HEdia eXercise Algorithm - HEXA Study.

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

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

Study Overview

• Status: Completed
• Conditions: Diabetes
• Intervention / Treatment: Device: Hedia Diabetes Assistant 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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Hillerød, Denmark, 3400
    • North Zealand Hospital - Hillerød

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: 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.
Active Comparator: 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).	Device: 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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glycemic variability 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 glycaemic variability (coefficient of variation and standard deviation).	24-hour period starting one hour before exercise
Daily insulin requirement of Hedia Diabetes Assistant bolus calculator with physical activity module	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.	24-hour period starting one hour before exercise
Daily correctional actions of Hedia Diabetes Assistant bolus calculator with physical activity module	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.	24-hour period starting one hour before exercise
Usability of Hedia Diabetes Assistant bolus calculator with physical activity module	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.	1 day

Collaborators and Investigators

• Sponsor: Hedia ApS
• Investigators: Study Director: Anne Østerskov, Hedia ApS

Study record dates

Study Major Dates

• Study Start (Actual): April 3, 2023
• Primary Completion (Actual): April 3, 2024
• Study Completion (Actual): April 3, 2024

Study Registration Dates

• First Submitted: July 11, 2022
• First Submitted That Met QC Criteria: July 13, 2022
• First Posted (Actual): July 14, 2022

Study Record Updates

• Last Update Posted (Actual): June 7, 2024
• Last Update Submitted That Met QC Criteria: June 6, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: HEXA study

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No