Dataset Information

Analysis of "Laboratory and Benchtop Performance of a Mealtime Insulin Delivery System".

ABSTRACT: In the current issue of Journal of Diabetes Science and Technology, Dreon et al give a comprehensive overview of the technical performance of a wearable patch for bolus insulin delivery. The test results generated by the manufacturer of the bolus-patch provide the technical prerequisites for clinical application. As the device received FDA clearance already in 2010, positive results from the nonclinical performance testing were to be expected, but present nevertheless interesting insights into the device development. The single-dose accuracy verification results seem especially promising, but tighter accuracy criteria could have been specified and information on outliers is missing from the analysis. The clinical application of the bolus-patch is currently under investigation in a large-scale 44-week intervention trial.

SUBMITTER: Zijlstra E

PROVIDER: S-EPMC6134312 | biostudies-literature | 2018 Jul

REPOSITORIES: biostudies-literature

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Analysis of "Laboratory and Benchtop Performance of a Mealtime Insulin Delivery System".

Zijlstra Eric E

Journal of diabetes science and technology 20180405 4

In the current issue of Journal of Diabetes Science and Technology, Dreon et al give a comprehensive overview of the technical performance of a wearable patch for bolus insulin delivery. The test results generated by the manufacturer of the bolus-patch provide the technical prerequisites for clinical application. As the device received FDA clearance already in 2010, positive results from the nonclinical performance testing were to be expected, but present nevertheless interesting insights into t ...[more]

PMID: 29619894

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Project description:Background: Automated insulin delivery (AID) systems have demonstrated improvements in time-in-range (TIR, blood glucose 70-180?mg/dL) without increasing hypoglycemia. Testing a closed-loop system in an inpatient environment with supervised challenges allows for initial evaluation of performance and safety of the system. Methods: Adults with type 1 diabetes (T1D) were enrolled into two similar studies (n?=?10 per study), with 3-day inpatient analysis periods. Participants tested a Lilly hybrid closed-loop (HCL) system comprising an investigational insulin pump, insulin lispro, a pump-embedded model predictive control algorithm, a continuous glucose monitor (CGM), and an external dedicated controller. Each protocol included meal-related and exercise challenges to simulate real-world diabetes self-management errors. Only study staff interacted with the HCL system. Performance was assessed using standard CGM metrics overall and within prespecified periods. Results: Participants (25% male) had mean?±?standard deviation (SD) age 44.7?±?14.2 years, T1D duration 30.2?±?11.1 years, A1C 7.2%?±?0.8%, and insulin usage 0.53?±?0.21?U/(kg·day). Percentage TIR 70-180?mg/dL (mean?±?SD) was 81.2?±?8.4 overall, 85.2?±?8.1 outside of challenge periods, 97.3?±?5.3 during the nocturnal periods, and 74.5?±?16.2 for the postprandial periods. During challenge periods, percentage TIR for the overbolus challenge was 65.4?±?29.2 and that for the delayed bolus challenge was 57.1?±?25.1. No adverse events (AEs), serious AEs, or unanticipated adverse device events occurred while participants were using the HCL system. Conclusions: In participants with T1D, Lilly AID system demonstrated expected algorithm performance and safety with satisfactory glycemic outcomes overall and in response to simulated diabetes management challenges. Additional studies in less supervised conditions and with broader patient populations are warranted. ClinicalTrials.gov Registration number NCT03743285, NCT03849612.

Dataset Information

Analysis of "Laboratory and Benchtop Performance of a Mealtime Insulin Delivery System".

Publications

Analysis of "Laboratory and Benchtop Performance of a Mealtime Insulin Delivery System".

Similar Datasets

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