Effects of Continuous Glucose Monitoring Versus Blood Glucose Monitoring During a Carbohydrate-Restricted Nutrition Intervention in People With Type 2 Diabetes: 6-Month Follow-up Outcomes From a Randomized Clinical Trial

Abstract

Objectives: Low and very-low carbohydrate eating patterns can improve glycemia in people with type 2 diabetes (T2D). Continuous glucose monitoring (CGM) may also help improve glycemic outcomes, like time in range (TIR). This research evaluated differences in diabetes-related outcomes when people with T2D used CGM or blood glucose monitoring (BGM) to support dietary choices and medication management for 6 months during a virtual, medically supervised ketogenic diet program (MSKDP). Three-month primary outcomes are published, and here we report 6-month follow-up outcomes.

Methods: The IGNITE study (Impact of Glucose moNitoring and nutrItion on Time in rangE) randomized participants to use CGM (N = 81) or BGM (N = 82) to support care during 6 months in a MSKDP. Glycemia, diabetes medications, dietary intake, ketones, and weight were assessed at baseline (Base) and month 6 (M6); differences between and within arms were evaluated.

Results: Adults (N = 163) with mean (SD) T2D duration of 9.7 (7.7) years and HbA1c of 8.1% (1.2%) participated. From Base to M6, TIR improved from 61% to 87% for CGM and from 63% to 88% for BGM (P < .001), with no difference in changes between arms (P = .99). HbA1c decreased at least 1.3% from Base to M6 in both arms (P < .001). Diabetes medications were deintensified in both arms based on medication effect scores (P < .01). Energy and carbohydrate intake decreased (P < .001) and participants in both arms had clinically meaningful weight loss (P < .001).

Conclusions: The CGM and BGM arms achieved similar and significant improvements in glycemia and other diabetes-related outcomes after 6 months in this MSKDP.

Keywords: carbohydrate; continuous glucose monitoring; diet; nutrition; time in range; type 2 diabetes.