Impact of rtCGM Usage on a Combined Patient Reported Outcome—A Post-Hoc Analysis of the HypoDE Study

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 min) per 28 days significantly 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. We analyzed the impact of rtCGM use on patient-reported-outcomes (PRO). A combined PRO consisting of a specific measure of satisfaction with glucose monitoring (GMSS), a diabetes-specific assessment (DDS) and a generic measure (EQ-5D) was used. In a factor analysis, all three scales loaded on one factor. All questionnaire scores were z-transformed as well as the number of low glucose events. The figure shows the effect sizes of the combined PRO and the single scores as well as of the low glucose events. There was a significant positive impact of rtCGM use on the combined PRO. However, only GMSS but not DDS or EQ-5D showed a significant impact. The more device-specific the PRO, the higher was the effect size. Interestingly, the impact of rtCGM use on biochemical hypoglycemia had a remarkably larger effect size than the combined PRO. Since most other rtCGM studies are powered to detect a benefit in glycemic endpoints and not in PRO, the lower impact of rtCGM on PRO is a barrier to prove the efficacy of rtCGM on PRO like quality of life, diabetes distress or satisfaction with treatment. Disclosure D. Ehrmann: Speaker's Bureau; Self; Berlin-Chemie AG. 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. 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..