diabetes

Diabetes and Endocrinology

PMID (1):

40952752

MeSH

Glucagon-Like Peptide-1 Receptor Agonists

Glycated Hemoglobin

overweight

glucagon-like peptide 1

Prediabetic State

blood pressure

pediatric obesity

Digestive System Diseases

A review of what we know about the use of GLP-1 RAs in children and adolescents. James W. Mold, MD, MPH

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Importance Obesity affects 1 in 5 children and adolescents, increasing the risk of type 2 diabetes (T2D). Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) are among the few pharmacotherapy options available for this population, necessitating a comprehensive evaluation of efficacy and safety.

Objective To assess the efficacy and safety of GLP-1 RAs in children and adolescents (<18 years) with obesity, prediabetes, or T2D.

Data Sources A systematic search was conducted in PubMed, Embase, and the Cochrane Central Register of Controlled Trials (CENTRAL) for randomized clinical trials (RCTs) published from inception until February 28, 2025. Data analysis was completed from January 2025 to April 2025.

Study Selection RCTs comparing GLP-1 RAs to placebo in children and adolescents with obesity, overweight, prediabetes, or T2D with reported safety and efficacy data were included.

Data Extraction and Synthesis Two reviewers independently extracted data on sample size, population, interventions, follow-up, and outcomes. Risk of bias was assessed using version 2 of the Cochrane risk of bias tool (RoB2). Efficacy outcomes (except lipids) were analyzed as estimated treatment differences, lipids as estimated treatment ratios, and safety via rate ratios. A random-effects inverse variance model was used for all outcomes.

Main Outcomes and Measures The primary efficacy outcomes were change in hemoglobin A1c (HbA1c) (in percentage points), fasting glucose (in milligrams per deciliter), body weight (in kilograms), body mass index (BMI, calculated as weight in kilograms divided by height in meters squared), BMI z scores or percentiles, BMI standard deviation score (SDS), lipid outcomes, and blood pressure. Exploratory efficacy outcomes included obstructive sleep apnea and metabolic dysfunction–associated steatohepatitis or metabolic dysfunction–associated steatotic liver disease. Safety outcomes included gastrointestinal adverse effects (GI AEs), infections, hepatobiliary disorders, suicidal ideation or behaviors, depression, hypoglycemia, and adverse event discontinuations.

Results A total of 18 RCTs (11 in obesity, 6 in T2D, and 1 in prediabetes) with 1402 participants (838 GLP-1 RA users and 564 placebo) were included (mean [range] age, 13.7 [6-17] years; 831 female participants (59.3%); median [IQR] treatment duration, 0.51 [0.25-1.00] years). GLP-1 RAs significantly reduced HbA1c (−0.44%; 95% CI, −0.68% to −0.21%), fasting glucose (−9.92 mg/dL; 95% CI, −16.20 to −3.64), body weight (−3.02 kg; 95% CI, −4.98 to −1.06), BMI (−1.45; 95% CI, −2.40 to −0.49), BMI SDS (−0.20; 95% CI, −0.36 to −0.05), BMI percentile (−7.24%; 95% CI, −12.97% to −1.51%), and systolic blood pressure (−2.73 mm Hg; 95% CI, −4.04 to −1.43) and increased GI AE (log[rate ratio] [RR], 0.75). Other AEs, including suicidal ideation or behaviors, showed no significant differences.

Conclusions and Relevance In this systematic review and meta-analysis of 18 trials, GLP-1 RAs significantly improved glycemic, weight, and cardiometabolic outcomes in children and adolescents with T2D or obesity. Available data over a relatively short follow-up suggested suicidal ideation or behaviors were not significantly different, although GI AEs warrant attention in long-term management.

