A Randomized Controlled Trial Using Continuous Glucose Monitoring to Guide Food Choices and Diabetes Self-Care in People with Type 2 Diabetes not Taking Insulin
Thomas W. Martens, Holly Willis, Richard M. Bergenstal, Davida Kruger, Esra Karslioglu French, Devin Steenkamp
Abstract
Objective: Continuous glucose monitoring (CGM) is an effective tool for individuals with type 2 diabetes (T2D) on insulin. This study evaluated the effect of using CGM to reduce hyperglycemia, by focusing on food and lifestyle choices, in people with T2D not taking insulin. Methods: A 6-month randomized, prospective four-center study was conducted. The primary end point was a within-group reduction in time above range >180 mg/dL (TAR180) at 3 months. Participants were asked not to make diabetes medication changes in the first 3 months. Seventy-two adults not on insulin or sulfonylurea therapy, with glycated hemoglobin (HbA1c) 7.5%–12%, were randomized to use CGM alone ( n = 31) or CGM plus a food logging app ( n = 41) to aid diabetes management. Participants attended guided education visits. Differences in CGM metrics, HbA1c, and body weight were compared. Results: The CGM alone group decreased TAR180 from 55% at baseline to 27% at 3 months ( P < 0.001) and 21% at 6 months ( P < 0.001); the CGM plus food logging app group decreased TAR180 from 53% at baseline to 30% at both 3 and 6 months ( P < 0.001 for both). For all participants, time in range (70–180 mg/dL) increased from 46% at baseline to 71% at 3 months ( P < 0.001) and to 72% at 6 months ( P < 0.001). HbA1c and weight were reduced by 1.3% ( P < 0.001) and 7 pounds (lbs.) ( P < 0.001) for all participants at 6 months. Conclusion: People with T2D not taking insulin showed large, clinically significant improvements in CGM metrics and HbA1c when using either CGM alone or with a food logging app. This occurred with a near absence of medication changes in the first 3 months and were therefore likely due to changes in food and/or lifestyle choices.