DiabetesNCT05458167
HEdia eXercise Algorithm - HEXA Study.
A study testing Hedia Diabetes Assistant bolus calculator with a physical activity module in people with Diabetes, run by Hedia ApS at 1 site in Denmark.
Trial summary
A randomised controlled crossover pilot study to evaluate safety and efficacy of a digital insulin bolus calculator with a physical activity module Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Diabetes
- What is being tested?
- Hedia Diabetes Assistant bolus calculator with a physical activity module
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- 3 Apr 2023to 3 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Signed informed consent.
- Ability to understand, speak and read Danish fluently.
- Diagnosis of type 1 diabetes mellitus for ≥12 months.
- Age between ≥18 and <60 years.
- Minimum one measurement of HbA1c between 6.0 to 8.6 % (42 to 70 mmol/mol) within the last four months. If several measurements, then it is the latest one that counts.
- Body mass index (BMI) between ≥18.5 and <30 kg/m2.
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- Ability to use an Apple® (iOS version 13 and up) or Android® (Android version 8.0 and up) smartphone.
- Treated with the same pen-based insulin regimen with basal insulin (insulin glargine, degludec, or detemir) and meal time insulin (insulin aspart, lispro, glulisine) for at least the three preceding months.
- Patients who can perform 45 min. of exercise at moderate intensity on an ergometer bike (investigator assessment).
- If female participants of childbearing potential; willing to have a pregnancy test performed and to use a highly effective method of contraception.
Who cannot join
- Already using Hedia Diabetes Assistant.
- Use of human insulin or premixed insulin.
- Blood pressure > 180/105 mmHg.
- Treatment with sodium-glucose transporter 2-inhibitors, glucagon-like peptide 1 receptor agonists, or glucocorticoids.
- Job situation entailing night shifts.
- Fever.
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- A mental state impeding compliance with the protocol.
- Expected non-compliance with the protocol at the discretion of the principal investigator.
- Pregnancy.
- Breast-feeding.
- Dialysis therapy or eGFR < 60 ml/min.
- Patients diagnosed with claudicatio intermittens, heart failure, ischaemic heart disease or stroke.
- Patients prescribed with beta blockers.
- Abuse of alcohol or drugs in the past two years.
- On-going participation, or participation within the last 3 months, in an organised clinical study in which participants received study medication (investigator assessment).
- Surgery scheduled for the study duration period.
- An episode of diabetic ketoacidosis or severe hypoglycaemia requiring third-party assistance within the preceding 6 months.
- Known gastroparesis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: HEdia eXercise Algorithm - HEXA Study. A Randomised Controlled Crossover Pilot Study
A randomised controlled crossover pilot study to evaluate safety and efficacy of a digital insulin bolus calculator with a physical activity module
Read the detailed description
Hedia Diabetes Assistant is a software device intended to monitor blood glucose and to support in the decision making of the optimal bolus insulin dose for management of insulin-dependent diabetes by providing the user with an indicative Bolus insulin dose.
This study has been designed to investigate the safety and efficacy of a digital insulin bolus calculator with a physical activity module that provides guidance on insulin reduction to patients with type 1 diabetes mellitus prior to and after exercise, based on exercise duration and intensity compared with the patients' habitual diabetes management.
- Conditions
- Diabetes
- Being tested
- Hedia Diabetes Assistant bolus calculator with a physical activity module
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hedia Diabetes Assistant bolus calculator with a physical activity moduleDevice
Hedia Diabetes Assistant bolus calculator with a physical activity module is a software device that calculates an insulin bolus based on blood glucose, carbohydrates and physical activity.
| Study group | Role | What they receive |
|---|---|---|
| Device: Hedia Diabetes Assistant with physical activity module. | Experimental | The participants will take part in a 45-minute moderate-intensity exercise bout on a stationary ergometer bike. Participants will use the Hedia Diabetes Assistant bolus calculator with the physical activity module (intervention) during a 24-hour period starting one hour before the bout of exercise. Receives: Device: Hedia Diabetes Assistant bolus calculator with a physical activity module |
| Usual treatment | Active comparator | The participants will take part in a 45-minute moderate-intensity exercise bout on a stationary ergometer bike. Participants will use their habitual diabetes management approach during a 24-hour period starting one hour before the bout of exercise (control). Receives: Device: Hedia Diabetes Assistant bolus calculator with a physical activity module |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time-in-range of Hedia Diabetes Assistant bolus calculator with physical activity module
To compare the efficacy of the physical activity module as part of the Hedia Diabetes Assistant bolus calculator compared to the participants' habitual diabetes management during a 24-hour period starting one hour before exercise in adults with type 1 diabetes mellitus in terms of time-in-range (blood glucose 3.9-10.0 mmol/l).
Measured: 24-hour period starting one hour before exercise
Secondary outcomes (3)
Hypoglycemic events of Hedia Diabetes Assistant bolus calculator with physical activity module
To compare the efficacy of the physical activity module as part of the Hedia Diabetes Assistant bolus calculator compared to the participants' habitual diabetes management during a 24-hour period starting one hour before exercise in adults with type 1 diabetes mellitus in terms of no. of hypoglycemic events (blood glucose < 3.9 mmol/l).
