Using Hedia Diabetes Assistant to improve glycemic control in adults with type 1 diabetes in France
The Effect of Hedia Diabetes Assistant on TiMe-in-range in People With Type 1 Diabetes and Sub-Optimal Glycemic Control in France - A Randomised Controlled Trial.
This study is testing if using the Hedia Diabetes Assistant can help adults with type 1 diabetes better control their blood sugar compared to just sticking with their usual treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 154 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hedia ApS Industry-sponsored |
| Locations | 6 sites (Angers and 5 other locations) |
| Trial ID | NCT06819306 on ClinicalTrials.gov |
What this trial studies
This randomized controlled trial aims to evaluate the effectiveness and safety of the Hedia Diabetes Assistant in adults with type 1 diabetes who have suboptimal glycemic control. Participants will be randomly assigned to either use the Hedia Diabetes Assistant alongside their standard treatment or continue with standard treatment alone for six months. The study will involve one in-person clinic visit and two remote follow-ups, with data collected through a telemonitoring platform. The primary focus is to determine if the Hedia Diabetes Assistant can enhance glycemic control compared to standard treatment.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with type 1 diabetes, suboptimal glycemic control, and the ability to use mobile applications.
Not a fit: Patients who do not have access to a smartphone or are unable to use mobile applications may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could lead to improved glycemic control for patients with type 1 diabetes, potentially reducing complications associated with the condition.
How similar studies have performed: Other studies have shown promising results with digital health interventions for diabetes management, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Signed informed consent * Aged ≥ 18 years at the time of signing the informed consent * Ability to understand, speak and read French fluently * Diagnosed with type 1 diabetes \> 12 months prior to the day of screening * Time in range \<60% of last 14 days * Subject must have the cognitive and physical skills to use mobile applications * Access to a smartphone with iOS version 13 and up or Android version 8 and up * Treated with the same pen-based insulin regimen with basal insulin (insulin glargine, degludec, or detemir) and rapid-acting insulin (insulin aspart, lispro, glulisine) for at least the three preceding months * Real- time CGM use ≥ 3 months from screening date with ≥70% measurements for the last ≥ 14 days * Willing to use the same CGM for the duration of the clinical investigation * Being tele monitored ≥ 3 months (including CGM data) by a health care professional and willing to continue during the study period * If female participants of childbearing potential; willing to have a pregnancy test performed and to use a highly effective method of contraception * Affiliated to the French social security system Exclusion Criteria: * Use of human insulin or premixed insulin * Using a bolus calculator as a part of standard of care treatment at the time of screening * If the principal investigator deems that subjects are not healthy, not capable of completing the investigation or in other ways deemed unfit for participation in the investigation * Ongoing participation in other interventional clinical trials or investigations during the investigation period if the principal investigator deems this to potentially affect the safety, clinical performance and/or any study outcomes * Female who is pregnant, breast-feeding or intends to be pregnant during the investigation period * Participant under guardianship, conservatorship, safeguard of justice, or any other legal protection measure for a vulnerable adult
Where this trial is running
Angers and 5 other locations
- Centre Hospitalier Universitaire d'Angers — Angers, France (Recruiting)
- Hospices Civils de Lyon — Lyon, France (Recruiting)
- Centre hospitalier universitaire de Nantes — Nantes, France (Recruiting)
- Centre hospitalier universitaire de Nîmes — Nîmes, France (Recruiting)
- Hôpital Bichat - Claude-Bernard — Paris, France (Recruiting)
- Centre hospitalier universitaire de Poitiers — Poitiers, France (Recruiting)
Study contacts
- Study coordinator: Ditte H Laursen, PhD
- Email: Ditte@hedia.com
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.