MDedge Endocrinology

The US Food and Drug Administration (FDA) is warning against the use of smartwatches and rings that are claimed to measure a person’s glucose levels without piercing the skin.

The warning doesn’t apply to authorized smartwatch applications that display glucose values from an FDA-approved continuous glucose monitor with a sensor implanted under the skin.

Rather, the warning pertains to watches or rings sold through online marketplaces or directly from sellers who claim that the devices measure blood sugar noninvasively without requiring the wearer to prick their finger or pierce their skin. These products are manufactured by dozens of companies and sold under many different brand names. The FDA’s warning applies to all of them.

These devices have not been evaluated by the FDA for safety and effectiveness, and their use by people with diabetes could result in inaccurate blood glucose measurements, with potentially serious consequences if relied upon for medication dosing.

“The FDA has not authorized, cleared, or approved any smartwatch or smart ring that is intended to measure or estimate blood glucose values on its own,” the agency said in a statement issued on February 21, 2024.

They added, “The agency is working to ensure that manufacturers, distributors, and sellers do not illegally market unauthorized smartwatches or smart rings that claim to measure blood glucose levels.”

People who experience any problems with inaccurate blood glucose measurement or experience any adverse events from using an unauthorized smartwatch or smart ring are urged to report it to the FDA through its MedWatch program.

A version of this article appeared on Medscape.com.

The US Food and Drug Administration (FDA) is warning against the use of smartwatches and rings that are claimed to measure a person’s glucose levels without piercing the skin.

The warning doesn’t apply to authorized smartwatch applications that display glucose values from an FDA-approved continuous glucose monitor with a sensor implanted under the skin.

Rather, the warning pertains to watches or rings sold through online marketplaces or directly from sellers who claim that the devices measure blood sugar noninvasively without requiring the wearer to prick their finger or pierce their skin. These products are manufactured by dozens of companies and sold under many different brand names. The FDA’s warning applies to all of them.

These devices have not been evaluated by the FDA for safety and effectiveness, and their use by people with diabetes could result in inaccurate blood glucose measurements, with potentially serious consequences if relied upon for medication dosing.

“The FDA has not authorized, cleared, or approved any smartwatch or smart ring that is intended to measure or estimate blood glucose values on its own,” the agency said in a statement issued on February 21, 2024.

They added, “The agency is working to ensure that manufacturers, distributors, and sellers do not illegally market unauthorized smartwatches or smart rings that claim to measure blood glucose levels.”

People who experience any problems with inaccurate blood glucose measurement or experience any adverse events from using an unauthorized smartwatch or smart ring are urged to report it to the FDA through its MedWatch program.

A version of this article appeared on Medscape.com.

The US Food and Drug Administration (FDA) is warning against the use of smartwatches and rings that are claimed to measure a person’s glucose levels without piercing the skin.

The warning doesn’t apply to authorized smartwatch applications that display glucose values from an FDA-approved continuous glucose monitor with a sensor implanted under the skin.

Rather, the warning pertains to watches or rings sold through online marketplaces or directly from sellers who claim that the devices measure blood sugar noninvasively without requiring the wearer to prick their finger or pierce their skin. These products are manufactured by dozens of companies and sold under many different brand names. The FDA’s warning applies to all of them.

These devices have not been evaluated by the FDA for safety and effectiveness, and their use by people with diabetes could result in inaccurate blood glucose measurements, with potentially serious consequences if relied upon for medication dosing.

“The FDA has not authorized, cleared, or approved any smartwatch or smart ring that is intended to measure or estimate blood glucose values on its own,” the agency said in a statement issued on February 21, 2024.

They added, “The agency is working to ensure that manufacturers, distributors, and sellers do not illegally market unauthorized smartwatches or smart rings that claim to measure blood glucose levels.”

People who experience any problems with inaccurate blood glucose measurement or experience any adverse events from using an unauthorized smartwatch or smart ring are urged to report it to the FDA through its MedWatch program.

A version of this article appeared on Medscape.com.

TOPLINE:

Gargling with mouthwash two to three times a day can reduce periodontopathic bacteria and possibly improve glycemic control in people with type 2 diabetes (T2D), especially younger adults.

METHODOLOGY:

• A total of 173 patients with T2D who had at least six total periodontopathic bacteria in their mouths and  ≥ 6.5% were instructed to gargle with water three times a day for 6 months, followed by gargling with chlorhexidine gluconate mouthwash three times a day for the next 6 months.
• Saliva specimens were collected every 1-2 months at clinic visits totaling 6-12 samples per study period and bacterial DNA examined for three red complex species, namely, Porphyromonas gingivalis, Treponema denticola, and Tannerella forsythia.

TAKEAWAY:

• Twelve individuals who gargled once a day or less showed no significant reductions in red complex species after mouthwash or water gargling.
• By contrast, significant decreases in red complex bacteria were seen after 6 months of mouthwash gargling (P < .001) in the 80 who gargled twice a day and the 81 who did so three times a day compared with no changes after water gargling.
• Among the 161 individuals who gargled at least twice a day, the decrease in red species with mouthwash vs water gargling was highly significant (P < .0001).
• After adjustment for A1c seasonal variation, neither water gargling nor mouthwash gargling led to significant overall reduction in A1c levels.
• However, A1c levels were significantly lower in the 83 individuals aged ≤ 68 years than among the 78 aged ≥ 69 years after gargling with mouthwash (P < .05), with no change in either group after water gargling.
• Similarly, A1c levels were significantly reduced (P < .05) after mouthwash in the 69 with baseline A1c ≥ 7.5% compared with the 92 whose baseline A1c levels were ≤ 7.4%, with no changes in either after water.

IN PRACTICE:

“A bidirectional relationship between periodontitis and T2D has been reported. Patients with T2D are more susceptible to severe periodontitis than subjects without diabetes, and inflammatory periodontitis aggravates hyperglycemia, leading to inadequate glycemic control.” “Recently, it has been reported that patients with T2D treated for periodontitis have reduced periodontopathic bacteria and improved glycemic control. Patients with T2D complicated by periodontitis have more red complex species, and poor glycemic control is thought to be associated with increased levels of red complex species in the oral cavity.” “Further studies should be planned, taking into account various patient factors to determine the effect of mouthwash gargling on the amount of red complex species and A1c levels in patients with T2D.”

SOURCE:

This study was conducted by Saaya Matayoshi, of the Joint Research Laboratory of Science for Oral and Systemic Connection, Osaka University Graduate School of Dentistry, Osaka, Japan, and colleagues and published in Scientific Reports.

LIMITATIONS:

Only polymerase chain reaction used to detect periodontopathic bacteria so not quantified. No assessment of periodontal pocket depth. Saliva sampling conditions not standardized. Study conducted during COVID-19 pandemic; all patients wore masks. Heterogeneity in patient responses to the mouthwash.

DISCLOSURES:

This work was supported by the Fund for Scientific Promotion of Weltec Corp, Osaka, Japan. The authors declared no competing interests.

A version of this article appeared on Medscape.com.

TOPLINE:

Gargling with mouthwash two to three times a day can reduce periodontopathic bacteria and possibly improve glycemic control in people with type 2 diabetes (T2D), especially younger adults.

METHODOLOGY:

• A total of 173 patients with T2D who had at least six total periodontopathic bacteria in their mouths and  ≥ 6.5% were instructed to gargle with water three times a day for 6 months, followed by gargling with chlorhexidine gluconate mouthwash three times a day for the next 6 months.
• Saliva specimens were collected every 1-2 months at clinic visits totaling 6-12 samples per study period and bacterial DNA examined for three red complex species, namely, Porphyromonas gingivalis, Treponema denticola, and Tannerella forsythia.

TAKEAWAY:

• Twelve individuals who gargled once a day or less showed no significant reductions in red complex species after mouthwash or water gargling.
• By contrast, significant decreases in red complex bacteria were seen after 6 months of mouthwash gargling (P < .001) in the 80 who gargled twice a day and the 81 who did so three times a day compared with no changes after water gargling.
• Among the 161 individuals who gargled at least twice a day, the decrease in red species with mouthwash vs water gargling was highly significant (P < .0001).
• After adjustment for A1c seasonal variation, neither water gargling nor mouthwash gargling led to significant overall reduction in A1c levels.
• However, A1c levels were significantly lower in the 83 individuals aged ≤ 68 years than among the 78 aged ≥ 69 years after gargling with mouthwash (P < .05), with no change in either group after water gargling.
• Similarly, A1c levels were significantly reduced (P < .05) after mouthwash in the 69 with baseline A1c ≥ 7.5% compared with the 92 whose baseline A1c levels were ≤ 7.4%, with no changes in either after water.

IN PRACTICE:

“A bidirectional relationship between periodontitis and T2D has been reported. Patients with T2D are more susceptible to severe periodontitis than subjects without diabetes, and inflammatory periodontitis aggravates hyperglycemia, leading to inadequate glycemic control.” “Recently, it has been reported that patients with T2D treated for periodontitis have reduced periodontopathic bacteria and improved glycemic control. Patients with T2D complicated by periodontitis have more red complex species, and poor glycemic control is thought to be associated with increased levels of red complex species in the oral cavity.” “Further studies should be planned, taking into account various patient factors to determine the effect of mouthwash gargling on the amount of red complex species and A1c levels in patients with T2D.”

SOURCE:

This study was conducted by Saaya Matayoshi, of the Joint Research Laboratory of Science for Oral and Systemic Connection, Osaka University Graduate School of Dentistry, Osaka, Japan, and colleagues and published in Scientific Reports.

LIMITATIONS:

Only polymerase chain reaction used to detect periodontopathic bacteria so not quantified. No assessment of periodontal pocket depth. Saliva sampling conditions not standardized. Study conducted during COVID-19 pandemic; all patients wore masks. Heterogeneity in patient responses to the mouthwash.

DISCLOSURES:

This work was supported by the Fund for Scientific Promotion of Weltec Corp, Osaka, Japan. The authors declared no competing interests.

A version of this article appeared on Medscape.com.

TOPLINE:

Gargling with mouthwash two to three times a day can reduce periodontopathic bacteria and possibly improve glycemic control in people with type 2 diabetes (T2D), especially younger adults.

METHODOLOGY:

• A total of 173 patients with T2D who had at least six total periodontopathic bacteria in their mouths and  ≥ 6.5% were instructed to gargle with water three times a day for 6 months, followed by gargling with chlorhexidine gluconate mouthwash three times a day for the next 6 months.
• Saliva specimens were collected every 1-2 months at clinic visits totaling 6-12 samples per study period and bacterial DNA examined for three red complex species, namely, Porphyromonas gingivalis, Treponema denticola, and Tannerella forsythia.

TAKEAWAY:

• Twelve individuals who gargled once a day or less showed no significant reductions in red complex species after mouthwash or water gargling.
• By contrast, significant decreases in red complex bacteria were seen after 6 months of mouthwash gargling (P < .001) in the 80 who gargled twice a day and the 81 who did so three times a day compared with no changes after water gargling.
• Among the 161 individuals who gargled at least twice a day, the decrease in red species with mouthwash vs water gargling was highly significant (P < .0001).
• After adjustment for A1c seasonal variation, neither water gargling nor mouthwash gargling led to significant overall reduction in A1c levels.
• However, A1c levels were significantly lower in the 83 individuals aged ≤ 68 years than among the 78 aged ≥ 69 years after gargling with mouthwash (P < .05), with no change in either group after water gargling.
• Similarly, A1c levels were significantly reduced (P < .05) after mouthwash in the 69 with baseline A1c ≥ 7.5% compared with the 92 whose baseline A1c levels were ≤ 7.4%, with no changes in either after water.

IN PRACTICE:

“A bidirectional relationship between periodontitis and T2D has been reported. Patients with T2D are more susceptible to severe periodontitis than subjects without diabetes, and inflammatory periodontitis aggravates hyperglycemia, leading to inadequate glycemic control.” “Recently, it has been reported that patients with T2D treated for periodontitis have reduced periodontopathic bacteria and improved glycemic control. Patients with T2D complicated by periodontitis have more red complex species, and poor glycemic control is thought to be associated with increased levels of red complex species in the oral cavity.” “Further studies should be planned, taking into account various patient factors to determine the effect of mouthwash gargling on the amount of red complex species and A1c levels in patients with T2D.”

SOURCE:

This study was conducted by Saaya Matayoshi, of the Joint Research Laboratory of Science for Oral and Systemic Connection, Osaka University Graduate School of Dentistry, Osaka, Japan, and colleagues and published in Scientific Reports.

LIMITATIONS:

Only polymerase chain reaction used to detect periodontopathic bacteria so not quantified. No assessment of periodontal pocket depth. Saliva sampling conditions not standardized. Study conducted during COVID-19 pandemic; all patients wore masks. Heterogeneity in patient responses to the mouthwash.

DISCLOSURES:

This work was supported by the Fund for Scientific Promotion of Weltec Corp, Osaka, Japan. The authors declared no competing interests.

A version of this article appeared on Medscape.com.

Poor communication between physician and patient can cause a lot of harm, according to Joseph N. Cappella, PhD, Gerald R. Miller Professor Emeritus of Communication at the University of Pennsylvania in Philadelphia, and Richard N. Street Jr, PhD, professor of communication and media science at Texas A&M University in Houston, Texas. When a physician and patient talk past each other, it may impair the patient’s compliance with preventive measures, screening, and treatment; undermine the physician-patient relationship; exacerbate fears and concerns; and possibly lead patients to rely on misleading, incomplete, or simply incorrect information, turning away from evidence-based medicine.

Drs. Cappella and Street made these points in an essay recently published in JAMA. The essay marks the beginning of the JAMA series Communicating Medicine.

“Helping clinicians deliver accurate information more effectively can lead to better-informed patients,” wrote Anne R. Cappola, MD, professor of endocrinology, diabetes, and metabolism at the University of Pennsylvania, and Kirsten Bibbins-Domingo, MD, PhD, professor of medicine at the University of California, San Francisco, in an accompanying editorial. Drs. Cappola and Bibbins-Domingo also are editors of JAMA.

To establish a common understanding between physician and patient, Drs. Cappella and Street identified the following four responsibilities of the physician:

• Discover what the patient understands and why
• Provide accurate information in an understandable manner
• Promote the credibility of the information
• Verify whether the patient has understood.

“Research has shown that although medical facts need to be the basis for the clinician’s core message, those facts are more effectively communicated in a patient-clinician relationship characterized by trust and cooperation and when the information is presented in a manner that fosters patient understanding,” wrote Drs. Cappella and Street. This approach includes using interpreters for patients who do not fluently speak the physician’s language and supplementing explanations with simple written information, images, and videos.

Patients generally believe their physician’s information, and most patients view their physicians as a trustworthy source. Trust is based on the belief that the physician has the patient’s best interests at heart.

However, patients may be distrustful of their physician’s information if it contradicts their own belief system or personal experiences or because they inherently distrust the medical profession.

In addition, patients are less willing to accept explanations and recommendations if they feel misunderstood, judged, discriminated against, or rushed by the physician. The basis for effective communication is a relationship with patients that is built on trust and respect. Empirically supported strategies for expressing respect and building trust include the following:

• Affirming the patient’s values
• Anticipating and addressing false or misleading information
• Using simple, jargon-free language
• Embedding facts into a story, rather than presenting the scientific evidence dryly.

“Conveying factual material using these techniques makes facts more engaging and memorable,” wrote Drs. Cappella and Street. It is crucial to inquire about and consider the patient’s perspective, health beliefs, assumptions, concerns, needs, and stories in the conversation.

This story was translated from the Medscape German edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

Poor communication between physician and patient can cause a lot of harm, according to Joseph N. Cappella, PhD, Gerald R. Miller Professor Emeritus of Communication at the University of Pennsylvania in Philadelphia, and Richard N. Street Jr, PhD, professor of communication and media science at Texas A&M University in Houston, Texas. When a physician and patient talk past each other, it may impair the patient’s compliance with preventive measures, screening, and treatment; undermine the physician-patient relationship; exacerbate fears and concerns; and possibly lead patients to rely on misleading, incomplete, or simply incorrect information, turning away from evidence-based medicine.

Drs. Cappella and Street made these points in an essay recently published in JAMA. The essay marks the beginning of the JAMA series Communicating Medicine.

“Helping clinicians deliver accurate information more effectively can lead to better-informed patients,” wrote Anne R. Cappola, MD, professor of endocrinology, diabetes, and metabolism at the University of Pennsylvania, and Kirsten Bibbins-Domingo, MD, PhD, professor of medicine at the University of California, San Francisco, in an accompanying editorial. Drs. Cappola and Bibbins-Domingo also are editors of JAMA.

To establish a common understanding between physician and patient, Drs. Cappella and Street identified the following four responsibilities of the physician:

• Discover what the patient understands and why
• Provide accurate information in an understandable manner
• Promote the credibility of the information
• Verify whether the patient has understood.

“Research has shown that although medical facts need to be the basis for the clinician’s core message, those facts are more effectively communicated in a patient-clinician relationship characterized by trust and cooperation and when the information is presented in a manner that fosters patient understanding,” wrote Drs. Cappella and Street. This approach includes using interpreters for patients who do not fluently speak the physician’s language and supplementing explanations with simple written information, images, and videos.

Patients generally believe their physician’s information, and most patients view their physicians as a trustworthy source. Trust is based on the belief that the physician has the patient’s best interests at heart.

However, patients may be distrustful of their physician’s information if it contradicts their own belief system or personal experiences or because they inherently distrust the medical profession.

In addition, patients are less willing to accept explanations and recommendations if they feel misunderstood, judged, discriminated against, or rushed by the physician. The basis for effective communication is a relationship with patients that is built on trust and respect. Empirically supported strategies for expressing respect and building trust include the following:

• Affirming the patient’s values
• Anticipating and addressing false or misleading information
• Using simple, jargon-free language
• Embedding facts into a story, rather than presenting the scientific evidence dryly.

“Conveying factual material using these techniques makes facts more engaging and memorable,” wrote Drs. Cappella and Street. It is crucial to inquire about and consider the patient’s perspective, health beliefs, assumptions, concerns, needs, and stories in the conversation.

This story was translated from the Medscape German edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

Poor communication between physician and patient can cause a lot of harm, according to Joseph N. Cappella, PhD, Gerald R. Miller Professor Emeritus of Communication at the University of Pennsylvania in Philadelphia, and Richard N. Street Jr, PhD, professor of communication and media science at Texas A&M University in Houston, Texas. When a physician and patient talk past each other, it may impair the patient’s compliance with preventive measures, screening, and treatment; undermine the physician-patient relationship; exacerbate fears and concerns; and possibly lead patients to rely on misleading, incomplete, or simply incorrect information, turning away from evidence-based medicine.

Drs. Cappella and Street made these points in an essay recently published in JAMA. The essay marks the beginning of the JAMA series Communicating Medicine.

“Helping clinicians deliver accurate information more effectively can lead to better-informed patients,” wrote Anne R. Cappola, MD, professor of endocrinology, diabetes, and metabolism at the University of Pennsylvania, and Kirsten Bibbins-Domingo, MD, PhD, professor of medicine at the University of California, San Francisco, in an accompanying editorial. Drs. Cappola and Bibbins-Domingo also are editors of JAMA.

To establish a common understanding between physician and patient, Drs. Cappella and Street identified the following four responsibilities of the physician:

• Discover what the patient understands and why
• Provide accurate information in an understandable manner
• Promote the credibility of the information
• Verify whether the patient has understood.

“Research has shown that although medical facts need to be the basis for the clinician’s core message, those facts are more effectively communicated in a patient-clinician relationship characterized by trust and cooperation and when the information is presented in a manner that fosters patient understanding,” wrote Drs. Cappella and Street. This approach includes using interpreters for patients who do not fluently speak the physician’s language and supplementing explanations with simple written information, images, and videos.

Patients generally believe their physician’s information, and most patients view their physicians as a trustworthy source. Trust is based on the belief that the physician has the patient’s best interests at heart.

However, patients may be distrustful of their physician’s information if it contradicts their own belief system or personal experiences or because they inherently distrust the medical profession.

In addition, patients are less willing to accept explanations and recommendations if they feel misunderstood, judged, discriminated against, or rushed by the physician. The basis for effective communication is a relationship with patients that is built on trust and respect. Empirically supported strategies for expressing respect and building trust include the following:

• Affirming the patient’s values
• Anticipating and addressing false or misleading information
• Using simple, jargon-free language
• Embedding facts into a story, rather than presenting the scientific evidence dryly.

“Conveying factual material using these techniques makes facts more engaging and memorable,” wrote Drs. Cappella and Street. It is crucial to inquire about and consider the patient’s perspective, health beliefs, assumptions, concerns, needs, and stories in the conversation.

This story was translated from the Medscape German edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

TOPLINE:

A value-based medication plan that lowers out-of-pocket costs for antidiabetic medications reduces health complications in commercially insured individuals with diabetes, especially those living in lower-income areas.

METHODOLOGY: 

• Researchers assessed the 1-year impact on type 2 diabetes outcomes from a preventive drug list (PDL), which employers can add to plans to reduce out-of-pocket costs (copayments or deductibles) for high-value preventive medications.
• Using data from a national insurer, they identified 10,588 members with diabetes newly enrolled in PDL plans between January 2004 and June 2017 (age, 12-64 years; 44.8% women; 45.5% from the South; 33.4% from employers with < 100 enrollees).
• The members with diabetes on a PDL plan for a full follow-up year were matched and weighted against 690,075 control participants whose employers did not offer PDL.
• In a subgroup analysis, health outcomes for members with diabetes residing in lower-income neighborhoods (53.1%) were evaluated.
• The primary outcome was acute, preventable diabetes complications, such as bacterial infections, neurovascular events, acute coronary disease, and diabetic ketoacidosis, measured as complication days per 1000 members per year.

TAKEAWAY: 

• Out-of-pocket costs for noninsulin antidiabetic agents and insulin declined by 30.7% and 38.6%, respectively, in the PDL group vs controls. 
• The 30-day prescription fills for noninsulin and insulin antidiabetic medication increased by 7.1% (95% CI, 5.0%-9.3%) and 5.3% (95% CI, 2.2%-8.4%), respectively, among PDL members and was slightly higher among PDL members residing in low-income areas. 
• The PDL transition was associated with an 8.4% relative reduction (95% CI, −13.9% to −2.8%) in complication days overall (absolute reduction, −20.2 days per 1000 members per year). 
• Among members from lower-income areas, PDL transition was associated with a 10.2% relative reduction (95% CI, −17.4% to −3.0%) in complication days (absolute reduction, −26.1 per 1000 members per year) compared with controls. 

