Visual Abstract
The Continuous Monitoring and Control of Hypoglycemia study aimed to evaluate use of a continuous glucose monitoring (CGM) system in adults with insulin-requiring diabetes who were new to CGM. The study design called for a 6-month phase in which insulin dosing decisions were based on self-monitored blood glucose (SMBG) values followed by a 6-month phase in which diabetes management decisions were based on nonadjunctive use of a Dexcom CGM. Patients were followed via usual care aside from monthly phone calls to document severe hypoglycemia and DKA. Changes in A1C were a secondary outcome. A1C values were available at 6 and 12 months from 517 individuals in the per-protocol population. There was a trend toward larger A1C reductions among individuals with higher baseline (Month 0) A1C values (Figure). Although the mean A1C was unchanged (Month 6 to Month 12) for those with baseline A1C values <7.0%, there was a significant decrease (p=0.0075) in the per-patient mean±SE rate of moderate to severe hypoglycemic events in this cohort, from 0.090±0.035 during the SMBG phase to 0.008±0.008 during the CGM phase. The number of subjects with severe hypoglycemic events in this subgroup decreased from 8 in the SMBG phase to 1 in the CGM phase. Changes in A1C associated with CGM use are related to A1C levels at the start of CGM use. Access to real-time CGM data may facilitate appropriate therapeutic decisions.
S. Beck: Employee; Self; Dexcom, Inc. C. Kelly: Consultant; Self; Ajinomoto Co., Inc., Dexcom, Inc., Hitachi, Ltd., Vascular Dynamics Inc. N. Njeru: None. J. Gorelick: Employee; Self; Dexcom, Inc., Edwards Lifesciences. J. C. Bowers: Employee; Self; Dexcom, Inc. D. A. Price: Employee; Self; Dexcom, Inc.
