The Relationship between A1C and Hypoglycemia in the HypoDE Study

Abstract

There is an inverse relationship between A1C and hypoglycemia which may be impacted by use of continuous glucose monitoring (CGM). Using data from the HypoDE clinical trial, we compared usual care to real-time CGM in subjects with type 1 diabetes using MDI and impaired hypoglycemia awareness or recent severe hypoglycemia. Data from 149 subjects (75 CGM/intervention and 74 SMBG/control) were analyzed. The percentages of sensor glucose (SG) values ≤70 mg/dL (≤3.9 mmol/L) (“%≤70”) and of those indicating clinically significant hypoglycemia (≤54 mg/dL [≤3.0 mmol/L]) (“%≤54”) during the blinded 4-week run-in and the final 4 weeks of the 26-week study were calculated for each subject and compared to corresponding baseline and 26-week A1C values. At baseline, the percent ≤70 and the percent ≤54 were similar for the two groups and there was a trend toward more hypoglycemia for subjects with lower A1C values (Figure A). At 26 weeks (Figure B), there were significant (p<0.01) between-group differences in favor of CGM at both thresholds, and the association between decreasing A1C and increasing exposure to SG values ≤54 mg/dL was attenuated. These data suggest patients at highest risk of hypoglycemia with access to CGM alerts and alarms take appropriate and timely measures to nearly eliminate exposure to clinically meaningful hypoglycemia. CGM allows safe intensification of MDI therapy and achievement of near-normal A1C levels in hypoglycemia-prone individuals. Disclosure N. Oliver: Advisory Panel; Self; Dexcom, Inc., Roche Diabetes Care Health and Digital Solutions, Medtronic. Research Support; Self; Dexcom, Inc., Roche Diabetes Care Health and Digital Solutions. Other Relationship; Self; Novo Nordisk A/S, Takeda Development Centre Europe Ltd. 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. M. Gimenez: None. M. Reddy: Advisory Panel; Self; Roche Diabetes Care Health and Digital Solutions. Other Relationship; Self; Dexcom, Inc. 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.