IN PRACTICE:

“Targeting out-of-pocket cost reductions to specific populations, in this case patients with diabetes from lower-income areas, might enhance health outcomes,” wrote the authors.

SOURCE: 

The study was conducted by J. Franklin Wharam, MD, MPH, Department of Medicine, Duke University, Durham, North Carolina. It was published online in JAMA Health Forum. 

LIMITATIONS: 

The findings may be generalized only to patients with diabetes enrolled in commercial health plans. Instead of being randomized, the PDL coverage was chosen by certain employers. Moreover, only outcomes associated with new PDL enrollment over a single year were evaluated.

DISCLOSURES: 

The study was funded by grants from the Centers for Disease Control and Prevention and National Institute of Diabetes and Digestive and Kidney Diseases. One of the authors reported receiving postmarket safety study stipends from Pfizer and GlaxoSmithKline outside the submitted work.

A version of this article appeared on Medscape.com.

TOPLINE:

A value-based medication plan that lowers out-of-pocket costs for antidiabetic medications reduces health complications in commercially insured individuals with diabetes, especially those living in lower-income areas.

METHODOLOGY: 

• Researchers assessed the 1-year impact on type 2 diabetes outcomes from a preventive drug list (PDL), which employers can add to plans to reduce out-of-pocket costs (copayments or deductibles) for high-value preventive medications.
• Using data from a national insurer, they identified 10,588 members with diabetes newly enrolled in PDL plans between January 2004 and June 2017 (age, 12-64 years; 44.8% women; 45.5% from the South; 33.4% from employers with < 100 enrollees).
• The members with diabetes on a PDL plan for a full follow-up year were matched and weighted against 690,075 control participants whose employers did not offer PDL.
• In a subgroup analysis, health outcomes for members with diabetes residing in lower-income neighborhoods (53.1%) were evaluated.
• The primary outcome was acute, preventable diabetes complications, such as bacterial infections, neurovascular events, acute coronary disease, and diabetic ketoacidosis, measured as complication days per 1000 members per year.

TAKEAWAY: 

• Out-of-pocket costs for noninsulin antidiabetic agents and insulin declined by 30.7% and 38.6%, respectively, in the PDL group vs controls. 
• The 30-day prescription fills for noninsulin and insulin antidiabetic medication increased by 7.1% (95% CI, 5.0%-9.3%) and 5.3% (95% CI, 2.2%-8.4%), respectively, among PDL members and was slightly higher among PDL members residing in low-income areas. 
• The PDL transition was associated with an 8.4% relative reduction (95% CI, −13.9% to −2.8%) in complication days overall (absolute reduction, −20.2 days per 1000 members per year). 
• Among members from lower-income areas, PDL transition was associated with a 10.2% relative reduction (95% CI, −17.4% to −3.0%) in complication days (absolute reduction, −26.1 per 1000 members per year) compared with controls. 

IN PRACTICE:

“Targeting out-of-pocket cost reductions to specific populations, in this case patients with diabetes from lower-income areas, might enhance health outcomes,” wrote the authors.

SOURCE: 

The study was conducted by J. Franklin Wharam, MD, MPH, Department of Medicine, Duke University, Durham, North Carolina. It was published online in JAMA Health Forum. 

LIMITATIONS: 

The findings may be generalized only to patients with diabetes enrolled in commercial health plans. Instead of being randomized, the PDL coverage was chosen by certain employers. Moreover, only outcomes associated with new PDL enrollment over a single year were evaluated.

DISCLOSURES: 

The study was funded by grants from the Centers for Disease Control and Prevention and National Institute of Diabetes and Digestive and Kidney Diseases. One of the authors reported receiving postmarket safety study stipends from Pfizer and GlaxoSmithKline outside the submitted work.

A version of this article appeared on Medscape.com.

TOPLINE:

A value-based medication plan that lowers out-of-pocket costs for antidiabetic medications reduces health complications in commercially insured individuals with diabetes, especially those living in lower-income areas.

METHODOLOGY: 

• Researchers assessed the 1-year impact on type 2 diabetes outcomes from a preventive drug list (PDL), which employers can add to plans to reduce out-of-pocket costs (copayments or deductibles) for high-value preventive medications.
• Using data from a national insurer, they identified 10,588 members with diabetes newly enrolled in PDL plans between January 2004 and June 2017 (age, 12-64 years; 44.8% women; 45.5% from the South; 33.4% from employers with < 100 enrollees).
• The members with diabetes on a PDL plan for a full follow-up year were matched and weighted against 690,075 control participants whose employers did not offer PDL.
• In a subgroup analysis, health outcomes for members with diabetes residing in lower-income neighborhoods (53.1%) were evaluated.
• The primary outcome was acute, preventable diabetes complications, such as bacterial infections, neurovascular events, acute coronary disease, and diabetic ketoacidosis, measured as complication days per 1000 members per year.

TAKEAWAY: 

• Out-of-pocket costs for noninsulin antidiabetic agents and insulin declined by 30.7% and 38.6%, respectively, in the PDL group vs controls. 
• The 30-day prescription fills for noninsulin and insulin antidiabetic medication increased by 7.1% (95% CI, 5.0%-9.3%) and 5.3% (95% CI, 2.2%-8.4%), respectively, among PDL members and was slightly higher among PDL members residing in low-income areas. 
• The PDL transition was associated with an 8.4% relative reduction (95% CI, −13.9% to −2.8%) in complication days overall (absolute reduction, −20.2 days per 1000 members per year). 
• Among members from lower-income areas, PDL transition was associated with a 10.2% relative reduction (95% CI, −17.4% to −3.0%) in complication days (absolute reduction, −26.1 per 1000 members per year) compared with controls. 

IN PRACTICE:

“Targeting out-of-pocket cost reductions to specific populations, in this case patients with diabetes from lower-income areas, might enhance health outcomes,” wrote the authors.

SOURCE: 

The study was conducted by J. Franklin Wharam, MD, MPH, Department of Medicine, Duke University, Durham, North Carolina. It was published online in JAMA Health Forum. 

LIMITATIONS: 

The findings may be generalized only to patients with diabetes enrolled in commercial health plans. Instead of being randomized, the PDL coverage was chosen by certain employers. Moreover, only outcomes associated with new PDL enrollment over a single year were evaluated.

DISCLOSURES: 

The study was funded by grants from the Centers for Disease Control and Prevention and National Institute of Diabetes and Digestive and Kidney Diseases. One of the authors reported receiving postmarket safety study stipends from Pfizer and GlaxoSmithKline outside the submitted work.

A version of this article appeared on Medscape.com.

TOPLINE:

Eating more than three meals daily, eating earlier, and eating lunch as the largest meal are linked to lower body mass index (BMI) and reduced obesity risk.

METHODOLOGY:

• According to recent research in the field of “chrononutrition,” which refers to the circadian pattern of eating behaviors, the timing of eating can affect an individual’s health and obesity.
• This exploratory, population-based study looked at the association between the timing of the largest meal of the day and the number of meals per day with BMI and obesity in 2050 nonpregnant adults in Brazil (ages 18-65 years; 15% with BMI ≥ 30; 73% women).
• In an online survey, participants reported their weight and height for BMI calculation and filled in questionnaires related to meal timing and frequency as well as diet quality and lifestyle traits.
• The 24-hour clock time (hh:mm) averages for the first eating event, lunch, and evening eating event were 8:27, 12:47, and 20:57, respectively, among all the participants.
• The median time of the largest meal was 12:38 and was the dividing line to classify people as early-eaters or late-eaters. Overall, lunch was the largest meal for 75% of people, and 75% ate more than three meals a day.

TAKEAWAY:

• Compared with participants who had up to three meals a day, those who reported more than three meals a day had a 0.48 lower BMI (P = .04) and lower odds of obesity (odds ratio [OR], 0.68; P = .005).
• Eating the largest meal later was associated with higher BMI values (0.07 for each additional hour; P = .03) and higher odds of obesity (OR, 1.04; P = .01).
• The group that reported dinner as the largest meal of the day had a 0.85 higher BMI (P = .02) and greater odds of obesity (OR, 1.67; P = .004) than the group that did not have dinner as the largest meal.
• On the other hand, having lunch as the main meal appeared to serve as a protective factor with lower odds of obesity (OR, 0.71; P = .01).

IN PRACTICE:

“Late-eaters (individuals who ate their largest meal after 12:38) exhibited several obesogenic and unhealthy behaviors (such as lower diet quality, shorter sleep duration, sedentary lifestyle, and prolonged screen time) that could potentially contribute to long-term weight gain and obesity,” the authors wrote.

SOURCE:

Giovana Longo-Silva, Faculty of Nutrition, Federal University of Alagoas, Maceió, Alagoas, Brazil, led this study, which was published online in Clinical Nutrition ESPEN.

LIMITATIONS:

The study used self-reported questionnaires, which are susceptible to underreporting. The participants included a greater number of highly educated women. The study used food scoring to evaluate the overall quality of each person’s dietary intake and may have missed variations in the distribution of nutrients in meals and in the total amount of energy and nutrients consumed, which could affect the BMI of participants. Despite adjustments for sociodemographic, diet-related, and lifestyle traits, a cross-sectional study cannot distinguish between cause and effect.

DISCLOSURES:

This work was supported by Fundação de Amparo à Pesquisa do Estado de Alagoas. The authors declared no conflicts of interest.
 

A version of this article appeared on Medscape.com.

TOPLINE:

Eating more than three meals daily, eating earlier, and eating lunch as the largest meal are linked to lower body mass index (BMI) and reduced obesity risk.

METHODOLOGY:

• According to recent research in the field of “chrononutrition,” which refers to the circadian pattern of eating behaviors, the timing of eating can affect an individual’s health and obesity.
• This exploratory, population-based study looked at the association between the timing of the largest meal of the day and the number of meals per day with BMI and obesity in 2050 nonpregnant adults in Brazil (ages 18-65 years; 15% with BMI ≥ 30; 73% women).
• In an online survey, participants reported their weight and height for BMI calculation and filled in questionnaires related to meal timing and frequency as well as diet quality and lifestyle traits.
• The 24-hour clock time (hh:mm) averages for the first eating event, lunch, and evening eating event were 8:27, 12:47, and 20:57, respectively, among all the participants.
• The median time of the largest meal was 12:38 and was the dividing line to classify people as early-eaters or late-eaters. Overall, lunch was the largest meal for 75% of people, and 75% ate more than three meals a day.

TAKEAWAY:

• Compared with participants who had up to three meals a day, those who reported more than three meals a day had a 0.48 lower BMI (P = .04) and lower odds of obesity (odds ratio [OR], 0.68; P = .005).
• Eating the largest meal later was associated with higher BMI values (0.07 for each additional hour; P = .03) and higher odds of obesity (OR, 1.04; P = .01).
• The group that reported dinner as the largest meal of the day had a 0.85 higher BMI (P = .02) and greater odds of obesity (OR, 1.67; P = .004) than the group that did not have dinner as the largest meal.
• On the other hand, having lunch as the main meal appeared to serve as a protective factor with lower odds of obesity (OR, 0.71; P = .01).

IN PRACTICE:

“Late-eaters (individuals who ate their largest meal after 12:38) exhibited several obesogenic and unhealthy behaviors (such as lower diet quality, shorter sleep duration, sedentary lifestyle, and prolonged screen time) that could potentially contribute to long-term weight gain and obesity,” the authors wrote.

