1343-OR: Continuous Glucose Monitoring vs. Blood Glucose Monitoring in Patients with Type 2 Diabetes Managed on Insulin in Primary Care: The GluCoCare Study

Introduction and Objective: We evaluated the effectiveness of CGM versus BGM in the pragmatic management of T2D on insulin in primary care, in a large randomized controlled trial in the upper Midwest. Methods: This two-arm trial was cluster-randomized based on primary care clinic attendance: (BGM 25 clinics) or CGM (25 clinics). We recruited 360 adults with T2D on insulin (basal 66%, bolus 27%, premixed 8%) with 37% GLP-1 and 22% SGLT2i use at baseline. Participants were age 18-75, with an A1C of 7.5-12%, and not using CGM. Management was during routine primary care visits over 12 months, with differential change in A1C (primary outcome), Diabetes Distress Scale score (DDS-17, secondary outcome) and CGM metrics comparing baseline to 12 months. Results: Adjusted mean A1C decreased by -0.80% to 7.97% (CGM group), and -0.47% to 8.30% (BGM group); adjusted mean differential change -0.33% (95% CI, -0.59, -0.07; P=0.012). There was no meaningful difference in DDS-17. Blinded CGM showed a non-significant differential improvement in time in range 70-180 mg/dL (∆ 4.6%, p=0.14) in the CGM group. Time with glucose 70mg/dL was minimal in both groups. Conclusion: CGM significantly improved A1C compared to BGM over 12 months, in individuals with T2D on insulin, in one of the first pragmatic trials in primary care. This supports the broad use of CGM in individuals on insulin in primary care. Disclosure T. Martens: Other - Research support, consulting; Current; Dexcom, Inc. Other - Research support, advisory panel; Current; Abbott Diabetes. Other - Research support, consulting; Current; Lilly. Other - Research support, advisory panel; Current; Sanofi. Research Support; Current; Tandem Diabetes Care, Inc., MannKind Corporation, Zealand Pharma A/S. Research Support; Ended; Omnipod. Research Support; Current; Novo Nordisk, Medtronic, Sequel. S.E. Asche: Stock/Shareholder; Current; AbbVie Inc., Gilead Sciences, Inc., GlaxoSmithKline plc. M.L. Johnson: Research Support; Current; Abbott Diabetes, Dexcom, Inc. M.M. JaKa: Research Support; Ended; Abbott, Dexcom, Inc. A. Haven: None. S.M. Dunnigan: Research Support; Current; Abbott Diabetes, Dexcom, Inc., Lilly Diabetes. S.K. Mercado: None. M. Maciosek: None. C. Morris: None. D. Barnaby: None. R.M. Bergenstal: Other - Advisory Panel, Consultant, Clinical Research Support; Current; Abbott Diabetes. Other - Consultant, Clinical Research Support; Current; Dexcom, Inc. Research Support; Current; Amgen Inc. Advisory Panel; Current; CeQur SA. Other - Advisory Panel, Consultant, Clinical Research Support; Current; Eli Lilly and Company. Research Support; Current; Insulet Corporation. Research Support; Ended; Luna. Research Support; Current; Medtronic. Other - Advisory Panel, Consultant, Clinical Research Support; Current; Novo Nordisk. Research Support; Current; Tandem Diabetes Care, Inc. Consultant; Current; Sanofi. Advisory Panel; Current; Vertex Pharmaceuticals Incorporated. Research Support; Current; Zealand Pharma A/S, Sequel, Embecta. Funding This work was supported through a Patient-Centered Outcomes Research Institute (PCORI) Award (IHS-2019C3-18083). DISCLAIMER: All statements in this report, including its findings and conclusions, are solely those of the authors and do not necessarily represent the views of the Patient-Centered Outcomes Research Institute (PCORI), its Board of Governors or Methodology Committee.