Assessing a new diabetes management program for teens with Type 1 diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Sachsska, barn- och ungdomssjukhuset
  Stockholm, Sweden Recruiting
• Norrlands universitetssjukhus
  Umeå, Sweden Recruiting
• Helsingborg Lasarett
  Helsingborg, Sweden Not yet recruiting

Study contacts

• Study coordinator: Henry TAUPIN
• Email: fralsi-ctpublication@airliquide.com
• Phone: +33619947113

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.