Last reviewed · How we verify
NCT03800875: Dual
Insulin-plus-pramlintide Closed-loop Strategy to Regulate Glucose Levels Without Carbohydrate Counting
Phase 2 trial testing 27-hour inpatient intervention in Diabetes Mellitus, Type 1 in 24 participants. Completed in 19 September 2020.
19 September 2020
Quick facts
| Lead sponsor | McGill University |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 24 |
| Start date | 8 February 2019 |
| Primary completion | 19 September 2020 |
| Estimated completion | 19 September 2020 |
| Sites | 1 location across Canada |
Drugs / interventions tested
- 27-hour inpatient intervention — full drug profile →
Conditions studied
- Diabetes Mellitus, Type 1 — all drugs for Diabetes Mellitus, Type 1 →
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):
-
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 -
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 -
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 -
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:
- PubMed search for NCT03800875
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Diabetes Mellitus, Type 1
Currently open trials in the same condition.
- NCT07325461 — Feasibility Study of Extended Wear Insulin Infusion Set Options During Home Use in People With Type 1 Diabetes · NA · recruiting
- NCT07305805 — A Research Study of a New Medicine NNC0363-1063 in Participants With Type 1 Diabetes · Phase 1 · recruiting
- NCT06282055 — Trajectories in Insulin Sensitivity Across MEnstrual cycleS in Women With Type 1 Diabetes · recruiting
- NCT06325202 — Closed Loop and Education for Hypoglycemia Awareness Restoration · NA · recruiting
- NCT07160816 — A Research Study to See How Insulin Icodec Helps People With Type 1 Diabetes Control Their Blood Sugar · recruiting
Other McGill University trials
Trials by the same sponsor.
- NCT07178535 — Feasibility of Real-Time Visual Feedback in Augmented Reality to Reduce Gait Asymmetry Post-Stroke · NA · not yet recruiting
- NCT07445841 — Protecting the Brain From Post-Stroke Cognitive Impairment and Dementia With Multimodal Exercise Training · NA · recruiting
- NCT07447830 — The Pain Reduction Using Immersive Virtual Reality During Wound Care Evaluation Study at Maimonides (PRISM) - Pilot Stud · NA · recruiting
- NCT07497425 — Neuroimmune Responses to Exercise in Chronic Back Pain · NA · recruiting
- NCT06994559 — Music as an Adjunct to Ketamine Therapy for Chronic Pain · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03800875 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by McGill University
- Last refreshed: 8 June 2021
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.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing