HEdia eXercise Algorithm - HEXA Study.

Study Overview
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Brief Summary
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A randomised controlled crossover pilot study to evaluate safety and efficacy of a digital insulin bolus calculator with a physical activity module

Detailed Description
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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.

Official Title
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HEdia eXercise Algorithm - HEXA Study. A Randomised Controlled Crossover Pilot Study

Conditions
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Diabetes

Intervention / Treatment
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* Device: Hedia Diabetes Assistant bolus calculator with a physical activity module


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. 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. Exclusion Criteria: 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. 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Device: Hedia Diabetes Assistant with physical activity module.<br>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. | Device: Hedia Diabetes Assistant bolus calculator with a physical activity module<br>* 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.<br>|
| Active Comparator: Usual treatment<br>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). | Device: Hedia Diabetes Assistant bolus calculator with a physical activity module<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 24-hour period starting one hour before exercise | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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). | 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). | 24-hour period starting one hour before exercise |