Predictors of Hypoglycemia Avoidance in a Randomized Controlled rtCGM Trial (HypoDE)

Abstract

The HypoDE study, a randomized multi-center trial, showed that rtCGM use reduces the number of low glucose events (<55 mg/dl for at least 20 minutes) per 28 days from 10.4 to 3.4 events compared to SMBG (13.5 to 13.2 events) in MDI-treated type 1 diabetic patients with hypoglycemia problems. In this post-hoc analysis, we analyzed which baseline variables predict successful reduction of low glucose events. The criterion was a reduction to 0 events or by 50% from baseline. In a block-wise, multivariate logistic regression, demographic and medical variables, patient-reported-outcomes, biochemical hypoglycemia at baseline (based on 4-week masked rtCGM use), hours per day in time in range and hyperglycemia, and use of rtCGM were used as predictors. Model fit of the block-wise regression suggests that none of the baseline characteristics did predict hypoglycemia avoidance. However, entering use of rtCGM led to a rise of Nagelkerke´s R² from 0.061 to 0.331. This indicates that rtCGM use was the most important predictor for hypoglycemia avoidance. In the CGM Group, 76.1% of the patients compared to 26.3% in the Control group could avoid hypoglycemic events (Odds ratio 9.8, 95% CI 4.2 to 23.0). This suggests that rtCGM use is effective in patients with type 1 diabetes and hypoglycemia problems regardless of diabetes duration, glycemic control, severity of hypoglycemia problems, and exposure to biochemical hypoglycemia at baseline. Predictors of hypoglycemia avoidanceCharacteristicsNagelkerke´s R²Delta - Nagelkerke´s R²Block 1Demographic variables (age, diabetes Duration)0.005Block 2Block 1 + medical variables (HbA1c, severe hypoglycemia in the past 12 month, hypoglycemia unawareness0.0220.017Block 3Block 2 + Patient reported outcomes (fear of hypoglycemia, diabetes distress, satisfaction with glucose monitoring, self-reported health status)0.0290.027Block 4Block 3 + biochemical hypoglycemia at baseline (time spent ≤70 and ≤55 mg/dl per day, baseline low glucose Events)0.0580.009Block51Block 4 + time in range and time in hyperglycemia (>180 mg/dl)0.0610.003Block 6Block 5 + Treatment (rtCGM vs. SMBG)0.3310.270 Disclosure 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. 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.