Diabeloop for Teens (NCT04725591) | Clinical Trial Compass
CompletedNot Applicable
Diabeloop for Teens
Belgium, France, Germany49 participantsStarted 2023-01-25
Plain-language summary
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.
Who can participate
Age range
12 Years – 17 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Device-related inclusion criteria
* age 12 - \<18 years (i.e 17 years and 364 days) at time of screening
* Type 1 diabetes Study-specific inclusion criteria
* Subject has a clinical diagnosis of type 1 diabetes for at least 1 year as determined via medical records or source documentation by an individual qualified to make a medical diagnosis or confirmed C peptide negative.
* An insulin pump user, or patient under Multiple Daily Injection (MDI), with or without CGM experience.
* Subject having a Glycosylated hemoglobin (HbA1c) blood value \> 8 % at time of screening visit-based on analysis from local laboratory within 3 months.
* Living in an area covered by a GSM (Global System for Mobile Communications) network
* Patient not isolated, does not live alone, or has a person living nearby who has a telephone and a key to his or her home
* Patient willing to wear the system continuously throughout the study
* Must be able to speak and be literate in French, in Dutch or in German
* Having provided written assent \& parents/guardian having provided written informed consent
Exclusion Criteria:
Device-related exclusion criteria
* Patient receiving a total daily dose of insulin lower than 8 U
* Patient having severe uncorrected problems of hearing and/or visual acuity
* Patient unable to understand and perform all of the instructions provided by Diabeloop SA Study-specific exclusion criteria
* Subject is unable to tolerate tape adhesive around the sensor or pu…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The primary outcome is the time spent of the glucose level in the widened target range 3.9-10.0 mmol/L over the 2 last weeks of each cross-over period, as recorded by continuous subcutaneous glucose monitoring (CGM).
Timeframe: 2 weeks
Trial details
NCT IDNCT04725591
SponsorCentre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète