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.

Launched by HEDIA APS · Feb 5, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at the Hedia Diabetes Assistant, a mobile app designed to help people with type 1 diabetes manage their blood sugar levels more effectively. The main goal is to see if using this app, along with standard diabetes treatments, can improve glycemic control—essentially, how well participants keep their blood sugar within a target range. Participants will either use the Hedia app along with their usual treatment or just stick to their usual treatment for six months. They will visit the clinic once when they start the study and then be monitored remotely. Additionally, they will fill out questionnaires at the beginning and after six months to share their experiences.

To be eligible for the trial, participants need to be at least 18 years old, understand and communicate in French, and have been diagnosed with type 1 diabetes for over a year. They should also have had poor blood sugar control recently, meaning their blood sugar has been out of range more than half of the time in the last two weeks. Participants need to have access to a smartphone that can run the app and be comfortable using mobile technology. The trial is currently recruiting participants, so if you or someone you know meets these criteria, you could consider joining to potentially help improve diabetes management in the future.

Gender

ALL

Eligibility 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 TIR \<70% of last 14 days or HbA1c \>53 mmol/mol (7%) measured within the last month
• • Subject must have the cognitive and physical skills to use mobile applications
• • Access to a smartphone with iOS version 16 and up or Android version 12 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
• • rtCGM use ≥ 1 month from screening date with ≥70% measurements for the last ≥ 14 days
• • Willing to use the same type of CGM for the duration of the clinical investigation
• • Willing to be telemonitored 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