Users Extol Continuous Glucose Monitors' Benefits

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.