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:

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% oflast 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 (insulinglargine, 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 ≥ 14days

• 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 testperformed 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 ofscreening

• If the principal investigator deems that subjects are not healthy, not capable ofcompleting the investigation or in other ways deemed unfit for participation in theinvestigation

• Ongoing participation in other interventional clinical trials or investigationsduring the investigation period if the principal investigator deems this topotentially affect the safety, clinical performance and/or any study outcomes

• Female who is pregnant, breast-feeding or intends to be pregnant during theinvestigation period

• Participant under guardianship, conservatorship, safeguard of justice, or any otherlegal protection measure for a vulnerable adult