Therapy adjustments in people with type 1 diabetes with impaired hypoglycemia awareness on multiple daily injections using real-time continuous glucose monitoring: a mechanistic analysis of the HypoDE study

Abstract

Introduction: Studies have shown beneficial effects of real-time continuous glucose monitoring (rtCGM) usage on clinical outcomes. The objective of this analysis was to identify which therapy adjustments were made by people with type 1 diabetes with impaired hypoglycemia awareness during rtCGM usage enabling reductions in the number of low glucose events observed in the HypoDE (Hypoglycemia in Deutschland) study.

Research design and methods: In the multicenter randomized controlled trial in people with type 1 diabetes on multiple daily injections with impaired hypoglycemia awareness, participants recorded their diabetes therapy in 7-day logbooks at baseline and at 6-month follow-up. They used rtCGM or self-monitoring of blood glucose for therapy adjustments. This mechanistic analysis looked at changes in various aspects of therapy.

Results: Logbooks were completed by 70 participants in the rtCGM group and 65 participants in the control group. Participants in the rtCGM group kept their total carbohydrate consumption, daily insulin doses and distribution constant during the study. However, they reported an increased intake of rescue carbohydrates (0.8±0.6 (mean±SD) vs 1.0±0.8 intake/day; baseline-adjusted between-group difference 0.3 intake (0.1-0.5), p=0.031). The glucose threshold at which rescue carbohydrate intake was initiated was elevated from 71±13 mg/dL (3.9±0.7 mmol/L) to 79±14 mg/dL (4.4±0.8 mmol/L) (adjusted between-group difference +7.6 mg/dL (2.4-12.8) (+0.4 mmol/L (0.1-0.7)); p=0.005) in the rtCGM group. Regression analysis showed that follow-up low glucose events were associated with group allocation (p<0.001), low glucose events at baseline (p=0.016) and rescue threshold (p=0.001).

Conclusions: No major adjustments in insulin therapy were made by study participants with impaired hypoglycemia awareness; however, they were more active in preventing hypoglycemia by taking rescue carbohydrates earlier and more often.

Trial registration number: NCT02671968.

Keywords: diet; hypoglycemia; insulin.

Conflict of interest statement

Competing interests: DW reports grants paid to employer from Dexcom, during the conduct of the study. GF reports grants from Dexcom, during the conduct of the study; personal fees from Abbott, Novo Nordisk and Ypsomed; grants and personal fees from Roche Diabetes Care and Sanofi; grants from AgaMatrix, Beurer, Dexcom, A Menarini Diagnostics, i-SENS, LifeScan, Metronom, Pharmasens, Profusa, Sensile, outside the submitted work. SP reports grants paid to employer from Dexcom, during the conduct of the study. LH reports grants from Dexcom, during the conduct of the study; personal fees from A Menarini Diagnostics, Becton Dickinson, Lifecare and Roche Diabetes Care, outside the submitted work. LH owns shares of Profil Institut für Stoffwechselforschung, Neuss, Germany and ProSciento, San Diego, USA. NH reports grants and personal fees from Dexcom, during the conduct of the study; grants from AstraZeneca, personal fees from Novo Nordisk and Eli Lilly, grants and personal fees from Abbott Diabetes Care, Berlin Chemie, Ypsomed, and Roche Diabetes Care, outside the submitted work. DE reports grants paid to employer and personal fees from Dexcom, during the conduct of the study and personal fees from Berlin-Chemie, Roche Diabetes Care, Abbott Diabetes Care, and Medtronic outside the submitted work. CH reports grants paid to employer from Dexcom, during the conduct of the study.

© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1

Corresponding glucose values at times of rescue carbohydrate intake during baseline and follow-up phase. rtCGM, real-time continuous glucose monitoring.