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NCT03800875: Dual

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

Completed Phase 2 Last updated 8 June 2021
What this trial tests

Phase 2 trial testing 27-hour inpatient intervention in Diabetes Mellitus, Type 1 in 24 participants. Completed in 19 September 2020.

Timeline
8 February 2019
Primary endpoint
19 September 2020
19 September 2020

Quick facts

Lead sponsorMcGill University
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingnone
Primary purposetreatment
Enrollment24
Start date8 February 2019
Primary completion19 September 2020
Estimated completion19 September 2020
Sites1 location across Canada

Drugs / interventions tested

Conditions studied

Sponsor

McGill University

Who can join

18 and older, any sex, with Diabetes Mellitus, Type 1. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

  1. A fully artificial pancreas versus a hybrid artificial pancreas for type 1 diabetes: a single-centre, open-label, randomised controlled, crossover, non-inferiority trial.
    Tsoukas MA, Majdpour D, Yale JF, Fathi AE, et al · · 2021 · cited 35× · PMID 34580055 · DOI 10.1016/s2589-7500(21)00139-4
  2. Pharmacologic treatment options for type 1 diabetes: what's new?
    Nally LM, Sherr JL, Van Name MA, Patel AD, et al · · 2019 · cited 13× · PMID 30892094 · DOI 10.1080/17512433.2019.1597705
  3. 56<sup>th</sup> EASD Annual Meeting of the European Association for the Study of Diabetes : 21-25 September 2020.
    · 2020 · cited 9× · PMID 32840677 · DOI 10.1007/s00125-020-05221-5
  4. Where Do We Stand with Closed-Loop Systems and Their Challenges?
    Jackson M, Castle JR. · · 2020 · cited 4× · PMID 32069100 · DOI 10.1089/dia.2019.0469

Verify or expand the search:

Other recruiting trials for Diabetes Mellitus, Type 1

Currently open trials in the same condition.

Other McGill University trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03800875.

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