69-LB: Nonadjunctive Continuous Glucose Monitoring to Control Hypoglycemia (COACH)

Abstract

Previous studies have been insufficiently powered to assess whether CGM can reduce severe hypoglycemia. The Continuous Monitoring and Control of Hypoglycemia study evaluated nonadjunctive use of the Dexcom CGM system for diabetes management decisions in adults new to CGM. This post-approval 12-month observational study enrolled adults with insulin-requiring diabetes who based diabetes management and insulin dosing decisions on self-monitored blood glucose (SMBG) values for 6 months and then on CGM for 6 months. Per protocol, diabetes management was per usual care. Subjects were queried monthly about hypoglycemic and diabetic ketoacidosis (DKA) events. The primary outcome was change in moderate (requiring third party assistance) and severe (seizure or loss of consciousness) hypoglycemic event frequency between SMBG and CGM phases; secondary outcomes included DKA events. The per-protocol population included all 519 adult subjects who completed the 12-month visit with mean±SD age 50.3±16.1 y, A1C 8.0±1.4%, 32.8% with impaired hypoglycemia awareness, 54.1% male, 66.5% and 33.5% with T1D/T2D, and 29.7% using pumps. Compared to the SMBG phase, the frequency of moderate and severe hypoglycemic events was significantly (p=0.0051) lower during the CGM phase; DKA frequency was also lower (Table). Compared to SMBG, nonadjunctive CGM use reduces rates of severe hypoglycemia and DKA. Disclosure S. Beck: Employee; Self; Dexcom, Inc. C. Kelly: Consultant; Self; Ajinomoto Co., Inc., Dexcom, Inc., Hitachi, Ltd., Vascular Dynamics Inc. N. Njeru: None. J. J. Gorelick: Employee; Self; Dexcom, Inc., Edwards Lifesciences. J. C. Bowers: Employee; Self; Dexcom, Inc. D. A. Price: Employee; Self; Dexcom, Inc.