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 | Active Not Recruiting

• 1 other identifier: 2024-A02199-38
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 6

Brief 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)

Keywords

Bolus calculator; Glycemic control; Digital health

Outcome Measures

Primary Outcomes (1)

• Time in range

  Glucose between 3.9 and 10 mmol/L (70 to 180 mg/dL)

  From 14 days before enrollment to the end of treatment at 26 weeks

Secondary Outcomes (9)

• Time above range

  From 14 days before enrollment to the end of treatment at 26 weeks

• HbA1c

  From enrollment to the end of treatment at 26 weeks

• Mean sensor glucose

  From 14 days before enrollment to the end of treatment at 26 weeks

• Glucose Management Indicator (GMI)

  From 14 days before enrollment to the end of treatment at 26 weeks

• Coefficient of Variation (CV)

  From 14 days before enrollment to the end of treatment at 26 weeks

Other Outcomes (13)

• Time above range level 2

  From 14 days before enrollment to the end of treatment at 26 weeks

• Time in tight range

  From 14 days before enrollment to the end of treatment at 26 weeks

• Number of hypoglycemic events

  From 14 days before enrollment to the end of treatment at 26 weeks

Study Arms (2)

Hedia Diabetes Assistant in addition to standard of care treatment

EXPERIMENTAL

Device: Hedia Diabetes Assistant

Standard of care treatment

NO INTERVENTION

Interventions

Hedia Diabetes Assistant 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.

Hedia Diabetes Assistant in addition to standard of care treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hedia ApS: lead
• Kyomed: collaborator

Study Sites (6)

Centre Hospitalier Universitaire d'Angers

Angers, France

Location

Hospices Civils de Lyon

Lyon, France

Location

Centre hospitalier universitaire de Nantes

Nantes, France

Location

Centre hospitalier universitaire de Nîmes

Nîmes, France

Location

Hôpital Bichat - Claude-Bernard

Paris, 75018, France

Location

Centre hospitalier universitaire de Poitiers

Poitiers, France

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2025
• First Posted: February 11, 2025
• Study Start: March 17, 2025
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: April 9, 2026

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (6)