Assessing a new diabetes management program for teens with Type 1 diabetes
Clinical Investigation to Assess the Feasibility of a New Diabetes Management Program, the dALi System, for Pediatric Type 1 Diabetes (T1D) Subjects
This study is testing a new personalized diabetes management program for teens with Type 1 diabetes to see if it helps them stick to their care plan better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 12 Years to 15 Years |
| Sex | All |
| Sponsor | Air Liquide Santé International Industry-sponsored |
| Locations | 3 sites (Helsingborg and 2 other locations) |
| Trial ID | NCT05793645 on ClinicalTrials.gov |
What this trial studies
This interventional study aims to evaluate the feasibility of a personalized care plan for adolescents aged 12-15 years with Type 1 diabetes. Participants will be required to have been diagnosed with Type 1 diabetes for at least eight months and must use a Continuous Glucose Monitoring (CGM) system. The study will focus on adherence to the personalized care plan, utilizing a remote diabetes management platform for data upload and follow-up. The goal is to improve diabetes management through tailored interventions.
Who should consider this trial
Good fit: Ideal candidates are adolescents aged 12-15 years diagnosed with Type 1 diabetes for at least eight months and using a CGM system.
Not a fit: Patients who have recently started using a hybrid closed-loop (HCL) system or those using a Medtronic insulin pump may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could enhance diabetes management and improve health outcomes for adolescents with Type 1 diabetes.
How similar studies have performed: While this approach is innovative, similar studies focusing on personalized diabetes management have shown promise in improving patient outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male or female, 12-15 years of age. * T1D diagnosis minimum 8 months prior to the Screening/Initiation visit (Visit 0). * Equipped with Continuous Glucose Monitoring (CGM) System, intermittent or real-time, either alone or associated with an insulin pump system * Subject and health care provider must use a Remote diabetes management platform for the upload and follow-up of CGM, pump data or HCL data (e.g.: Glooko, Diasend). * Parent or guardian able and willing to give informed consent for the subject's participation in the investigation. Exclusion Criteria: * Initiation of use of HCL System during the last 2 months or during the investigation. * Use of Medtronic insulin pump. * Any disease or other medical condition, prior or concomitant medication /treatment /intervention, that may affect this clinical investigation or in other ways make the subject unsuitable for participation in this investigation, according to the judgement of the Principal Investigator (PI), or authorized designee. * Participation in any clinical investigation or study within the previous 30 days, that may affect the safety or performance of this investigation. * Mental incapacity precluding understanding or cooperation. * Subject not able to read and communicate in Swedish without an interpreter.
Where this trial is running
Helsingborg and 2 other locations
- Helsingborg Lasarett — Helsingborg, Sweden (Not_yet_recruiting)
- Sachsska, barn- och ungdomssjukhuset — Stockholm, Sweden (Recruiting)
- Norrlands universitetssjukhus — Umeå, Sweden (Recruiting)
Study contacts
- Study coordinator: Henry TAUPIN
- Email: fralsi-ctpublication@airliquide.com
- Phone: +33619947113
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.