA communicates its decisions to approve an application—option 1—will not change.

The move brings the process for communication about drug licensing applications in line with that of biologics. The revision should not affect the overall time it takes the FDA to review new or generic drug applications, the agency said.

The Food and Drug Administration will no longer issue “approvable” or “not approvable” letters when a drug application is not approved, but will instead issue a “complete response” letter at the end of the review period, the agency has announced.

The change went into effect on Aug. 11 for all drug applications, regardless of when they were submitted.

“These new regulations will help the FDA adopt a more consistent and neutral way of conveying information to a company when we cannot approve a drug application in its present form,” Dr. Janet Woodcock, director of the agency's Center for Drug Evaluation and Research, said in a statement.

Currently, when assessing new drug and generic drug applications, the FDA can respond to a sponsor in one of three types of letters: an “approval” letter, meaning the drug has met agency standards for safety and efficacy and can be marketed for sale in the United States; an “approvable” letter, which generally indicates that the drug can probably be approved at a later date provided that the applicant provides certain additional information or makes specified changes (such as to the labeling); or a “not approvable” letter, meaning the application has deficiencies generally requiring the submission of substantial additional data before approval.

A “complete response” letter, which will replace options 2 and 3, will be issued to inform the company that the review period for a drug is complete and that the application is not yet ready for approval, the statement said. The letter will describe specific deficiencies and, when possible, will outline recommended actions the applicant might take to prepare the application for approval. The way that the FDA communicates its decisions to approve an application—option 1—will not change.

The move brings the process for communication about drug licensing applications in line with that of biologics. The revision should not affect the overall time it takes the FDA to review new or generic drug applications, the agency said.

The Food and Drug Administration will no longer issue “approvable” or “not approvable” letters when a drug application is not approved, but will instead issue a “complete response” letter at the end of the review period, the agency has announced.

The change went into effect on Aug. 11 for all drug applications, regardless of when they were submitted.

“These new regulations will help the FDA adopt a more consistent and neutral way of conveying information to a company when we cannot approve a drug application in its present form,” Dr. Janet Woodcock, director of the agency's Center for Drug Evaluation and Research, said in a statement.

Currently, when assessing new drug and generic drug applications, the FDA can respond to a sponsor in one of three types of letters: an “approval” letter, meaning the drug has met agency standards for safety and efficacy and can be marketed for sale in the United States; an “approvable” letter, which generally indicates that the drug can probably be approved at a later date provided that the applicant provides certain additional information or makes specified changes (such as to the labeling); or a “not approvable” letter, meaning the application has deficiencies generally requiring the submission of substantial additional data before approval.

A “complete response” letter, which will replace options 2 and 3, will be issued to inform the company that the review period for a drug is complete and that the application is not yet ready for approval, the statement said. The letter will describe specific deficiencies and, when possible, will outline recommended actions the applicant might take to prepare the application for approval. The way that the FDA communicates its decisions to approve an application—option 1—will not change.

The move brings the process for communication about drug licensing applications in line with that of biologics. The revision should not affect the overall time it takes the FDA to review new or generic drug applications, the agency said.

SAN FRANCISCO — An interest in endocrinology was noted by just over 1% of more than 500 students at 47 U.S. medical schools, and 3 of those 7 students said they wanted to pursue diabetes care.

The findings of the survey, funded and conducted by the diabetes consulting firm Close Concerns Inc., suggest that care of patients with diabetes will fall even more to primary care providers in the future than it does today.

A recent study estimates a 12%-15% undersupply of endocrinologists in the United States (J. Clin. Endocrinol. Metab. 2008;93:1164–6).

“Unless this trend is reversed, in the coming decade the critical shortfall in diabetes specialists may compromise patient care,” Kelly L. Close, founder and president of Close Concerns, and her associates said in a poster presented at the annual scientific sessions of the American Diabetes Association.

The 524 survey respondents represented approximately 5%-10% of medical students who were sent electronic surveys between April 2007 and August 2007; the percentage of respondents varied by school. Thirty-nine percent were first-year students; 23% were second-year; 12%, third-year; and 26%, fourth-year.

Slightly more than a quarter (26%) were from the University of California San Francisco; 17% were from Harvard University, Boston; and 15% were from Columbia University, New York. The remainder came from 44 other medical schools including Emory University, Atlanta; Loma Linda (Calif.) University; Stanford (Calif.) University; Cornell University, New York; Johns Hopkins University, Baltimore; Philadelphia College of Osteopathic Medicine; and Meharry Medical College, Nashville, Tenn.

When asked to rank from 1 to 6 the factors that were most important in choosing a specialty, with 1 being “not important” and 6 being “extremely important,” the group gave the highest ranking (5.1) to “intellectual satisfaction,” followed by 4.7 for “work-life balance” (hours, call frequency), 4.4 for “scope” (specific or broad skills), 4.4 for type of patient interaction (brief/long-term), and 4.4 for location (or location possibilities).

Most students reported having had some exposure to diabetes during medical school. Nearly 36% of the entire group reported having had “a little” exposure to diabetes, 31% reported “some,” and 7% said they had “a lot.”

Although just over 1.3% of the students expressed an interest in pursuing endocrinology and even fewer in diabetes in particular, 26% indicated that they had actually considered a career in diabetes care before deciding against it. When queried about the two most important factors that would attract them to the field of diabetes, nearly half (49%) checked “social importance,” 33% cited the disease's “pandemic status,” 25% named “unique challenges to treat,” and 24% “good work-life balance.”

When asked to check the factors that would deter them from the field of diabetes, 46% checked the statement “It's too difficult to change or impact patient behavior.” That was followed by “not interested in endocrinology” (42%), “lack of procedures” (38%), “overall compensation is too low” (21%), “scientific advances lacking or not as exciting as in other areas” (16%), and “reimbursement too low for time it takes to help patients” (14%).

“We believe that increasing physician interest in diabetes will require significant changes to reimbursement structure and physician economics. New and improved therapies may also increase interest in diabetes care by providing viable alternatives to behavioral modification.”

SAN FRANCISCO — An interest in endocrinology was noted by just over 1% of more than 500 students at 47 U.S. medical schools, and 3 of those 7 students said they wanted to pursue diabetes care.

The findings of the survey, funded and conducted by the diabetes consulting firm Close Concerns Inc., suggest that care of patients with diabetes will fall even more to primary care providers in the future than it does today.

A recent study estimates a 12%-15% undersupply of endocrinologists in the United States (J. Clin. Endocrinol. Metab. 2008;93:1164–6).

“Unless this trend is reversed, in the coming decade the critical shortfall in diabetes specialists may compromise patient care,” Kelly L. Close, founder and president of Close Concerns, and her associates said in a poster presented at the annual scientific sessions of the American Diabetes Association.

The 524 survey respondents represented approximately 5%-10% of medical students who were sent electronic surveys between April 2007 and August 2007; the percentage of respondents varied by school. Thirty-nine percent were first-year students; 23% were second-year; 12%, third-year; and 26%, fourth-year.

Slightly more than a quarter (26%) were from the University of California San Francisco; 17% were from Harvard University, Boston; and 15% were from Columbia University, New York. The remainder came from 44 other medical schools including Emory University, Atlanta; Loma Linda (Calif.) University; Stanford (Calif.) University; Cornell University, New York; Johns Hopkins University, Baltimore; Philadelphia College of Osteopathic Medicine; and Meharry Medical College, Nashville, Tenn.

When asked to rank from 1 to 6 the factors that were most important in choosing a specialty, with 1 being “not important” and 6 being “extremely important,” the group gave the highest ranking (5.1) to “intellectual satisfaction,” followed by 4.7 for “work-life balance” (hours, call frequency), 4.4 for “scope” (specific or broad skills), 4.4 for type of patient interaction (brief/long-term), and 4.4 for location (or location possibilities).

Most students reported having had some exposure to diabetes during medical school. Nearly 36% of the entire group reported having had “a little” exposure to diabetes, 31% reported “some,” and 7% said they had “a lot.”

Although just over 1.3% of the students expressed an interest in pursuing endocrinology and even fewer in diabetes in particular, 26% indicated that they had actually considered a career in diabetes care before deciding against it. When queried about the two most important factors that would attract them to the field of diabetes, nearly half (49%) checked “social importance,” 33% cited the disease's “pandemic status,” 25% named “unique challenges to treat,” and 24% “good work-life balance.”

When asked to check the factors that would deter them from the field of diabetes, 46% checked the statement “It's too difficult to change or impact patient behavior.” That was followed by “not interested in endocrinology” (42%), “lack of procedures” (38%), “overall compensation is too low” (21%), “scientific advances lacking or not as exciting as in other areas” (16%), and “reimbursement too low for time it takes to help patients” (14%).

“We believe that increasing physician interest in diabetes will require significant changes to reimbursement structure and physician economics. New and improved therapies may also increase interest in diabetes care by providing viable alternatives to behavioral modification.”

SAN FRANCISCO — An interest in endocrinology was noted by just over 1% of more than 500 students at 47 U.S. medical schools, and 3 of those 7 students said they wanted to pursue diabetes care.

The findings of the survey, funded and conducted by the diabetes consulting firm Close Concerns Inc., suggest that care of patients with diabetes will fall even more to primary care providers in the future than it does today.

A recent study estimates a 12%-15% undersupply of endocrinologists in the United States (J. Clin. Endocrinol. Metab. 2008;93:1164–6).

“Unless this trend is reversed, in the coming decade the critical shortfall in diabetes specialists may compromise patient care,” Kelly L. Close, founder and president of Close Concerns, and her associates said in a poster presented at the annual scientific sessions of the American Diabetes Association.

The 524 survey respondents represented approximately 5%-10% of medical students who were sent electronic surveys between April 2007 and August 2007; the percentage of respondents varied by school. Thirty-nine percent were first-year students; 23% were second-year; 12%, third-year; and 26%, fourth-year.

Slightly more than a quarter (26%) were from the University of California San Francisco; 17% were from Harvard University, Boston; and 15% were from Columbia University, New York. The remainder came from 44 other medical schools including Emory University, Atlanta; Loma Linda (Calif.) University; Stanford (Calif.) University; Cornell University, New York; Johns Hopkins University, Baltimore; Philadelphia College of Osteopathic Medicine; and Meharry Medical College, Nashville, Tenn.

When asked to rank from 1 to 6 the factors that were most important in choosing a specialty, with 1 being “not important” and 6 being “extremely important,” the group gave the highest ranking (5.1) to “intellectual satisfaction,” followed by 4.7 for “work-life balance” (hours, call frequency), 4.4 for “scope” (specific or broad skills), 4.4 for type of patient interaction (brief/long-term), and 4.4 for location (or location possibilities).

Most students reported having had some exposure to diabetes during medical school. Nearly 36% of the entire group reported having had “a little” exposure to diabetes, 31% reported “some,” and 7% said they had “a lot.”

Although just over 1.3% of the students expressed an interest in pursuing endocrinology and even fewer in diabetes in particular, 26% indicated that they had actually considered a career in diabetes care before deciding against it. When queried about the two most important factors that would attract them to the field of diabetes, nearly half (49%) checked “social importance,” 33% cited the disease's “pandemic status,” 25% named “unique challenges to treat,” and 24% “good work-life balance.”

When asked to check the factors that would deter them from the field of diabetes, 46% checked the statement “It's too difficult to change or impact patient behavior.” That was followed by “not interested in endocrinology” (42%), “lack of procedures” (38%), “overall compensation is too low” (21%), “scientific advances lacking or not as exciting as in other areas” (16%), and “reimbursement too low for time it takes to help patients” (14%).

“We believe that increasing physician interest in diabetes will require significant changes to reimbursement structure and physician economics. New and improved therapies may also increase interest in diabetes care by providing viable alternatives to behavioral modification.”

WASHINGTON — Users of continuous glucose monitoring are a surprisingly diverse group.

That conclusion, from a survey conducted by researchers at the Rocky Mountain Diabetes Center, Idaho Falls, Idaho, suggests that different educational approaches may be needed for different types of patients, said Becky Sulik, R.D., a certified diabetes educator who works at the center.

The 26 men and 28 women had an average age of 45 years; 19% were older than age 60 years. Most (85%) had been trained to use the CGM by a certified diabetes educator who was employed either by the center or by the device manufacturer. Three-fourths of the patients came in for at least one follow-up visit after receiving their training, but only 41% of the group had downloaded the information from their receiver to a computer. Of those who did download, 75% discussed the results with the educator or physician.

In the context of formal education, patients ranged from those having several advanced degrees to those who dropped out of school in the eighth grade. “It wasn't just the highly educated patients” who used CSM, Ms. Sulik noted at the annual meeting of the American Association of Diabetes Educators.

Both staff and patients were initially very excited about real-time CGM technology when it first became available in 2006, but over time a more realistic picture has emerged. Although the technology does provide valuable information about glucose trends and warnings of highs and lows, it's important for patients to be told at the outset that they will still need to do finger sticks, and that those finger-stick values will be different from those of the sensor. Otherwise, they will perceive the discrepancy as an accuracy issue, she cautioned.

Patients also need to be prepared for the annoyance of the alarms going off at inconvenient times. And overall, they need to know that “it's not going to fix everything. … It only provides information. Judgment is still needed,” Ms. Sulik said.

Good candidates for CGM will have taken the time to learn about the technology and how it works; they are already testing at least four times a day as well as when they are suspicious about how they feel, and they are committed to working with their health care providers. Ideally, they also have computer access for downloading the data, and have either good insurance coverage or disposable income to pay for the technology.

When educating patients, diabetes professionals should tailor terminology to the patient's level of understanding, as words such as “calibration,” “interstitial,” or “initializing” may be unfamiliar. To explain the calibration process and why it's necessary, Ms. Sulik shows patients a picture of a roller coaster, with the plasma glucose represented as the first car and the interstitial glucose as the caboose, lagging behind. She uses the terms “tissue sugar” instead of “interstitial,” and “warm up” instead of “initialization.”

And, although diabetes professionals tend to use the word “sensor” to refer to the entire CGM system, it's important to explain to patients that the CGM actually includes three separate parts: the sensor, the transmitter, and the receiver.

As with all diabetes education, CGM training must be tailored to the individual patient. However, Ms. Sulik described the following several broad patient “types” that she and her colleagues have identified over time, and the educational approaches that might work best for each:

▸ “Deer in the Headlights.” These patients are overwhelmed with the amount of data yielded by the CGM and may feel helpless and frightened. Such patients are often older and not as comfortable with technology. They may even become immobilized and end up doing nothing with the data.

For these patients, the key is to start simple. It may take more than one visit to teach them how to use the device, with several follow-up visits to reinforce the skills. Get them to practice the basics of pattern management, and build their confidence by focusing on small successes, Ms. Sulik advised.

▸ “The Analyzers.” These patients “really like the data” and may become so preoccupied with individual readings that they miss overall trends. They are often quick to make multiple changes without waiting to see the effect of one change before making more. Sometimes it's the parent or spouse who is the analyzer, Ms. Sulik said.

With these patients it helps to focus on pattern management. Tell them to “experiment” with cause and effect before making more changes. Prioritizing the changes is also key. For example, reducing insulin doses at certain times to correct low blood sugars may take precedence over correcting highs. “Patients should make a change and then wait and watch,” she advised.

▸ “The Complainers.” Every practice has a few of these. They tend to see the downsides of the technology—such as the nuisance of the alarms or what they perceive as the CGM's accuracy problems—rather than its benefits. With these patients, it's important to reset their expectations, to make sure that they're doing the basics, such as blood glucose monitoring, and to remind them of the reasons they were interested in the device in the first place.

Ultimately, CGM isn't for everyone. “Patients need to be willing to do the work to make the device successful,” Ms. Sulik said.

WASHINGTON — Users of continuous glucose monitoring are a surprisingly diverse group.

That conclusion, from a survey conducted by researchers at the Rocky Mountain Diabetes Center, Idaho Falls, Idaho, suggests that different educational approaches may be needed for different types of patients, said Becky Sulik, R.D., a certified diabetes educator who works at the center.

The 26 men and 28 women had an average age of 45 years; 19% were older than age 60 years. Most (85%) had been trained to use the CGM by a certified diabetes educator who was employed either by the center or by the device manufacturer. Three-fourths of the patients came in for at least one follow-up visit after receiving their training, but only 41% of the group had downloaded the information from their receiver to a computer. Of those who did download, 75% discussed the results with the educator or physician.

In the context of formal education, patients ranged from those having several advanced degrees to those who dropped out of school in the eighth grade. “It wasn't just the highly educated patients” who used CSM, Ms. Sulik noted at the annual meeting of the American Association of Diabetes Educators.

Both staff and patients were initially very excited about real-time CGM technology when it first became available in 2006, but over time a more realistic picture has emerged. Although the technology does provide valuable information about glucose trends and warnings of highs and lows, it's important for patients to be told at the outset that they will still need to do finger sticks, and that those finger-stick values will be different from those of the sensor. Otherwise, they will perceive the discrepancy as an accuracy issue, she cautioned.

Patients also need to be prepared for the annoyance of the alarms going off at inconvenient times. And overall, they need to know that “it's not going to fix everything. … It only provides information. Judgment is still needed,” Ms. Sulik said.

Good candidates for CGM will have taken the time to learn about the technology and how it works; they are already testing at least four times a day as well as when they are suspicious about how they feel, and they are committed to working with their health care providers. Ideally, they also have computer access for downloading the data, and have either good insurance coverage or disposable income to pay for the technology.

When educating patients, diabetes professionals should tailor terminology to the patient's level of understanding, as words such as “calibration,” “interstitial,” or “initializing” may be unfamiliar. To explain the calibration process and why it's necessary, Ms. Sulik shows patients a picture of a roller coaster, with the plasma glucose represented as the first car and the interstitial glucose as the caboose, lagging behind. She uses the terms “tissue sugar” instead of “interstitial,” and “warm up” instead of “initialization.”

And, although diabetes professionals tend to use the word “sensor” to refer to the entire CGM system, it's important to explain to patients that the CGM actually includes three separate parts: the sensor, the transmitter, and the receiver.

As with all diabetes education, CGM training must be tailored to the individual patient. However, Ms. Sulik described the following several broad patient “types” that she and her colleagues have identified over time, and the educational approaches that might work best for each:

▸ “Deer in the Headlights.” These patients are overwhelmed with the amount of data yielded by the CGM and may feel helpless and frightened. Such patients are often older and not as comfortable with technology. They may even become immobilized and end up doing nothing with the data.

For these patients, the key is to start simple. It may take more than one visit to teach them how to use the device, with several follow-up visits to reinforce the skills. Get them to practice the basics of pattern management, and build their confidence by focusing on small successes, Ms. Sulik advised.

▸ “The Analyzers.” These patients “really like the data” and may become so preoccupied with individual readings that they miss overall trends. They are often quick to make multiple changes without waiting to see the effect of one change before making more. Sometimes it's the parent or spouse who is the analyzer, Ms. Sulik said.

With these patients it helps to focus on pattern management. Tell them to “experiment” with cause and effect before making more changes. Prioritizing the changes is also key. For example, reducing insulin doses at certain times to correct low blood sugars may take precedence over correcting highs. “Patients should make a change and then wait and watch,” she advised.

▸ “The Complainers.” Every practice has a few of these. They tend to see the downsides of the technology—such as the nuisance of the alarms or what they perceive as the CGM's accuracy problems—rather than its benefits. With these patients, it's important to reset their expectations, to make sure that they're doing the basics, such as blood glucose monitoring, and to remind them of the reasons they were interested in the device in the first place.

Ultimately, CGM isn't for everyone. “Patients need to be willing to do the work to make the device successful,” Ms. Sulik said.

WASHINGTON — Users of continuous glucose monitoring are a surprisingly diverse group.

That conclusion, from a survey conducted by researchers at the Rocky Mountain Diabetes Center, Idaho Falls, Idaho, suggests that different educational approaches may be needed for different types of patients, said Becky Sulik, R.D., a certified diabetes educator who works at the center.

The 26 men and 28 women had an average age of 45 years; 19% were older than age 60 years. Most (85%) had been trained to use the CGM by a certified diabetes educator who was employed either by the center or by the device manufacturer. Three-fourths of the patients came in for at least one follow-up visit after receiving their training, but only 41% of the group had downloaded the information from their receiver to a computer. Of those who did download, 75% discussed the results with the educator or physician.

In the context of formal education, patients ranged from those having several advanced degrees to those who dropped out of school in the eighth grade. “It wasn't just the highly educated patients” who used CSM, Ms. Sulik noted at the annual meeting of the American Association of Diabetes Educators.

Both staff and patients were initially very excited about real-time CGM technology when it first became available in 2006, but over time a more realistic picture has emerged. Although the technology does provide valuable information about glucose trends and warnings of highs and lows, it's important for patients to be told at the outset that they will still need to do finger sticks, and that those finger-stick values will be different from those of the sensor. Otherwise, they will perceive the discrepancy as an accuracy issue, she cautioned.

Patients also need to be prepared for the annoyance of the alarms going off at inconvenient times. And overall, they need to know that “it's not going to fix everything. … It only provides information. Judgment is still needed,” Ms. Sulik said.

Good candidates for CGM will have taken the time to learn about the technology and how it works; they are already testing at least four times a day as well as when they are suspicious about how they feel, and they are committed to working with their health care providers. Ideally, they also have computer access for downloading the data, and have either good insurance coverage or disposable income to pay for the technology.

When educating patients, diabetes professionals should tailor terminology to the patient's level of understanding, as words such as “calibration,” “interstitial,” or “initializing” may be unfamiliar. To explain the calibration process and why it's necessary, Ms. Sulik shows patients a picture of a roller coaster, with the plasma glucose represented as the first car and the interstitial glucose as the caboose, lagging behind. She uses the terms “tissue sugar” instead of “interstitial,” and “warm up” instead of “initialization.”

And, although diabetes professionals tend to use the word “sensor” to refer to the entire CGM system, it's important to explain to patients that the CGM actually includes three separate parts: the sensor, the transmitter, and the receiver.

As with all diabetes education, CGM training must be tailored to the individual patient. However, Ms. Sulik described the following several broad patient “types” that she and her colleagues have identified over time, and the educational approaches that might work best for each:

▸ “Deer in the Headlights.” These patients are overwhelmed with the amount of data yielded by the CGM and may feel helpless and frightened. Such patients are often older and not as comfortable with technology. They may even become immobilized and end up doing nothing with the data.

For these patients, the key is to start simple. It may take more than one visit to teach them how to use the device, with several follow-up visits to reinforce the skills. Get them to practice the basics of pattern management, and build their confidence by focusing on small successes, Ms. Sulik advised.

▸ “The Analyzers.” These patients “really like the data” and may become so preoccupied with individual readings that they miss overall trends. They are often quick to make multiple changes without waiting to see the effect of one change before making more. Sometimes it's the parent or spouse who is the analyzer, Ms. Sulik said.

With these patients it helps to focus on pattern management. Tell them to “experiment” with cause and effect before making more changes. Prioritizing the changes is also key. For example, reducing insulin doses at certain times to correct low blood sugars may take precedence over correcting highs. “Patients should make a change and then wait and watch,” she advised.

▸ “The Complainers.” Every practice has a few of these. They tend to see the downsides of the technology—such as the nuisance of the alarms or what they perceive as the CGM's accuracy problems—rather than its benefits. With these patients, it's important to reset their expectations, to make sure that they're doing the basics, such as blood glucose monitoring, and to remind them of the reasons they were interested in the device in the first place.

Ultimately, CGM isn't for everyone. “Patients need to be willing to do the work to make the device successful,” Ms. Sulik said.

WASHINGTON — Use of continuous glucose monitoring appeared to significantly improve diabetes control, reduce the incidence of hypoglycemia, and diminish levels of diabetes-associated stress among patients surveyed at a diabetes center in Idaho Falls, Idaho.

The results from two anonymous surveys of patients with type 1 diabetes at the Rocky Mountain Diabetes and Osteoporosis Center are among the first data on continuous glucose monitoring (CGM) to come from a real-life patient setting rather than an industry-sponsored study. Although the numbers are small—54 and 58 patients, respectively, responded out of 150 to whom surveys were sent—the results are statistically significant and can be used to petition third-party payers for reimbursement, Jean Halford said at the annual meeting of the American Association of Diabetes Educators.

Insurance coverage for CGM has increased over the last year with the establishment of new billing codes, but it is by no means universal. “The biggest roadblock to early adoption of this technology and more widespread reimbursement has been and continues to be the lack of long-term clinically significant outcome data demonstrating benefit,” said Ms. Halford, a licensed dietitian and certified diabetes educator at the Rocky Mountain facility, which is the largest diabetes practice in the state of Idaho.

The first survey used two tools. One, the Diabetes Distress Scale (DDS), is a validated 17-item, single-page questionnaire designed to assess emotional burden (for example, “feeling overwhelmed by the demands of living with diabetes”), physician-related distress (for example, “feeling that my doctor doesn't take my concerns seriously enough”), regimen-related distress (for example, “feeling that I am not sticking closely enough to a good meal plan”), and diabetes-related interpersonal distress (for example, “feeling that my friends/family don't appreciate how difficult living with diabetes can be”).

Respondents rate each on a scale of 1–5, with 5 being the highest distress level (Diabetes Care 2005;28:626–31). The other tool was a multipage quality of life questionnaire developed by the Rocky Mountain Diabetes Center, also using a 1–5 scale.

Of the 54 respondents, 27 had stopped using CGM and 27 were continuing to use it at the time of the survey. The difference in usage time was 6 vs. 14.4 months, respectively. Compared with those who quit using CGM, those who continued using it had significantly lower levels of both physician-related distress (1.22 vs. 1.67) and regimen-related distress (2.46 vs. 3.03). Emotional burden was also lower for those who continued (2.77 vs. 3.23), but that difference didn't reach statistical significance.

Among another 54 diabetic patients who had never used CGM, scores on the DDS were just slightly lower than those of the patients who continued to use CGM, with a mean overall score of 2.08 for the never-users and 2.20 for those who continued, compared with 2.62 for those who stopped. This finding suggests that, contrary to what some have suggested, the CGM doesn't increase stress by “overwhelming” the user with data, Ms. Halford said.

Future studies could look at DDS scores before and after CGM use to determine whether there might be a way to predict how a given patient might do with CGM. “We may be able to identify patients who need a different type of education, or those who aren't the best candidates for CGM,” she said.

The Rocky Mountain Center's questionnaire inquired retrospectively about hypoglycemia before and after CGM use. Among all CGM users, the reported fear of hypoglycemia dropped from a score of 3.30 to 2.52, a statistically significant difference. The drop was significant for both those who continued using CGM (3.44 vs. 2.64) and those who quit (3.19 vs. 2.41). Fear of severe hypoglycemia dropped from 2.48 to 1.67 overall, from 2.70 to 1.89 among the continuing users, and from 2.24 to 1.44 among those who quit. Those values were also all statistically significant.

It's possible that for the quitters, even the short 6 months of use might have improved glucose control enough that they felt more confident in managing it themselves, or that those with hypoglycemic unawareness regained their symptoms to the extent that their fear was diminished, Ms. Halford suggested.

A follow-up questionnaire was sent to the same 150 patients, this time asking about actual rates of severe hypoglycemia requiring assistance from individuals nearby or emergency personnel. Among the 58 who responded, 33 reported having had at least one episode of severe hypoglycemia in the 6 months prior to using CGM, and 25 had not.

Fourteen reported an episode of severe hypoglycemia while using CGM, and 44 said they had no such episodes. That 33% reduction in severe hypoglycemia was highly statistically significant, with a P value of .0006.

“The costs of CGM are easily justified by the avoidance of one emergency room visit or automobile accident,” Ms. Halford said.

There was a statistically significant drop in self-reported hemoglobin A1c of 0.65 percentage points (from a baseline of 7.69%) among those who continued using CGM, while there was virtually no change in HbA1c among those who stopped using CGM, with a drop of just 0.04 percentage points from a baseline of 7.8%.

“[These findings] now give us the tools we need to go fight the insurance companies to get reimbursement for patients who want to use CGM,” Ms. Halford said.

WASHINGTON — Use of continuous glucose monitoring appeared to significantly improve diabetes control, reduce the incidence of hypoglycemia, and diminish levels of diabetes-associated stress among patients surveyed at a diabetes center in Idaho Falls, Idaho.

The results from two anonymous surveys of patients with type 1 diabetes at the Rocky Mountain Diabetes and Osteoporosis Center are among the first data on continuous glucose monitoring (CGM) to come from a real-life patient setting rather than an industry-sponsored study. Although the numbers are small—54 and 58 patients, respectively, responded out of 150 to whom surveys were sent—the results are statistically significant and can be used to petition third-party payers for reimbursement, Jean Halford said at the annual meeting of the American Association of Diabetes Educators.

Insurance coverage for CGM has increased over the last year with the establishment of new billing codes, but it is by no means universal. “The biggest roadblock to early adoption of this technology and more widespread reimbursement has been and continues to be the lack of long-term clinically significant outcome data demonstrating benefit,” said Ms. Halford, a licensed dietitian and certified diabetes educator at the Rocky Mountain facility, which is the largest diabetes practice in the state of Idaho.

The first survey used two tools. One, the Diabetes Distress Scale (DDS), is a validated 17-item, single-page questionnaire designed to assess emotional burden (for example, “feeling overwhelmed by the demands of living with diabetes”), physician-related distress (for example, “feeling that my doctor doesn't take my concerns seriously enough”), regimen-related distress (for example, “feeling that I am not sticking closely enough to a good meal plan”), and diabetes-related interpersonal distress (for example, “feeling that my friends/family don't appreciate how difficult living with diabetes can be”).

Respondents rate each on a scale of 1–5, with 5 being the highest distress level (Diabetes Care 2005;28:626–31). The other tool was a multipage quality of life questionnaire developed by the Rocky Mountain Diabetes Center, also using a 1–5 scale.

Of the 54 respondents, 27 had stopped using CGM and 27 were continuing to use it at the time of the survey. The difference in usage time was 6 vs. 14.4 months, respectively. Compared with those who quit using CGM, those who continued using it had significantly lower levels of both physician-related distress (1.22 vs. 1.67) and regimen-related distress (2.46 vs. 3.03). Emotional burden was also lower for those who continued (2.77 vs. 3.23), but that difference didn't reach statistical significance.

Among another 54 diabetic patients who had never used CGM, scores on the DDS were just slightly lower than those of the patients who continued to use CGM, with a mean overall score of 2.08 for the never-users and 2.20 for those who continued, compared with 2.62 for those who stopped. This finding suggests that, contrary to what some have suggested, the CGM doesn't increase stress by “overwhelming” the user with data, Ms. Halford said.

Future studies could look at DDS scores before and after CGM use to determine whether there might be a way to predict how a given patient might do with CGM. “We may be able to identify patients who need a different type of education, or those who aren't the best candidates for CGM,” she said.

The Rocky Mountain Center's questionnaire inquired retrospectively about hypoglycemia before and after CGM use. Among all CGM users, the reported fear of hypoglycemia dropped from a score of 3.30 to 2.52, a statistically significant difference. The drop was significant for both those who continued using CGM (3.44 vs. 2.64) and those who quit (3.19 vs. 2.41). Fear of severe hypoglycemia dropped from 2.48 to 1.67 overall, from 2.70 to 1.89 among the continuing users, and from 2.24 to 1.44 among those who quit. Those values were also all statistically significant.

It's possible that for the quitters, even the short 6 months of use might have improved glucose control enough that they felt more confident in managing it themselves, or that those with hypoglycemic unawareness regained their symptoms to the extent that their fear was diminished, Ms. Halford suggested.

A follow-up questionnaire was sent to the same 150 patients, this time asking about actual rates of severe hypoglycemia requiring assistance from individuals nearby or emergency personnel. Among the 58 who responded, 33 reported having had at least one episode of severe hypoglycemia in the 6 months prior to using CGM, and 25 had not.

Fourteen reported an episode of severe hypoglycemia while using CGM, and 44 said they had no such episodes. That 33% reduction in severe hypoglycemia was highly statistically significant, with a P value of .0006.

“The costs of CGM are easily justified by the avoidance of one emergency room visit or automobile accident,” Ms. Halford said.

There was a statistically significant drop in self-reported hemoglobin A1c of 0.65 percentage points (from a baseline of 7.69%) among those who continued using CGM, while there was virtually no change in HbA1c among those who stopped using CGM, with a drop of just 0.04 percentage points from a baseline of 7.8%.

“[These findings] now give us the tools we need to go fight the insurance companies to get reimbursement for patients who want to use CGM,” Ms. Halford said.

WASHINGTON — Use of continuous glucose monitoring appeared to significantly improve diabetes control, reduce the incidence of hypoglycemia, and diminish levels of diabetes-associated stress among patients surveyed at a diabetes center in Idaho Falls, Idaho.

The results from two anonymous surveys of patients with type 1 diabetes at the Rocky Mountain Diabetes and Osteoporosis Center are among the first data on continuous glucose monitoring (CGM) to come from a real-life patient setting rather than an industry-sponsored study. Although the numbers are small—54 and 58 patients, respectively, responded out of 150 to whom surveys were sent—the results are statistically significant and can be used to petition third-party payers for reimbursement, Jean Halford said at the annual meeting of the American Association of Diabetes Educators.

Insurance coverage for CGM has increased over the last year with the establishment of new billing codes, but it is by no means universal. “The biggest roadblock to early adoption of this technology and more widespread reimbursement has been and continues to be the lack of long-term clinically significant outcome data demonstrating benefit,” said Ms. Halford, a licensed dietitian and certified diabetes educator at the Rocky Mountain facility, which is the largest diabetes practice in the state of Idaho.

The first survey used two tools. One, the Diabetes Distress Scale (DDS), is a validated 17-item, single-page questionnaire designed to assess emotional burden (for example, “feeling overwhelmed by the demands of living with diabetes”), physician-related distress (for example, “feeling that my doctor doesn't take my concerns seriously enough”), regimen-related distress (for example, “feeling that I am not sticking closely enough to a good meal plan”), and diabetes-related interpersonal distress (for example, “feeling that my friends/family don't appreciate how difficult living with diabetes can be”).

Respondents rate each on a scale of 1–5, with 5 being the highest distress level (Diabetes Care 2005;28:626–31). The other tool was a multipage quality of life questionnaire developed by the Rocky Mountain Diabetes Center, also using a 1–5 scale.

Of the 54 respondents, 27 had stopped using CGM and 27 were continuing to use it at the time of the survey. The difference in usage time was 6 vs. 14.4 months, respectively. Compared with those who quit using CGM, those who continued using it had significantly lower levels of both physician-related distress (1.22 vs. 1.67) and regimen-related distress (2.46 vs. 3.03). Emotional burden was also lower for those who continued (2.77 vs. 3.23), but that difference didn't reach statistical significance.

Among another 54 diabetic patients who had never used CGM, scores on the DDS were just slightly lower than those of the patients who continued to use CGM, with a mean overall score of 2.08 for the never-users and 2.20 for those who continued, compared with 2.62 for those who stopped. This finding suggests that, contrary to what some have suggested, the CGM doesn't increase stress by “overwhelming” the user with data, Ms. Halford said.

Future studies could look at DDS scores before and after CGM use to determine whether there might be a way to predict how a given patient might do with CGM. “We may be able to identify patients who need a different type of education, or those who aren't the best candidates for CGM,” she said.

The Rocky Mountain Center's questionnaire inquired retrospectively about hypoglycemia before and after CGM use. Among all CGM users, the reported fear of hypoglycemia dropped from a score of 3.30 to 2.52, a statistically significant difference. The drop was significant for both those who continued using CGM (3.44 vs. 2.64) and those who quit (3.19 vs. 2.41). Fear of severe hypoglycemia dropped from 2.48 to 1.67 overall, from 2.70 to 1.89 among the continuing users, and from 2.24 to 1.44 among those who quit. Those values were also all statistically significant.

It's possible that for the quitters, even the short 6 months of use might have improved glucose control enough that they felt more confident in managing it themselves, or that those with hypoglycemic unawareness regained their symptoms to the extent that their fear was diminished, Ms. Halford suggested.

A follow-up questionnaire was sent to the same 150 patients, this time asking about actual rates of severe hypoglycemia requiring assistance from individuals nearby or emergency personnel. Among the 58 who responded, 33 reported having had at least one episode of severe hypoglycemia in the 6 months prior to using CGM, and 25 had not.

Fourteen reported an episode of severe hypoglycemia while using CGM, and 44 said they had no such episodes. That 33% reduction in severe hypoglycemia was highly statistically significant, with a P value of .0006.

“The costs of CGM are easily justified by the avoidance of one emergency room visit or automobile accident,” Ms. Halford said.

There was a statistically significant drop in self-reported hemoglobin A1c of 0.65 percentage points (from a baseline of 7.69%) among those who continued using CGM, while there was virtually no change in HbA1c among those who stopped using CGM, with a drop of just 0.04 percentage points from a baseline of 7.8%.

“[These findings] now give us the tools we need to go fight the insurance companies to get reimbursement for patients who want to use CGM,” Ms. Halford said.

WASHINGTON — The use of therapeutic shoes and the home monitoring of foot skin temperature by diabetic patients who are at high risk for foot ulceration are two simple, low-tech, preventive measures that could greatly reduce costs and improve patient outcomes if adopted more widely, according to Lawrence A. Lavery, D.P.M.

A foot ulcer is one of the most common precursors to the more than 100,000 diabetes-related amputations performed in the United States every year. Yet simple measures that can reduce the rate of foot ulceration are not being done, he said at the annual meeting of the American Association of Diabetes Educators.

“Prevention is a low-tech process,” said Dr. Lavery of the department of surgery at Texas A&M University, Temple.

Prevention efforts should focus on patients who are at greatest risk. In a study of 1,666 diabetic patients, Dr. Lavery and his associates stratified the risk classification beyond the current system that was established by an international working group (Diabetes Care 2001;24:1442–7).

