[Skip to Content]
[Skip to Content Landing]
Views 6,906
Citations 0
Original Investigation
November 4, 2019

Comparison of Group Medical Visits Combined With Intensive Weight Management vs Group Medical Visits Alone for Glycemia in Patients With Type 2 Diabetes: A Noninferiority Randomized Clinical Trial

Author Affiliations
  • 1Center of Innovation to Accelerate Discovery and Practice Transformation, Department of Veterans Affairs, Durham, North Carolina
  • 2Division of General Internal Medicine, Department of Medicine, Duke University Medical Center, Durham, North Carolina
  • 3Duke Diet and Fitness Center, Durham, North Carolina
  • 4Division of Endocrinology, Department of Medicine, Duke University Medical Center, Durham, North Carolina
  • 5Greenville Health Care Center, Department of Veterans Affairs, Greenville, North Carolina
  • 6Brody School of Medicine, Greenville, North Carolina
  • 7Department of Biostatistics and Bioinformatics, Duke University Medical Center, Durham, North Carolina
  • 8Department of Population Health Sciences, Duke University Medical Center, Durham, North Carolina
  • 9William S. Middleton Memorial Veterans Hospital, Madison, Wisconsin
  • 10Department of Surgery, University of Wisconsin, Madison
  • 11Bon Secours Health System, Richmond, Virginia
JAMA Intern Med. Published online November 4, 2019. doi:https://doi.org/10.1001/jamainternmed.2019.4802
Key Points

Question  Does adding intensive weight management to group medical visits improve glycemia compared with group medical visits alone while also enhancing weight loss and decreasing medication intensity in patients with type 2 diabetes?

Findings  In this randomized clinical trial of 263 individuals with diabetes and mean hemoglobin A1c level of 9.1% at baseline, during the 48 weeks, hemoglobin A1c level improved in both study arms (8.2% and 8.3%). Weight management added to group medical visits also led to reduced diabetes medication use, greater weight loss, and fewer hypoglycemic events.

Meaning  For persons with diabetes who attended group medical visits, adding intensive weight management using low-carbohydrate nutrition counseling showed comparable glycemic improvement plus advantages in several clinically important outcomes.

Abstract

Importance  Traditionally, group medical visits (GMVs) for persons with diabetes improved glycemia by intensifying medications, which infrequently led to weight loss. Incorporating GMVs with intensive dietary change could enable weight loss and improve glycemia while decreasing medication intensity.

Objective  To examine whether a program of GMVs combined with intensive weight management (WM) is noninferior to GMVs alone for change in glycated hemoglobin (HbA1c) level at 48 weeks (prespecified margin of 0.5%) and superior to GMVs alone for hypoglycemic events, diabetes medication intensity, and weight loss.

Design, Setting, and Participants  This randomized clinical trial identified via the electronic medical record 2814 outpatients with type 2 diabetes, uncontrolled HbA1c, and body mass index (BMI; calculated as weight in kilograms divided by height in meters squared) of 27 or higher from Veterans Affairs Medical Center clinics in Durham and Greenville, North Carolina. Between January 12, 2015, and May 30, 2017, 263 outpatients started the intervention.

Interventions  Participants randomized to the GMV group (n = 136) received counseling about diabetes-related topics with medication optimization every 4 weeks for 16 weeks, then every 8 weeks (9 visits). Participants randomized to the WM/GMV group (n = 127) received low-carbohydrate diet counseling with baseline medication reduction and subsequent medication optimization every 2 weeks for 16 weeks followed by an abbreviated GMV intervention every 8 weeks (13 visits).

Main Outcomes and Measures  Outcomes included HbA1c level, hypoglycemic events, diabetes medication effect score, and weight at 48 weeks analyzed using hierarchical generalized mixed models to account for clustering within group sessions.

Results  Among 263 participants (mean [SD] age, 60.7 [8.2] years; 235 [89.4%] men; 143 [54.4%] black), baseline HbA1c level was 9.1% (1.3%) and BMI was 35.3 (5.1). At 48 weeks, HbA1c level was improved in both study arms (8.2% in the WM/GMV arm and 8.3% in the GMV arm; mean difference, −0.1%; 95% CI, −0.5% to 0.2%; upper 95% CI, <0.5% threshold; P = .44). The WM/GMV arm had lower diabetes medication use (mean difference in medication effect score, −0.5; 95% CI, −0.6 to −0.3; P < .001) and greater weight loss (mean difference, −3.7 kg; 95% CI, −5.5 to −1.9 kg; P < .001) than did the GMV arm at 48 weeks and approximately 50% fewer hypoglycemic events (incidence rate ratio, 0.49; 95% CI, 0.27 to 0.71; P < .001) during the 48-week period.

Conclusions and Relevance  In GMVs for diabetes, addition of WM using a low-carbohydrate diet was noninferior for lowering HbA1c levels compared with conventional medication management and showed advantages in other clinically important outcomes.

Trial Registration  ClinicalTrials.gov identifier: NCT01973972

Limit 200 characters
Limit 25 characters
Conflicts of Interest Disclosure

Identify all potential conflicts of interest that might be relevant to your comment.

Conflicts of interest comprise financial interests, activities, and relationships within the past 3 years including but not limited to employment, affiliation, grants or funding, consultancies, honoraria or payment, speaker's bureaus, stock ownership or options, expert testimony, royalties, donation of medical equipment, or patents planned, pending, or issued.

Err on the side of full disclosure.

If you have no conflicts of interest, check "No potential conflicts of interest" in the box below. The information will be posted with your response.

Not all submitted comments are published. Please see our commenting policy for details.

Limit 140 characters
Limit 3600 characters or approximately 600 words
    ×