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. (TEMPO)

Hedia

Status

Not yet enrolling

Conditions

Type 1 Diabetes Mellitus (T1DM)

Treatments

Device: Hedia Diabetes Assistant

Study type

Interventional

Funder types

Industry

Other

Identifiers

NCT06819306

2024-A02199-38

Details and patient eligibility

About

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.

Full description

This randomized controlled trial will enroll 154 adults with type 1 diabetes who have suboptimal glycemic control and are treated with multiple daily injections (MDI) of insulin using a pen-based basal-bolus regimen. Subjects must be using a continuous glucose monitor (CGM) as part of their standard care and be telemonitored.

The study will be conducted at multiple centres in France, with each subject followed for a total duration of six months. During this period, they will have one in-person visit and two follow-up assessments conducted via phone. Data will be collected through the telemonitoring platform.

Subjects will be randomly assigned to either the intervention or control group. The intervention group will use the Hedia Diabetes Assistant in addition to their standard treatment for six months, while the control group will continue with their standard treatment.

Enrollment

154 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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