Background: Shared medical appointments (SMA) improve outcomes in diabetes. SMAs often address lifestyle but infrequently lead to weight loss. Because weight loss reduces glycemia and medication use, we hypothesized an SMA intervention with weight management (WM/SMA) would be non-inferior for glycemic control and superior for patient-centered outcomes versus SMA alone.
Methods: In a 48-week, randomized trial with primary outcome of HbA1c (non-inferiority margin 0.5%), we recruited outpatients with uncontrolled T2DM and BMI ≥27 from two Veterans Health Administration sites. WM/SMA participants received baseline medication reduction and low-carbohydrate diet counseling with medication optimization every 2 weeks for 16 weeks, then an abbreviated SMA intervention every 8 weeks. SMA participants received group counseling on diabetes-related topics with medication optimization every 4 weeks for 16 weeks, then every 8 weeks. HbA1c, diabetes medication effect score (MES) and hypoglycemic events were analyzed using linear mixed models.
Results: In 263 participants, baseline mean age was 61, HbA1c 9.1% and BMI 35.3; 10.6% were women and 54.4% were black. At 48 weeks, HbA1c decreased 0.9% for WM/SMA and 0.8% for SMA (mean difference -0.1%, 95% CI -0.5, 0.3; non-inferiority criterion met), and decreased more with WM/SMA than SMA alone at interim weeks 16 (-0.7%, 95% CI -1.0, -0.4) and 32 (-0.5%; 95% CI -0.8, -0.2). At 48 weeks, diabetes medication use was lower in the WM/SMA than SMA group (mean difference in MES -0.5, 95% CI -0.6, -0.3; p<0.0001). WM/SMA participants had 51% fewer hypoglycemic events than SMA participants over 48 weeks (Incident Rate Ratio=0.49; 95% CI 0.27, 0.71; p<0.001).
Conclusion: Compared with conventional SMA-based medication management for patients with T2DM, SMA with intensive low-carbohydrate diet counseling yielded similar glycemic control while improving hypoglycemia and decreasing medication burden.
W.S. Yancy: None. C. Coffman: None. M. Crowley: None. M. Dar: None. A.S. Jeffreys: None. M.L. Maciejewski: Employee; Spouse/Partner; Amgen Inc. Stock/Shareholder; Spouse/Partner; Amgen Inc. C.I. Voils: None. A.E. Barton: None. D. Edelman: None.
U.S. Department of Veterans Affairs