Author/s:

Pareeta Kotecha, Wenxi Huang, Ya-Yun Yeh

Diagnosis and Treatment of Type 2 Diabetes in Adults A Review

Hope Smashey — Tue, 01 Jul 2025 19:34:58 +0000

Date Added:

July 1, 2025

Journal/Publication:

JAMA

Publication Date:

June 23, 2025

URL:

Diagnosis and Treatment of Type 2 Diabetes in Adults: A Review

Type:

Meta-analyses, Reviews, and Guidelines

Format:

Article

DOI (1):

10.1001/jama.2025.5956

Keywords

type 2 diabetes

treatment

PMID (1):

40549398

MeSH

dipeptidyl-peptidase IV inhibitors

Type 2

cardiovascular diseases

Insulin Resistance

Insulin Secretion

Glucose Tolerance Test

overweight

risk factors

An evidence-based review of the treatment of patients with Type 2 diabetes mellitus. James W. Mold, MD, MPH

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Importance: Type 2 diabetes involves progressive loss of insulin secretion from pancreatic β cells in the setting of insulin resistance and manifests clinically as hyperglycemia. Type 2 diabetes accounts for 90% to 95% of all cases of diabetes globally, with estimates ranging from 589 million to 828 million people worldwide. In the US, type 2 diabetes affects approximately 1 in 6 adults.

Observations: Risk factors for type 2 diabetes include older age, family history, overweight or obesity, physical inactivity, gestational diabetes, Hispanic ethnicity, and American Indian or Alaska Native, Asian, or Black race. Diabetes is diagnosed if fasting plasma glucose is greater than or equal to 126 mg/dL, hemoglobin A1C is greater than or equal to 6.5%, or 2-hour glucose during 75-g oral glucose tolerance testing is greater than or equal to 200 mg/dL. Approximately one-third of adults with type 2 diabetes have cardiovascular disease and 10.1% have severe vision difficulty or blindness. The prevalence of type 2 diabetes is 39.2% among patients with kidney failure. Although weight management is an important component of treatment for type 2 diabetes, no specific diet has been proven to be most effective for improving health outcomes. Physical activity can reduce hemoglobin A1C by 0.4% to 1.0% and improve cardiovascular risk factors (ie, hypertension and dyslipidemia). Randomized clinical trials have reported absolute reductions in microvascular disease (3.5%), such as retinopathy and nephropathy, myocardial infarction (3.3%-6.2%), and mortality (2.7%-4.9%), with intensive glucose-lowering strategies (hemoglobin A1C <7%) vs conventional treatment 2 decades after trial completion. First-line medications for type 2 diabetes include metformin and, in patients with cardiovascular or kidney comorbidities or at high cardiovascular risk, glucagon-like peptide-1 receptor agonists (GLP-1RAs) or sodium-glucose cotransporter 2 inhibitors (SGLT2is). Common add-on medications include dual glucose-dependent insulinotropic polypeptide (GIP)/GLP-1RAs, dipeptidyl peptidase-4 inhibitors, sulfonylureas, and thiazolidinediones. Approximately one-third of patients with type 2 diabetes require treatment with insulin during their lifetime. Several randomized clinical trials have demonstrated benefits of specific SGLT2i and GLP-1RA medications compared with placebo for atherosclerotic cardiovascular disease (12%-26% risk reduction), heart failure (18%-25% risk reduction), and kidney disease (24%-39% risk reduction) over 2 to 5 years. Most trial participants with type 2 diabetes were taking metformin. High-potency GLP-1RA and dual GIP/GLP-1RA medications result in weight loss of greater than 5% in most individuals with type 2 diabetes, and weight loss may exceed 10%.

Conclusions: Type 2 diabetes affects up to 14% of the global population and is associated with preventable long-term complications, such as cardiovascular disease, kidney failure, vision loss, and increased mortality. In addition to lifestyle modifications including diet, exercise, and weight management, metformin is generally first-line therapy for attainment of hemoglobin A1C targets. For individuals with type 2 diabetes and cardiovascular or kidney disease or at high cardiovascular risk, guidelines recommend early treatment with SGLT2i and/or GLP-1RA medications.

Author/s:

Rita R Kalyani, Joshua J Neumiller, Nisa M Maruthur, Deborah J Wexler

Optimization of type 2 diabetes care in adults aged 65 or older: Practical approach to deintensification

Alex Haga — Thu, 20 Jun 2024 21:18:18 +0000

Date Added:

June 20, 2024

Journal/Publication:

Canadian Family Physician

Publication Date:

June 1, 2024

Issue:

Volume:

Pages:

391-394

URL:

Optimization of type 2 diabetes care in adults aged 65 or older: Practical approach to deintensification

Type:

Meta-analyses, Reviews, and Guidelines

Format:

Article

DOI (1):

10.46747/cfp.7006391

Keywords

blood glucose

aged

PMID (1):

38886078

MeSH

Hypoglycemic Agents* / therapeutic use

Type 2* / therapy

aged

Aged, 80 and over

aged

The benefits of lowering blood glucose levels are limited and potentially burdensome and even dangerous in people with limited life expectancies. Diabetes management in those over 65, in particular, should be individualized. James W. Mold, MD, MPH

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Effective diabetes management, particularly in older and frail adults, requires a nuanced approach that balances the benefits of antihyperglycemic medications with the risks of intensive glycemic control. While certain diabetes medications are important to the prevention of chronic complications of diabetes, intensive glycemic management can increase the risk of hypoglycemia, potentially leading to serious adverse outcomes (eg, falls, seizures, hospitalizations, death). In patients aged 65 or older and those with frailty, a tailored approach to diabetes care is crucial. A patient-centred approach might include individualizing glycemic targets and reducing the intensity of both pharmacologic treatment and routine monitoring to prioritize patient safety and quality of life. Implementing such patient-centred care requires clinicians to thoroughly consider each patient’s overall health, preferences, and social context, thus ensuring that treatment decisions align with the patient’s personal goals of care and life circumstances.

Author/s:

Julia B Bardoczi, Carole E Aubert

Management of Outpatients With Diabetes at High Risk of Hypoglycemia

Erin Blanchette — Tue, 26 Mar 2024 16:29:29 +0000

Date Added:

March 26, 2024

Journal/Publication:

JAMA

Publisher:

American Medical Association

Publication Date:

March 14, 2024

URL:

Management of Outpatients With Diabetes at High Risk of Hypoglycemia

Type:

Meta-analyses, Reviews, and Guidelines

Format:

Article

DOI (1):

10.1001/jama.2024.1137

Keywords

Diabetes and Endocrinology

Endocrinology

insulin

PMID (1):

38483370

MeSH

dipeptidyl-peptidase IV inhibitors

diabetes mellitus, type 1

blood glucose

Hypoglycemia

Insulins

Guidance for management of diabetes in patients at risk of hypoglycemia. James W. Mold, MD, MPH

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More than 30 million people in the US have diabetes, approximately 5% with type 1 and approximately 95% with type 2. About 5 million individuals in the US with type 2 diabetes use insulin and 7 million take sulfonylureas; both of these medications have a greater association with hypoglycemia than metformin, glucagon-like peptide 1 receptor agonists, dipeptidyl peptidase 4 inhibitors, or sodium-glucose cotransporter 2 inhibitors. Each month, 70% of people with type 1 diabetes experience some degree of hypoglycemia.1 Level 1 hypoglycemia is defined as blood glucose of 54 to 70 mg/dL; level 2 is less than 54 mg/dL; and severe hypoglycemia (level 3) occurs when low blood glucose levels cause neurologic or physical symptoms that require help from others. Furthermore, recurrent severe hypoglycemia increases risk of future dementia.2 Hypoglycemia occurs more often in people with lower education, lower income, and food insecurity.3 This synopsis focuses on outpatient management of diabetes with high risk of hypoglycemia; the guideline also addresses prevention of hypoglycemia in hospitalized patients.4

Author/s:

Celeste C Thomas, Karishma Chopra, Andrew M Davis

Thyroid Cancer: A Review

Erin Blanchette — Mon, 19 Feb 2024 16:44:44 +0000

Date Added:

February 19, 2024

Journal/Publication:

JAMA

Publisher:

American Medical Association

Publication Date:

February 6, 2024

Issue:

Volume:

331

Pages:

425-435

URL:

Thyroid Cancer: A Review

Type:

Meta-analyses, Reviews, and Guidelines

Format:

Article

DOI (1):

10.1001/jama.2023.26348

Keywords

Targeted and Immune Therapy

PMID (1):

38319329

MeSH

Thyroid Epithelial Cells

An update on thyroid cancer detection, types, and treatment. James W. Mold, MD, MPH

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Importance: Approximately 43 720 new cases of thyroid carcinoma are expected to be diagnosed in 2023 in the US. Five-year relative survival is approximately 98.5%. This review summarizes current evidence regarding pathophysiology, diagnosis, and management of early-stage and advanced thyroid cancer.