SOURCE:

Giovana Longo-Silva, Faculty of Nutrition, Federal University of Alagoas, Maceió, Alagoas, Brazil, led this study, which was published online in Clinical Nutrition ESPEN.

LIMITATIONS:

The study used self-reported questionnaires, which are susceptible to underreporting. The participants included a greater number of highly educated women. The study used food scoring to evaluate the overall quality of each person’s dietary intake and may have missed variations in the distribution of nutrients in meals and in the total amount of energy and nutrients consumed, which could affect the BMI of participants. Despite adjustments for sociodemographic, diet-related, and lifestyle traits, a cross-sectional study cannot distinguish between cause and effect.

DISCLOSURES:

This work was supported by Fundação de Amparo à Pesquisa do Estado de Alagoas. The authors declared no conflicts of interest.
 

A version of this article appeared on Medscape.com.

TOPLINE:

Eating more than three meals daily, eating earlier, and eating lunch as the largest meal are linked to lower body mass index (BMI) and reduced obesity risk.

METHODOLOGY:

• According to recent research in the field of “chrononutrition,” which refers to the circadian pattern of eating behaviors, the timing of eating can affect an individual’s health and obesity.
• This exploratory, population-based study looked at the association between the timing of the largest meal of the day and the number of meals per day with BMI and obesity in 2050 nonpregnant adults in Brazil (ages 18-65 years; 15% with BMI ≥ 30; 73% women).
• In an online survey, participants reported their weight and height for BMI calculation and filled in questionnaires related to meal timing and frequency as well as diet quality and lifestyle traits.
• The 24-hour clock time (hh:mm) averages for the first eating event, lunch, and evening eating event were 8:27, 12:47, and 20:57, respectively, among all the participants.
• The median time of the largest meal was 12:38 and was the dividing line to classify people as early-eaters or late-eaters. Overall, lunch was the largest meal for 75% of people, and 75% ate more than three meals a day.

TAKEAWAY:

• Compared with participants who had up to three meals a day, those who reported more than three meals a day had a 0.48 lower BMI (P = .04) and lower odds of obesity (odds ratio [OR], 0.68; P = .005).
• Eating the largest meal later was associated with higher BMI values (0.07 for each additional hour; P = .03) and higher odds of obesity (OR, 1.04; P = .01).
• The group that reported dinner as the largest meal of the day had a 0.85 higher BMI (P = .02) and greater odds of obesity (OR, 1.67; P = .004) than the group that did not have dinner as the largest meal.
• On the other hand, having lunch as the main meal appeared to serve as a protective factor with lower odds of obesity (OR, 0.71; P = .01).

IN PRACTICE:

“Late-eaters (individuals who ate their largest meal after 12:38) exhibited several obesogenic and unhealthy behaviors (such as lower diet quality, shorter sleep duration, sedentary lifestyle, and prolonged screen time) that could potentially contribute to long-term weight gain and obesity,” the authors wrote.

SOURCE:

Giovana Longo-Silva, Faculty of Nutrition, Federal University of Alagoas, Maceió, Alagoas, Brazil, led this study, which was published online in Clinical Nutrition ESPEN.

LIMITATIONS:

The study used self-reported questionnaires, which are susceptible to underreporting. The participants included a greater number of highly educated women. The study used food scoring to evaluate the overall quality of each person’s dietary intake and may have missed variations in the distribution of nutrients in meals and in the total amount of energy and nutrients consumed, which could affect the BMI of participants. Despite adjustments for sociodemographic, diet-related, and lifestyle traits, a cross-sectional study cannot distinguish between cause and effect.

DISCLOSURES:

This work was supported by Fundação de Amparo à Pesquisa do Estado de Alagoas. The authors declared no conflicts of interest.
 

A version of this article appeared on Medscape.com.

A new position statement from the Endocrine Society aims to help clinicians prioritize patient experiences in the management of diabetes to optimize outcomes.

The statement reflects consensus from two virtual roundtables held in 2022, with participation from representatives of the American Diabetes Association, the American College of Cardiology, the American College of Physicians, the Association of Diabetes Care and Education Specialists, and the US Centers for Disease Control and Prevention, among others.

“Although we’ve had many new classes of medications and many new technologies introduced into the care of people with diabetes over the past decade, there continues to be significant gaps between what our clinical guidelines recommend needs to be done in order to attain optimal health outcomes and what is actually able to be implemented in practice,” writing panel chair Rita R. Kalyani, MD, told this news organization.

The roundtable discussions addressed existing gaps in diabetes care and available tools to support patient-centered care in practice, focusing on the importance of acknowledging the experience of the person living with diabetes, said Dr. Kalyani, professor of medicine, Division of Endocrinology, Diabetes, & Metabolism, Johns Hopkins University School of Medicine, Baltimore. “What is most important to them? What are the challenges they have in their day-to-day life, and what is being communicated or understood?”

The statement is targeted at all individuals involved in the care of people with diabetes, including endocrinologists, primary care providers, other specialists such as cardiologists and nephrologists, as well as pharmacists, educators, and nutritionists, she noted.

Asked to comment, David T. Ahn, MD, chief of diabetes services at Mary & Dick Allen Diabetes Center at Hoag, Newport Beach, California, said “the statement importantly emphasizes that optimally supporting a person with diabetes is about the entire patient experience and not simply their glycemic performance. People with diabetes are truly the biggest stakeholders in diabetes management, and their perspectives should matter.”

Published on February 21, 2024, in the Journal of Clinical Endocrinology and Metabolism, the statement covers the following topics in separate sections:

• The importance of effective patient-provider communication at the time of diagnosis and at every clinic visit
• Addressing emotional and psychosocial needs, including helping people through diabetes distress or “burnout”
• Referring patients for diabetes self-management education and support
• Navigating available therapeutic options and explaining complex regimens to patients
• Minimizing therapeutic and clinical inertia
• Reducing cardiovascular, kidney, and other complication risks, including with the use of newer medications
• Discussing strategies to minimize hypoglycemia when relevant
• Using telehealth when appropriate
• Integrating diabetes technologies into routine diabetes management

Each section begins with an illustrative clinical patient vignette. For example, one describes a 42-year-old man with type 2 diabetes on basal insulin who experienced hyperglycemia during illness. His provider advises him to dramatically increase his insulin dose, but he doesn’t because he remembers his father had a severe hypoglycemia episode when he did that. The man ends up hospitalized with dehydration and renal failure.

In another, a doctor hesitates to share test results with a patient during a telehealth visit because family members are in the room. During the same visit, the patient is unable to show the doctor her swollen foot because “If I move from this spot, the Internet connection will be lost.”

Dr. Ahn said, “I like the structure of the statement because the case-based format should help clinicians better identify potential blind spots in their own practice, as sometimes it can be easy to assume that we are immune to these potential pitfalls. I found the vignettes to be very realistic, and the discussions around them were extremely detailed, with many practical suggestions for improvement.”

Also scattered through the document are graphics to help visualize the content. Tables include a list of common psychosocial conditions in diabetes, a list of questions to ask people to help determine if they need additional psychosocial screening or resources, and questionnaires to assess an individual’s risk for hypoglycemia and the appropriateness of telehealth.

However, Dr. Ahn also noted, “I agree with all the major recommendations from the statement. Unfortunately, as the authors point out, practically implementing all the recommendations in this article may not be feasible in a traditional busy clinic, especially for primary care providers managing juggling multiple acute and chronic conditions ... The biggest challenge is being able to have the time and resources to actually implement these suggestions.”

Kalyani said, “tools to support patient-centered care cannot be burdensome for people with diabetes or the healthcare provider who already has limited time in order to be effective. They have to meet the ever-changing demands of new medications, new recommendations, and new technologies. New tools and resources will continue to need to be developed in the future.”

The position statement is a summary of discussions that occurred during two consensus roundtables in 2022 that were supported by educational grants to the Endocrine Society from Abbott, Medtronic, Novo Nordisk, and Vertex. However, this position statement was developed by the authors independently. Dr. Kalyani had no disclosures. Dr. Ahn consults for Lilly Diabetes and Ascensia Diabetes Care and is on the speakers bureau for Abbott, Ascensia, Insulet, Lilly, Mannkind, Novo, and Xeris.
 

A version of this article appeared on Medscape.com.

A new position statement from the Endocrine Society aims to help clinicians prioritize patient experiences in the management of diabetes to optimize outcomes.

The statement reflects consensus from two virtual roundtables held in 2022, with participation from representatives of the American Diabetes Association, the American College of Cardiology, the American College of Physicians, the Association of Diabetes Care and Education Specialists, and the US Centers for Disease Control and Prevention, among others.

“Although we’ve had many new classes of medications and many new technologies introduced into the care of people with diabetes over the past decade, there continues to be significant gaps between what our clinical guidelines recommend needs to be done in order to attain optimal health outcomes and what is actually able to be implemented in practice,” writing panel chair Rita R. Kalyani, MD, told this news organization.

The roundtable discussions addressed existing gaps in diabetes care and available tools to support patient-centered care in practice, focusing on the importance of acknowledging the experience of the person living with diabetes, said Dr. Kalyani, professor of medicine, Division of Endocrinology, Diabetes, & Metabolism, Johns Hopkins University School of Medicine, Baltimore. “What is most important to them? What are the challenges they have in their day-to-day life, and what is being communicated or understood?”

The statement is targeted at all individuals involved in the care of people with diabetes, including endocrinologists, primary care providers, other specialists such as cardiologists and nephrologists, as well as pharmacists, educators, and nutritionists, she noted.

Asked to comment, David T. Ahn, MD, chief of diabetes services at Mary & Dick Allen Diabetes Center at Hoag, Newport Beach, California, said “the statement importantly emphasizes that optimally supporting a person with diabetes is about the entire patient experience and not simply their glycemic performance. People with diabetes are truly the biggest stakeholders in diabetes management, and their perspectives should matter.”

Published on February 21, 2024, in the Journal of Clinical Endocrinology and Metabolism, the statement covers the following topics in separate sections:

• The importance of effective patient-provider communication at the time of diagnosis and at every clinic visit
• Addressing emotional and psychosocial needs, including helping people through diabetes distress or “burnout”
• Referring patients for diabetes self-management education and support
• Navigating available therapeutic options and explaining complex regimens to patients
• Minimizing therapeutic and clinical inertia
• Reducing cardiovascular, kidney, and other complication risks, including with the use of newer medications
• Discussing strategies to minimize hypoglycemia when relevant
• Using telehealth when appropriate
• Integrating diabetes technologies into routine diabetes management

Each section begins with an illustrative clinical patient vignette. For example, one describes a 42-year-old man with type 2 diabetes on basal insulin who experienced hyperglycemia during illness. His provider advises him to dramatically increase his insulin dose, but he doesn’t because he remembers his father had a severe hypoglycemia episode when he did that. The man ends up hospitalized with dehydration and renal failure.

In another, a doctor hesitates to share test results with a patient during a telehealth visit because family members are in the room. During the same visit, the patient is unable to show the doctor her swollen foot because “If I move from this spot, the Internet connection will be lost.”

Dr. Ahn said, “I like the structure of the statement because the case-based format should help clinicians better identify potential blind spots in their own practice, as sometimes it can be easy to assume that we are immune to these potential pitfalls. I found the vignettes to be very realistic, and the discussions around them were extremely detailed, with many practical suggestions for improvement.”

