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 A 1c level of 9.1% at baseline, during the 48 weeks, hemoglobin A 1c 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 (HbA 1c ) 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 HbA 1c , 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 HbA 1c 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 HbA 1c level was 9.1% (1.3%) and BMI was 35.3 (5.1). At 48 weeks, HbA 1c 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 HbA 1c levels compared with conventional medication management and showed advantages in other clinically important outcomes.

Trial Registration ClinicalTrials.gov identifier: NCT01973972