HEdia eXercise Algorithm - HEXA Study.

NCT05458167 | Completed

• 1 other identifier: HEXA study
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Diabetes

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Hypoglycemic events of Hedia Diabetes Assistant bolus calculator with physical activity module

  24-hour period starting one hour before exercise

• Time-above-range of Hedia Diabetes Assistant bolus calculator with physical activity module

  24-hour period starting one hour before exercise

• Time-below-range of Hedia Diabetes Assistant bolus calculator with physical activity module

  24-hour period starting one hour before exercise

Other Outcomes (4)

• Glycemic variability of Hedia Diabetes Assistant bolus calculator with physical activity module

  24-hour period starting one hour before exercise

• Daily insulin requirement of Hedia Diabetes Assistant bolus calculator with physical activity module

  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

Study Arms (2)

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.

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).

Device: Hedia Diabetes Assistant bolus calculator with a physical activity module

Interventions

Hedia Diabetes Assistant bolus calculator with a physical activity module 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.

Device: Hedia Diabetes Assistant with physical activity module.; Usual treatment

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Hedia ApS: lead

Study Sites (1)

North Zealand Hospital - Hillerød

Hillerød, 3400, Denmark

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Anne Østerskov

  Hedia ApS

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2022
• First Posted: July 14, 2022
• Study Start: April 3, 2023
• Primary Completion: April 3, 2024
• Study Completion: April 3, 2024
• Last Updated: June 7, 2024

Record last verified: 2024-06

Locations

DK (1)