Last reviewed · How we verify
NCT04725591: DBL4T
Diabeloop for Teens
NA trial testing Dexcom G6 Continuous Glucose Monitoring in Closed Loop in 49 participants. Completed in 19 May 2024.
14 February 2024
Quick facts
| Lead sponsor | Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 49 |
| Start date | 25 January 2023 |
| Primary completion | 14 February 2024 |
| Estimated completion | 19 May 2024 |
| Sites | 3 locations across Belgium, France, Germany |
Drugs / interventions tested
- Dexcom G6 Continuous Glucose Monitoring
- MEDISAFE WITH External Insulin Pump
- Diabeloop Software (Model predictive control)
- Declaration of meals
- No declaration of meals
- Remote monitoring (Telemedicine)
Conditions studied
- Closed Loop — all drugs for Closed Loop →
- Diabetes Mellitus, Type 1 — all drugs for Diabetes Mellitus, Type 1 →
- Adolescents (12 to 17 Years Old) — all drugs for Adolescents (12 to 17 Years Old) →
Sponsor
Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
Who can join
Adults 12 to 17, any sex, with Closed Loop or Diabetes Mellitus, Type 1. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
An open-label, three-centers, controlled, randomized, and crossover study containing 14 days of baseline period with standard of care (SOC) therapy followed by two-sessions of 4-weeks home study phase with Diabeloop closed-loop (CL) system comparing the declaration of meals and the non-declaration of meals.
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 NCT04725591
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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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 NCT04725591 (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 Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
- Last refreshed: 26 September 2024
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/NCT04725591.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing