Switching from Flash Glucose Monitoring to Continuous Glucose Monitoring on Hypoglycemia in Adults with Type 1 Diabetes at High Hypoglycemia Risk: The Extension Phase of the I HART CGM Study

Monika Reddy, Narvada Jugnee, Sinthuka Anantharaja, Nick Oliver, Monika Reddy, Narvada Jugnee, Sinthuka Anantharaja, Nick Oliver

Abstract

Background: The I HART CGM study showed that real-time continuous glucose monitoring (RT-CGM) has greater beneficial impact on hypoglycemia than intermittent flash glucose monitoring (flash) in adults with type 1 diabetes (T1D) at high risk. The impact of continuing RT-CGM or switching from flash to RT-CGM for another 8 weeks was then evaluated.

Methods: Prospective randomized parallel group study with an extension phase. After a 2-week run-in with blinded CGM, participants were randomized to either RT-CGM or flash for 8 weeks. All participants were then given the option to continue with RT-CGM for another 8 weeks. Glycemic outcomes at 8 weeks are compared with the 16-week endpoint.

Results: Forty adults with T1D on intensified multiple daily insulin injections and with impaired awareness of hypoglycemia or a recent episode of severe hypoglycemia were included (40% female, median [IQR] age 49.5 [37.5-63.5] years, diabetes duration 30.0 [21.0-36.5] years, HbA1c 56 [48-63] mmol/mol, and Gold Score 5 [4-5]), of whom 36 completed the final 16-week extension. There was a significant reduction in percentage time in hypoglycemia (<3.0 mmol/L) in the group switching from flash to RT-CGM (from 5.0 [3.7-8.6]% to 0.8 [0.4-1.9]%, P = 0.0001), whereas no change was observed in the RT-CGM group continuing with the additional 8 weeks of RT-CGM (1.3 [0.4-2.8] vs. 1.3 [0.8-2.5], P = 0.82). Time in target (3.9-10 mmol/L) increased in the flash group after switching to RT-CGM (60.0 [54.5-67.8] vs. 67.4 [56.3-72.4], P = 0.02) and remained the same in the RT-CGM group that continued with RT-CGM (65.9 [54.1-74.8] vs. 64.9 [49.2-73.9], P = 0.64).

Conclusions: Our data suggest that switching from flash to RT-CGM has a significant beneficial impact on hypoglycemia outcomes and that continued use of RT-CGM maintains hypoglycemia risk benefit in this high-risk population.

Keywords: Continuous Glucose monitoring; Flash glucose monitoring; Hypoglycemia.; Type 1 diabetes.

Conflict of interest statement

M.R. has received honoraria for advisory board participation from Dexcom and Roche Diabetes. N.O. has received honoraria for speaking and advisory board participation from Abbott Diabetes, Dexcom, Medtronic Diabetes, and Roche Diabetes.

Figures

FIG. 1.
FIG. 1.
Study design and participant recruitment.
FIG. 2.
FIG. 2.
Percentage time in hypoglycemia ((a) and in target range (3.9–10 mmol/L) (b) at baseline (weeks −2 to 0), at 8-week endpoint (weeks 4–8), and at 16-week endpoint. The bar charts represent median (IQR) and the range (minimum to maximum).

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