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. (TEMPO)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Type 1 Diabetes Mellitus (T1DM)
• Intervention / Treatment: Device: Hedia Diabetes Assistant

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.

• Study Type: Interventional
• Enrollment (Estimated): 154
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Angers, France
    • Centre Hospitalier Universitaire d'Angers
  • Lyon, France
    • Hospices Civils de Lyon
  • Nantes, France
    • Centre Hospitalier Universitaire de Nantes
  • Nîmes, France
    • Centre Hospitalier Universitaire de Nîmes
  • Paris, France, 75018
    • Hôpital Bichat - Claude-Bernard
  • Poitiers, France
    • Centre Hospitalier Universitaire de Poitiers

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hedia Diabetes Assistant in addition to standard of care treatment	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.
No Intervention: Standard of care treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time above range	Glucose > 10.0 mmol/L (> 180 mg/dL)	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
SD of mean glucose		From 14 days before enrollment to the end of treatment at 26 weeks
Time below range	Glucose < 3.9 mmol/L (< 70 mg/dL)	From 14 days before enrollment to the end of treatment at 26 weeks
Diabetes Treatment Satisfaction	Diabetes Treatment Satisfaction is measured by the Diabetes Treatment Satisfaction Questionnaire	From enrollment to the end of treatment at 26 weeks
WHOQoL-BREF	Quality of life is measured by the WHOQoL-BREF questionnaire.	From enrollment to the end of treatment at 26 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time above range level 2	Glucose > 13.9 mmol/L (> 250 mg/dL)	From 14 days before enrollment to the end of treatment at 26 weeks
Time in tight range	Glucose between 3.9 - 7.8 mmol/L (70-140 mg/dL)	From 14 days before enrollment to the end of treatment at 26 weeks
Number of hypoglycemic events	Number of episodes with glucose < 3.9 mmol/L (< 70 mg/dL) defined as lasting at least 15 minutes.	From 14 days before enrollment to the end of treatment at 26 weeks
Time below range level 2	Glucose < 3.0 mmol/L (< 54 mg/dL)	From 14 days before enrollment to the end of treatment at 26 weeks
Number of extended hyperglycemic events	Number of episodes with glucose > 13.9 mmol/L (> 250 mg/dL) lasting at least 120 minutes	From 14 days before enrollment to the end of treatment at 26 weeks
Number of extended hypoglycemic events	Number of epsiodes with glucose < 3.9 mmol/L (< 70 mg/dL) lasting at least 120 minutes.	From 14 days before enrollment to the end of treatment at 26 weeks
Proportion with time in range	Proportion with glucose between 3.9 - 10.0 mmol/L (70 - 140 mg/dL)	From 14 days before enrollment to the end of treatment at 26 weeks
Proportion with ≥5% points improvement in time in range from baseline		From 14 days before enrollment to the end of treatment at 26 weeks
Proportion with ≥10% points improvement in time in range from baseline		From 14 days before enrollment to the end of treatment at 26 weeks
Proportion with time below range < 3.9 mmol/L (< 70 mg/dL) for <4% of the time		From 14 days before enrollment to the end of treatment at 26 weeks
Proportion with time below range < 3.0 mmol/L (< 54 mg/dL) for <1% of the time		From 14 days before enrollment to the end of treatment at 26 weeks
Proportion with time above range >10.0 mmol/L (> 180 mg/dL) for <25% of the time		From 14 days before enrollment to the end of treatment at 26 weeks
Proportion with time above range >13.9 mmol/L (> 250 mg/dL) for <5% of the time		From 14 days before enrollment to the end of treatment at 26 weeks

Collaborators and Investigators

• Sponsor: Hedia ApS
• Collaborators: Kyomed

Study record dates

Study Major Dates

• Study Start (Actual): March 17, 2025
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: February 5, 2025
• First Submitted That Met QC Criteria: February 5, 2025
• First Posted (Actual): February 11, 2025

Study Record Updates

• Last Update Posted (Actual): April 9, 2026
• Last Update Submitted That Met QC Criteria: April 8, 2026
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Glycemic control; Digital health; Bolus calculator
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Autoimmune Diseases; Immune System Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 1
• Other Study ID Numbers: 2024-A02199-38

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No