Observations: Papillary thyroid cancer accounts for approximately 84% of all thyroid cancers. Papillary, follicular (≈4%), and oncocytic (≈2%) forms arise from thyroid follicular cells and are termed well-differentiated thyroid cancer. Aggressive forms of follicular cell-derived thyroid cancer are poorly differentiated thyroid cancer (≈5%) and anaplastic thyroid cancer (≈1%). Medullary thyroid cancer (≈4%) arises from parafollicular C cells. Most cases of well-differentiated thyroid cancer are asymptomatic and detected during physical examination or incidentally found on diagnostic imaging studies. For microcarcinomas (≤1 cm), observation without surgical resection can be considered. For tumors larger than 1 cm with or without lymph node metastases, surgery with or without radioactive iodine is curative in most cases. Surgical resection is the preferred approach for patients with recurrent locoregional disease. For metastatic disease, surgical resection or stereotactic body irradiation is favored over systemic therapy (eg, lenvatinib, dabrafenib). Antiangiogenic multikinase inhibitors (eg, sorafenib, lenvatinib, cabozantinib) are approved for thyroid cancer that does not respond to radioactive iodine, with response rates 12% to 65%. Targeted therapies such as dabrafenib and selpercatinib are directed to genetic mutations (BRAF, RET, NTRK, MEK) that give rise to thyroid cancer and are used in patients with advanced thyroid carcinoma.

Conclusions: Approximately 44 000 new cases of thyroid cancer are diagnosed each year in the US, with a 5-year relative survival of 98.5%. Surgery is curative in most cases of well-differentiated thyroid cancer. Radioactive iodine treatment after surgery improves overall survival in patients at high risk of recurrence. Antiangiogenic multikinase inhibitors and targeted therapies to genetic mutations that give rise to thyroid cancer are increasingly used in the treatment of metastatic disease.

Author/s:

Laura Boucai, Mark Zafereo, Maria E Cabanillas

Risk of Gastrointestinal Adverse Events Associated With Glucagon-Like Peptide-1 Receptor Agonists for Weight Loss

Erin Blanchette — Mon, 12 Feb 2024 17:22:55 +0000

Date Added:

February 12, 2024

Journal/Publication:

JAMA

Publisher:

American Medical Association

Publication Date:

October 5, 2023

Issue:

Volume:

330

Pages:

1795-1797

URL:

Risk of Gastrointestinal Adverse Events Associated With Glucagon-Like Peptide-1 Receptor Agonists for Weight Loss

Type:

Clinical Research Results

Format:

Article

DOI (1):

10.1001/jama.2023.19574

Keywords

PMID (1):

37796527

MeSH

glucagon-like peptide 1

Estimated rates of various adverse GI events in patients taking GLP1 receptor agonists. James W. Mold, MD, MPH

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This database study examines the association between glucagon-like peptide 1 agonists (eg, semaglutide, liraglutide) used for weight loss and reports of gastrointestinal adverse events.

Author/s:

Mohit Sodhi, Ramin Rezaeianzadeh, Abbas Kezouh, Mahyar Etminan

Effect of Continuous Glucose Monitoring on Glycemic Control in Patients With Type 2 Diabetes Treated With Basal Insulin: A Randomized Clinical Trial

Saige Blanchard — Tue, 08 Jun 2021 05:00:00 +0000

Date Added:

June 8, 2021

Journal/Publication:

Journal of the American Medical Association

Publisher:

American Medical Association

Publication Date:

June 8, 2021

Issue:

Volume:

325

Pages:

2262-2272

URL:

Effect of Continuous Glucose Monitoring on Glycemic Control in Patients With Type 2 Diabetes Treated With Basal Insulin: A Randomized Clinical Trial

Format:

Article

DOI (1):

10.1001/jama.2021.7444

Keywords

PMID (1):

34077499

MeSH

glycated hemoglobin a

Use of continuous glucose monitoring devices by people with Type 2 diabetes who are being treated with supplementary basal insulin results in significantly better glycemic control. James W. Mold, MD, MPH

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Importance: Continuous glucose monitoring (CGM) has been shown to be beneficial for adults with type 2 diabetes using intensive insulin therapy, but its use in type 2 diabetes treated with basal insulin without prandial insulin has not been well studied.

Objective: To determine the effectiveness of CGM in adults with type 2 diabetes treated with basal insulin without prandial insulin in primary care practices.