Measured: 24-hour period starting one hour before exercise
Time-above-range of Hedia Diabetes Assistant bolus calculator with physical activity module
To compare the efficacy of the physical activity module as part of the Hedia Diabetes Assistant bolus calculator compared to the participants' habitual diabetes management during a 24-hour period starting one hour before exercise in adults with type 1 diabetes mellitus in terms of time-above-range (>10.0 mmol/l).
Measured: 24-hour period starting one hour before exercise
Time-below-range of Hedia Diabetes Assistant bolus calculator with physical activity module
To compare the efficacy of the physical activity module as part of the Hedia Diabetes Assistant bolus calculator compared to the participants' habitual diabetes management during a 24-hour period starting one hour before exercise in adults with type 1 diabetes mellitus in terms of time-below-range (blood glucose < 3.9 mmol/l).
Measured: 24-hour period starting one hour before exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2022
- Study start3 Apr 2023
- Primary completion3 Apr 2024
- Study completion3 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hedia ApS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anne Østerskov, Study director, Hedia ApS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05458167
- Sponsor's protocol ID
- HEXA study
- Status last verified
- Jun 2024
- First submitted
- 11 Jul 2022
- Last updated
- 7 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HEdia eXercise Algorithm - HEXA Study. A Randomised Controlled Crossover Pilot Study
- ClinicalTrials.gov ID
- NCT05458167
- Acronym / sponsor ID
- HEXA study
- Conditions
- Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Hedia ApSIndustry (pharma, biotech, devices)
- Study start
- 3 Apr 2023 (actual)
- Primary completion
- 3 Apr 2024 (actual)
- Study completion
- 3 Apr 2024 (actual)
- First posted
- 14 Jul 2022 (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.
A randomised controlled crossover pilot study to evaluate safety and efficacy of a digital insulin bolus calculator with a physical activity module
Detailed description
Hedia Diabetes Assistant is a software device intended to monitor blood glucose and to support in the decision making of the optimal bolus insulin dose for management of insulin-dependent diabetes by providing the user with an indicative Bolus insulin dose.
This study has been designed to investigate the safety and efficacy of a digital insulin bolus calculator with a physical activity module that provides guidance on insulin reduction to patients with type 1 diabetes mellitus prior to and after exercise, based on exercise duration and intensity compared with the patients' habitual diabetes management.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Device: Hedia Diabetes Assistant with physical activity module. | Experimental | Device: Hedia Diabetes Assistant bolus calculator with a physical activity moduleThe participants will take part in a 45-minute moderate-intensity exercise bout on a stationary ergometer bike. Participants will use the Hedia Diabetes Assistant bolus calculator with the physical activity module (intervention) during a 24-hour period starting one hour before the bout of exercise. |
| Usual treatment | Active comparator | Device: Hedia Diabetes Assistant bolus calculator with a physical activity moduleThe participants will take part in a 45-minute moderate-intensity exercise bout on a stationary ergometer bike. Participants will use their habitual diabetes management approach during a 24-hour period starting one hour before the bout of exercise (control). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Signed informed consent.
- Ability to understand, speak and read Danish fluently.
- Diagnosis of type 1 diabetes mellitus for ≥12 months.
- Age between ≥18 and <60 years.
- Minimum one measurement of HbA1c between 6.0 to 8.6 % (42 to 70 mmol/mol) within the last four months. If several measurements, then it is the latest one that counts.
Key exclusion criteria (18 listed)
- Already using Hedia Diabetes Assistant.
- Use of human insulin or premixed insulin.
- Blood pressure > 180/105 mmHg.
- Treatment with sodium-glucose transporter 2-inhibitors, glucagon-like peptide 1 receptor agonists, or glucocorticoids.
- Job situation entailing night shifts.
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 Assistant bolus calculator with a physical activity moduleHedia Diabetes Assistant bolus calculator with a physical activity module is a software device that calculates an insulin bolus based on blood glucose, carbohydrates and physical activity. | Device | Device: Hedia Diabetes Assistant with physical activity module., Usual treatment |
Primary outcome
Time-in-range of Hedia Diabetes Assistant bolus calculator with physical activity module
Time frame: 24-hour period starting one hour before exercise
To compare the efficacy of the physical activity module as part of the Hedia Diabetes Assistant bolus calculator compared to the participants' habitual diabetes management during a 24-hour period starting one hour before exercise in adults with type 1 diabetes mellitus in terms of time-in-range (blood glucose 3.9-10.0 mmol/l).
3 secondary outcomes
Hypoglycemic events of Hedia Diabetes Assistant bolus calculator with physical activity module
Time frame: 24-hour period starting one hour before exercise
Time-above-range of Hedia Diabetes Assistant bolus calculator with physical activity module
Time frame: 24-hour period starting one hour before exercise
Time-below-range of Hedia Diabetes Assistant bolus calculator with physical activity module
Time frame: 24-hour period starting one hour before exercise
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2024.
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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.
Anne Østerskov study director
Hedia ApS
1 site 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 bolus calculator with a physical activity module in people with Diabetes, run by Hedia ApS at 1 site in Denmark.
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 10 inclusion and 18 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: finished, as of the sponsor's last update on 7 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 of Hedia Diabetes Assistant bolus calculator with physical activity module (time frame: 24-hour period starting one hour before exercise). 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 7 Jun 2024.