Clinical trial NCT05458167: HEdia eXercise Algorithm - HEXA Study.
Official title: HEdia eXercise Algorithm - HEXA Study. A Randomised Controlled Crossover Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Lead sponsor: Hedia ApS
Sponsor class: INDUSTRY
First posted: 2022-07-14
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Time-in-range of Hedia Diabetes Assistant bolus calculator with physical activity module
timeFrame: 24-hour period starting one hour before exercise
Secondary outcomes:
measure: Hypoglycemic events of Hedia Diabetes Assistant bolus calculator with physical activity module
timeFrame: 24-hour period starting one hour before exercise
measure: Time-above-range of Hedia Diabetes Assistant bolus calculator with physical activity module
timeFrame: 24-hour period starting one hour before exercise
measure: Time-below-range of Hedia Diabetes Assistant bolus calculator with physical activity module
timeFrame: 24-hour period starting one hour before exercise
Other outcomes:
measure: Glycemic variability of Hedia Diabetes Assistant bolus calculator with physical activity module
timeFrame: 24-hour period starting one hour before exercise
measure: Daily insulin requirement of Hedia Diabetes Assistant bolus calculator with physical activity module
timeFrame: 24-hour period starting one hour before exercise
measure: Daily correctional actions of Hedia Diabetes Assistant bolus calculator with physical activity module
timeFrame: 24-hour period starting one hour before exercise
measure: Usability of Hedia Diabetes Assistant bolus calculator with physical activity module
timeFrame: 1 day
Locations:
city: Hillerød
country: Denmark
facility: North Zealand Hospital - Hillerød
Study officials:
affiliation: Hedia ApS
name: Anne Østerskov
role: STUDY_DIRECTOR
References: