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.
The goal of this randomized controlled study is to assess the clinical performance and safety of Hedia Diabetes Assistant in adults with type 1 diabetes and suboptimal glycemic control in France. The main question to answer is: \- Does Hedia Diabetes Assistant improve glycemic control? Researchers will compare Hedia Diabetes Assistant in addition to standard treatment to standard treatment alone to see if Hedia Diabetes Assistant can improve glycemic control. Subjects will: * Use Hedia Diabetes Assistant in addition to their standard treatment or only use standard treatment for 6 months. * Visit the clinic once when they are included into the study and will otherwise be followed remotely. * Fill out questionnaires when they are included and after 6 months.
⁃ 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