Objective: A CGM sensor that is disposable and requires no calibration may make glucose management easier for people living with diabetes. The present study reports on the interim analysis of a new disposable zero-calibration sensor in adults and youth with type 1 (T1D) or type 2 diabetes (T2D) .
Methods: A prospective study enrolled individuals (N=123 adults, aged 18-80 years and N=120 youth, aged 2-17 years) with diabetes at 13 sites in the United States. Raw sensor data were compared with a YSI (Yellow Springs Instruments) or blood glucose (BG) reference and involved N=15388 paired points (pps) from the arm of adults, and N=8627pps from the arm and 7781pps from the buttock of youth. Data were processed using a new zero-calibration algorithm. The primary endpoint was agreement within 20%/20mg/dL (sensor glucose [SG] ≥80mg/dL/<80mg/dL) . Multiple secondary and descriptive endpoints included agreement within 15%/15mg/dL (SG ≥70mg/dL/<70mg/dL) and the mean absolute relative difference (MARD) for the adult arm location and youth arm and buttock locations.
Results: The overall 20%/20mg/dL agreement rate was 90.6% for adults, and 87.8% and 88.5% for youth arm and buttock, respectively. For adults, the 15%/15mg/dL agreement rates were 90.1% and 87.6% (SG <70 mg/dL and SG >180 mg/dL, respectively) . For youth, the 15%/15mg/dL rates were 93.2% and 86.5% for the arm (SG <70 mg/dL and SG >180 mg/dL, respectively) and 90.3% and 89.5% for the buttock (SG <70 mg/dL and SG>180 mg/dL, respectively) . The MARDs were 10.2% for adults, and 10.7% and 10.1% for youth arm and buttock, respectively.
Conclusion: These interim findings on the clinical performance of the new disposable and calibration-free sensor are good and may support non-adjunctive insulin dosing in standalone CGM and automated insulin delivery systems.
B.W.Bode: Advisory Panel; CeQur SA, MannKind Corporation, Medtronic, Novo Nordisk, Zealand Pharma A/S, Consultant; Bigfoot Biomedical, Inc., Research Support; Abbott, Beta Bionics, Inc., Dexcom, Inc., Diasome, Dompé, Eli Lilly and Company, Insulet Corporation, IQVIA Inc., Jaeb Center for Health Research, Medtronic, Novo Nordisk, Provention Bio, Inc., REMD Biotherapeutics, Sanvita Medical, Senseonics, ViaCyte, Inc., Speaker’s Bureau; Abbott, Boehringer Ingelheim International GmbH, Eli Lilly and Company, Insulet Corporation, MannKind Corporation, Novo Nordisk, Sanofi, Xeris Pharmaceuticals, Inc., Stock/Shareholder; AgaMatrix, Glytec, LLC. J.Shin: Employee; Medtronic. F.Peng: None. S.Huang: n/a. A.S.Rhinehart: Employee; Medtronic, Stock/Shareholder; Medtronic. R.A.Vigersky: Employee; Medtronic. T.S.Bailey: Advisory Panel; Abbott Diabetes, CeQur SA, MannKind Corporation, Medtronic, Novo Nordisk, Consultant; LifeScan, Sanofi, Research Support; Abbott Diabetes, Abbott Diagnostics, Biolinq, Capillary Biomedical, Inc., Dexcom, Inc., Eli Lilly and Company, Kowa Research Institute, Inc., Livongo, MannKind Corporation, Medtronic, Novo Nordisk, REMD Biotherapeutics, Sanofi, Sanvita Medical, Senseonics, ViaCyte, Inc., vTv Therapeutics, Zealand Pharma A/S, Speaker’s Bureau; Becton, Dickinson and Company, Medtronic, Sanofi. K.N.Castorino: Consultant; Lilly Diabetes, Research Support; Abbott Diabetes, Dexcom, Inc., Drawbridge Health, Inc., Eyenuk, Inc., Laxmi Therapeutic Devices, Medtronic, National Institute of Diabetes and Digestive and Kidney Diseases, Novo Nordisk, Speaker’s Bureau; Dexcom, Inc. M.P.Christiansen: Research Support; Abbott Diabetes, Ascensia Diabetes Care, AstraZeneca, Biolinq, Dexcom, Inc., Eli Lilly and Company, Helixmith, MannKind Corporation, Medtronic, Merck Sharp & Dohme Corp. S.K.Garg: Advisory Panel; Bayer AG, Medtronic, Zealand Pharma A/S, Consultant; Novo Nordisk, Research Support; Dexcom, Inc., Medtronic. K.B.Kaiserman: Advisory Panel; Medtronic, Consultant; Medtronic, Employee; MannKind Corporation, Research Support; Medtronic, Speaker’s Bureau; Medtronic, Stock/Shareholder; MannKind Corporation. D.R.Liljenquist: None. D.I.Shulman: Advisory Panel; Medtronic. R.H.Slover: None.