95-OR: Impact of Flash Glucose Monitoring in People with Type 2 Diabetes Inadequately Controlled with Noninsulin Antihyperglycemic Therapy: IMMEDIATE Study

Continuous glucose monitoring (CGM) has been shown to improve glycemic outcomes in people with diabetes using insulin therapies. In this multi-site, randomized trial, we studied adults with T2D inadequately controlled with non-insulin antihyperglycemic therapy to evaluate the impact of flash glucose monitoring (FGM) on glycemic and patient-reported outcomes. Participants received FGM + diabetes self-management education (DSME) or matched DSME alone for 16 weeks. Primary outcome was assessed by a blinded CGM device worn at baseline and at outcome. Among 116 participants enrolled (age 58.4 ± 10.1 years; T2D duration 10.1 ± 6.1 years; HbA1c 8.6 ± 1.1%) , the initial 82 completers (41 FGM + DSME, 41 DSME) showed time in range significantly greater in the FGM + DSME arm (76.1 ± 16.9%) compared to DSME arm (64.3 ± 23.2%) (p<0.01) . Time above range was similarly lower in the FGM + DSME arm (21.5 ± 17.8% vs. 31.3 ± 25.6%, p=0.03) . Hypoglycemia was rare in both arms. Glucose monitoring satisfaction scores improved in the FGM + DSME arm only (0.6 ± 0.5 vs. 0.0 ± 0.5, p<0.01) . Change in HbA1c was also greater in the FGM + DSME arm (-0.9 ± 0.9% vs. -0.5 ± 0.9%, p=0.03) . In this interim analysis, FGM users with T2D using non-insulin therapies had significantly greater time in range, satisfaction with glucose monitoring, and a greater reduction in HbA1c. Disclosure R.E.Brown: None. R.Aronson: Consultant; AstraZeneca, Becton, Dickinson and Company, Boehringer Ingelheim International GmbH, Eli Lilly and Company, Gilead Sciences, Inc., HTL Strefa, Janssen Pharmaceuticals, Inc., Merck & Co., Inc., Novo Nordisk, Sanofi, Research Support; AstraZeneca, Bausch Health, Canada, Bayer AG, Becton, Dickinson and Company, Boehringer Ingelheim International GmbH, Dexcom, Inc., Eli Lilly and Company, Insulet Corporation, Janssen Pharmaceuticals, Inc., Kowa Pharmaceuticals America, Inc., Medpace, Novo Nordisk, Sanofi, Tandem Diabetes Care, Inc., Xeris Pharmaceuticals, Inc., Zealand Pharma A/S. Funding Abbott Diabetes Care, Inc.