97-LB: Safety and Glycemic Outcomes of the MiniMed Advanced Hybrid Closed-Loop (AHCL) System in Subjects with T1D
| العنوان: | 97-LB: Safety and Glycemic Outcomes of the MiniMed Advanced Hybrid Closed-Loop (AHCL) System in Subjects with T1D |
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| المؤلفون: | Neha J. Parikh, Anirban Roy, Ronald L. Brazg, James Thrasher, Bruce W. Bode, Andrew S. Rhinehart, Robert H. Slover, Lintereur Louis J, David R. Liljenquist, Scott W. Lee, Xiaoxiao Chen, Mark P. Christiansen, John H. Shin, Dorothy I. Shulman, Rodica Pop-Busui, Athena Philis-Tsimikas, Margaret Liu, Robert A. Vigersky, Benyamin Grosman, Anders L. Carlson, Jennifer L. Sherr, Mark Kipnes, Satish K. Garg, Di Wu, Fen Peng, Kamalpreet K. Singh, Kevin B. Kaiserman |
| المصدر: | Diabetes. 69 |
| بيانات النشر: | American Diabetes Association, 2020. |
| سنة النشر: | 2020 |
| مصطلحات موضوعية: | 0301 basic medicine, American diabetes association, medicine.medical_specialty, business.industry, Endocrinology, Diabetes and Metabolism, Insulin delivery, 030209 endocrinology & metabolism, Severe hypoglycemia, Set point, 03 medical and health sciences, Low glucose, 030104 developmental biology, 0302 clinical medicine, Family medicine, Internal Medicine, Medicine, business, Closed loop |
| الوصف: | Background: Automated insulin delivery systems improve glycemic control including time spent in, below and above range (TIR, TBR and TAR, respectively) in people with T1D. A next generation system, the MiniMedTM AHCL system, that offers a target set point (SP) of 100 or 120mg/dL, autocorrects to 120mg/dL every 5 mins and has fewer Auto Mode exits, was evaluated. Methods: A 16-site, single-arm, in-home trial of the AHCL system in 39 adolescents (14-21yrs) and 118 adults (≥22yrs) with T1D was conducted. After a baseline period of sensor-integrated pump, HCL feature, or predictive low glucose feature use (~14 days), the AHCL feature was enabled with a 100 or 120mg/dL SP for ~45 days and then the other SP for ~45 days. Study endpoints included safety events, change in A1C, sensor glucose (SG), %TIR, %TBR and %TAR. Results: There were no DKA or severe hypoglycemia episodes during the study period. Auto Mode was used ≥95% of the time; autocorrection was 22% of daily bolus. The table shows outcomes (mean±SD) for the overall group and each age group at baseline and study period (100 and 120mg/dL SP), and at the 100mg/dL SP. Best glycemic results (SG of 141±8.8mg/dL, TIR of 78.8±5.5% and TBR of 2.6±2.0%; N=29) were seen with a 100mg/dL SP and active insulin time of 120 minutes. Conclusion: These pivotal trial data demonstrate that AHCL is safe and significantly improved A1C and SG in subjects aged ≥14 years with T1D. Disclosure A.L. Carlson: Consultant; Self; Medtronic. Research Support; Self; Abbott, Dexcom, Inc., Eli Lilly and Company, Insulet Corporation, Medtronic, Novo Nordisk A/S, Sanofi, UnitedHealth Group. B.W. Bode: Advisory Panel; Self; Medtronic, Novo Nordisk A/S. Consultant; Self; Eli Lilly and Company, Medtronic, Novo Nordisk A/S. Research Support; Self; Abbott, Advance, Boehringer Ingelheim Pharmaceuticals, Inc., Dexcom, Inc., Diasome Pharmaceuticals, Inc., Eli Lilly and Company, Insulet