MedTrace Logo

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.

NCT06819306 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 154

Last updated 2026-04-09

No results posted yet for this study

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.

Conditions

  • Type 1 Diabetes Mellitus (T1DM)

Interventions

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.

Sponsors & Collaborators

  • Kyomed

    collaborator UNKNOWN

  • Hedia ApS

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-17
Primary Completion
2026-05-31
Completion
2026-05-31

Countries

  • France

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06819306 on ClinicalTrials.gov