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.

Inclusion 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