Over a mean follow-up of 27 months, the risk of ulceration for patients with no peripheral neuropathy or peripheral vascular disease (PVD) was 2%, whereas those with neuropathy alone had a 4.5% risk and those with neuropathy plus a foot deformity had a 3% ulceration risk. High rates of ulceration occurred in patients with a history of PVD (14% risk) and in those with a previous ulcer or a history of amputation (14% risk) (Diabetes Care 2008;31:154–6).

Hospitalization rates, which were 1% for patients with neuropathy alone and 2% for those with a deformity, jumped to 16% for patients with PVD, 8% for those with a history of ulceration, and 50% for those with a previous amputation. Amputation rates were relatively low: from 0% in those with no disease or neuropathy alone to 0.7%-2.2% among those with deformity, PVD, and ulcer history. But “just 20% of the patients account for 70% of the ulcers and 90% of the amputations and hospitalizations. This tells us where to focus our educational efforts appropriately,” said Dr. Lavery, coauthor of a new task force report on foot assessment from the American Diabetes Association.

For patients at risk, elimination of the shoe as a source of pathology is a simple yet underutilized measure. About 20% of foot ulcers are triggered by ill-fitting shoes, mostly among women. “The easiest thing to do is just look at their shoes,” Dr. Lavery noted.

Since 1995, Medicare has covered therapeutic footwear and insoles for patients who are at risk for ulceration, but fewer than 3% of eligible patients receive the benefit. This is presumably because of a lack of awareness among providers as well as the cumbersome paperwork involved. “This is a simple, low-tech, very effective intervention that we don't do,” he said.

Even when physicians are diligent about checking the feet and shoes of their diabetic patients at every office visit, the transformation from injury to ulceration occurs far too rapidly to be left to examinations at 3-month intervals. That's why it's essential for patients to check their feet at home on a daily basis.

But about 54% of patients can't see the bottoms of their feet, because of impaired vision, obesity, limited joint mobility, or a combination of those factors (Arch. Intern. Med. 1998;158:157–62).

“About half of patients whom we're asking to inspect their feet haven't been able to see their feet in the last several years,” Dr. Lavery remarked.

Moreover, the cardinal signs of inflammation that precedes ulceration—including pain, loss of function, edema, redness, and heat—can go unnoticed, particularly among patients who have neuropathy. Indeed, “even trained health care professionals probably cannot identify subtle precursors to ulceration,” he said.

Of the five factors, heat may be the easiest to identify. In three published studies, a long-armed handheld infrared skin thermometer called TempTouch (www.temptouch.com

In the initial pilot study, 85 patients with either neuropathy and foot deformity, or previous history of ulceration or partial foot amputation, were randomized to standard therapy—including therapeutic footwear, diabetic foot education, and regular foot evaluation by a podiatrist—or to “enhanced” therapy, which included the standard measures plus twice-daily use of the dermal thermometer device at six sites on each foot. Patients were instructed to contact a study nurse and to minimize walking if they detected a temperature difference of more than 4° F. in the corresponding sites of the two feet.

At 6 months, there were nine foot complications, including seven ulcers and two Charcot's fractures, among the 44 patients in the standard therapy group (20%), compared with just one ulcer (2%) in the 41 patients who used the thermometer, Dr. Lavery and his associates reported (Diabetes Care 2004;27:2642–7).

In a second study of 225 similarly high-risk patients that used the same methods, patients in the dermal thermometry group were one-third as likely to ulcerate at 18 months as were those in the standard therapy group (12% vs. 5%), and the thermometry was associated with a longer time to ulceration (Am. J. Med. 2007;120:1042–6).

In the third study, 173 high-risk patients with a history of foot wound and sensory neuropathy with a loss of protective sensation were randomized to one of three groups. Standard therapy consisted of lower-extremity evaluation by a physician every 8 weeks; education focusing on foot complications and self-care practices; therapeutic insoles and footwear; and advice to the patients to inspect their feet every day and to contact the study nurse if they identified any areas of concern (Diabetes Care 2007;30:14–20).

A second group had the standard therapy plus a structured foot exam, in which they were trained to use a mirror twice a day to inspect the bottom of their feet for redness, discoloration, swelling, and warmth by palpation and to log the results. Patients in a third group received standard therapy and were instructed to use the digital infrared thermometer twice daily and to record the temperatures.

At 15 months, the ulceration rate was essentially identical in the standard and structured foot exam groups (29% and 30%, respectively). In contrast, only 8.5% of the group that used the thermometer developed a foot ulcer, a fourfold reduction in risk. Not surprisingly, the patients in the thermometer group who did develop ulcers were less compliant in using the device: Overall, 80% of them recorded temperature values at least 50% of the recommended time, compared with 92% of those who didn't develop ulcers, Dr. Lavery and his associates reported.

The number of patients needed to treat to prevent one foot ulceration with the thermometer is just 4, compared with 30 to prevent microproteinuria with an ACE inhibitor, and 260 to prevent pneumonia with the pneumococcal vaccine.

Use of the thermometer is “inexpensive, practical, and something patients can do,” Dr. Lavery said.

Lawrence A. Lavery, D.P.M., checks the temperature of a patient's foot using a dermal thermometer device. ©Susan Gaetz Photography

WASHINGTON — The use of therapeutic shoes and the home monitoring of foot skin temperature by diabetic patients who are at high risk for foot ulceration are two simple, low-tech, preventive measures that could greatly reduce costs and improve patient outcomes if adopted more widely, according to Lawrence A. Lavery, D.P.M.

A foot ulcer is one of the most common precursors to the more than 100,000 diabetes-related amputations performed in the United States every year. Yet simple measures that can reduce the rate of foot ulceration are not being done, he said at the annual meeting of the American Association of Diabetes Educators.

“Prevention is a low-tech process,” said Dr. Lavery of the department of surgery at Texas A&M University, Temple.

Prevention efforts should focus on patients who are at greatest risk. In a study of 1,666 diabetic patients, Dr. Lavery and his associates stratified the risk classification beyond the current system that was established by an international working group (Diabetes Care 2001;24:1442–7).

Over a mean follow-up of 27 months, the risk of ulceration for patients with no peripheral neuropathy or peripheral vascular disease (PVD) was 2%, whereas those with neuropathy alone had a 4.5% risk and those with neuropathy plus a foot deformity had a 3% ulceration risk. High rates of ulceration occurred in patients with a history of PVD (14% risk) and in those with a previous ulcer or a history of amputation (14% risk) (Diabetes Care 2008;31:154–6).

Hospitalization rates, which were 1% for patients with neuropathy alone and 2% for those with a deformity, jumped to 16% for patients with PVD, 8% for those with a history of ulceration, and 50% for those with a previous amputation. Amputation rates were relatively low: from 0% in those with no disease or neuropathy alone to 0.7%-2.2% among those with deformity, PVD, and ulcer history. But “just 20% of the patients account for 70% of the ulcers and 90% of the amputations and hospitalizations. This tells us where to focus our educational efforts appropriately,” said Dr. Lavery, coauthor of a new task force report on foot assessment from the American Diabetes Association.

For patients at risk, elimination of the shoe as a source of pathology is a simple yet underutilized measure. About 20% of foot ulcers are triggered by ill-fitting shoes, mostly among women. “The easiest thing to do is just look at their shoes,” Dr. Lavery noted.

Since 1995, Medicare has covered therapeutic footwear and insoles for patients who are at risk for ulceration, but fewer than 3% of eligible patients receive the benefit. This is presumably because of a lack of awareness among providers as well as the cumbersome paperwork involved. “This is a simple, low-tech, very effective intervention that we don't do,” he said.

Even when physicians are diligent about checking the feet and shoes of their diabetic patients at every office visit, the transformation from injury to ulceration occurs far too rapidly to be left to examinations at 3-month intervals. That's why it's essential for patients to check their feet at home on a daily basis.

But about 54% of patients can't see the bottoms of their feet, because of impaired vision, obesity, limited joint mobility, or a combination of those factors (Arch. Intern. Med. 1998;158:157–62).

“About half of patients whom we're asking to inspect their feet haven't been able to see their feet in the last several years,” Dr. Lavery remarked.

Moreover, the cardinal signs of inflammation that precedes ulceration—including pain, loss of function, edema, redness, and heat—can go unnoticed, particularly among patients who have neuropathy. Indeed, “even trained health care professionals probably cannot identify subtle precursors to ulceration,” he said.

Of the five factors, heat may be the easiest to identify. In three published studies, a long-armed handheld infrared skin thermometer called TempTouch (www.temptouch.com

In the initial pilot study, 85 patients with either neuropathy and foot deformity, or previous history of ulceration or partial foot amputation, were randomized to standard therapy—including therapeutic footwear, diabetic foot education, and regular foot evaluation by a podiatrist—or to “enhanced” therapy, which included the standard measures plus twice-daily use of the dermal thermometer device at six sites on each foot. Patients were instructed to contact a study nurse and to minimize walking if they detected a temperature difference of more than 4° F. in the corresponding sites of the two feet.

At 6 months, there were nine foot complications, including seven ulcers and two Charcot's fractures, among the 44 patients in the standard therapy group (20%), compared with just one ulcer (2%) in the 41 patients who used the thermometer, Dr. Lavery and his associates reported (Diabetes Care 2004;27:2642–7).

In a second study of 225 similarly high-risk patients that used the same methods, patients in the dermal thermometry group were one-third as likely to ulcerate at 18 months as were those in the standard therapy group (12% vs. 5%), and the thermometry was associated with a longer time to ulceration (Am. J. Med. 2007;120:1042–6).

In the third study, 173 high-risk patients with a history of foot wound and sensory neuropathy with a loss of protective sensation were randomized to one of three groups. Standard therapy consisted of lower-extremity evaluation by a physician every 8 weeks; education focusing on foot complications and self-care practices; therapeutic insoles and footwear; and advice to the patients to inspect their feet every day and to contact the study nurse if they identified any areas of concern (Diabetes Care 2007;30:14–20).

A second group had the standard therapy plus a structured foot exam, in which they were trained to use a mirror twice a day to inspect the bottom of their feet for redness, discoloration, swelling, and warmth by palpation and to log the results. Patients in a third group received standard therapy and were instructed to use the digital infrared thermometer twice daily and to record the temperatures.

At 15 months, the ulceration rate was essentially identical in the standard and structured foot exam groups (29% and 30%, respectively). In contrast, only 8.5% of the group that used the thermometer developed a foot ulcer, a fourfold reduction in risk. Not surprisingly, the patients in the thermometer group who did develop ulcers were less compliant in using the device: Overall, 80% of them recorded temperature values at least 50% of the recommended time, compared with 92% of those who didn't develop ulcers, Dr. Lavery and his associates reported.

The number of patients needed to treat to prevent one foot ulceration with the thermometer is just 4, compared with 30 to prevent microproteinuria with an ACE inhibitor, and 260 to prevent pneumonia with the pneumococcal vaccine.

Use of the thermometer is “inexpensive, practical, and something patients can do,” Dr. Lavery said.

Lawrence A. Lavery, D.P.M., checks the temperature of a patient's foot using a dermal thermometer device. ©Susan Gaetz Photography

WASHINGTON — The use of therapeutic shoes and the home monitoring of foot skin temperature by diabetic patients who are at high risk for foot ulceration are two simple, low-tech, preventive measures that could greatly reduce costs and improve patient outcomes if adopted more widely, according to Lawrence A. Lavery, D.P.M.

A foot ulcer is one of the most common precursors to the more than 100,000 diabetes-related amputations performed in the United States every year. Yet simple measures that can reduce the rate of foot ulceration are not being done, he said at the annual meeting of the American Association of Diabetes Educators.

“Prevention is a low-tech process,” said Dr. Lavery of the department of surgery at Texas A&M University, Temple.

Prevention efforts should focus on patients who are at greatest risk. In a study of 1,666 diabetic patients, Dr. Lavery and his associates stratified the risk classification beyond the current system that was established by an international working group (Diabetes Care 2001;24:1442–7).

Over a mean follow-up of 27 months, the risk of ulceration for patients with no peripheral neuropathy or peripheral vascular disease (PVD) was 2%, whereas those with neuropathy alone had a 4.5% risk and those with neuropathy plus a foot deformity had a 3% ulceration risk. High rates of ulceration occurred in patients with a history of PVD (14% risk) and in those with a previous ulcer or a history of amputation (14% risk) (Diabetes Care 2008;31:154–6).

Hospitalization rates, which were 1% for patients with neuropathy alone and 2% for those with a deformity, jumped to 16% for patients with PVD, 8% for those with a history of ulceration, and 50% for those with a previous amputation. Amputation rates were relatively low: from 0% in those with no disease or neuropathy alone to 0.7%-2.2% among those with deformity, PVD, and ulcer history. But “just 20% of the patients account for 70% of the ulcers and 90% of the amputations and hospitalizations. This tells us where to focus our educational efforts appropriately,” said Dr. Lavery, coauthor of a new task force report on foot assessment from the American Diabetes Association.

For patients at risk, elimination of the shoe as a source of pathology is a simple yet underutilized measure. About 20% of foot ulcers are triggered by ill-fitting shoes, mostly among women. “The easiest thing to do is just look at their shoes,” Dr. Lavery noted.

Since 1995, Medicare has covered therapeutic footwear and insoles for patients who are at risk for ulceration, but fewer than 3% of eligible patients receive the benefit. This is presumably because of a lack of awareness among providers as well as the cumbersome paperwork involved. “This is a simple, low-tech, very effective intervention that we don't do,” he said.

Even when physicians are diligent about checking the feet and shoes of their diabetic patients at every office visit, the transformation from injury to ulceration occurs far too rapidly to be left to examinations at 3-month intervals. That's why it's essential for patients to check their feet at home on a daily basis.

But about 54% of patients can't see the bottoms of their feet, because of impaired vision, obesity, limited joint mobility, or a combination of those factors (Arch. Intern. Med. 1998;158:157–62).

“About half of patients whom we're asking to inspect their feet haven't been able to see their feet in the last several years,” Dr. Lavery remarked.

Moreover, the cardinal signs of inflammation that precedes ulceration—including pain, loss of function, edema, redness, and heat—can go unnoticed, particularly among patients who have neuropathy. Indeed, “even trained health care professionals probably cannot identify subtle precursors to ulceration,” he said.

Of the five factors, heat may be the easiest to identify. In three published studies, a long-armed handheld infrared skin thermometer called TempTouch (www.temptouch.com

In the initial pilot study, 85 patients with either neuropathy and foot deformity, or previous history of ulceration or partial foot amputation, were randomized to standard therapy—including therapeutic footwear, diabetic foot education, and regular foot evaluation by a podiatrist—or to “enhanced” therapy, which included the standard measures plus twice-daily use of the dermal thermometer device at six sites on each foot. Patients were instructed to contact a study nurse and to minimize walking if they detected a temperature difference of more than 4° F. in the corresponding sites of the two feet.

At 6 months, there were nine foot complications, including seven ulcers and two Charcot's fractures, among the 44 patients in the standard therapy group (20%), compared with just one ulcer (2%) in the 41 patients who used the thermometer, Dr. Lavery and his associates reported (Diabetes Care 2004;27:2642–7).

In a second study of 225 similarly high-risk patients that used the same methods, patients in the dermal thermometry group were one-third as likely to ulcerate at 18 months as were those in the standard therapy group (12% vs. 5%), and the thermometry was associated with a longer time to ulceration (Am. J. Med. 2007;120:1042–6).

In the third study, 173 high-risk patients with a history of foot wound and sensory neuropathy with a loss of protective sensation were randomized to one of three groups. Standard therapy consisted of lower-extremity evaluation by a physician every 8 weeks; education focusing on foot complications and self-care practices; therapeutic insoles and footwear; and advice to the patients to inspect their feet every day and to contact the study nurse if they identified any areas of concern (Diabetes Care 2007;30:14–20).

A second group had the standard therapy plus a structured foot exam, in which they were trained to use a mirror twice a day to inspect the bottom of their feet for redness, discoloration, swelling, and warmth by palpation and to log the results. Patients in a third group received standard therapy and were instructed to use the digital infrared thermometer twice daily and to record the temperatures.

At 15 months, the ulceration rate was essentially identical in the standard and structured foot exam groups (29% and 30%, respectively). In contrast, only 8.5% of the group that used the thermometer developed a foot ulcer, a fourfold reduction in risk. Not surprisingly, the patients in the thermometer group who did develop ulcers were less compliant in using the device: Overall, 80% of them recorded temperature values at least 50% of the recommended time, compared with 92% of those who didn't develop ulcers, Dr. Lavery and his associates reported.

The number of patients needed to treat to prevent one foot ulceration with the thermometer is just 4, compared with 30 to prevent microproteinuria with an ACE inhibitor, and 260 to prevent pneumonia with the pneumococcal vaccine.

Use of the thermometer is “inexpensive, practical, and something patients can do,” Dr. Lavery said.

Lawrence A. Lavery, D.P.M., checks the temperature of a patient's foot using a dermal thermometer device. ©Susan Gaetz Photography

Data from a prospective colonic surveillance program involving 259 patients with chronic extensive Crohn's disease revealed a 25% cumulative risk of developing definite dysplasia or cancer by the 10th surveillance exam after an initial negative screening exam according to the findings of a longitudinal cohort study.

The cumulative risk of an initial finding of flat high-grade dysplasia or cancer after a negative screening colonoscopy was 7% after the ninth surveillance exam, with a median interval of 18 months between exams. The findings suggest that periodic surveillance colonoscopy should be part of routine management of chronic extensive Crohn's disease, said Dr. Sonia Friedman of Brigham and Women's Hospital, Boston, and her associates.

While the increased risk of colonic dysplasia and carcinoma in patients with chronic, extensive ulcerative colitis has been well described, less is known about those risks in patients with long-standing Crohn's disease. Previous studies often lumped together all patients with Crohn's disease and didn't separately examine those with extensive long-standing Crohn's colitis.

In 2001, Dr. Friedman and her associates reported a 22% chance of developing definite dysplasia or cancer by the fourth surveillance exam among 259 patients with chronic Crohn's disease who were followed from 1980 through 1998 (Gastroenterology 2001;120:820-6).

Now they report an update in those same patients, all of whom had at least 7 years of Crohn's colitis affecting at least one-third of the colon. Those in whom the results of screening colonoscopy were negative were contacted for a repeat examination at 2 years. Patients with results classified as indefinite (IND) for dysplasia were contacted for extensive repeat biopsies within 1 year, while those with one area of flat low-grade dysplasia (LGD) were contacted for repeat endoscopy within 1–6 months. Patients with recurrent or multifocal flat low-grade dysplasia (LGD), high-grade dysplasia (HGD), or cancer were referred for surgery. Those with “adenoma-like” polypoid dysplastic lesions that had been removed were contacted for repeat endoscopy within 1–6 months [Epub doi:10.1016/j.cgh.2008.03.019]).

A total of 1,424 examinations (screening and surveillance) was performed, with a median of 5 per patient. In all, 90% of the patients had extensive colitis, and 31% had undergone segmental colon resection. At the initial screen, definite dysplasia was found in 18 patients (7%). Of those 18 patients, 13 had LGD (7 polyps, 6 flat), 2 had HGD (both flat), and 3 had carcinoma (all masses). There were no colonoscopic complications, the investigators said.

The prevalence of definite dysplasia or cancer was significantly higher among patients who were older than 45 years than in those younger, but the prevalence for those older than 45 did not vary with disease duration.

In surveillance exams, a first positive finding of definite dysplasia or cancer was found in 30 patients, including LGD in 22 (14 polyps, 8 flat), HGD in 4 patients (2 polyps, 2 flat), and carcinoma in 4 patients (2 polyps, 2 masses). Analysis of several factors, such as age greater than 45 years or disease duration longer than 20 years at exam, family history of cancer or inflammatory bowel disease, female gender, pancolitis, and prior resection, did not identify any as consistent predictors of risk for dysplasia or cancer over time.

Compared with age- and gender-based cancer registry data from the general population, the 11 cancers detected in this study were significantly more than the 1.13 expected, suggesting that patients with extensive Crohn's disease are indeed at increased risk for developing colon cancer, Dr. Friedman and her associates said.

The calculated cumulative risks—25% for LGD, HGD, or cancer, and 7% for flat HGD or cancer by the 10th surveillance exam—are high, considering that 31% of the screening exams and 4.8% of the surveillance exams were preceded by a partial colon resection. However, these data parallel those of studies of cancer in ulcerative colitis patients with similar extent and duration of disease, they commented.

Data from a prospective colonic surveillance program involving 259 patients with chronic extensive Crohn's disease revealed a 25% cumulative risk of developing definite dysplasia or cancer by the 10th surveillance exam after an initial negative screening exam according to the findings of a longitudinal cohort study.

The cumulative risk of an initial finding of flat high-grade dysplasia or cancer after a negative screening colonoscopy was 7% after the ninth surveillance exam, with a median interval of 18 months between exams. The findings suggest that periodic surveillance colonoscopy should be part of routine management of chronic extensive Crohn's disease, said Dr. Sonia Friedman of Brigham and Women's Hospital, Boston, and her associates.

While the increased risk of colonic dysplasia and carcinoma in patients with chronic, extensive ulcerative colitis has been well described, less is known about those risks in patients with long-standing Crohn's disease. Previous studies often lumped together all patients with Crohn's disease and didn't separately examine those with extensive long-standing Crohn's colitis.

In 2001, Dr. Friedman and her associates reported a 22% chance of developing definite dysplasia or cancer by the fourth surveillance exam among 259 patients with chronic Crohn's disease who were followed from 1980 through 1998 (Gastroenterology 2001;120:820-6).

Now they report an update in those same patients, all of whom had at least 7 years of Crohn's colitis affecting at least one-third of the colon. Those in whom the results of screening colonoscopy were negative were contacted for a repeat examination at 2 years. Patients with results classified as indefinite (IND) for dysplasia were contacted for extensive repeat biopsies within 1 year, while those with one area of flat low-grade dysplasia (LGD) were contacted for repeat endoscopy within 1–6 months. Patients with recurrent or multifocal flat low-grade dysplasia (LGD), high-grade dysplasia (HGD), or cancer were referred for surgery. Those with “adenoma-like” polypoid dysplastic lesions that had been removed were contacted for repeat endoscopy within 1–6 months [Epub doi:10.1016/j.cgh.2008.03.019]).

A total of 1,424 examinations (screening and surveillance) was performed, with a median of 5 per patient. In all, 90% of the patients had extensive colitis, and 31% had undergone segmental colon resection. At the initial screen, definite dysplasia was found in 18 patients (7%). Of those 18 patients, 13 had LGD (7 polyps, 6 flat), 2 had HGD (both flat), and 3 had carcinoma (all masses). There were no colonoscopic complications, the investigators said.

The prevalence of definite dysplasia or cancer was significantly higher among patients who were older than 45 years than in those younger, but the prevalence for those older than 45 did not vary with disease duration.

In surveillance exams, a first positive finding of definite dysplasia or cancer was found in 30 patients, including LGD in 22 (14 polyps, 8 flat), HGD in 4 patients (2 polyps, 2 flat), and carcinoma in 4 patients (2 polyps, 2 masses). Analysis of several factors, such as age greater than 45 years or disease duration longer than 20 years at exam, family history of cancer or inflammatory bowel disease, female gender, pancolitis, and prior resection, did not identify any as consistent predictors of risk for dysplasia or cancer over time.

Compared with age- and gender-based cancer registry data from the general population, the 11 cancers detected in this study were significantly more than the 1.13 expected, suggesting that patients with extensive Crohn's disease are indeed at increased risk for developing colon cancer, Dr. Friedman and her associates said.

The calculated cumulative risks—25% for LGD, HGD, or cancer, and 7% for flat HGD or cancer by the 10th surveillance exam—are high, considering that 31% of the screening exams and 4.8% of the surveillance exams were preceded by a partial colon resection. However, these data parallel those of studies of cancer in ulcerative colitis patients with similar extent and duration of disease, they commented.

Data from a prospective colonic surveillance program involving 259 patients with chronic extensive Crohn's disease revealed a 25% cumulative risk of developing definite dysplasia or cancer by the 10th surveillance exam after an initial negative screening exam according to the findings of a longitudinal cohort study.

The cumulative risk of an initial finding of flat high-grade dysplasia or cancer after a negative screening colonoscopy was 7% after the ninth surveillance exam, with a median interval of 18 months between exams. The findings suggest that periodic surveillance colonoscopy should be part of routine management of chronic extensive Crohn's disease, said Dr. Sonia Friedman of Brigham and Women's Hospital, Boston, and her associates.

While the increased risk of colonic dysplasia and carcinoma in patients with chronic, extensive ulcerative colitis has been well described, less is known about those risks in patients with long-standing Crohn's disease. Previous studies often lumped together all patients with Crohn's disease and didn't separately examine those with extensive long-standing Crohn's colitis.

In 2001, Dr. Friedman and her associates reported a 22% chance of developing definite dysplasia or cancer by the fourth surveillance exam among 259 patients with chronic Crohn's disease who were followed from 1980 through 1998 (Gastroenterology 2001;120:820-6).

