RtCGM Usage Is Associated with a Significant Reduction of Time Spent in Hypoglycemia in Patients with Type 1 Diabetes Treated with Multiple Daily Injections—Results of the HypoDE Study

Abstract

In this randomized multi-center study, performed in 12 specialized diabetes practices in Germany, we examined the impact of rtCGM use (Dexcom G5) on the duration of time spent in hypoglycemia. In total, 149 MDI-treated patients with type 1 diabetes and hypoglycemia problems (age 47±20 years, HbA1c 7.5±1.0%, 60.4% with at least one recent severe hypoglycemic event, unawareness score 4.9±1.2) used a masked rtCGM system for 4 weeks. After this baseline phase, 75 patients were randomized to rtCGM use and 74 were randomized to the control group with continuation of SMBG for the next 26 weeks. From week 22 till 26 after randomization, the control group had a masked rtCGM system again. The CGM group continued their use of rtCGM. Six-month follow-up data could be obtained from 141 participants. In the CGM group, the duration of time per day spent ≤70 mg/dl was lower compared to the Control group (42.6 vs. 112.0 min/day; adjusted Δ 69.4 min/day, 95% CI 52.4 to 86.4 min/day, p<0.0001). The time per day spent in <55 mg/dl showed the same pattern (11.2 vs. 53.2 min/day; adjusted Δ 41.9 min/day, 95% CI 31.4 to 52.2 min/day, p<0.0001). Time in range per day was longer in the CGM group than in the Control group (850.5 vs. 805.6 min/day; adjusted Δ 44.9 min/day, 95% CI -0.3 to 90.0 min/day, p=0.051). Time per day spent in hyperglycemia (>180 mg/dl) was slightly higher in the CGM group than in the Control group (544.2 vs. 525.5 min/day; adjusted Δ -18.7 min/day, 95% CI -70.3 to 32.9 min/day, p=0.474). HbA1c at follow-up was comparable between CGM and Control group (7.3% vs. 7.3%; adjusted Δ 0.0%, 95% CI -0.1 to 0.2%, p=0.665). The use of rtCGM in MDI-treated type 1 diabetic patients with hypoglycemia problems can significantly reduce exposure to hypoglycemic glucose values without compromising glycemic control. Given the rather higher costs of CSII treatment compared to MDI, these results are of high clinical as well as health-economic relevance. Disclosure L. Heinemann: Stock/Shareholder; Self; Profil Institute for Metabolic Research, ProSciento. Consultant; Self; Roche Diabetes Care Health and Digital Solutions. G. Freckmann: Speaker's Bureau; Self; Ascensia Diabetes Care. Research Support; Self; Ascensia Diabetes Care. Speaker's Bureau; Self; Roche Diabetes Care Health and Digital Solutions. Advisory Panel; Self; Roche Diabetes Care Health and Digital Solutions. Research Support; Self; Roche Diabetes Care Health and Digital Solutions. Advisory Panel; Self; Abbott, Novo Nordisk Inc.. Consultant; Self; Sensile Medical AG. Speaker's Bureau; Self; Ypsomed AG. D. Waldenmaier: None. D. Ehrmann: Speaker's Bureau; Self; Berlin-Chemie AG. N. Hermanns: Speaker's Bureau; Self; Berlin-Chemie AG. Advisory Panel; Self; Abbott. Research Support; Self; Abbott. Speaker's Bureau; Self; Abbott. Research Support; Self; Berlin-Chemie AG. Advisory Panel; Self; Eli Lilly and Company. Speaker's Bureau; Self; Eli Lilly and Company. Advisory Panel; Self; Roche Diabetes Care Health and Digital Solutions. Research Support; Self; Ypsomed AG, Dexcom, Inc.. Speaker's Bureau; Self; Novo Nordisk Inc..