Corporation, Janssen Pharmaceuticals, Inc., MannKind Corporation, Medtronic, National Institutes of Health, Nova Biomedical, Novo Nordisk A/S, Provention Bio, Inc., Sanofi, Senseonics. Speaker’s Bureau; Self; AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, Janssen Pharmaceuticals, Inc., MannKind Corporation, Medtronic, Novo Nordisk A/S, Sanofi, Senseonics. Stock/Shareholder; Self; Aseko. R.L. Brazg: None. M.P. Christiansen: Research Support; Self; Abbott, Ascensia Diabetes Care, Biolinq, Dexcom, Inc., Eli Lilly and Company, Lexicon Pharmaceuticals, Inc., Medtronic, Merck & Co., Inc., Novo Nordisk A/S, Sanofi-Aventis, Senseonics, ViroMed Laboratories, Xeris Pharmaceuticals, Inc. S.K. Garg: Advisory Panel; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, Medtronic, Novo Nordisk A/S, Roche Diagnostics France. Research Support; Self; Dexcom, Inc., Eli Lilly and Company, Medtronic. K. Kaiserman: Advisory Panel; Self; Medtronic. Consultant; Self; Medtronic. Research Support; Self; Medtronic. Speaker’s Bureau; Self; Medtronic. M. Kipnes: None. D.R. Liljenquist: None. A. Philis-Tsimikas: Advisory Panel; Self; Lilly Diabetes, Medtronic, Novo Nordisk A/S, Sanofi. Employee; Spouse/Partner; Ionis Pharmaceuticals, Inc. Research Support; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Dexcom, Inc., Lilly Diabetes, Medtronic, Novo Nordisk A/S, Sanofi. R. Pop-Busui: Advisory Panel; Self; Boehringer Ingelheim Pharmaceuticals, Inc. Consultant; Self; Bayer Healthcare Pharmaceuticals Inc., Novo Nordisk Inc. Research Support; Self; AstraZeneca. Other Relationship; Self; American Diabetes Association. J. Sherr: Advisory Panel; Self; Bigfoot Biomedical, Cecelia Health. Consultant; Self; Eli Lilly and Company, Lexicon Pharmaceuticals, Inc., Medtronic, Sanofi, T1D Exchange. D.I. Shulman: Advisory Panel; Self; Medtronic. K.K. Singh: None. R.H. Slover: None. J. Thrasher: Advisory Panel; Self; Lexicon Pharmaceuticals, Inc., Novo Nordisk Inc., Sanofi. Board Member; Self; Medtronic. Consultant; Self; Medtronic. Research Support; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Bristol-Myers Squibb, Eli Lilly and Company, Lexicon Pharmaceuticals, Inc., Medtronic, Mylan, Novo Nordisk Inc., Sanofi. Speaker’s Bureau; Self; AstraZeneca, Janssen Pharmaceuticals, Inc., Medtronic, Sanofi. X. Chen: Employee; Self; Medtronic. B. Grosman: Employee; Self; Medtronic. S.W. Lee: Employee; Self; Medtronic. L.J. Lintereur: Employee; Self; Medtronic. M. Liu: Employee; Self; Medtronic. N. Parikh: None. A.S. Rhinehart: Employee; Self; Glytec, Medtronic. Stock/Shareholder; Self; Dexcom, Inc., Glytec, Lexicon Pharmaceuticals, Inc., MannKind Corporation, Tandem Diabetes Care. F. Peng: None. A. Roy: Employee; Self; Medtronic. J. Shin: Employee; Self; Medtronic. D. Wu: None. R. Vigersky: Employee; Self; Medtronic. |
| تدمد: | 1939-327X 0012-1797 |
| الوصول الحر: | https://explore.openaire.eu/search/publication?articleId=doi_________::cc27d2c2b8a1afdc635f0206e5859f06Test https://doi.org/10.2337/db20-97-lbTest |
| حقوق: | CLOSED |
| رقم الانضمام: | edsair.doi...........cc27d2c2b8a1afdc635f0206e5859f06 |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 1939327X 00121797 |
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