Also scattered through the document are graphics to help visualize the content. Tables include a list of common psychosocial conditions in diabetes, a list of questions to ask people to help determine if they need additional psychosocial screening or resources, and questionnaires to assess an individual’s risk for hypoglycemia and the appropriateness of telehealth.

However, Dr. Ahn also noted, “I agree with all the major recommendations from the statement. Unfortunately, as the authors point out, practically implementing all the recommendations in this article may not be feasible in a traditional busy clinic, especially for primary care providers managing juggling multiple acute and chronic conditions ... The biggest challenge is being able to have the time and resources to actually implement these suggestions.”

Kalyani said, “tools to support patient-centered care cannot be burdensome for people with diabetes or the healthcare provider who already has limited time in order to be effective. They have to meet the ever-changing demands of new medications, new recommendations, and new technologies. New tools and resources will continue to need to be developed in the future.”

The position statement is a summary of discussions that occurred during two consensus roundtables in 2022 that were supported by educational grants to the Endocrine Society from Abbott, Medtronic, Novo Nordisk, and Vertex. However, this position statement was developed by the authors independently. Dr. Kalyani had no disclosures. Dr. Ahn consults for Lilly Diabetes and Ascensia Diabetes Care and is on the speakers bureau for Abbott, Ascensia, Insulet, Lilly, Mannkind, Novo, and Xeris.
 

A version of this article appeared on Medscape.com.

A new position statement from the Endocrine Society aims to help clinicians prioritize patient experiences in the management of diabetes to optimize outcomes.

The statement reflects consensus from two virtual roundtables held in 2022, with participation from representatives of the American Diabetes Association, the American College of Cardiology, the American College of Physicians, the Association of Diabetes Care and Education Specialists, and the US Centers for Disease Control and Prevention, among others.

“Although we’ve had many new classes of medications and many new technologies introduced into the care of people with diabetes over the past decade, there continues to be significant gaps between what our clinical guidelines recommend needs to be done in order to attain optimal health outcomes and what is actually able to be implemented in practice,” writing panel chair Rita R. Kalyani, MD, told this news organization.

The roundtable discussions addressed existing gaps in diabetes care and available tools to support patient-centered care in practice, focusing on the importance of acknowledging the experience of the person living with diabetes, said Dr. Kalyani, professor of medicine, Division of Endocrinology, Diabetes, & Metabolism, Johns Hopkins University School of Medicine, Baltimore. “What is most important to them? What are the challenges they have in their day-to-day life, and what is being communicated or understood?”

The statement is targeted at all individuals involved in the care of people with diabetes, including endocrinologists, primary care providers, other specialists such as cardiologists and nephrologists, as well as pharmacists, educators, and nutritionists, she noted.

Asked to comment, David T. Ahn, MD, chief of diabetes services at Mary & Dick Allen Diabetes Center at Hoag, Newport Beach, California, said “the statement importantly emphasizes that optimally supporting a person with diabetes is about the entire patient experience and not simply their glycemic performance. People with diabetes are truly the biggest stakeholders in diabetes management, and their perspectives should matter.”

Published on February 21, 2024, in the Journal of Clinical Endocrinology and Metabolism, the statement covers the following topics in separate sections:

• The importance of effective patient-provider communication at the time of diagnosis and at every clinic visit
• Addressing emotional and psychosocial needs, including helping people through diabetes distress or “burnout”
• Referring patients for diabetes self-management education and support
• Navigating available therapeutic options and explaining complex regimens to patients
• Minimizing therapeutic and clinical inertia
• Reducing cardiovascular, kidney, and other complication risks, including with the use of newer medications
• Discussing strategies to minimize hypoglycemia when relevant
• Using telehealth when appropriate
• Integrating diabetes technologies into routine diabetes management

Each section begins with an illustrative clinical patient vignette. For example, one describes a 42-year-old man with type 2 diabetes on basal insulin who experienced hyperglycemia during illness. His provider advises him to dramatically increase his insulin dose, but he doesn’t because he remembers his father had a severe hypoglycemia episode when he did that. The man ends up hospitalized with dehydration and renal failure.

In another, a doctor hesitates to share test results with a patient during a telehealth visit because family members are in the room. During the same visit, the patient is unable to show the doctor her swollen foot because “If I move from this spot, the Internet connection will be lost.”

Dr. Ahn said, “I like the structure of the statement because the case-based format should help clinicians better identify potential blind spots in their own practice, as sometimes it can be easy to assume that we are immune to these potential pitfalls. I found the vignettes to be very realistic, and the discussions around them were extremely detailed, with many practical suggestions for improvement.”

Also scattered through the document are graphics to help visualize the content. Tables include a list of common psychosocial conditions in diabetes, a list of questions to ask people to help determine if they need additional psychosocial screening or resources, and questionnaires to assess an individual’s risk for hypoglycemia and the appropriateness of telehealth.

However, Dr. Ahn also noted, “I agree with all the major recommendations from the statement. Unfortunately, as the authors point out, practically implementing all the recommendations in this article may not be feasible in a traditional busy clinic, especially for primary care providers managing juggling multiple acute and chronic conditions ... The biggest challenge is being able to have the time and resources to actually implement these suggestions.”

Kalyani said, “tools to support patient-centered care cannot be burdensome for people with diabetes or the healthcare provider who already has limited time in order to be effective. They have to meet the ever-changing demands of new medications, new recommendations, and new technologies. New tools and resources will continue to need to be developed in the future.”

The position statement is a summary of discussions that occurred during two consensus roundtables in 2022 that were supported by educational grants to the Endocrine Society from Abbott, Medtronic, Novo Nordisk, and Vertex. However, this position statement was developed by the authors independently. Dr. Kalyani had no disclosures. Dr. Ahn consults for Lilly Diabetes and Ascensia Diabetes Care and is on the speakers bureau for Abbott, Ascensia, Insulet, Lilly, Mannkind, Novo, and Xeris.
 

A version of this article appeared on Medscape.com.

Bariatric surgery is associated with long-term improvements in cognition and brain structure in addition to general health benefits and expected weight loss, a large study found.

Among 133 adults with severe obesity who underwent bariatric surgery, roughly two in five showed > 20% improvement in global cognitive function at 24 months following the surgery. 

“Notably, the temporal cortex exhibited not only higher cortical thickness but also higher vascular efficiency after surgery,” reported Amanda Kiliaan, PhD, Radboud University Medical Center, Nijmegen, the Netherlands, and colleagues.

“These results highlight beneficial vascular responses occurring in conjunction with bariatric surgery,” the researchers wrote. 

They also suggested that weight-loss surgery may represent a treatment option for patients with obesity and dementia. 

The study was published online on February 9, 2024, in JAMA Network Open.

Obesity is associated with an increased risk of developing dementia. Bariatric surgery-induced weight loss has been associated with improvements in brain function and structure in some small cohort studies with short follow-up periods. However, long-term neurological outcomes associated with bariatric surgery are unclear. 

To investigate, Dr. Kiliaan and colleagues studied 133 adults with severe obesity (mean age, 46 years; 84% women) who underwent Roux-en-Y gastric bypass. The researchers collected relevant data from laboratory tests, cognitive tests, and MRI brain scans before surgery and at 6 and 24 months after surgery.

Overall, mean body weight, body mass index, waist circumference, and blood pressure were significantly lower at 6 and 24 months after surgery. At 24 months, significantly fewer patients were taking antihypertensive medication (17% vs 36% before surgery). 

Improvements in inflammatory markers, depressive symptoms, and physical activity were also evident after surgery. 
 

Cognitive Improvements 

Several cognitive domains showed significant improvement at 6 and 24 months after bariatric surgery. Based on the 20% change index, improvements in working memory, episodic memory, and verbal fluency were seen in 11%, 32%, and 24% of participants, respectively. 

Forty percent of patients showed improvement in their able to shift their attention, and 43% showed improvements in global cognition after surgery. 

Several changes in brain parameters were also noted. Despite lower cerebral blood flow (CBF) in several regions, volumes of hippocampus, nucleus accumbens, frontal cortex, white matter, and white matter hyperintensity remained stable after surgery. 

The temporal cortex showed a greater thickness (mean, 2.724 mm vs 2.761 mm; P = .007) and lower spatial coefficient of variation (sCOV; median, 4.41% vs 3.97%; P = .02) after surgery. 

Overall, the results suggest that cognitive improvements “begin shortly after bariatric surgery and are long lasting,” the authors wrote. 

Various factors may be involved including remission of comorbidities, higher physical activity, lower depressive symptoms, and lower inflammatory factors, they suggest. Stabilization of volume, CBF, and sCOV in brain regions, coupled with gains in cortical thickness and vascular efficiency in the temporal cortex could also play a role.
 

‘Remarkable’ Results

“Taken together, the research intimates bariatric surgery’s potential protective effects against dementia manifest through both weight-related brain changes and reducing cardiovascular risk factors,” Shaheen Lakhan, MD, a neurologist and researcher based in Miami, who wasn’t involved in the study, told this news organization.

“These remarkable neurological transformations intimate this surgery represents a pivotal opportunity to combat the parallel public health crises of obesity and dementia threatening society,” he said. 

“In demonstrating a durable cognitive and brain boost out years beyond surgery, patients now have an emphatic answer — these aren’t short-lived benefits but rather profound improvements propelling them positively for the rest of life,” he added. 

This opens up questions on whether the new class of obesity medications targeting glucagon-like peptide 1 (GLP-1) and gastric inhibitory polypeptide pathways, that can achieve weight loss approaching that of bariatric surgery, could have similar benefits. 

The use of GLP-1 drugs have also shown neuroprotective effects such as improvement in motor and cognitive deficits, reduction of neuroinflammation, prevention of neuronal loss, and possibly slowing of neurodegeneration across animal models of Parkinson’s disease, Alzheimer’s disease, and stroke, said Dr. Lakhan. However, the exact mechanisms and ability to cross the blood-brain barrier require further confirmation, especially in humans.

Large, long-term, randomized controlled trials looking into potential effects of semaglutide on early Alzheimer›s disease, including the EVOKE Plus trial, are currently underway, he noted. 

“These game-changing obesity drugs may hand us medicine’s holy grail — a pill to rival surgery’s brain benefits without the scalpel, allowing patients a more accessible path to protecting their brain,” Dr. Lakhan said.

The study had no funding from industry. Dr. Kiliaan and Dr. Lakhan had no relevant disclosures.

A version of this article first appeared on Medscape.com.

Bariatric surgery is associated with long-term improvements in cognition and brain structure in addition to general health benefits and expected weight loss, a large study found.

Among 133 adults with severe obesity who underwent bariatric surgery, roughly two in five showed > 20% improvement in global cognitive function at 24 months following the surgery. 

“Notably, the temporal cortex exhibited not only higher cortical thickness but also higher vascular efficiency after surgery,” reported Amanda Kiliaan, PhD, Radboud University Medical Center, Nijmegen, the Netherlands, and colleagues.

“These results highlight beneficial vascular responses occurring in conjunction with bariatric surgery,” the researchers wrote. 

They also suggested that weight-loss surgery may represent a treatment option for patients with obesity and dementia. 

The study was published online on February 9, 2024, in JAMA Network Open.

Obesity is associated with an increased risk of developing dementia. Bariatric surgery-induced weight loss has been associated with improvements in brain function and structure in some small cohort studies with short follow-up periods. However, long-term neurological outcomes associated with bariatric surgery are unclear. 