Now they report an update in those same patients, all of whom had at least 7 years of Crohn's colitis affecting at least one-third of the colon. Those in whom the results of screening colonoscopy were negative were contacted for a repeat examination at 2 years. Patients with results classified as indefinite (IND) for dysplasia were contacted for extensive repeat biopsies within 1 year, while those with one area of flat low-grade dysplasia (LGD) were contacted for repeat endoscopy within 1–6 months. Patients with recurrent or multifocal flat low-grade dysplasia (LGD), high-grade dysplasia (HGD), or cancer were referred for surgery. Those with “adenoma-like” polypoid dysplastic lesions that had been removed were contacted for repeat endoscopy within 1–6 months [Epub doi:10.1016/j.cgh.2008.03.019]).

A total of 1,424 examinations (screening and surveillance) was performed, with a median of 5 per patient. In all, 90% of the patients had extensive colitis, and 31% had undergone segmental colon resection. At the initial screen, definite dysplasia was found in 18 patients (7%). Of those 18 patients, 13 had LGD (7 polyps, 6 flat), 2 had HGD (both flat), and 3 had carcinoma (all masses). There were no colonoscopic complications, the investigators said.

The prevalence of definite dysplasia or cancer was significantly higher among patients who were older than 45 years than in those younger, but the prevalence for those older than 45 did not vary with disease duration.

In surveillance exams, a first positive finding of definite dysplasia or cancer was found in 30 patients, including LGD in 22 (14 polyps, 8 flat), HGD in 4 patients (2 polyps, 2 flat), and carcinoma in 4 patients (2 polyps, 2 masses). Analysis of several factors, such as age greater than 45 years or disease duration longer than 20 years at exam, family history of cancer or inflammatory bowel disease, female gender, pancolitis, and prior resection, did not identify any as consistent predictors of risk for dysplasia or cancer over time.

Compared with age- and gender-based cancer registry data from the general population, the 11 cancers detected in this study were significantly more than the 1.13 expected, suggesting that patients with extensive Crohn's disease are indeed at increased risk for developing colon cancer, Dr. Friedman and her associates said.

The calculated cumulative risks—25% for LGD, HGD, or cancer, and 7% for flat HGD or cancer by the 10th surveillance exam—are high, considering that 31% of the screening exams and 4.8% of the surveillance exams were preceded by a partial colon resection. However, these data parallel those of studies of cancer in ulcerative colitis patients with similar extent and duration of disease, they commented.

WASHINGTON — The use of therapeutic shoes and the home monitoring of foot-skin temperature by diabetic patients who are at high risk for foot ulceration are two simple, low-tech preventive measures that could greatly reduce costs and improve patient outcomes if adopted more widely, according to Lawrence A. Lavery, D.P.M.

A foot ulcer is one of the most common precursors to the more than 100,000 diabetes-related amputations performed in the United States every year. Yet simple measures that can reduce the rate of foot ulceration are not being done, he said at the annual meeting of the American Association of Diabetes Educators.

“Prevention is a low-tech process,” said Dr. Lavery of the department of surgery at Texas A&M University, Temple.

Prevention efforts should focus on patients who are at greatest risk. In a study of 1,666 diabetic patients, Dr. Lavery and his associates stratified the risk classification beyond the current system that was established by an international working group (Diabetes Care 2001;24:1442-7).

Over a mean follow-up of 27 months, the risk of ulceration for patients with no peripheral neuropathy or peripheral vascular disease (PVD) was 2%, whereas those with neuropathy alone had a 4.5% risk and those with neuropathy plus a foot deformity had a 3.0% ulceration risk. High rates of ulceration occurred in patients with a history of PVD (14% risk) and in those with a previous ulcer or a history of amputation (14% risk) (Diabetes Care 2008;31:154-6).

Hospitalization rates, which were 1% for patients with neuropathy alone and 2% for those with a deformity, jumped to 16% for patients with PVD, 8% for those with a history of ulceration, and 50% for those with a previous amputation. Amputation rates were relatively low: from 0% in those with no disease or neuropathy alone to 0.7%–2.2% among those with deformity, PVD, and ulcer history. But the risk for a second amputation was 50% among those who already had one.

“Just 20% of the patients account for 70% of the ulcers and 90% of the amputations and hospitalizations. This tells us where to focus our educational efforts appropriately,” said Dr. Lavery, coauthor of a new task force report on foot assessment from the American Diabetes Association.

For patients at risk, elimination of the shoe as a source of pathology is a simple yet underutilized measure. About 20% of foot ulcers are triggered by ill-fitting shoes, mostly among women. “The easiest thing to do is just look at their shoes,” Dr. Lavery noted.

Since 1995, Medicare has covered therapeutic footwear and insoles for patients who are at risk for ulceration, but fewer than 3% of eligible patients receive the benefit. This is presumably because of a lack of awareness among providers as well as the cumbersome paperwork involved. “This is a simple, low-tech, very effective intervention that we don't do,” he said.

Even when physicians are diligent about checking the feet and shoes of their patients, the transformation from injury to ulceration occurs far too rapidly to be left to examinations at 3-month intervals. That's why it's essential for patients to check their feet at home on a daily basis.

But about 54% of patients can't see the bottoms of their feet, because of impaired vision, obesity, limited joint mobility, or a combination of those factors (Arch. Intern. Med. 1998;158:157-62).

“About half of patients whom we're asking to inspect their feet haven't been able to see their feet in the last several years,” Dr. Lavery remarked.

Moreover, the cardinal signs of inflammation that precedes ulceration—including pain, loss of function, edema, redness, and heat—can go unnoticed, particularly among patients who have neuropathy. Indeed, “even trained health care professionals probably cannot identify subtle precursors to ulceration,” he said.

Of the five factors, heat may be the easiest to identify. In three published studies, a long-armed handheld infrared skin thermometer called TempTouch (www.temptouch.com

In the initial pilot study, 85 patients with neuropathy and foot deformity, or with previous history of ulceration or partial foot amputation, were randomized to standard therapy—including therapeutic footwear, diabetic foot education, and regular foot evaluation by a podiatrist—or to “enhanced” therapy, which included the standard measures plus twice-daily use of the dermal thermometer device at six sites on each foot. Patients were instructed to contact a study nurse and to minimize walking if they detected a temperature difference of more than 4° F. in the corresponding sites of the two feet.

At 6 months, there were nine foot complications, including seven ulcers and two Charcot's fractures, among the 44 patients in the standard therapy group (20%), compared with just one ulcer (2%) in the 41 patients who used the thermometer, Dr. Lavery and his associates reported (Diabetes Care 2004;27:2642-7).

In a second study of 225 similarly high-risk patients that used the same methods, patients in the dermal thermometry group were one-third as likely to ulcerate at 18 months as were those in the standard therapy group (12% vs. 5%), and the thermometry was associated with a longer time to ulceration (Am. J. Med. 2007;120:1042-6).

In the third study, 173 high-risk patients with a history of foot wound and sensory neuropathy with a loss of protective sensation were randomized to one of three groups. Standard therapy consisted of lower-extremity evaluation by a physician every 8 weeks; education focusing on foot complications and self-care practices; therapeutic insoles and footwear; and advice to the patients to inspect their feet every day and to contact the study nurse if they identified any areas of concern (Diabetes Care 2007;30:14-20).

A second group had the standard therapy plus a structured foot exam, in which they were trained to use a mirror twice a day to inspect the bottom of their feet for redness, discoloration, swelling, and warmth by palpation and to log the results. Patients in a third group received standard therapy and were instructed to use the digital infrared thermometer twice daily and to record the temperatures.

At 15 months, the ulceration rate was essentially identical in the standard and structured foot exam groups (29% and 30%, respectively). In contrast, only 8.5% of the group that used the thermometer developed a foot ulcer, a fourfold reduction in risk.

Heat is an easy risk factor to identify, said Dr. Lavery, shown taking the temperature of a patient's Lawrence A. foot. ©Susan Gaetz Photography

WASHINGTON — The use of therapeutic shoes and the home monitoring of foot-skin temperature by diabetic patients who are at high risk for foot ulceration are two simple, low-tech preventive measures that could greatly reduce costs and improve patient outcomes if adopted more widely, according to Lawrence A. Lavery, D.P.M.

A foot ulcer is one of the most common precursors to the more than 100,000 diabetes-related amputations performed in the United States every year. Yet simple measures that can reduce the rate of foot ulceration are not being done, he said at the annual meeting of the American Association of Diabetes Educators.

“Prevention is a low-tech process,” said Dr. Lavery of the department of surgery at Texas A&M University, Temple.

Prevention efforts should focus on patients who are at greatest risk. In a study of 1,666 diabetic patients, Dr. Lavery and his associates stratified the risk classification beyond the current system that was established by an international working group (Diabetes Care 2001;24:1442-7).

Over a mean follow-up of 27 months, the risk of ulceration for patients with no peripheral neuropathy or peripheral vascular disease (PVD) was 2%, whereas those with neuropathy alone had a 4.5% risk and those with neuropathy plus a foot deformity had a 3.0% ulceration risk. High rates of ulceration occurred in patients with a history of PVD (14% risk) and in those with a previous ulcer or a history of amputation (14% risk) (Diabetes Care 2008;31:154-6).

Hospitalization rates, which were 1% for patients with neuropathy alone and 2% for those with a deformity, jumped to 16% for patients with PVD, 8% for those with a history of ulceration, and 50% for those with a previous amputation. Amputation rates were relatively low: from 0% in those with no disease or neuropathy alone to 0.7%–2.2% among those with deformity, PVD, and ulcer history. But the risk for a second amputation was 50% among those who already had one.

“Just 20% of the patients account for 70% of the ulcers and 90% of the amputations and hospitalizations. This tells us where to focus our educational efforts appropriately,” said Dr. Lavery, coauthor of a new task force report on foot assessment from the American Diabetes Association.

For patients at risk, elimination of the shoe as a source of pathology is a simple yet underutilized measure. About 20% of foot ulcers are triggered by ill-fitting shoes, mostly among women. “The easiest thing to do is just look at their shoes,” Dr. Lavery noted.

Since 1995, Medicare has covered therapeutic footwear and insoles for patients who are at risk for ulceration, but fewer than 3% of eligible patients receive the benefit. This is presumably because of a lack of awareness among providers as well as the cumbersome paperwork involved. “This is a simple, low-tech, very effective intervention that we don't do,” he said.

Even when physicians are diligent about checking the feet and shoes of their patients, the transformation from injury to ulceration occurs far too rapidly to be left to examinations at 3-month intervals. That's why it's essential for patients to check their feet at home on a daily basis.

But about 54% of patients can't see the bottoms of their feet, because of impaired vision, obesity, limited joint mobility, or a combination of those factors (Arch. Intern. Med. 1998;158:157-62).

“About half of patients whom we're asking to inspect their feet haven't been able to see their feet in the last several years,” Dr. Lavery remarked.

Moreover, the cardinal signs of inflammation that precedes ulceration—including pain, loss of function, edema, redness, and heat—can go unnoticed, particularly among patients who have neuropathy. Indeed, “even trained health care professionals probably cannot identify subtle precursors to ulceration,” he said.

Of the five factors, heat may be the easiest to identify. In three published studies, a long-armed handheld infrared skin thermometer called TempTouch (www.temptouch.com

In the initial pilot study, 85 patients with neuropathy and foot deformity, or with previous history of ulceration or partial foot amputation, were randomized to standard therapy—including therapeutic footwear, diabetic foot education, and regular foot evaluation by a podiatrist—or to “enhanced” therapy, which included the standard measures plus twice-daily use of the dermal thermometer device at six sites on each foot. Patients were instructed to contact a study nurse and to minimize walking if they detected a temperature difference of more than 4° F. in the corresponding sites of the two feet.

At 6 months, there were nine foot complications, including seven ulcers and two Charcot's fractures, among the 44 patients in the standard therapy group (20%), compared with just one ulcer (2%) in the 41 patients who used the thermometer, Dr. Lavery and his associates reported (Diabetes Care 2004;27:2642-7).

In a second study of 225 similarly high-risk patients that used the same methods, patients in the dermal thermometry group were one-third as likely to ulcerate at 18 months as were those in the standard therapy group (12% vs. 5%), and the thermometry was associated with a longer time to ulceration (Am. J. Med. 2007;120:1042-6).

In the third study, 173 high-risk patients with a history of foot wound and sensory neuropathy with a loss of protective sensation were randomized to one of three groups. Standard therapy consisted of lower-extremity evaluation by a physician every 8 weeks; education focusing on foot complications and self-care practices; therapeutic insoles and footwear; and advice to the patients to inspect their feet every day and to contact the study nurse if they identified any areas of concern (Diabetes Care 2007;30:14-20).

A second group had the standard therapy plus a structured foot exam, in which they were trained to use a mirror twice a day to inspect the bottom of their feet for redness, discoloration, swelling, and warmth by palpation and to log the results. Patients in a third group received standard therapy and were instructed to use the digital infrared thermometer twice daily and to record the temperatures.

