NCT05458167

HEdia eXercise Algorithm - HEXA Study.

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Hedia ApS · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-04-03
• Primary completion: 2024-04-03
• Completion: 2024-04-03
• First posted: 2022-07-14
• Last updated: 2024-06-07

Locations

1 site across 1 country: Denmark