Positive Impact of the Bionic Pancreas on Diabetes Control in Youth 6-17 Years Old with Type 1 Diabetes: A Multicenter Randomized Trial.

Autor: Messer LH; Barbara Davis Center for Diabetes, University of Colorado, Aurora, Colorado, USA., Buckingham BA; Department of Pediatrics, Division of Pediatric Endocrinology and Diabetes, Stanford University School of Medicine, Palo Alto, California, USA., Cogen F; Department of Endocrinology and Diabetes, Children's National Medical Center, Washington, District of Columbia, USA., Daniels M; Endocrinology and Diabetes Division, Children's Hospital of Orange County, Orange, California, USA., Forlenza G; Barbara Davis Center for Diabetes, University of Colorado, Aurora, Colorado, USA., Jafri RZ; Division of Pediatric Endocrinology and Diabetes, University of Texas Health Science Center, San Antonio, San Antonio, Texas, USA., Mauras N; Division of Endocrinology, Diabetes & Metabolism, Department of Pediatrics, Nemours Children's Health System, Jacksonville, Florida, USA., Muir A; Department of Pediatrics, Emory University, Atlanta, Georgia, USA., Wadwa RP; Barbara Davis Center for Diabetes, University of Colorado, Aurora, Colorado, USA., White PC; Department of Pediatrics, University of Texas Southwestern Medical Center, Dallas, Texas, USA., Russell SJ; Diabetes Research Center, Department of Medicine, Massachusetts General Hospital, Boston, Massachusetts, USA., Damiano ER; Department of Biomedical Engineering, Boston University, Boston, Massachusetts, USA.; Beta Bionics, Concord, Massachusetts, USA., El-Khatib FH; Department of Biomedical Engineering, Boston University, Boston, Massachusetts, USA.; Beta Bionics, Concord, Massachusetts, USA., Ruedy KJ; JAEB Center for Health Research, Tampa, Florida, USA., Balliro CA; Diabetes Research Center, Department of Medicine, Massachusetts General Hospital, Boston, Massachusetts, USA., Li Z; JAEB Center for Health Research, Tampa, Florida, USA., Marak MC; JAEB Center for Health Research, Tampa, Florida, USA., Calhoun P; JAEB Center for Health Research, Tampa, Florida, USA., Beck RW; JAEB Center for Health Research, Tampa, Florida, USA.
Jazyk: angličtina
Zdroj: Diabetes technology & therapeutics [Diabetes Technol Ther] 2022 Oct; Vol. 24 (10), pp. 712-725.
DOI: 10.1089/dia.2022.0201.pub
Abstrakt: Objective: To evaluate the insulin-only configuration of the iLet ® bionic pancreas (BP) in youth 6-17 years old with type 1 diabetes (T1D). Research Design and Methods: In this multicenter, randomized, controlled trial, 165 youth with T1D (6-17 years old; baseline HbA1c 5.8%-12.2%; 35% using multiple daily injections, 36% using an insulin pump without automation, 4% using an insulin pump with low glucose suspend, and 25% using a hybrid closed-loop system before the study) were randomly assigned 2:1 to use BP ( n  = 112) with insulin aspart or insulin lispro (BP group) or to a control group ( n  = 53) using their personal standard care insulin delivery (SC group) plus real-time continuous glucose monitoring (CGM). The primary outcome was HbA1c at 13 weeks. Results: Mean HbA1c decreased from 8.1% ± 1.2% at baseline to 7.5% ± 0.7% at 13 weeks with BP versus 7.8% ± 1.1% at both baseline and 13 weeks with SC (adjusted difference = -0.5%, 95% CI -0.7% to -0.2%, P  < 0.001). Participants with baseline HbA1c ≥9.0% ( n  = 34) decreased mean HbA1c from 9.7% ± 0.8% to 7.9% ± 0.6% after 13 weeks with BP compared with 9.7% ± 0.5% to 9.8% ± 0.8% with SC. Over 13 weeks, mean time in range (TIR) 70-180 mg/dL increased by 10% (2.4 h per day) and mean CGM glucose was reduced by 15 mg/dL with BP compared with SC ( P  < 0.001). Analyses of time >180 mg/dL, time >250 mg/dL, and standard deviation of CGM glucose favored BP ( P  < 0.001). Time <54 mg/dL was low at baseline (median 0.2%) and not significantly different between groups over 13 weeks ( P  = 0.24). A severe hypoglycemia event occurred in 3 (2.7%) participants in the BP group and in 1 (1.9%) in the SC group. Conclusions: In youth 6-17 years old with T1D, use of insulin-only configuration of BP improved HbA1c, TIR, and hyperglycemic metrics without increasing CGM-measured hypoglycemia compared with standard of care. Improvement in glycemic metrics was most pronounced in participants with high baseline HbA1c levels. Clinical Trial Registry: clinicaltrials.gov; NCT04200313.
Databáze: MEDLINE
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