Ignite Creation Date:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2026-02-23 @ 1:11 AM
Study NCT ID:
NCT05458167
Status:
COMPLETED
Last Update Posted:
2024-06-07
First Post:
2022-07-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
HEdia eXercise Algorithm - HEXA Study.
Sponsor:
Hedia ApS
Organization:
Study Overview
Official Title:
HEdia eXercise Algorithm - HEXA Study. A Randomised Controlled Crossover Pilot Study
Status:
COMPLETED
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: