Clinical trial NCT06819306: 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.
Official title: 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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Type 1 Diabetes Mellitus (T1DM)
Keywords: Bolus calculator
Glycemic control
Digital health
Lead sponsor: Hedia ApS
Sponsor class: INDUSTRY
Collaborators: name: Kyomed
First posted: 2025-02-11
Enrollment: 154
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Time in range
timeFrame: From 14 days before enrollment to the end of treatment at 26 weeks
Secondary outcomes:
measure: Time above range
timeFrame: From 14 days before enrollment to the end of treatment at 26 weeks
measure: HbA1c
timeFrame: From enrollment to the end of treatment at 26 weeks
measure: Mean sensor glucose
timeFrame: From 14 days before enrollment to the end of treatment at 26 weeks
measure: Glucose Management Indicator (GMI)
timeFrame: From 14 days before enrollment to the end of treatment at 26 weeks
measure: Coefficient of Variation (CV)
timeFrame: From 14 days before enrollment to the end of treatment at 26 weeks
measure: SD of mean glucose
timeFrame: From 14 days before enrollment to the end of treatment at 26 weeks
measure: Time below range
timeFrame: From 14 days before enrollment to the end of treatment at 26 weeks
measure: Diabetes Treatment Satisfaction
timeFrame: From enrollment to the end of treatment at 26 weeks
measure: WHOQoL-BREF
timeFrame: From enrollment to the end of treatment at 26 weeks
Other outcomes:
measure: Time above range level 2
timeFrame: From 14 days before enrollment to the end of treatment at 26 weeks
measure: Time in tight range
timeFrame: From 14 days before enrollment to the end of treatment at 26 weeks
measure: Number of hypoglycemic events
timeFrame: From 14 days before enrollment to the end of treatment at 26 weeks
measure: Time below range level 2
timeFrame: From 14 days before enrollment to the end of treatment at 26 weeks
measure: Number of extended hyperglycemic events
timeFrame: From 14 days before enrollment to the end of treatment at 26 weeks
measure: Number of extended hypoglycemic events
timeFrame: From 14 days before enrollment to the end of treatment at 26 weeks
measure: Proportion with time in range
timeFrame: From 14 days before enrollment to the end of treatment at 26 weeks
measure: Proportion with ≥5% points improvement in time in range from baseline
timeFrame: From 14 days before enrollment to the end of treatment at 26 weeks
measure: Proportion with ≥10% points improvement in time in range from baseline
timeFrame: From 14 days before enrollment to the end of treatment at 26 weeks
measure: Proportion with time below range < 3.9 mmol/L (< 70 mg/dL) for <4% of the time
timeFrame: From 14 days before enrollment to the end of treatment at 26 weeks
measure: Proportion with time below range < 3.0 mmol/L (< 54 mg/dL) for <1% of the time
timeFrame: From 14 days before enrollment to the end of treatment at 26 weeks
measure: Proportion with time above range >10.0 mmol/L (> 180 mg/dL) for <25% of the time
timeFrame: From 14 days before enrollment to the end of treatment at 26 weeks
measure: Proportion with time above range >13.9 mmol/L (> 250 mg/dL) for <5% of the time
timeFrame: From 14 days before enrollment to the end of treatment at 26 weeks
Locations:
city: Angers
country: France
facility: Centre Hospitalier Universitaire d'Angers
city: Lyon
country: France
facility: Hospices Civils de Lyon
city: Nantes
country: France
facility: Centre hospitalier universitaire de Nantes
city: Nîmes
country: France
facility: Centre hospitalier universitaire de Nîmes
city: Paris
country: France
facility: Hôpital Bichat - Claude-Bernard
city: Poitiers
country: France
facility: Centre hospitalier universitaire de Poitiers
Study officials:
References: