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NCT05543850: PAPAYA 1
Portable Artificial Pancreas Applied for Youth and Adolescents
NA trial testing Bi-hormonal closed-loop control in Diabetes Mellitus, Type 1 in 20 participants. Completed in 19 May 2023.
19 May 2023
Quick facts
| Lead sponsor | Inreda Diabetic B.V. |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 20 |
| Start date | 28 October 2022 |
| Primary completion | 19 May 2023 |
| Estimated completion | 19 May 2023 |
| Sites | 1 location across Netherlands |
Drugs / interventions tested
- Bi-hormonal closed-loop control
- Open-loop control
Conditions studied
- Diabetes Mellitus, Type 1 — all drugs for Diabetes Mellitus, Type 1 →
Sponsor
Inreda Diabetic B.V. — full company profile →
Who can join
Adults 12 to 18, any sex, with Diabetes Mellitus, Type 1. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of this study is to determine the performance of a bi-hormonal reactive closed-loop system in adolscents with type 1 diabetes mellitus. The percentage of time spent in the target range (3.9-10.0 mmol/L) is the main outcome and will be compared between the bi-hormonal closed-loop system and the current treatment of the patients. Also, safety parameters, pharmacodynamics and patient reported outcomes (expectations, trust and treatment satisfaction scores) are compared. This study is a monocenter, randomized, cross-over trial with 20 subjects. The subjects will be randomized to receive either the open-loop therapy or the closed-loop therapy for the first two-week study period and switch to the alternate treatment with at least two weeks in between.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05543850
- 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 Inreda Diabetic B.V. trials
Trials by the same sponsor.
- NCT05454709 — A Stable Glucagon Analog Administered by a Bihormonal Closed Loop System · Phase 2 · withdrawn
- NCT05508061 — Ultrarapid Insulin Administered by a Bihormonal Closed Loop System in Patients With Type 1 Diabetes · NA · completed
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 NCT05543850 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Inreda Diabetic B.V.
- Last refreshed: 14 August 2023
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/NCT05543850.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing