Diabetes
Conditions
Brief summary
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.
Interventions
DEVICEHedia Diabetes Assistant bolus calculator with a physical activity module
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.
Sponsors
Hedia ApS
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time-in-range of Hedia Diabetes Assistant bolus calculator with physical activity module | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hypoglycemic events of Hedia Diabetes Assistant bolus calculator with physical activity module | 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 no. of hypoglycemic events (blood glucose \< 3.9 mmol/l). |
| Time-above-range of Hedia Diabetes Assistant bolus calculator with physical activity module | 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-above-range (\>10.0 mmol/l). |
| Time-below-range of Hedia Diabetes Assistant bolus calculator with physical activity module | 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-below-range (blood glucose \< 3.9 mmol/l). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Glycemic variability of Hedia Diabetes Assistant bolus calculator with physical activity module | 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 glycaemic variability (coefficient of variation and standard deviation). |
| Daily insulin requirement of Hedia Diabetes Assistant bolus calculator with physical activity module | 24-hour period starting one hour before exercise | To compare the daily intake of insulin in adults with type 1 diabetes mellitus utilising the physical activity module as part of the Hedia Diabetes Assistant bolus calculator compared to their habitual diabetes management during a 24-hour period starting one hour before exercise. |
| Daily correctional actions of Hedia Diabetes Assistant bolus calculator with physical activity module | 24-hour period starting one hour before exercise | To compare the number of daily correctional actions (intake of food or injection of insulin) in adults with type 1 diabetes mellitus utilising the physical activity module as part of the Hedia Diabetes Assistant bolus calculator compared to their habitual diabetes management during a 24-hour period starting one hour before exercise. |
| Usability of Hedia Diabetes Assistant bolus calculator with physical activity module | 1 day | To compare the usability of the physical activity module as part of the Hedia Diabetes Assistant application by System Usability Scale (SUS) in adult patients with type 1 diabetes mellitus. |
Countries
Denmark
Outcome results
None listed