Design, setting, and participants: This randomized clinical trial was conducted at 15 centers in the US (enrollment from July 30, 2018, to October 30, 2019; follow-up completed July 7, 2020) and included adults with type 2 diabetes receiving their diabetes care from a primary care clinician and treated with 1 or 2 daily injections of long- or intermediate-acting basal insulin without prandial insulin, with or without noninsulin glucose-lowering medications.

Interventions: Random assignment 2:1 to CGM (n = 116) or traditional blood glucose meter (BGM) monitoring (n = 59).

Main outcomes and measures: The primary outcome was hemoglobin A1c (HbA1c) level at 8 months. Key secondary outcomes were CGM-measured time in target glucose range of 70 to 180 mg/dL, time with glucose level at greater than 250 mg/dL, and mean glucose level at 8 months.

Results: Among 175 randomized participants (mean [SD] age, 57 [9] years; 88 women [50%]; 92 racial/ethnic minority individuals [53%]; mean [SD] baseline HbA1c level, 9.1% [0.9%]), 165 (94%) completed the trial. Mean HbA1c level decreased from 9.1% at baseline to 8.0% at 8 months in the CGM group and from 9.0% to 8.4% in the BGM group (adjusted difference, -0.4% [95% CI, -0.8% to -0.1%]; P = .02). In the CGM group, compared with the BGM group, the mean percentage of CGM-measured time in the target glucose range of 70 to 180 mg/dL was 59% vs 43% (adjusted difference, 15% [95% CI, 8% to 23%]; P < .001), the mean percentage of time at greater than 250 mg/dL was 11% vs 27% (adjusted difference, -16% [95% CI, -21% to -11%]; P < .001), and the means of the mean glucose values were 179 mg/dL vs 206 mg/dL (adjusted difference, -26 mg/dL [95% CI, -41 to -12]; P < .001). Severe hypoglycemic events occurred in 1 participant (1%) in the CGM group and in 1 (2%) in the BGM group.

Conclusions and relevance: Among adults with poorly controlled type 2 diabetes treated with basal insulin without prandial insulin, continuous glucose monitoring, as compared with blood glucose meter monitoring, resulted in significantly lower HbA1c levels at 8 months.

Author/s:

Martens, T., Beck, R. W., Bailey, R., Ruedy, K. J., Calhoun, P., Peters, A. L., Pop-Busui, R., Philis-Tsimikas, A., Bao, S., Umpierrez, G., Davis, G., Kruger, D., Bhargava, A., Young, L., McGill, J. B., Aleppo, G., Nguyen, Q. T., Orozco, I., Biggs, W., Lucas, K. J., Polonsky, W. H., Buse, J. B., Price, D., Bergenstal, R. M.

Obesity in adults: a clinical practice guideline

Devin Evans — Thu, 21 Jan 2021 06:00:00 +0000

Date Added:

January 21, 2021

Journal/Publication:

Canadian Medical Association Journal

Publication Date:

August 4, 2020

Issue:

Volume:

192

Pages:

875-891

URL:

Obesity in adults: a clinical practice guideline

Type:

Meta-analyses, Reviews, and Guidelines

Format:

Article

DOI (1):

10.1503/cmaj.191707

Keywords

non-alcoholic fatty liver disease

Gout

PMID (1):

32753461

MeSH

An excellent guideline for management of obesity in adults from the Canadians. James W. Mold, MD, MPH

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Obesity is a prevalent, complex, progressive and relapsing chronic disease, characterized by abnormal or excessive body fat (adiposity), that impairs health.
People living with obesity face substantial bias and stigma, which contribute to increased morbidity and mortality independent of weight or body mass index.
This guideline update reflects substantial advances in the epidemiology, determinants, pathophysiology, assessment, prevention and treatment of obesity, and shifts the focus of obesity management toward improving patient-centred health outcomes, rather than weight loss alone.
Obesity care should be based on evidence-based principles of chronic disease management, must validate patients’ lived experiences, move beyond simplistic approaches of “eat less, move more,” and address the root drivers of obesity.
People living with obesity should have access to evidence-informed interventions, including medical nutrition therapy, physical activity, psychological interventions, pharmacotherapy and surgery.

