2021
DOI: 10.1007/s13300-021-01087-x
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Improvements in Glycemic Control Achieved by Altering the tmax Setting in the iLet® Bionic Pancreas When Using Fast-Acting Insulin Aspart: A Randomized Trial

Abstract: Introduction: We investigated the safety of, and glucose control by, the insulin-only configuration of the iLet Ò 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, singleblinded, crossover (two 7-day treatment peri-ods) escalation trial over three sequential cohorts. Participants from each cohort were random… Show more

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Cited by 11 publications
(10 citation statements)
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References 26 publications
(38 reference statements)
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“…In the study by Hsu et al [13], 19 people with T1DM were randomized to receive either FIAsp or aspart insulin through MiniMed670G in- [12], and Hsu et al [13] respectively, after which cross-over switch was done for the study participants for same time period. The RCT by Russel et al [14] was excluded as it used only FI-Asp insulin with different settings of the insulin pump in the three different arms of the RCT. The study by Grosman et al [15] was excluded as it was done using a virtual patient simulation and not in real patients.…”
Section: Resultsmentioning
confidence: 99%
“…In the study by Hsu et al [13], 19 people with T1DM were randomized to receive either FIAsp or aspart insulin through MiniMed670G in- [12], and Hsu et al [13] respectively, after which cross-over switch was done for the study participants for same time period. The RCT by Russel et al [14] was excluded as it used only FI-Asp insulin with different settings of the insulin pump in the three different arms of the RCT. The study by Grosman et al [15] was excluded as it was done using a virtual patient simulation and not in real patients.…”
Section: Resultsmentioning
confidence: 99%
“…For example, a randomized trial of adults with T1D was conducted to investigate the safety of, and glucose control by, faster aspart in the insulin-only configuration of the iLet ® bionic pancreas (iLet; Beta Bionics, Inc., Concord, MA), fully automated insulin delivery system. 13 The results suggest that glucose control is even further improved when the time to maximal serum drug concentration ( t max ) setting is adapted to the pharmacological profile of faster aspart. There were no safety concerns with faster aspart using the iLet with nondefault t max settings, and improvements were observed in mean sensor glucose values without increases in low sensor glucose.…”
Section: Discussionmentioning
confidence: 99%
“…There were no safety concerns with faster aspart using the iLet with nondefault t max settings, and improvements were observed in mean sensor glucose values without increases in low sensor glucose. 13 …”
Section: Discussionmentioning
confidence: 99%
“…iLet is a new type of insulin system with a CGM that is able to detect the glycemic level in the body and deliver a controlled amount of insulin needed at a given time. However, in this study, a fast-acting insulin aspart was used to determine the safety profile in the original setting of the iLet system, and no safety concerns were observed with this change (NCT03816761) [ 160 ]. Another artificial pancreas system that could achieve constant glucose monitoring for controlled insulin delivery upon detected patterns of change in glucose has been studied (NCT01484457).…”
Section: Advancement Of Alternative Routes For Insulin Delivery To Cl...mentioning
confidence: 99%
“…ability of patients to use PaQ (patch on insulin delivery device) for the control of blood glucose NCT01535612[158] PaQ Insulin delivery device (Insulin aspart) Type 2 diabetes (Adult) -To evaluate the efficacy and safety of basal bolus insulin delivery with PaQ in insulin NCT02419859[159] iLet bionic pancreas (insulin aspart) Type 1 diabetes (adult) 2To evaluate the safety of insulin aspart in a different insulin delivery setting in the iLet NCT03816761[160] iLet bionic pancreas (BP) (Insulin lispro or aspart)Type 1 diabetes (children, adult) -To compare the insulin-only configuration of the iLet BP system in maintaining normal glycemia compared to usual care in a home-use setting NCT04200313 efficacy of regular human insulin on the V-Go device as compared to rapid-acting insulin in the V-Go device NCT03495908[164] …”
mentioning
confidence: 99%