Predictors of hypoglycemia avoidance in a randomized controlled rtCGM trial (HypoDE)

Faculty/Professorship: Clinical Psychology and Psychotherapy  
Author(s): Hermanns, Norbert  ; Heinemann, Lutz; Freckmann, Guido; Waldenmaier, Delia; Ehrmann, Dominic  
Title of the Journal: Diabetes
ISSN: 0012-1797
Corporate Body: American Diabetes Association
Publisher Information: Alexandria, Va : American Diabetes Association
Year of publication: 2018
Volume: 67
Issue: Suppl. 1
Pages: A79 (298-OR)
Language(s): English
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.
DOI: 10.2337/db18-298-OR
Peer Reviewed: Ja
International Distribution: Ja
Type: Article
Release Date: 15. January 2020