To investigate, Dr. Kiliaan and colleagues studied 133 adults with severe obesity (mean age, 46 years; 84% women) who underwent Roux-en-Y gastric bypass. The researchers collected relevant data from laboratory tests, cognitive tests, and MRI brain scans before surgery and at 6 and 24 months after surgery.

Overall, mean body weight, body mass index, waist circumference, and blood pressure were significantly lower at 6 and 24 months after surgery. At 24 months, significantly fewer patients were taking antihypertensive medication (17% vs 36% before surgery). 

Improvements in inflammatory markers, depressive symptoms, and physical activity were also evident after surgery. 
 

Cognitive Improvements 

Several cognitive domains showed significant improvement at 6 and 24 months after bariatric surgery. Based on the 20% change index, improvements in working memory, episodic memory, and verbal fluency were seen in 11%, 32%, and 24% of participants, respectively. 

Forty percent of patients showed improvement in their able to shift their attention, and 43% showed improvements in global cognition after surgery. 

Several changes in brain parameters were also noted. Despite lower cerebral blood flow (CBF) in several regions, volumes of hippocampus, nucleus accumbens, frontal cortex, white matter, and white matter hyperintensity remained stable after surgery. 

The temporal cortex showed a greater thickness (mean, 2.724 mm vs 2.761 mm; P = .007) and lower spatial coefficient of variation (sCOV; median, 4.41% vs 3.97%; P = .02) after surgery. 

Overall, the results suggest that cognitive improvements “begin shortly after bariatric surgery and are long lasting,” the authors wrote. 

Various factors may be involved including remission of comorbidities, higher physical activity, lower depressive symptoms, and lower inflammatory factors, they suggest. Stabilization of volume, CBF, and sCOV in brain regions, coupled with gains in cortical thickness and vascular efficiency in the temporal cortex could also play a role.
 

‘Remarkable’ Results

“Taken together, the research intimates bariatric surgery’s potential protective effects against dementia manifest through both weight-related brain changes and reducing cardiovascular risk factors,” Shaheen Lakhan, MD, a neurologist and researcher based in Miami, who wasn’t involved in the study, told this news organization.

“These remarkable neurological transformations intimate this surgery represents a pivotal opportunity to combat the parallel public health crises of obesity and dementia threatening society,” he said. 

“In demonstrating a durable cognitive and brain boost out years beyond surgery, patients now have an emphatic answer — these aren’t short-lived benefits but rather profound improvements propelling them positively for the rest of life,” he added. 

This opens up questions on whether the new class of obesity medications targeting glucagon-like peptide 1 (GLP-1) and gastric inhibitory polypeptide pathways, that can achieve weight loss approaching that of bariatric surgery, could have similar benefits. 

The use of GLP-1 drugs have also shown neuroprotective effects such as improvement in motor and cognitive deficits, reduction of neuroinflammation, prevention of neuronal loss, and possibly slowing of neurodegeneration across animal models of Parkinson’s disease, Alzheimer’s disease, and stroke, said Dr. Lakhan. However, the exact mechanisms and ability to cross the blood-brain barrier require further confirmation, especially in humans.

Large, long-term, randomized controlled trials looking into potential effects of semaglutide on early Alzheimer›s disease, including the EVOKE Plus trial, are currently underway, he noted. 

“These game-changing obesity drugs may hand us medicine’s holy grail — a pill to rival surgery’s brain benefits without the scalpel, allowing patients a more accessible path to protecting their brain,” Dr. Lakhan said.

The study had no funding from industry. Dr. Kiliaan and Dr. Lakhan had no relevant disclosures.

A version of this article first appeared on Medscape.com.

Bariatric surgery is associated with long-term improvements in cognition and brain structure in addition to general health benefits and expected weight loss, a large study found.

Among 133 adults with severe obesity who underwent bariatric surgery, roughly two in five showed > 20% improvement in global cognitive function at 24 months following the surgery. 

“Notably, the temporal cortex exhibited not only higher cortical thickness but also higher vascular efficiency after surgery,” reported Amanda Kiliaan, PhD, Radboud University Medical Center, Nijmegen, the Netherlands, and colleagues.

“These results highlight beneficial vascular responses occurring in conjunction with bariatric surgery,” the researchers wrote. 

They also suggested that weight-loss surgery may represent a treatment option for patients with obesity and dementia. 

The study was published online on February 9, 2024, in JAMA Network Open.

Obesity is associated with an increased risk of developing dementia. Bariatric surgery-induced weight loss has been associated with improvements in brain function and structure in some small cohort studies with short follow-up periods. However, long-term neurological outcomes associated with bariatric surgery are unclear. 

To investigate, Dr. Kiliaan and colleagues studied 133 adults with severe obesity (mean age, 46 years; 84% women) who underwent Roux-en-Y gastric bypass. The researchers collected relevant data from laboratory tests, cognitive tests, and MRI brain scans before surgery and at 6 and 24 months after surgery.

Overall, mean body weight, body mass index, waist circumference, and blood pressure were significantly lower at 6 and 24 months after surgery. At 24 months, significantly fewer patients were taking antihypertensive medication (17% vs 36% before surgery). 

Improvements in inflammatory markers, depressive symptoms, and physical activity were also evident after surgery. 
 

Cognitive Improvements 

Several cognitive domains showed significant improvement at 6 and 24 months after bariatric surgery. Based on the 20% change index, improvements in working memory, episodic memory, and verbal fluency were seen in 11%, 32%, and 24% of participants, respectively. 

Forty percent of patients showed improvement in their able to shift their attention, and 43% showed improvements in global cognition after surgery. 

Several changes in brain parameters were also noted. Despite lower cerebral blood flow (CBF) in several regions, volumes of hippocampus, nucleus accumbens, frontal cortex, white matter, and white matter hyperintensity remained stable after surgery. 

The temporal cortex showed a greater thickness (mean, 2.724 mm vs 2.761 mm; P = .007) and lower spatial coefficient of variation (sCOV; median, 4.41% vs 3.97%; P = .02) after surgery. 

Overall, the results suggest that cognitive improvements “begin shortly after bariatric surgery and are long lasting,” the authors wrote. 

Various factors may be involved including remission of comorbidities, higher physical activity, lower depressive symptoms, and lower inflammatory factors, they suggest. Stabilization of volume, CBF, and sCOV in brain regions, coupled with gains in cortical thickness and vascular efficiency in the temporal cortex could also play a role.
 

‘Remarkable’ Results

“Taken together, the research intimates bariatric surgery’s potential protective effects against dementia manifest through both weight-related brain changes and reducing cardiovascular risk factors,” Shaheen Lakhan, MD, a neurologist and researcher based in Miami, who wasn’t involved in the study, told this news organization.

“These remarkable neurological transformations intimate this surgery represents a pivotal opportunity to combat the parallel public health crises of obesity and dementia threatening society,” he said. 

“In demonstrating a durable cognitive and brain boost out years beyond surgery, patients now have an emphatic answer — these aren’t short-lived benefits but rather profound improvements propelling them positively for the rest of life,” he added. 

This opens up questions on whether the new class of obesity medications targeting glucagon-like peptide 1 (GLP-1) and gastric inhibitory polypeptide pathways, that can achieve weight loss approaching that of bariatric surgery, could have similar benefits. 

The use of GLP-1 drugs have also shown neuroprotective effects such as improvement in motor and cognitive deficits, reduction of neuroinflammation, prevention of neuronal loss, and possibly slowing of neurodegeneration across animal models of Parkinson’s disease, Alzheimer’s disease, and stroke, said Dr. Lakhan. However, the exact mechanisms and ability to cross the blood-brain barrier require further confirmation, especially in humans.

Large, long-term, randomized controlled trials looking into potential effects of semaglutide on early Alzheimer›s disease, including the EVOKE Plus trial, are currently underway, he noted. 

“These game-changing obesity drugs may hand us medicine’s holy grail — a pill to rival surgery’s brain benefits without the scalpel, allowing patients a more accessible path to protecting their brain,” Dr. Lakhan said.

The study had no funding from industry. Dr. Kiliaan and Dr. Lakhan had no relevant disclosures.

A version of this article first appeared on Medscape.com.

A significant quantity of dysfunctional monocytes appears to indicate poor cardiovascular prognosis in patients with type 2 diabetes, according to a new publication. Nicolas Venteclef, PhD, director of an Inserm institute for diabetes research at Necker Enfants Malades Hospital in Paris, France, led the research.

Quantifying Inflammation

Patients with type 2 diabetes have about twice the risk for a cardiovascular event associated with atherosclerosis, such as a heart attack or stroke, during their lifetimes. “Predicting these complications in diabetic patients is usually very difficult,” Dr. Venteclef told this news organization.

“They are strongly associated with inflammation in these patients. Therefore, we sought to quantify this inflammation in the blood.” To do this, his team focused on monocytes, a category of white blood cells circulating in the blood. They measured the blood concentration of monocytes and the subtypes present in patients with type 2 diabetes.

The results were published in Circulation Research.
 

Dysfunctional Monocytes

The team worked with three cohorts of patients. The first, named AngioSafe-2, consisting of 672 patients with type 2 diabetes, was recruited from the diabetology departments of Lariboisière and Bichat Claude Bernard hospitals in France. This cohort allowed researchers to demonstrate that the higher the number of circulating monocytes, the greater the risk for cardiovascular events, independent of age and duration of diabetes. This observation was confirmed through a second cohort, GLUTADIAB, that comprised 279 patients with type 2 diabetes. Scientists complemented their work with molecular analysis of circulating monocytes in these two cohorts, which revealed certain predominant monocyte subtypes in patients with type 2 diabetes at high cardiovascular risk. “These monocytes are dysfunctional because they have a mitochondrial problem,” Dr. Venteclef explained.

To better understand how these results could be used to predict cardiovascular risk, the team collaborated with colleagues from the University Hospital of Nantes on a cohort called SURDIAGENE, which included 757 patients with type 2 diabetes. “We conducted a longitudinal study by following these patients for 10 years and quantifying cardiovascular events and deaths,” said Dr. Venteclef. Circulating monocyte levels were correlated with the occurrence of heart attacks or strokes. The researchers observed that patients with type 2 diabetes with a monocyte count above a certain threshold (0.5 × 109/L) had a five- to seven-times higher risk for cardiovascular events over 10 years than those with a monocyte count below this threshold.

A patent was filed at the end of 2023 to protect this discovery. “Our next step is to develop a sensor to quantify monocytes more easily and avoid blood draws,” said Dr. Venteclef. “As part of a European project, we will also launch a trial with an anti-inflammatory drug in diabetics, with the hope of interrupting the inflammatory trajectory and preventing complications.”
 

This story was translated from the Medscape French edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

A significant quantity of dysfunctional monocytes appears to indicate poor cardiovascular prognosis in patients with type 2 diabetes, according to a new publication. Nicolas Venteclef, PhD, director of an Inserm institute for diabetes research at Necker Enfants Malades Hospital in Paris, France, led the research.

Quantifying Inflammation

Patients with type 2 diabetes have about twice the risk for a cardiovascular event associated with atherosclerosis, such as a heart attack or stroke, during their lifetimes. “Predicting these complications in diabetic patients is usually very difficult,” Dr. Venteclef told this news organization.

“They are strongly associated with inflammation in these patients. Therefore, we sought to quantify this inflammation in the blood.” To do this, his team focused on monocytes, a category of white blood cells circulating in the blood. They measured the blood concentration of monocytes and the subtypes present in patients with type 2 diabetes.