Author/s:

Wharton, Sean, Lau, David C., Vallis, Mchael, Sharma, Arya M., Biertho, Laurent, Campbell-Scherer, Denise, Adamo, Kristi, Alberga, Anela, Bell, Rhonda, Boule, Normand, Boyling, Elaine, Calam, Betty, Brown, Jennifer, Clarke, Carol, Crowshoe, Lindsay", Mary, Freedhoff, Yoni, Gagner, Michel, Grand, Cindy, Glazer, Stephen", Michael, Hahn, Margaret, Hawa, Raed, Henderson, Rita, Hong, Dennis, Hung, Pam, Janssen, Ian, Jacklin, Kristen, Johnson-Stoklossa, Carlene, Kemp, Amy, Kirk, Sra, :Kuk, Jennifer, Langlois, Marie-France, Lear, Scott, McInnes, Ashley, Macklin, David, Naji, Leen, Manjoo, Priya, Morin, Marie-Philippe, Nerenberg, Kara, Patton, Ian, Pedersen, Sue, Pereira, Leticia, Piccinini-Vallis, Helena, Poddar, Megha, Poirier, Paul, Prud'homme, Denis, Romos Salas, Ximena, Rueda-Clausen, Christian, Russell-Mayhew, Shelly, Shiau, Judy, Sherifali, Diana, Sievenpiper, John, Sockalingam, Sanjeev, Taylor, Valerie, Toth, Ellen, Twells, Laurie, Tytus, RIchard, Walji, Shahebina, Walker, Leah

Impact of Diabetes Medications on Cardiovascular Events and Mortality

John Bayhi — Thu, 02 Apr 2020 17:49:16 +0000

Date Added:

April 2, 2020

Publication Date:

April 2, 2020

Type:

Clinical Decision Aids

Format:

Poster

Keywords

Summary of Revisions: Standards of Medical Care in Diabetes—2020

cardiovascular events

mortality

risk

medication

A table showing the size of the risks and risk reductions of several classes of diabetes medications on cardiovascular events. The data was derived from 232 meta-analyses in Zhu J, Zheng Y, et al in Lancet Diabetes Endocrinol 2020; 8(3): 192-205. James W. Mold, MD, MPH.

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Author/s:

Mold, James W.

Summary of Revisions: Standards of Medical Care in Diabetes—2020

John Bayhi — Sat, 14 Mar 2020 19:35:38 +0000

Date Added:

March 14, 2020

Journal/Publication:

Diabetes Care

Publisher:

American Diabetes Association

Publication Date:

January 1, 2020

Issue:

Supplement 1

Volume:

Pages:

S4-S6

URL:

Type:

Meta-analyses, Reviews, and Guidelines

Format:

Article

DOI (1):

10.2337/dc20-Srev

Keywords

PMID (1):

31862743

MeSH

Sodium-Glucose Transporter 2 Inhibitors

Diabetic Ketoacidosis

Ficus

Glucagon-Like Peptide-1 Receptor

glycated hemoglobin a

cardiovascular diseases

Consensus

Farmers

Cystic Fibrosis

Transients and Migrants

Pharmaceutical Preparations

depression

Smell

Patient Comfort

electronic nicotine delivery systems

Blood Glucose Self-Monitoring

celiac disease

follow-up studies

Latent Autoimmune Diabetes in Adults

seasons

social determinants of health

Standard of Care

Time-to-Treatment

united states food and drug administration

risk reduction behavior

Centers for Disease Control and Prevention

glucagon-like peptide 1

anxiety disorders

Feeding and Eating Disorders

thyroid diseases

Infections

This is a three-page summary of the 2020 updates to the ADA Guidelines for Type 2 diabetes. James W. Mold, MD, MPH

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No abstract available.

A Multinational, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Efficacy of Cyclical Topical Wound Oxygen Therapy (TWO2) in the Treatment of Chronic Diabetic Foot Ulcers: The TWO2 Study

John Bayhi — Wed, 13 Nov 2019 18:19:52 +0000

Date Added:

November 13, 2019

Journal/Publication:

Diabetes Care

Publisher:

American Diabetes Association

Publication Date:

October 16, 2019

URL:

A Multinational, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Efficacy of Cyclical Topical Wound Oxygen Therapy (TWO2) in the Treatment of Chronic Diabetic Foot Ulcers: The TWO2 Study

Type:

Clinical Research Results

Format:

Article

DOI (1):

