Insulin-plus-pramlintide Closed-loop Strategy to Regulate Glucose Levels Without Carbohydrate Counting

Phase 2 Completed 24 enrolled McGill University Diabetes Canada · collab

RandomizedCrossoverOpen-labelTreatment

Summary

Closed-loop system systems that are shown to alleviate the burden of carbohydrate counting without degrading glucose control are still lacking. In this proposal, the investigators aim to develop a novel, fully-automated, closed-loop system that delivers insulin and pramlintide that controls postprandial glucose levels without any input from the user.

Timeline

Start: 2019-02-08
Primary completion: 2020-09-19
Completion: 2020-09-19

Outcome

Missed primary endpoint

paper system was not non-inferior to the Fiasp-alone hybrid closed-loop system for the overall percentage of time in the glucose target range. PMID 34580055 ↗

paper paired difference 2·6%, 95% CI -2·4 to 12·2; non-inferiority p=0·28 PMID 34580055 ↗

Publications

Tsoukas MA, Majdpour D, Yale JF, Fathi AE, Garfield N, Rutkowski J, Rene J, Legault L, Haidar A. A fully artificial pancreas versus a hybrid artificial pancreas for type 1 diabetes: a single-centre, open-label, randomised controlled, crossover, non-inferiority trial. Lancet Digit Health. 2021 Nov;3(11):e723-e732. doi: 10.1016/S2589-7500(21)00139-4. Epub 2021 Sep 24.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Pramlintide	Peptide	—	—
Subject	insulin aspart	Protein / enzyme biologic	—	Subcutaneous