Improvements in Glycemic Control Achieved by Altering the t max Setting in the iLet ® Bionic Pancreas When Using Fast-Acting Insulin Aspart: A Randomized Trial.

Autor: Russell SJ; Diabetes Research Center, Massachusetts General Hospital, Boston, MA, USA. SJRUSSELL@mgh.harvard.edu.; Diabetes Research Unit, Massachusetts General Hospital, Boston, MA, USA. SJRUSSELL@mgh.harvard.edu., Balliro C; Diabetes Research Center, Massachusetts General Hospital, Boston, MA, USA., Ekelund M; Type 1 Diabetes and Functional Insulins, Novo Nordisk A/S, Søborg, Denmark., El-Khatib F; Department of Biomedical Engineering, Boston University, Boston, MA, USA.; Research and Innovation, Beta Bionics, Inc., Boston, MA, USA., Graungaard T; Biostatistics, Novo Nordisk A/S, Aalborg, Denmark., Greaux E; Diabetes Research Center, Massachusetts General Hospital, Boston, MA, USA., Hillard M; Diabetes Research Center, Massachusetts General Hospital, Boston, MA, USA., Jafri RZ; Diabetes Research Center, Massachusetts General Hospital, Boston, MA, USA.; Division of Pediatric Endocrinology, University of Texas Health Science Center, San Antonio, TX, USA., Rathor N; Novo Nordisk Service Centre India Private Ltd., Bangalore, India., Selagamsetty R; Department of Biomedical Engineering, Boston University, Boston, MA, USA.; Research and Innovation, Beta Bionics, Inc., Boston, MA, USA., Sherwood J; Diabetes Research Center, Massachusetts General Hospital, Boston, MA, USA., Damiano ER; Department of Biomedical Engineering, Boston University, Boston, MA, USA.
Jazyk: angličtina
Zdroj: Diabetes therapy : research, treatment and education of diabetes and related disorders [Diabetes Ther] 2021 Jul; Vol. 12 (7), pp. 2019-2033. Date of Electronic Publication: 2021 Jun 19.
DOI: 10.1007/s13300-021-01087-x
Abstrakt: Introduction: We investigated the safety of, and glucose control by, the insulin-only configuration of the iLet ® bionic pancreas delivering fast-acting insulin aspart (faster aspart), using the same insulin-dosing algorithm but different time to maximal serum drug concentration (t max ) settings, in adults with type 1 diabetes.
Methods: We performed a single-center, single-blinded, crossover (two 7-day treatment periods) escalation trial over three sequential cohorts. Participants from each cohort were randomized to a default t max setting (t 65  [t max  = 65 min]) followed by a non-default t max setting (t 50 [t max  = 50 min; cohort 1], t 40 [t max  = 40 min; cohort 2], t 30 [t max  = 30 min; cohort 3]), or vice versa, all with faster aspart. Each cohort randomized eight new participants if escalation-stopping criteria were not met in the previous cohort.
Results: Overall, 24 participants were randomized into three cohorts. Two participants discontinued treatment, one due to reported 'low blood glucose' during the first treatment period of cohort 3 (t 30 ). Mean time in low sensor glucose (< 54 mg/dl, primary endpoint) was < 1.0% for all t max settings. Mean sensor glucose in cohorts 1 and 2 was significantly lower at non-default versus default t max settings, with comparable insulin dosing. The mean time sensor glucose was in range (70-180 mg/dl) was > 70% for all cohorts, except the default t max setting in cohort 1. No severe hypoglycemic episodes were reported. Furthermore, there were no clinically significant differences in adverse events between the groups.
Conclusion: There were no safety concerns with faster aspart in the iLet at non-default t max settings. Improvements were observed in mean sensor glucose without increases in low sensor glucose at non-default t max settings.
Trial Registration: ClinicalTrials.gov, NCT03816761.
Databáze: MEDLINE
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