We combined rtCGM-baseline-data of the HypoDE and DIAMOND study to predict future severe hypoglycemia (SH; third party assistance for recovery). At baseline, in both studies, the rtCGM system (Dexcom G4) was masked. We analyzed the data of 127 study participants in the control groups with type 1 diabetes (age 46.0 ±11.5 years; diabetes duration 22.4 ±14.1 years, A1c 7.9 ±1.0%) using SMBG during the trials. According to the consensus statement we used the following hypoglycemia-specific predictors: % of glucose values < 70mg/dl and <54 mg/dl, the number of such events, Low Blood Glucose Index (LBGI), and the coefficient of variation (CV). After baseline, a total of 44 severe hypoglycemic events were observed during the following 6-months; with 12.6% affected participants. We analyzed the area under the Receiver Operating Characteristics (ROC) curves and determined cut-off values with an optimal sensitivity and specificity (Table). All hypoglycemia-related parameters, except CV, were able to predict SH during the next 6 months significantly better than prediction by chance; e.g., if ≥ 7% of glucose values were < 70 mg/dl, the probability for SH in the next 6-months was 23.4%. CGM-derived hypoglycemic outcome parameters might help to identify people with diabetes who have an increased risk for future hypoglycemia. These results should be corroborated by non-masked use of rtCGM but might also be useful in patients using SMBG.
N. Hermanns: Advisory Panel; Self; Abbott. Board Member; Self; Eli Lilly and Company. Research Support; Self; Abbott, Berlin-Chemie AG, Dexcom, Inc., Roche Diabetes Care. Speaker's Bureau; Self; Berlin-Chemie AG, Dexcom, Inc., Novo Nordisk A/S. D. Ehrmann: Advisory Panel; Self; Medtronic. Speaker's Bureau; Self; Abbott, Berlin-Chemie AG, Dexcom, Inc. P. Calhoun: Stock/Shareholder; Self; Dexcom, Inc. G. Freckmann: Advisory Panel; Self; Abbott, Novo Nordisk Pharma GmbH, Sensile Medical AG. Consultant; Self; Metronom Health Europe, Roche Diabetes Care, Sanofi. Speaker's Bureau; Self; Ascensia Diabetes Care, Dexcom, Inc., Ypsomed AG. L. Heinemann: Consultant; Self; Roche Diabetes Care. Research Support; Self; Dexcom, Inc. Stock/Shareholder; Self; Profil Institute for Metabolic Research, ProSciento.
Dexcom, Inc.
