RecruitingNot ApplicableNCT06819306

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.

Sponsor

Hedia ApS

Enrollment

154 participants

Start Date

Mar 17, 2025

Study Type

INTERVENTIONAL

Conditions

Type 1 Diabetes Mellitus (T1DM)

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether a smartphone app called Hedia Diabetes Assistant can help adults with type 1 diabetes in France spend more time in their target blood sugar range. Participants will use continuous glucose monitors (real-time CGM) alongside the app. **You may be eligible if...** - You are 18 or older and diagnosed with type 1 diabetes for more than 12 months - You are based in France and can speak/read French fluently - Your blood sugar control is suboptimal (less than 70% time-in-range, or HbA1c above 7%) - You use a real-time continuous glucose monitor at least 70% of the time - You use a pen-based insulin regimen (basal + rapid-acting) that has been stable for 3 months - You have a compatible iPhone (iOS 16+) or Android (version 12+) smartphone **You may NOT be eligible if...** - You use an insulin pump - You are pregnant or planning pregnancy during the study - You have conditions that affect your ability to manage the technology Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEHedia 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.