The results were published in Circulation Research.
 

Dysfunctional Monocytes

The team worked with three cohorts of patients. The first, named AngioSafe-2, consisting of 672 patients with type 2 diabetes, was recruited from the diabetology departments of Lariboisière and Bichat Claude Bernard hospitals in France. This cohort allowed researchers to demonstrate that the higher the number of circulating monocytes, the greater the risk for cardiovascular events, independent of age and duration of diabetes. This observation was confirmed through a second cohort, GLUTADIAB, that comprised 279 patients with type 2 diabetes. Scientists complemented their work with molecular analysis of circulating monocytes in these two cohorts, which revealed certain predominant monocyte subtypes in patients with type 2 diabetes at high cardiovascular risk. “These monocytes are dysfunctional because they have a mitochondrial problem,” Dr. Venteclef explained.

To better understand how these results could be used to predict cardiovascular risk, the team collaborated with colleagues from the University Hospital of Nantes on a cohort called SURDIAGENE, which included 757 patients with type 2 diabetes. “We conducted a longitudinal study by following these patients for 10 years and quantifying cardiovascular events and deaths,” said Dr. Venteclef. Circulating monocyte levels were correlated with the occurrence of heart attacks or strokes. The researchers observed that patients with type 2 diabetes with a monocyte count above a certain threshold (0.5 × 109/L) had a five- to seven-times higher risk for cardiovascular events over 10 years than those with a monocyte count below this threshold.

A patent was filed at the end of 2023 to protect this discovery. “Our next step is to develop a sensor to quantify monocytes more easily and avoid blood draws,” said Dr. Venteclef. “As part of a European project, we will also launch a trial with an anti-inflammatory drug in diabetics, with the hope of interrupting the inflammatory trajectory and preventing complications.”
 

This story was translated from the Medscape French edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

A significant quantity of dysfunctional monocytes appears to indicate poor cardiovascular prognosis in patients with type 2 diabetes, according to a new publication. Nicolas Venteclef, PhD, director of an Inserm institute for diabetes research at Necker Enfants Malades Hospital in Paris, France, led the research.

Quantifying Inflammation

Patients with type 2 diabetes have about twice the risk for a cardiovascular event associated with atherosclerosis, such as a heart attack or stroke, during their lifetimes. “Predicting these complications in diabetic patients is usually very difficult,” Dr. Venteclef told this news organization.

“They are strongly associated with inflammation in these patients. Therefore, we sought to quantify this inflammation in the blood.” To do this, his team focused on monocytes, a category of white blood cells circulating in the blood. They measured the blood concentration of monocytes and the subtypes present in patients with type 2 diabetes.

The results were published in Circulation Research.
 

Dysfunctional Monocytes

The team worked with three cohorts of patients. The first, named AngioSafe-2, consisting of 672 patients with type 2 diabetes, was recruited from the diabetology departments of Lariboisière and Bichat Claude Bernard hospitals in France. This cohort allowed researchers to demonstrate that the higher the number of circulating monocytes, the greater the risk for cardiovascular events, independent of age and duration of diabetes. This observation was confirmed through a second cohort, GLUTADIAB, that comprised 279 patients with type 2 diabetes. Scientists complemented their work with molecular analysis of circulating monocytes in these two cohorts, which revealed certain predominant monocyte subtypes in patients with type 2 diabetes at high cardiovascular risk. “These monocytes are dysfunctional because they have a mitochondrial problem,” Dr. Venteclef explained.

To better understand how these results could be used to predict cardiovascular risk, the team collaborated with colleagues from the University Hospital of Nantes on a cohort called SURDIAGENE, which included 757 patients with type 2 diabetes. “We conducted a longitudinal study by following these patients for 10 years and quantifying cardiovascular events and deaths,” said Dr. Venteclef. Circulating monocyte levels were correlated with the occurrence of heart attacks or strokes. The researchers observed that patients with type 2 diabetes with a monocyte count above a certain threshold (0.5 × 109/L) had a five- to seven-times higher risk for cardiovascular events over 10 years than those with a monocyte count below this threshold.

A patent was filed at the end of 2023 to protect this discovery. “Our next step is to develop a sensor to quantify monocytes more easily and avoid blood draws,” said Dr. Venteclef. “As part of a European project, we will also launch a trial with an anti-inflammatory drug in diabetics, with the hope of interrupting the inflammatory trajectory and preventing complications.”
 

This story was translated from the Medscape French edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

TOPLINE:

Selenium supplementation is associated with improvements in key thyroid measures in patients with Hashimoto thyroiditis who are not treated with thyroid hormone replacement therapy, research from a new meta-analysis showed.

METHODOLOGY:

• For the systematic review and meta-analysis, 35 randomized controlled trials were identified that included evaluation of selenium supplementation’s effects on thyroid function.
• The studies focused on a variety of key thyroid function measures, including thyroid-stimulating hormone (TSH), free and total thyroxine (fT4, T4), free and total triiodothyronine (fT3, T3), thyroid antibodies, safety, and other factors.
• Stratified analyses were conducted to evaluate key factors including the dose and duration of selenium supplementation; patients’ thyroid status, age, gender, treatment with hormone replacement, and selenium status, such as deficiency or sufficiency; and other factors.
• While patients’ selenium levels at baseline were reported in only about half of the studies, among those that did have the data, the vast majority — 89% of cohorts — were selenium deficient.
• The study populations ranged from 31 to 364 and included children, adolescents, and adults.

TAKEAWAY:

• The analysis showed selenium supplementation to be significantly associated with decreased TSH in patients who were not treated with thyroid hormone replacement therapy (standardized mean difference [SMD], −0.21 in seven cohorts, involving 869 participants).
• Improvements associated with selenium replacement were also observed regardless of whether patients were on thyroid hormone replacement therapy in terms of decreases in thyroid peroxidase antibodies (TPOAb) (SMD, −0.96 in 29 cohorts, involving 2358 participants) and malondialdehyde (SMD, −1.16 in three cohorts, involving 248 participants).
• Overall, selenium supplementation had no significant effects on other notable thyroid measures, including fT4, T4, fT3, T3, thyroglobulin antibody (TGAb), thyroid volume, interleukin 2, or interleukin 10. However, when the analysis only included adults aged 18 and older, the selenium supplementation was linked to reductions in TSH and TPOAb, as well as increases in fT4 levels.
• Importantly, no significant differences were observed in terms of adverse effects between the studies’ intervention and control groups at selenium supplementation doses ranging from 80 to 400 μg/d for up to 12 months (odds ratio, 0.89 in 16 cohorts, involving 1339 participants).
• The authors determined that the certainty of evidence, overall, was moderate.

IN PRACTICE:

The results regarding effects of selenium on TSH “add to the existing knowledge in this field by demonstrating an effect of selenium supplementation on lowering TSH levels exclusively in Hashimoto thyroiditis patients without thyroid hormone replacement therapy,” the authors wrote. Furthermore, “our study reaffirmed the results of six prior meta-analyses reporting an effect of selenium in reducing TPOAb levels,” they added. “The inclusion of 31 cohorts enhanced statistical power compared to the previous meta-analyses, which included a maximum of nine cohorts.” “Our study suggests that selenium supplementation is safe and holds potential as a disease-modifying factor for Hashimoto thyroiditis–associated hypothyroidism,” the authors reported. “Further research is needed to confirm its efficacy, fully understand its mechanism of action, and elucidate its cost-effectiveness.”

SOURCE:

The study’s first author was Valentina V. Huwiler, MSc, of the Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland. The study was published in Thyroid.

LIMITATIONS:

Due to variations in assays used in the different studies for measures including TPOAb and TGAb, the authors used SMD instead of the mean difference typically recommended when varying assays are used; however, only the effect size can be interpreted and not the clinical significance, the authors noted. Serum selenium concentrations may vary based on the analytical technique. Data on participants’ dietary habits and compliance with study regimens were not available.

DISCLOSURES:

The authors had no disclosures to report.

A version of this article appeared on Medscape.com.

TOPLINE:

Selenium supplementation is associated with improvements in key thyroid measures in patients with Hashimoto thyroiditis who are not treated with thyroid hormone replacement therapy, research from a new meta-analysis showed.

METHODOLOGY:

• For the systematic review and meta-analysis, 35 randomized controlled trials were identified that included evaluation of selenium supplementation’s effects on thyroid function.
• The studies focused on a variety of key thyroid function measures, including thyroid-stimulating hormone (TSH), free and total thyroxine (fT4, T4), free and total triiodothyronine (fT3, T3), thyroid antibodies, safety, and other factors.
• Stratified analyses were conducted to evaluate key factors including the dose and duration of selenium supplementation; patients’ thyroid status, age, gender, treatment with hormone replacement, and selenium status, such as deficiency or sufficiency; and other factors.
• While patients’ selenium levels at baseline were reported in only about half of the studies, among those that did have the data, the vast majority — 89% of cohorts — were selenium deficient.
• The study populations ranged from 31 to 364 and included children, adolescents, and adults.

TAKEAWAY:

• The analysis showed selenium supplementation to be significantly associated with decreased TSH in patients who were not treated with thyroid hormone replacement therapy (standardized mean difference [SMD], −0.21 in seven cohorts, involving 869 participants).
• Improvements associated with selenium replacement were also observed regardless of whether patients were on thyroid hormone replacement therapy in terms of decreases in thyroid peroxidase antibodies (TPOAb) (SMD, −0.96 in 29 cohorts, involving 2358 participants) and malondialdehyde (SMD, −1.16 in three cohorts, involving 248 participants).
• Overall, selenium supplementation had no significant effects on other notable thyroid measures, including fT4, T4, fT3, T3, thyroglobulin antibody (TGAb), thyroid volume, interleukin 2, or interleukin 10. However, when the analysis only included adults aged 18 and older, the selenium supplementation was linked to reductions in TSH and TPOAb, as well as increases in fT4 levels.
• Importantly, no significant differences were observed in terms of adverse effects between the studies’ intervention and control groups at selenium supplementation doses ranging from 80 to 400 μg/d for up to 12 months (odds ratio, 0.89 in 16 cohorts, involving 1339 participants).
• The authors determined that the certainty of evidence, overall, was moderate.

IN PRACTICE:

The results regarding effects of selenium on TSH “add to the existing knowledge in this field by demonstrating an effect of selenium supplementation on lowering TSH levels exclusively in Hashimoto thyroiditis patients without thyroid hormone replacement therapy,” the authors wrote. Furthermore, “our study reaffirmed the results of six prior meta-analyses reporting an effect of selenium in reducing TPOAb levels,” they added. “The inclusion of 31 cohorts enhanced statistical power compared to the previous meta-analyses, which included a maximum of nine cohorts.” “Our study suggests that selenium supplementation is safe and holds potential as a disease-modifying factor for Hashimoto thyroiditis–associated hypothyroidism,” the authors reported. “Further research is needed to confirm its efficacy, fully understand its mechanism of action, and elucidate its cost-effectiveness.”

SOURCE:

The study’s first author was Valentina V. Huwiler, MSc, of the Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland. The study was published in Thyroid.

LIMITATIONS:

Due to variations in assays used in the different studies for measures including TPOAb and TGAb, the authors used SMD instead of the mean difference typically recommended when varying assays are used; however, only the effect size can be interpreted and not the clinical significance, the authors noted. Serum selenium concentrations may vary based on the analytical technique. Data on participants’ dietary habits and compliance with study regimens were not available.