At 15 months, the ulceration rate was essentially identical in the standard and structured foot exam groups (29% and 30%, respectively). In contrast, only 8.5% of the group that used the thermometer developed a foot ulcer, a fourfold reduction in risk.

Heat is an easy risk factor to identify, said Dr. Lavery, shown taking the temperature of a patient's Lawrence A. foot. ©Susan Gaetz Photography

WASHINGTON — The use of therapeutic shoes and the home monitoring of foot-skin temperature by diabetic patients who are at high risk for foot ulceration are two simple, low-tech preventive measures that could greatly reduce costs and improve patient outcomes if adopted more widely, according to Lawrence A. Lavery, D.P.M.

A foot ulcer is one of the most common precursors to the more than 100,000 diabetes-related amputations performed in the United States every year. Yet simple measures that can reduce the rate of foot ulceration are not being done, he said at the annual meeting of the American Association of Diabetes Educators.

“Prevention is a low-tech process,” said Dr. Lavery of the department of surgery at Texas A&M University, Temple.

Prevention efforts should focus on patients who are at greatest risk. In a study of 1,666 diabetic patients, Dr. Lavery and his associates stratified the risk classification beyond the current system that was established by an international working group (Diabetes Care 2001;24:1442-7).

Over a mean follow-up of 27 months, the risk of ulceration for patients with no peripheral neuropathy or peripheral vascular disease (PVD) was 2%, whereas those with neuropathy alone had a 4.5% risk and those with neuropathy plus a foot deformity had a 3.0% ulceration risk. High rates of ulceration occurred in patients with a history of PVD (14% risk) and in those with a previous ulcer or a history of amputation (14% risk) (Diabetes Care 2008;31:154-6).

Hospitalization rates, which were 1% for patients with neuropathy alone and 2% for those with a deformity, jumped to 16% for patients with PVD, 8% for those with a history of ulceration, and 50% for those with a previous amputation. Amputation rates were relatively low: from 0% in those with no disease or neuropathy alone to 0.7%–2.2% among those with deformity, PVD, and ulcer history. But the risk for a second amputation was 50% among those who already had one.

“Just 20% of the patients account for 70% of the ulcers and 90% of the amputations and hospitalizations. This tells us where to focus our educational efforts appropriately,” said Dr. Lavery, coauthor of a new task force report on foot assessment from the American Diabetes Association.

For patients at risk, elimination of the shoe as a source of pathology is a simple yet underutilized measure. About 20% of foot ulcers are triggered by ill-fitting shoes, mostly among women. “The easiest thing to do is just look at their shoes,” Dr. Lavery noted.

Since 1995, Medicare has covered therapeutic footwear and insoles for patients who are at risk for ulceration, but fewer than 3% of eligible patients receive the benefit. This is presumably because of a lack of awareness among providers as well as the cumbersome paperwork involved. “This is a simple, low-tech, very effective intervention that we don't do,” he said.

Even when physicians are diligent about checking the feet and shoes of their patients, the transformation from injury to ulceration occurs far too rapidly to be left to examinations at 3-month intervals. That's why it's essential for patients to check their feet at home on a daily basis.

But about 54% of patients can't see the bottoms of their feet, because of impaired vision, obesity, limited joint mobility, or a combination of those factors (Arch. Intern. Med. 1998;158:157-62).

“About half of patients whom we're asking to inspect their feet haven't been able to see their feet in the last several years,” Dr. Lavery remarked.

Moreover, the cardinal signs of inflammation that precedes ulceration—including pain, loss of function, edema, redness, and heat—can go unnoticed, particularly among patients who have neuropathy. Indeed, “even trained health care professionals probably cannot identify subtle precursors to ulceration,” he said.

Of the five factors, heat may be the easiest to identify. In three published studies, a long-armed handheld infrared skin thermometer called TempTouch (www.temptouch.com

In the initial pilot study, 85 patients with neuropathy and foot deformity, or with previous history of ulceration or partial foot amputation, were randomized to standard therapy—including therapeutic footwear, diabetic foot education, and regular foot evaluation by a podiatrist—or to “enhanced” therapy, which included the standard measures plus twice-daily use of the dermal thermometer device at six sites on each foot. Patients were instructed to contact a study nurse and to minimize walking if they detected a temperature difference of more than 4° F. in the corresponding sites of the two feet.

At 6 months, there were nine foot complications, including seven ulcers and two Charcot's fractures, among the 44 patients in the standard therapy group (20%), compared with just one ulcer (2%) in the 41 patients who used the thermometer, Dr. Lavery and his associates reported (Diabetes Care 2004;27:2642-7).

In a second study of 225 similarly high-risk patients that used the same methods, patients in the dermal thermometry group were one-third as likely to ulcerate at 18 months as were those in the standard therapy group (12% vs. 5%), and the thermometry was associated with a longer time to ulceration (Am. J. Med. 2007;120:1042-6).

In the third study, 173 high-risk patients with a history of foot wound and sensory neuropathy with a loss of protective sensation were randomized to one of three groups. Standard therapy consisted of lower-extremity evaluation by a physician every 8 weeks; education focusing on foot complications and self-care practices; therapeutic insoles and footwear; and advice to the patients to inspect their feet every day and to contact the study nurse if they identified any areas of concern (Diabetes Care 2007;30:14-20).

A second group had the standard therapy plus a structured foot exam, in which they were trained to use a mirror twice a day to inspect the bottom of their feet for redness, discoloration, swelling, and warmth by palpation and to log the results. Patients in a third group received standard therapy and were instructed to use the digital infrared thermometer twice daily and to record the temperatures.

At 15 months, the ulceration rate was essentially identical in the standard and structured foot exam groups (29% and 30%, respectively). In contrast, only 8.5% of the group that used the thermometer developed a foot ulcer, a fourfold reduction in risk.

Heat is an easy risk factor to identify, said Dr. Lavery, shown taking the temperature of a patient's Lawrence A. foot. ©Susan Gaetz Photography

WASHINGTON — The use of scheduled narcotic analgesics delayed the time to diagnosis of Clostridium difficile infection and also was associated with a greater risk of both severe and refractory infection in a study that involved more than 21,000 hospitalized patients.

Narcotic analgesics have antimotility effects similar to those of antiperistaltics, which have been shown to increase the risk of complications associated with C. difficile infection (CDI).

Although this 2-year retrospective cohort study did not show an increase in the overall risk of developing CDI among hospitalized patients who were given narcotics, the findings of delayed diagnosis and increased severity suggest that if possible, these agents should be withheld from patients with suspected or proven CDI and those who may be at high risk, Andrea L. Mora, Pharm.D., said at the jointly held annual Interscience Conference on Antimicrobial Agents and Chemotherapy and the annual meeting of the Infectious Diseases Society of America.

The study population included 21,358 adult patients admitted to St. Luke's Episcopal Hospital, Houston, between August 2005 and April 2007 who had received previous broad-spectrum systemic antibiotics. Of those, 241 developed CDI while in the hospital, and of this group, 123 had been in the hospital for more than 48 hours at onset of diarrhea (considered hospital-acquired). Compared with the 21,117 who did not develop CDI, the 123 who developed hospital-acquired CDI were significantly older (67.7 vs. 62.5 years), had longer lengths of stay (24 vs. 9.2 days), and had longer stays in intensive care (10.8 vs. 3.1 days).

The use of multiple broad-spectrum antibiotics was greater among those who developed CDI than among those who did not, including cefepime (55.3% vs. 20.5%), ceftriaxone (30.1% vs. 18%), meropenem (17.9% vs. 4.5%), and piperacillin/tazobactam (32.5% vs. 15%). The treatment of CDI included metronidazole in 90.2% of the 123 patients who were hospitalized 48 hours or longer and in 92.1% of all 241 CDI patients; vancomycin was used in 18.9% and 24.5%, respectively, said Dr. Mora, who is now with the South Texas Veterans Health Care System, San Antonio. Dr. Mora completed this study during her residency training at St. Luke's Episcopal Hospital.

Narcotics were used in 51.2% of the 123 CDI patients hospitalized 48 hours or longer at onset, compared with 49.3% of the 21,117 hospitalized patients without CDI, a nonsignificant difference. However, the diagnosis of CDI was significantly delayed among those who received narcotics—17.0 days from admission to the first positive C. difficile test, compared with 7.9 days among those who did not receive narcotics—even after researchers controlled for age, antibiotic use, and sex.

The reason for this isn't entirely clear, but it is believed that the constipation induced by the narcotics may mask the diarrhea that is the most characteristic symptom of CDI infection. Thus, patients may be infected but don't get tested as early as those who experience diarrhea, Dr. Mora said in an interview.

Severe CDI was also significantly more likely among those receiving narcotics (61.5% vs. 40.4%), as was refractory CDI (20% vs. 10.4%). These differences were not associated with age, sex, ethnicity, antibiotic use, or ICU status.

“We believe these results are significant because minimizing these risk factors is an important part of managing CDI,” Dr. Mora said.

Dr. Mora stated that she had no disclosures.

WASHINGTON — The use of scheduled narcotic analgesics delayed the time to diagnosis of Clostridium difficile infection and also was associated with a greater risk of both severe and refractory infection in a study that involved more than 21,000 hospitalized patients.

Narcotic analgesics have antimotility effects similar to those of antiperistaltics, which have been shown to increase the risk of complications associated with C. difficile infection (CDI).

Although this 2-year retrospective cohort study did not show an increase in the overall risk of developing CDI among hospitalized patients who were given narcotics, the findings of delayed diagnosis and increased severity suggest that if possible, these agents should be withheld from patients with suspected or proven CDI and those who may be at high risk, Andrea L. Mora, Pharm.D., said at the jointly held annual Interscience Conference on Antimicrobial Agents and Chemotherapy and the annual meeting of the Infectious Diseases Society of America.

The study population included 21,358 adult patients admitted to St. Luke's Episcopal Hospital, Houston, between August 2005 and April 2007 who had received previous broad-spectrum systemic antibiotics. Of those, 241 developed CDI while in the hospital, and of this group, 123 had been in the hospital for more than 48 hours at onset of diarrhea (considered hospital-acquired). Compared with the 21,117 who did not develop CDI, the 123 who developed hospital-acquired CDI were significantly older (67.7 vs. 62.5 years), had longer lengths of stay (24 vs. 9.2 days), and had longer stays in intensive care (10.8 vs. 3.1 days).

The use of multiple broad-spectrum antibiotics was greater among those who developed CDI than among those who did not, including cefepime (55.3% vs. 20.5%), ceftriaxone (30.1% vs. 18%), meropenem (17.9% vs. 4.5%), and piperacillin/tazobactam (32.5% vs. 15%). The treatment of CDI included metronidazole in 90.2% of the 123 patients who were hospitalized 48 hours or longer and in 92.1% of all 241 CDI patients; vancomycin was used in 18.9% and 24.5%, respectively, said Dr. Mora, who is now with the South Texas Veterans Health Care System, San Antonio. Dr. Mora completed this study during her residency training at St. Luke's Episcopal Hospital.

Narcotics were used in 51.2% of the 123 CDI patients hospitalized 48 hours or longer at onset, compared with 49.3% of the 21,117 hospitalized patients without CDI, a nonsignificant difference. However, the diagnosis of CDI was significantly delayed among those who received narcotics—17.0 days from admission to the first positive C. difficile test, compared with 7.9 days among those who did not receive narcotics—even after researchers controlled for age, antibiotic use, and sex.

The reason for this isn't entirely clear, but it is believed that the constipation induced by the narcotics may mask the diarrhea that is the most characteristic symptom of CDI infection. Thus, patients may be infected but don't get tested as early as those who experience diarrhea, Dr. Mora said in an interview.

Severe CDI was also significantly more likely among those receiving narcotics (61.5% vs. 40.4%), as was refractory CDI (20% vs. 10.4%). These differences were not associated with age, sex, ethnicity, antibiotic use, or ICU status.

“We believe these results are significant because minimizing these risk factors is an important part of managing CDI,” Dr. Mora said.

Dr. Mora stated that she had no disclosures.

WASHINGTON — The use of scheduled narcotic analgesics delayed the time to diagnosis of Clostridium difficile infection and also was associated with a greater risk of both severe and refractory infection in a study that involved more than 21,000 hospitalized patients.

Narcotic analgesics have antimotility effects similar to those of antiperistaltics, which have been shown to increase the risk of complications associated with C. difficile infection (CDI).

Although this 2-year retrospective cohort study did not show an increase in the overall risk of developing CDI among hospitalized patients who were given narcotics, the findings of delayed diagnosis and increased severity suggest that if possible, these agents should be withheld from patients with suspected or proven CDI and those who may be at high risk, Andrea L. Mora, Pharm.D., said at the jointly held annual Interscience Conference on Antimicrobial Agents and Chemotherapy and the annual meeting of the Infectious Diseases Society of America.

