التفاصيل البيبلوغرافية
| العنوان: |
A Multicenter Randomized Trial Evaluating Fast-Acting Insulin Aspart in the Bionic Pancreas in Adults with Type 1 Diabetes. |
| المؤلفون: |
Beck, Roy W.1 (AUTHOR) rbeck@jaeb.org, Russell, Steven J.2 (AUTHOR), Damiano, Edward R.3,4 (AUTHOR), El-Khatib, Firas H.4 (AUTHOR), Ruedy, Katrina J.1 (AUTHOR), Balliro, Courtney2 (NURSE), Li, Zoey1 (AUTHOR), Calhoun, Peter1 (AUTHOR) |
| المصدر: |
Diabetes Technology & Therapeutics. Oct2022, Vol. 24 Issue 10, p681-696. 16p. |
| مصطلحات موضوعية: |
*INSULIN aspart, *TYPE 1 diabetes, *BIONICS, *PANCREAS, *INSULIN therapy |
| مستخلص: |
Objective: To evaluate the insulin-only configuration of the iLet® bionic pancreas (BP) using fast-acting insulin aspart (Fiasp®) in adults with type 1 diabetes (T1D). Research Design and Methods: In this multicenter, randomized trial, 275 adults with T1D (18–83 years old, baseline HbA1c 5.3%–14.9%) were randomly assigned 2:2:1 to use the BP with fast-acting insulin aspart (BP-F group, N = 114), BP with aspart or lispro (BP-A/L group, N = 107), or a control group using their standard-care insulin delivery (SC group, N = 54) plus real-time continuous glucose monitoring (CGM). The primary outcome was HbA1c at 13 weeks. The BP-F versus SC comparison was considered primary and BP-F versus BP-A/L secondary. Results: Mean ± standard deviation (SD) HbA1c decreased from 7.8% ± 1.2% at baseline to 7.1% ± 0.6% at 13 weeks with BP-F versus 7.6% ± 1.2% to 7.5% ± 0.9% with SC (adjusted difference = −0.5%, 95% CI −0.7 to −0.3, P < 0.001). CGM-measured percent time <54 mg/dL over 13 weeks with BP-F was noninferior to SC (adjusted difference = 0.00%, 95% CI −0.07 to 0.05, P < 0.001 for noninferiority based on a prespecified noninferiority limit of 1%). Over 13 weeks, mean time in range 70–180 mg/dL (TIR) increased by 14% (3.4 h/day) and mean CGM glucose was reduced by 18 mg/dL with BP-F compared with SC (P < 0.001). Analyses of time >180 mg/dL, time >250 mg/dL, and the SD of CGM glucose all favored BP-F compared with SC (P < 0.001). Differences between BP-F and BP-A/L were minimal, with no difference in HbA1c at 13 weeks (adjusted difference = −0.0%, 95% CI −0.2 to 0.1, P = 0.67) or mean glucose (adjusted difference = −2.0 mg/dL, 95% CI −4.3 to 0.4, P = 0.10). Mean TIR was 2% greater with BP-F than BP-A/L (95% CI 1 to 4, P = 0.005), but the percentages of participants improving TIR by ≥5% were not significantly different (P = 0.49) and there were no significant differences comparing BP-F versus BP-A/L across nine patient-reported outcome surveys. The rate of severe hypoglycemia events did not differ among the three groups. Conclusions: In adults with T1D, HbA1c was improved with the BP using fast-acting insulin aspart compared with standard care without increasing CGM-measured hypoglycemia. However, the effect was no better than the reduction observed with the BP using aspart or lispro. Clinical Trial Registry: clinicaltrials.gov; NCT04200313. [ABSTRACT FROM AUTHOR] |
| قاعدة البيانات: |
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