DISCLOSURES:

The authors had no disclosures to report.

A version of this article appeared on Medscape.com.

TOPLINE:

Selenium supplementation is associated with improvements in key thyroid measures in patients with Hashimoto thyroiditis who are not treated with thyroid hormone replacement therapy, research from a new meta-analysis showed.

METHODOLOGY:

• For the systematic review and meta-analysis, 35 randomized controlled trials were identified that included evaluation of selenium supplementation’s effects on thyroid function.
• The studies focused on a variety of key thyroid function measures, including thyroid-stimulating hormone (TSH), free and total thyroxine (fT4, T4), free and total triiodothyronine (fT3, T3), thyroid antibodies, safety, and other factors.
• Stratified analyses were conducted to evaluate key factors including the dose and duration of selenium supplementation; patients’ thyroid status, age, gender, treatment with hormone replacement, and selenium status, such as deficiency or sufficiency; and other factors.
• While patients’ selenium levels at baseline were reported in only about half of the studies, among those that did have the data, the vast majority — 89% of cohorts — were selenium deficient.
• The study populations ranged from 31 to 364 and included children, adolescents, and adults.

TAKEAWAY:

• The analysis showed selenium supplementation to be significantly associated with decreased TSH in patients who were not treated with thyroid hormone replacement therapy (standardized mean difference [SMD], −0.21 in seven cohorts, involving 869 participants).
• Improvements associated with selenium replacement were also observed regardless of whether patients were on thyroid hormone replacement therapy in terms of decreases in thyroid peroxidase antibodies (TPOAb) (SMD, −0.96 in 29 cohorts, involving 2358 participants) and malondialdehyde (SMD, −1.16 in three cohorts, involving 248 participants).
• Overall, selenium supplementation had no significant effects on other notable thyroid measures, including fT4, T4, fT3, T3, thyroglobulin antibody (TGAb), thyroid volume, interleukin 2, or interleukin 10. However, when the analysis only included adults aged 18 and older, the selenium supplementation was linked to reductions in TSH and TPOAb, as well as increases in fT4 levels.
• Importantly, no significant differences were observed in terms of adverse effects between the studies’ intervention and control groups at selenium supplementation doses ranging from 80 to 400 μg/d for up to 12 months (odds ratio, 0.89 in 16 cohorts, involving 1339 participants).
• The authors determined that the certainty of evidence, overall, was moderate.

IN PRACTICE:

The results regarding effects of selenium on TSH “add to the existing knowledge in this field by demonstrating an effect of selenium supplementation on lowering TSH levels exclusively in Hashimoto thyroiditis patients without thyroid hormone replacement therapy,” the authors wrote. Furthermore, “our study reaffirmed the results of six prior meta-analyses reporting an effect of selenium in reducing TPOAb levels,” they added. “The inclusion of 31 cohorts enhanced statistical power compared to the previous meta-analyses, which included a maximum of nine cohorts.” “Our study suggests that selenium supplementation is safe and holds potential as a disease-modifying factor for Hashimoto thyroiditis–associated hypothyroidism,” the authors reported. “Further research is needed to confirm its efficacy, fully understand its mechanism of action, and elucidate its cost-effectiveness.”

SOURCE:

The study’s first author was Valentina V. Huwiler, MSc, of the Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland. The study was published in Thyroid.

LIMITATIONS:

Due to variations in assays used in the different studies for measures including TPOAb and TGAb, the authors used SMD instead of the mean difference typically recommended when varying assays are used; however, only the effect size can be interpreted and not the clinical significance, the authors noted. Serum selenium concentrations may vary based on the analytical technique. Data on participants’ dietary habits and compliance with study regimens were not available.

DISCLOSURES:

The authors had no disclosures to report.

A version of this article appeared on Medscape.com.

TOPLINE:

Greater adherence to a plant-based dietary pattern was associated with a lower risk of developing type 2 diabetes (T2D) among middle-aged US adults. Greater intake of healthful plant foods, rather than lower intake of non-red meat animal foods, was the main factor underlying the inverse associations.

METHODOLOGY:

• The study population was 11,965 adults aged 45-64 years from the Atherosclerosis Risk in Communities (ARIC) study who didn›t have diabetes at baseline and who completed food-frequency questionnaires.
• Plant-based diet adherence was classified overall with the plant-based diet index (PDI) and also with higher healthful PDI (hPDI) and higher unhealthful PDI (uPDI) indexes.

TAKEAWAY:

• Mean daily total plant and animal food intakes for the highest quintile (5) were 15.1 and 3.4 servings per day, respectively, whereas average consumption for the lowest quintile (1) was 9.9 and 5.8 servings per day, respectively.
• During a median 22 years’ follow-up, 35% (n = 4208) of the participants developed T2D.
• After controlling for age, sex, race center, energy intake, education, income, smoking, alcohol intake, physical activity, and margarine intake, those in PDI quintile 5 had a significantly lower risk of developing T2D than in quintile 1 (hazard ratio, 0.89; P = .01).
• As a continuous score, each 10-point higher PDI score was associated with a significant 6% lower risk for T2D (P = .01).
• Higher hPDI scores were also inversely associated with T2D risk (hazard ratio, 0.85 for quintiles 5 vs 1; P < .001), and (0.90 per each 10 units higher; P < .001).
• Higher uPDI scores were not significantly associated with diabetes risk, regardless of adjustments (P > .05).
• Associations between plant-based diet scores and diabetes did not differ by sex, age, race, or body mass index (BMI) after accounting for multiple comparisons (all P interaction > .05).
• Further adjustment for BMI attenuated the associations between overall and healthy plant-based diets and diabetes risk, suggesting that lower adiposity may partly explain the favorable association.

IN PRACTICE:

“Emphasizing plant foods may be an effective dietary strategy to delay or prevent the onset of diabetes.”

SOURCE:

The study conducted by Valerie K. Sullivan, PhD, RD, of the Welch Center for Prevention, Epidemiology, and Clinical Research, Johns Hopkins University, Baltimore, Maryland, and colleagues was published online in Diabetes Care.

LIMITATIONS:

The limitations were self-reported dietary intake, diets assessed decades ago, possible food misclassification, possible selection bias, and residual confounding.

DISCLOSURES:

The ARIC study was funded by the US National Institutes of Health. The authors had no further disclosures.

A version of this article appeared on Medscape.com.

TOPLINE:

Greater adherence to a plant-based dietary pattern was associated with a lower risk of developing type 2 diabetes (T2D) among middle-aged US adults. Greater intake of healthful plant foods, rather than lower intake of non-red meat animal foods, was the main factor underlying the inverse associations.

METHODOLOGY:

• The study population was 11,965 adults aged 45-64 years from the Atherosclerosis Risk in Communities (ARIC) study who didn›t have diabetes at baseline and who completed food-frequency questionnaires.
• Plant-based diet adherence was classified overall with the plant-based diet index (PDI) and also with higher healthful PDI (hPDI) and higher unhealthful PDI (uPDI) indexes.

TAKEAWAY:

• Mean daily total plant and animal food intakes for the highest quintile (5) were 15.1 and 3.4 servings per day, respectively, whereas average consumption for the lowest quintile (1) was 9.9 and 5.8 servings per day, respectively.
• During a median 22 years’ follow-up, 35% (n = 4208) of the participants developed T2D.
• After controlling for age, sex, race center, energy intake, education, income, smoking, alcohol intake, physical activity, and margarine intake, those in PDI quintile 5 had a significantly lower risk of developing T2D than in quintile 1 (hazard ratio, 0.89; P = .01).
• As a continuous score, each 10-point higher PDI score was associated with a significant 6% lower risk for T2D (P = .01).
• Higher hPDI scores were also inversely associated with T2D risk (hazard ratio, 0.85 for quintiles 5 vs 1; P < .001), and (0.90 per each 10 units higher; P < .001).
• Higher uPDI scores were not significantly associated with diabetes risk, regardless of adjustments (P > .05).
• Associations between plant-based diet scores and diabetes did not differ by sex, age, race, or body mass index (BMI) after accounting for multiple comparisons (all P interaction > .05).
• Further adjustment for BMI attenuated the associations between overall and healthy plant-based diets and diabetes risk, suggesting that lower adiposity may partly explain the favorable association.

IN PRACTICE:

“Emphasizing plant foods may be an effective dietary strategy to delay or prevent the onset of diabetes.”

SOURCE:

The study conducted by Valerie K. Sullivan, PhD, RD, of the Welch Center for Prevention, Epidemiology, and Clinical Research, Johns Hopkins University, Baltimore, Maryland, and colleagues was published online in Diabetes Care.

LIMITATIONS:

The limitations were self-reported dietary intake, diets assessed decades ago, possible food misclassification, possible selection bias, and residual confounding.

DISCLOSURES:

The ARIC study was funded by the US National Institutes of Health. The authors had no further disclosures.

A version of this article appeared on Medscape.com.

TOPLINE:

Greater adherence to a plant-based dietary pattern was associated with a lower risk of developing type 2 diabetes (T2D) among middle-aged US adults. Greater intake of healthful plant foods, rather than lower intake of non-red meat animal foods, was the main factor underlying the inverse associations.

METHODOLOGY:

• The study population was 11,965 adults aged 45-64 years from the Atherosclerosis Risk in Communities (ARIC) study who didn›t have diabetes at baseline and who completed food-frequency questionnaires.
• Plant-based diet adherence was classified overall with the plant-based diet index (PDI) and also with higher healthful PDI (hPDI) and higher unhealthful PDI (uPDI) indexes.

TAKEAWAY:

• Mean daily total plant and animal food intakes for the highest quintile (5) were 15.1 and 3.4 servings per day, respectively, whereas average consumption for the lowest quintile (1) was 9.9 and 5.8 servings per day, respectively.
• During a median 22 years’ follow-up, 35% (n = 4208) of the participants developed T2D.
• After controlling for age, sex, race center, energy intake, education, income, smoking, alcohol intake, physical activity, and margarine intake, those in PDI quintile 5 had a significantly lower risk of developing T2D than in quintile 1 (hazard ratio, 0.89; P = .01).
• As a continuous score, each 10-point higher PDI score was associated with a significant 6% lower risk for T2D (P = .01).
• Higher hPDI scores were also inversely associated with T2D risk (hazard ratio, 0.85 for quintiles 5 vs 1; P < .001), and (0.90 per each 10 units higher; P < .001).
• Higher uPDI scores were not significantly associated with diabetes risk, regardless of adjustments (P > .05).
• Associations between plant-based diet scores and diabetes did not differ by sex, age, race, or body mass index (BMI) after accounting for multiple comparisons (all P interaction > .05).
• Further adjustment for BMI attenuated the associations between overall and healthy plant-based diets and diabetes risk, suggesting that lower adiposity may partly explain the favorable association.

IN PRACTICE:

“Emphasizing plant foods may be an effective dietary strategy to delay or prevent the onset of diabetes.”

SOURCE:

The study conducted by Valerie K. Sullivan, PhD, RD, of the Welch Center for Prevention, Epidemiology, and Clinical Research, Johns Hopkins University, Baltimore, Maryland, and colleagues was published online in Diabetes Care.

LIMITATIONS:

The limitations were self-reported dietary intake, diets assessed decades ago, possible food misclassification, possible selection bias, and residual confounding.

DISCLOSURES:

The ARIC study was funded by the US National Institutes of Health. The authors had no further disclosures.

A version of this article appeared on Medscape.com.