HEdia eXercise Algorithm - HEXA Study.

NCT ID: NCT05458167

Last Updated: 2024-06-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-03
• Study Completion Date: 2024-04-03

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.

Conditions

Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Device: Hedia Diabetes Assistant with physical activity module.

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.

Group Type: EXPERIMENTAL

Hedia Diabetes Assistant bolus calculator with a physical activity module

Intervention Type: DEVICE

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.

Usual treatment

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).

Group Type: ACTIVE_COMPARATOR

Hedia Diabetes Assistant bolus calculator with a physical activity module

Intervention Type: DEVICE

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.

Interventions

Hedia 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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hedia ApS

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anne Østerskov

Role: STUDY_DIRECTOR

Hedia ApS

Locations

North Zealand Hospital - Hillerød

Hillerød, , Denmark

Countries

Denmark

Other Identifiers

HEXA study

Identifier Type: -

Identifier Source: org_study_id