The Effect of Hedia Diabetes Assistant on TiMe-in-range in People With Type 1 Diabetes and Sub-Optimal Glycemic Control in France

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

154 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-17

Study Completion Date

2025-12-31

Brief Summary

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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.

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Detailed Description

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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

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Type 1 Diabetes Mellitus (T1DM)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Hedia Diabetes Assistant in addition to standard of care treatment

Group Type EXPERIMENTAL

Hedia Diabetes Assistant

Intervention Type DEVICE

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.

Standard of care treatment

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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% of last 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 (insulin glargine, 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 ≥ 14 days
* 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 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No