10.2337/dc19-0476

Keywords

wound therapy

topical wound oxygen therapy

diabetic foot ulcer

two2

PMID (1):

31619393

MeSH

Oxygen Inhalation Therapy

treatment outcome

Home Care Services

Intermittent pressurized oxygen therapy appears to improve wound healing in diabetic foot ulcers. James W. Mold, MD, MPH

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OBJECTIVE:

Topical oxygen has been used for the treatment of chronic wounds for more than 50 years. Its effectiveness remains disputed due to the limited number of robust high-quality investigations. The aim of this study was to assess the efficacy of multimodality cyclical pressure Topical Wound Oxygen (TWO2) home care therapy in healing refractory diabetic foot ulcers (DFUs) that had failed to heal with standard of care (SOC) alone.

RESEARCH DESIGN AND METHODS:

Patients with diabetes and chronic DFUs were randomized (double-blind) to either active TWO2 therapy or sham control therapy-both in addition to optimal SOC. The primary outcome was the percentage of ulcers in each group achieving 100% healing at 12 weeks. A group sequential design was used for the study with three predetermined analyses and hard stopping rules once 73, 146, and ultimately 220 patients completed the 12-week treatment phase.

RESULTS:

At the first analysis point, the active TWO2 arm was found to be superior to the sham arm, with a closure rate of 41.7% compared with 13.5%. This difference in outcome produced an odds ratio (OR) of 4.57 (97.8% CI 1.19, 17.57), P = 0.010. After adjustment for University of Texas Classification (UTC) ulcer grade, the OR increased to 6.00 (97.8% CI 1.44, 24.93), P = 0.004. Cox proportional hazards modeling, also after adjustment for UTC grade, demonstrated >4.5 times the likelihood to heal DFUs over 12 weeks compared with the sham arm with a hazard ratio of 4.66 (97.8% CI 1.36, 15.98), P = 0.004. At 12 months postenrollment, 56% of active arm ulcers were closed compared with 27% of the sham arm ulcers (P = 0.013).

CONCLUSIONS:

This sham-controlled, double-blind randomized controlled trial demonstrates that, at both 12 weeks and 12 months, adjunctive cyclical pressurized TWO2 therapy was superior in healing chronic DFUs compared with optimal SOC alone.

Author/s:

Frykberg, RG, Franks, PJ, Edmonds, M, Brantley, JN, Téot, L, Wild, T, Garoufalis, MG, Lee, AM, Thompson, JA, Reach, G, Dove, CR, Lachgar, K, Grotemeyer, D, Renton, SC, TWO2 Study Group

Standards of Medical Care in Diabetes—2019 Abridged for Primary Care Providers

John Bayhi — Fri, 02 Aug 2019 17:59:06 +0000

Date Added:

August 2, 2019

Journal/Publication:

Clinical Diabetes

Publisher:

American Diabetes Association

Publication Date:

January 1, 2019

Issue:

Volume:

Pages:

11-34

URL:

Standards of Medical Care in Diabetes — 2019 Abridged for Primary Care Providers

Type:

Meta-analyses, Reviews, and Guidelines

Format:

Article

DOI (1):

10.2337/cd18-0105

Keywords

PMID (1):

30705493

MeSH

diabetes mellitus, type 1

blood glucose

Prediabetic State

Glucose Tolerance Test

Treatment Adherence and Compliance

Standard of Care

self-management

This is the 2019 version of the ADA Guidelines for managing diabetes in primary care. James W. Mold, MD, MPH

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The American Diabetes Association’s (ADA’s) Standards of Medical Care in Diabetes is updated and published annually in a supplement to the January issue of Diabetes Care. The ADA’s Professional Practice Committee, which includes physicians, diabetes educators, registered dietitians (RDs), and public health experts, develops the Standards. The Standards include the most current evidence-based recommendations for diagnosing and treating adults and children with all forms of diabetes. ADA’s grading system uses A, B, C, or E to show the evidence level that supports each recommendation.

A—Clear evidence from well-conducted, generalizable randomized controlled trials that are adequately powered
B—Supportive evidence from well-conducted cohort studies
C—Supportive evidence from poorly controlled or uncontrolled studies
E—Expert consensus or clinical experience

This is an abridged version of the 2019 Standards containing the evidence-based recommendations most pertinent to primary care. The tables and figures have been renumbered from the original document to match this version. The complete 2019 Standards of Care document, including all supporting references, is available at professional.diabetes.org/standards.