The study population included 21,358 adult patients admitted to St. Luke's Episcopal Hospital, Houston, between August 2005 and April 2007 who had received previous broad-spectrum systemic antibiotics. Of those, 241 developed CDI while in the hospital, and of this group, 123 had been in the hospital for more than 48 hours at onset of diarrhea (considered hospital-acquired). Compared with the 21,117 who did not develop CDI, the 123 who developed hospital-acquired CDI were significantly older (67.7 vs. 62.5 years), had longer lengths of stay (24 vs. 9.2 days), and had longer stays in intensive care (10.8 vs. 3.1 days).

The use of multiple broad-spectrum antibiotics was greater among those who developed CDI than among those who did not, including cefepime (55.3% vs. 20.5%), ceftriaxone (30.1% vs. 18%), meropenem (17.9% vs. 4.5%), and piperacillin/tazobactam (32.5% vs. 15%). The treatment of CDI included metronidazole in 90.2% of the 123 patients who were hospitalized 48 hours or longer and in 92.1% of all 241 CDI patients; vancomycin was used in 18.9% and 24.5%, respectively, said Dr. Mora, who is now with the South Texas Veterans Health Care System, San Antonio. Dr. Mora completed this study during her residency training at St. Luke's Episcopal Hospital.

Narcotics were used in 51.2% of the 123 CDI patients hospitalized 48 hours or longer at onset, compared with 49.3% of the 21,117 hospitalized patients without CDI, a nonsignificant difference. However, the diagnosis of CDI was significantly delayed among those who received narcotics—17.0 days from admission to the first positive C. difficile test, compared with 7.9 days among those who did not receive narcotics—even after researchers controlled for age, antibiotic use, and sex.

The reason for this isn't entirely clear, but it is believed that the constipation induced by the narcotics may mask the diarrhea that is the most characteristic symptom of CDI infection. Thus, patients may be infected but don't get tested as early as those who experience diarrhea, Dr. Mora said in an interview.

Severe CDI was also significantly more likely among those receiving narcotics (61.5% vs. 40.4%), as was refractory CDI (20% vs. 10.4%). These differences were not associated with age, sex, ethnicity, antibiotic use, or ICU status.

“We believe these results are significant because minimizing these risk factors is an important part of managing CDI,” Dr. Mora said.

Dr. Mora stated that she had no disclosures.

The risk of developing diabetes after a history of gestational diabetes increased over time and reached nearly 20% by 9 years post partum, according to results from a large, population-based study involving Canadian women.

The finding confirms those from the United States and elsewhere regarding the rise in both gestational diabetes and type 2 diabetes, as well as the highly elevated risk for the development of subsequent diabetes among women who have gestational diabetes. “This estimate should be used by clinicians to assist in their counseling of pregnant women and by policy makers to target these women for screening and prevention,” said Dr. Denice S. Feig of the University of Toronto and her associates (CMAJ;2008:179:229-34).

They utilized data from two sources: a database of hospital discharges for deliveries that occurred in Ontario from April 1, 1995, to March 31, 2002; and a database of all Ontario residents diagnosed with diabetes through March 31, 2004. Of 659,164 women aged 16-49 years without pre-existing diabetes who delivered a baby between 1995 and 2002, a total of 21,823 were diagnosed with gestational diabetes. The overall incidence of gestational diabetes in Ontario rose from 3.2% in 1995 to 3.6% in 2001.

The incidence of having gestational diabetes was higher among women with higher Charlson Comorbidity Index scores (an estimate of the risk of death from comorbid disease), those with lower incomes, and those living in urban areas, compared with rural. Women who had 10 or fewer primary care visits in the 2 years prior to the index delivery were less likely to be diagnosed with gestational diabetes than were women with more than 10 visits (2.7% vs. 3.7%), and those without a usual care provider were less likely to be diagnosed with gestational diabetes than were those who did have one (3.0% vs. 3.4%).

Following delivery, the probability of developing diabetes among the women with gestational diabetes during pregnancy rose rapidly during the first 9 months post partum, and remained more or less constant thereafter over the 9-year follow-up period of the study.

At 9 months, 3.7% of the women had been diagnosed with diabetes. Most of these women probably had pre-existing type 2 diabetes that was only discovered via screening for gestational diabetes. The database doesn't distinguish between type 1 and type 2 diabetes, but most were probably type 2, Dr. Feig and her associates noted.

The probability of developing diabetes among those with a history of gestational diabetes was 5% at the end of 15 months and 13% at 5 years. By the end of the 9-year follow-up, 19% had developed diabetes, compared with just 2% of those without gestational diabetes. The women with gestational diabetes who delivered during 1999-2001 had a higher risk of subsequent diabetes than did those who delivered during 1995-1996. Among the women in the later group, diabetes had developed in 16% by 5 years, whereas it took 9 years for the earlier group to reach a rate of 16%, they said.

Other factors increasing the risk of diabetes following gestational diabetes included Charlson index, greater age, a higher number of primary care visits prepregnancy, and the development of hypertension after delivery. On the other hand, living in a rural area, having a higher income, and having a prior pregnancy within 4 years of the index pregnancy decreased the risk. However, previous gestational diabetes was a more significant predictive factor than all the others were, the investigators said.

In an accompanying editorial, Dr. David Simmons of the Institute of Metabolic Science, Cambridge University Hospitals NHS Foundation Trust, England, called the study “timely, allowing renewal of attention to an important condition where we could do better.” Among the areas needing improvement, he said, are increased efforts to prevent progression to diabetes in these women, particularly those who might become pregnant again, and to improve the diagnosis of type 2 diabetes prior to pregnancy.

“Even if there were no primary prevention programs in place, there should be secondary prevention programs to detect diabetes as near to its development as possible. Such programs would allow control of hyperglycemia before a subsequent pregnancy, something clearly of benefit to any future fetus,” he commented.

The risk of developing diabetes after a history of gestational diabetes increased over time and reached nearly 20% by 9 years post partum, according to results from a large, population-based study involving Canadian women.

The finding confirms those from the United States and elsewhere regarding the rise in both gestational diabetes and type 2 diabetes, as well as the highly elevated risk for the development of subsequent diabetes among women who have gestational diabetes. “This estimate should be used by clinicians to assist in their counseling of pregnant women and by policy makers to target these women for screening and prevention,” said Dr. Denice S. Feig of the University of Toronto and her associates (CMAJ;2008:179:229-34).

They utilized data from two sources: a database of hospital discharges for deliveries that occurred in Ontario from April 1, 1995, to March 31, 2002; and a database of all Ontario residents diagnosed with diabetes through March 31, 2004. Of 659,164 women aged 16-49 years without pre-existing diabetes who delivered a baby between 1995 and 2002, a total of 21,823 were diagnosed with gestational diabetes. The overall incidence of gestational diabetes in Ontario rose from 3.2% in 1995 to 3.6% in 2001.

The incidence of having gestational diabetes was higher among women with higher Charlson Comorbidity Index scores (an estimate of the risk of death from comorbid disease), those with lower incomes, and those living in urban areas, compared with rural. Women who had 10 or fewer primary care visits in the 2 years prior to the index delivery were less likely to be diagnosed with gestational diabetes than were women with more than 10 visits (2.7% vs. 3.7%), and those without a usual care provider were less likely to be diagnosed with gestational diabetes than were those who did have one (3.0% vs. 3.4%).

Following delivery, the probability of developing diabetes among the women with gestational diabetes during pregnancy rose rapidly during the first 9 months post partum, and remained more or less constant thereafter over the 9-year follow-up period of the study.

At 9 months, 3.7% of the women had been diagnosed with diabetes. Most of these women probably had pre-existing type 2 diabetes that was only discovered via screening for gestational diabetes. The database doesn't distinguish between type 1 and type 2 diabetes, but most were probably type 2, Dr. Feig and her associates noted.

The probability of developing diabetes among those with a history of gestational diabetes was 5% at the end of 15 months and 13% at 5 years. By the end of the 9-year follow-up, 19% had developed diabetes, compared with just 2% of those without gestational diabetes. The women with gestational diabetes who delivered during 1999-2001 had a higher risk of subsequent diabetes than did those who delivered during 1995-1996. Among the women in the later group, diabetes had developed in 16% by 5 years, whereas it took 9 years for the earlier group to reach a rate of 16%, they said.

Other factors increasing the risk of diabetes following gestational diabetes included Charlson index, greater age, a higher number of primary care visits prepregnancy, and the development of hypertension after delivery. On the other hand, living in a rural area, having a higher income, and having a prior pregnancy within 4 years of the index pregnancy decreased the risk. However, previous gestational diabetes was a more significant predictive factor than all the others were, the investigators said.

In an accompanying editorial, Dr. David Simmons of the Institute of Metabolic Science, Cambridge University Hospitals NHS Foundation Trust, England, called the study “timely, allowing renewal of attention to an important condition where we could do better.” Among the areas needing improvement, he said, are increased efforts to prevent progression to diabetes in these women, particularly those who might become pregnant again, and to improve the diagnosis of type 2 diabetes prior to pregnancy.

“Even if there were no primary prevention programs in place, there should be secondary prevention programs to detect diabetes as near to its development as possible. Such programs would allow control of hyperglycemia before a subsequent pregnancy, something clearly of benefit to any future fetus,” he commented.

The risk of developing diabetes after a history of gestational diabetes increased over time and reached nearly 20% by 9 years post partum, according to results from a large, population-based study involving Canadian women.

The finding confirms those from the United States and elsewhere regarding the rise in both gestational diabetes and type 2 diabetes, as well as the highly elevated risk for the development of subsequent diabetes among women who have gestational diabetes. “This estimate should be used by clinicians to assist in their counseling of pregnant women and by policy makers to target these women for screening and prevention,” said Dr. Denice S. Feig of the University of Toronto and her associates (CMAJ;2008:179:229-34).

They utilized data from two sources: a database of hospital discharges for deliveries that occurred in Ontario from April 1, 1995, to March 31, 2002; and a database of all Ontario residents diagnosed with diabetes through March 31, 2004. Of 659,164 women aged 16-49 years without pre-existing diabetes who delivered a baby between 1995 and 2002, a total of 21,823 were diagnosed with gestational diabetes. The overall incidence of gestational diabetes in Ontario rose from 3.2% in 1995 to 3.6% in 2001.

The incidence of having gestational diabetes was higher among women with higher Charlson Comorbidity Index scores (an estimate of the risk of death from comorbid disease), those with lower incomes, and those living in urban areas, compared with rural. Women who had 10 or fewer primary care visits in the 2 years prior to the index delivery were less likely to be diagnosed with gestational diabetes than were women with more than 10 visits (2.7% vs. 3.7%), and those without a usual care provider were less likely to be diagnosed with gestational diabetes than were those who did have one (3.0% vs. 3.4%).

Following delivery, the probability of developing diabetes among the women with gestational diabetes during pregnancy rose rapidly during the first 9 months post partum, and remained more or less constant thereafter over the 9-year follow-up period of the study.

At 9 months, 3.7% of the women had been diagnosed with diabetes. Most of these women probably had pre-existing type 2 diabetes that was only discovered via screening for gestational diabetes. The database doesn't distinguish between type 1 and type 2 diabetes, but most were probably type 2, Dr. Feig and her associates noted.

The probability of developing diabetes among those with a history of gestational diabetes was 5% at the end of 15 months and 13% at 5 years. By the end of the 9-year follow-up, 19% had developed diabetes, compared with just 2% of those without gestational diabetes. The women with gestational diabetes who delivered during 1999-2001 had a higher risk of subsequent diabetes than did those who delivered during 1995-1996. Among the women in the later group, diabetes had developed in 16% by 5 years, whereas it took 9 years for the earlier group to reach a rate of 16%, they said.

Other factors increasing the risk of diabetes following gestational diabetes included Charlson index, greater age, a higher number of primary care visits prepregnancy, and the development of hypertension after delivery. On the other hand, living in a rural area, having a higher income, and having a prior pregnancy within 4 years of the index pregnancy decreased the risk. However, previous gestational diabetes was a more significant predictive factor than all the others were, the investigators said.

In an accompanying editorial, Dr. David Simmons of the Institute of Metabolic Science, Cambridge University Hospitals NHS Foundation Trust, England, called the study “timely, allowing renewal of attention to an important condition where we could do better.” Among the areas needing improvement, he said, are increased efforts to prevent progression to diabetes in these women, particularly those who might become pregnant again, and to improve the diagnosis of type 2 diabetes prior to pregnancy.

“Even if there were no primary prevention programs in place, there should be secondary prevention programs to detect diabetes as near to its development as possible. Such programs would allow control of hyperglycemia before a subsequent pregnancy, something clearly of benefit to any future fetus,” he commented.