Type 1 Diabetes Mellitus (T1DM)TEMPONCT06819306
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.
A study testing Hedia Diabetes Assistant in people with Type 1 Diabetes Mellitus (T1DM), run by Hedia ApS at 6 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 1 Diabetes Mellitus (T1DM)
- What is being tested?
- Hedia Diabetes Assistant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 6 sitesFrance
- Study dates
- 17 Mar 2025to May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
Centre Hospitalier Universitaire d'Angers
Angers
Hospices Civils de Lyon
Lyon
Centre hospitalier universitaire de Nantes
Nantes
Centre hospitalier universitaire de Nîmes
Nîmes
Hôpital Bichat - Claude-Bernard
Paris, 75018
Centre hospitalier universitaire de Poitiers
Poitiers
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Type 1 Diabetes Mellitus (T1DM)
- Being tested
- Hedia Diabetes Assistant
- Keywords
- Bolus calculator, Glycemic control, Digital health
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hedia Diabetes AssistantDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Hedia Diabetes Assistant in addition to standard of care treatment | Experimental | Not described Receives: Device: Hedia Diabetes Assistant |
| Standard of care treatment | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time in range
Glucose between 3.9 and 10 mmol/L (70 to 180 mg/dL)
Measured: From 14 days before enrollment to the end of treatment at 26 weeks
Secondary outcomes (9)
Time above range
Glucose > 10.0 mmol/L (> 180 mg/dL)
Measured: From 14 days before enrollment to the end of treatment at 26 weeks
HbA1c
Measured: From enrollment to the end of treatment at 26 weeks
Mean sensor glucose
Measured: From 14 days before enrollment to the end of treatment at 26 weeks
Glucose Management Indicator (GMI)
Measured: From 14 days before enrollment to the end of treatment at 26 weeks
Coefficient of Variation (CV)
Measured: From 14 days before enrollment to the end of treatment at 26 weeks
SD of mean glucose
Measured: From 14 days before enrollment to the end of treatment at 26 weeks
Time below range
Glucose < 3.9 mmol/L (< 70 mg/dL)
Measured: 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
Measured: From enrollment to the end of treatment at 26 weeks
WHOQoL-BREF
Quality of life is measured by the WHOQoL-BREF questionnaire.
Measured: From enrollment to the end of treatment at 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2025
- Study start17 Mar 2025
- Primary completionMay 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes Mellitus (T1DM)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 154 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hedia ApS
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Kyomed
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06819306
- Sponsor's protocol ID
- 2024-A02199-38
- Acronym
- TEMPO
- Status last verified
- Jun 2025
- First submitted
- 5 Feb 2025
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06819306
- Acronym / sponsor ID
- TEMPO / 2024-A02199-38
- Conditions
- Type 1 Diabetes Mellitus (T1DM)
- Keywords
- Bolus calculator, Glycemic control, Digital health
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 154 participants (estimated)
- Lead sponsor
- Hedia ApSIndustry (pharma, biotech, devices)
- Collaborators
- Kyomed
- Study start
- 17 Mar 2025 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 11 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hedia Diabetes Assistant in addition to standard of care treatment | Experimental | Device: Hedia Diabetes Assistant |
| Standard of care treatment | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hedia Diabetes AssistantHedia 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. | Device | Hedia Diabetes Assistant in addition to standard of care treatment |
Primary outcome
Time in range
Time frame: From 14 days before enrollment to the end of treatment at 26 weeks
Glucose between 3.9 and 10 mmol/L (70 to 180 mg/dL)
9 secondary outcomes
Time above range
Time frame: From 14 days before enrollment to the end of treatment at 26 weeks
HbA1c
Time frame: From enrollment to the end of treatment at 26 weeks
Mean sensor glucose
Time frame: From 14 days before enrollment to the end of treatment at 26 weeks
Glucose Management Indicator (GMI)
Time frame: From 14 days before enrollment to the end of treatment at 26 weeks
Coefficient of Variation (CV)
Time frame: From 14 days before enrollment to the end of treatment at 26 weeks
SD of mean glucose
Time frame: From 14 days before enrollment to the end of treatment at 26 weeks
Time below range
Time frame: From 14 days before enrollment to the end of treatment at 26 weeks
Diabetes Treatment Satisfaction
Time frame: From enrollment to the end of treatment at 26 weeks
WHOQoL-BREF
Time frame: From enrollment to the end of treatment at 26 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for Type 1 Diabetes Mellitus (T1DM)
RecruitingPhase 3
A Study of Baricitinib (LY3009104) to Preserve Beta Cell Function in Children and Adults Newly Diagnosed With Type 1 Diabetes (BARICADE-PRESERVE)
Diabetes Mellitus, Type 1
Not yet recruitingPhase 2
JAK1 Inhibitor Ivarmacitinib for Improving Pancreatic Islet Function in T1D
T1DM - Type 1 Diabetes Mellitus
RecruitingObservational study
Environmental Determinants of Type 1 Diabetes Risk
Type 1 Diabetes Mellitus (T1DM), Healthy Control
Not yet recruiting
Pre-Exercise Whey and Pea Protein in Adolescents With Type 1 Diabetes
T1D, T1DM
Recruiting
Drawing and Writing Activities in Adolescents With Type 1 Diabetes
Type 1 Diabetes Mellitus (T1DM), Anxiety
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hedia Diabetes Assistant in people with Type 1 Diabetes Mellitus (T1DM), run by Hedia ApS at 6 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time in range (time frame: From 14 days before enrollment to the end of treatment at 26 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2026.