149-OR: Evaluation of the Next Generation 180-Day Long-Term Implantable Eversense CGM System: PROMISE Study

Autor: David R. Liljenquist, Timothy S. Bailey, Francine R. Kaufman, Mark P. Christiansen, Satish K. Garg, Halis Kaan Akturk, Douglas S Denham, Andrew Dehennis, Bruce W. Bode, Katherine S. Tweden, Ronald L. Brazg, Anna Chang
Rok vydání: 2021
Předmět:
Zdroj: Diabetes. 70
ISSN: 1939-327X
0012-1797
DOI: 10.2337/db21-149-or
Popis: Background: The prospective, multi-center PROMISE study evaluated the safety and accuracy of the next generation Eversense CGM System for up to 180 days in 181 adults with diabetes at 8 US clinical sites. Methods: Accuracy was evaluated by comparing CGM and reference values from Yellow Springs Instruments (YSI) during 10 clinic visits from day 1-180, which included hyperglycemia and hypoglycemia challenges. Eighty-five and 96 subjects had 1 and 2 sensors inserted in the arm, respectively, with 2 replaced sensors for 279 sensors (558 insertions/removals). The CGM prompts 2 calibrations/day to day 21, after which it primarily prompts 1 calibration/day. Results: The Table shows accuracy analyses based on 49,613 matched pairs over 180 days. Percent CGM readings within 15/15% and 20/20% of YSI values was 85.6% and 92.9%, respectively, and the MARD was 9.1%. MARDs across different glucose ranges from 40-400 mg/dL were ≤9.4% (Table). The confirmed hypoglycemia detection rates at 70mg/dL and 60 mg/dL were 93% and 87%, respectively. Hyperglycemia at 180mg/dL was detected in 99%. There were no device or insertion/removal procedure-related serious adverse events. Two mild skin infections occurred for a rate of 0.36% per procedure. Conclusion: These results indicate the next generation Eversense long-term implantable CGM System has sustained accuracy and safety up to 180 days with primarily one calibration/day. Disclosure S. K. Garg: Advisory Panel; Self; Eli Lilly and Company, Medtronic, Novo Nordisk Inc., Zealand Pharma A/S, Research Support; Self; Dexcom, Inc., Eli Lilly and Company, Medtronic. A. D. Dehennis: Employee; Self; Senseonics. K. Tweden: Employee; Self; Senseonics. F. R. Kaufman: Advisory Panel; Self; Virta Health Corp., Employee; Self; Senseonics, Stock/Shareholder; Self; Medtronic. D. R. Liljenquist: Research Support; Self; Abbott Diabetes, AbbVie Inc., Ascensia Diabetes Care, Dexcom, Inc., Drawbridge Health, Inc., Eyenuk, Inc., Jaeb Center for Health Research, Medtronic, Provention Bio, Inc., Senseonics. B. W. Bode: Advisory Panel; Self; Eli Lilly and Company, Consultant; Self; Bigfoot Biomedical, Inc., Companion Medical, Lexicon Pharmaceuticals, Inc., Medtronic, Novo Nordisk Inc., Zealand Pharma A/S, Research Support; Self; Abvance Therapeutics, Dexcom, Inc., Diasome Pharmaceuticals, Inc., Dompe, Eli Lilly and Company, Eyenuk, Inc., Insulet Corporation, Jaeb Center for Health Research, Medtronic, Nova Biomedical, Novo Nordisk, Provention Bio, Inc., REMD Biotherapeutics, Sanofi, Senseonics, Viacyte, Inc., vTv Therapeutics, Xeris Pharmaceuticals, Inc., Speaker’s Bureau; Self; AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, MannKind Corporation, Medtronic, Novo Nordisk, Sanofi, Stock/Shareholder; Self; AgaMatrix, Aseko, Inc., Glytec, LLC. M. P. Christiansen: Research Support; Self; Abbott Diabetes, Biolinq, Dexcom, Inc., Eli Lilly and Company, Medtronic, Merck & Co., Inc., Novo Nordisk A/S, Pfizer Inc., Viacyte, Inc. T. S. Bailey: Consultant; Self; Abbott Diabetes, LifeScan, Novo Nordisk, Sanofi, Research Support; Self; Abbott, Abbott Diabetes, Biolinq, Capillary Biomedical, Inc., Dexcom, Inc., Eli Lilly and Company, Kowa Research Institute, Inc., Lexicon Pharmaceuticals, Inc., Livongo, Medtronic, Medtrum Technologies, Novo Nordisk, REMD Biotherapeutics, Sanofi, Sanvita, Viacyte, Inc., vTv Therapeutics, Zealand Pharma A/S, Speaker’s Bureau; Self; BD, Medtronic, Sanofi. R. L. Brazg: Research Support; Self; Abbott Diabetes, Ascensia Diabetes Care, Lexicon Pharmaceuticals, Inc., Lilly Diabetes, Medtronic, Pfizer Inc., Roche Diagnostic USA, Senseonics. D. S. Denham: None. A. Chang: None. H. K. Akturk: Consultant; Self; American Diabetes Association, Research Support; Self; Dexcom, Inc., Eli Lilly and Company, IM Therapeutics, MannKind Corporation, REMD Biotherapeutics, Senseonics, Speaker’s Bureau; Self; American Diabetes Association. Funding Senseonics, Inc.
Databáze: OpenAIRE
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