NCT06819306

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.

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 154 (estimated)
• Sponsor: Hedia ApS · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Type 1 Diabetes Mellitus (T1DM)

Interventions

Type	Name	Description
DEVICE	Hedia Diabetes Assistant	Hedia Diabetes Assistant is an insulin bolus calculator app designed to calculate an insulin bolus dose recommendation for people with type 1 or type 2 diabetes on rapid-acting insulin treatment.

Timeline

• Start date: 2025-03-17
• Primary completion: 2026-05-01
• Completion: 2026-05-01
• First posted: 2025-02-11
• Last updated: 2026-04-09

Locations

6 sites across 1 country: France