Author/s:

American Diabetes Association

Intensive Glucose Control in Patients with Type 2 Diabetes — 15-Year Follow-up

Brian Desmarais — Mon, 10 Jun 2019 14:27:35 +0000

Date Added:

June 10, 2019

Journal/Publication:

New England Journal of Medicine

Publication Date:

June 6, 2019

Issue:

Volume:

380

Pages:

2215-2224

URL:

Intensive Glucose Control in Patients with Type 2 Diabetes — 15-Year Follow-up

Type:

Clinical Research Results

Format:

Article

DOI (1):

10.1056/NEJMoa1806802.

Keywords

MeSH

glycated hemoglobin a

myocardial infarction

stroke

heart failure

amputation

Vitamin D and diabetic foot ulcer: a systematic review and meta-analysis.

Intensive management of glucose levels in patients with Type 2 DM does not extend life. This is not new news, but it is a reminder that the benefit of treatment of Type 2 DM is improved quality of life, primarily fewer symptoms and a reduced risk of future microvascular problems, though those problems are relatively uncommon even without treatment.

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BACKGROUND

We previously reported that a median of 5.6 years of intensive as compared with standard glucose lowering in 1791 military veterans with type 2 diabetes resulted in a risk of major cardiovascular events that was significantly lower (by 17%) after a total of 10 years of combined intervention and observational follow-up. We now report the full 15-year follow-up.

METHODS

We observationally followed enrolled participants (complete cohort) after the conclusion of the original clinical trial by using central databases to identify cardiovascular events, hospitalizations, and deaths. Participants were asked whether they would be willing to provide additional data by means of surveys and chart reviews (survey cohort). The prespecified primary outcome was a composite of major cardiovascular events, including nonfatal myocardial infarction, nonfatal stroke, new or worsening congestive heart failure, amputation for ischemic gangrene, and death from cardiovascular causes. Death from any cause was a prespecified secondary outcome.

RESULTS

There were 1655 participants in the complete cohort and 1391 in the survey cohort. During the trial (which originally enrolled 1791 participants), the separation of the glycated hemoglobin curves between the intensive-therapy group (892 participants) and the standard-therapy group (899 participants) averaged 1.5 percentage points, and this difference declined to 0.2 to 0.3 percentage points by 3 years after the trial ended. Over a period of 15 years of follow-up (active treatment plus post-trial observation), the risks of major cardiovascular events or death were not lower in the intensive-therapy group than in the standard-therapy group (hazard ratio for primary outcome, 0.91; 95% confidence interval [CI], 0.78 to 1.06; P=0.23; hazard ratio for death, 1.02; 95% CI, 0.88 to 1.18). The risk of major cardiovascular disease outcomes was reduced, however, during an extended interval of separation of the glycated hemoglobin curves (hazard ratio, 0.83; 95% CI, 0.70 to 0.99), but this benefit did not continue after equalization of the glycated hemoglobin levels (hazard ratio, 1.26; 95% CI, 0.90 to 1.75).

CONCLUSIONS

Participants with type 2 diabetes who had been randomly assigned to intensive glucose control for 5.6 years had a lower risk of cardiovascular events than those who received standard therapy only during the prolonged period in which the glycated hemoglobin curves were separated. There was no evidence of a legacy effect or a mortality benefit with intensive glucose control. (Funded by the VA Cooperative Studies Program; VADT ClinicalTrials.gov number, NCT00032487.)

Author/s:

Emanuele, N.V., Reaven, P.D., Wiitala, W.L., Bahn, G.D., Reda D.J., McCarren, M., Duckworth, W.C., Hayward, R.A., VADT Investigators

Vitamin D and diabetic foot ulcer: a systematic review and meta-analysis

Tracy Ashby — Tue, 09 Apr 2019 05:00:00 +0000

Date Added:

April 9, 2019

Journal/Publication:

Nutrition & Diabetes

Publication Date:

March 11, 2019

Issue:

Volume:

URL:

Type:

Meta-analyses, Reviews, and Guidelines

Format:

Article

DOI (1):

10.1038/s41387-019-0078-9

Keywords

diabetes complications

risk factors