The effect of dishabituation on hypoglycaemia awareness in patients with type 1 diabetes and impaired hypoglycaemia awareness.

Not Applicable

Completed

• Conditions: Type 1 diabetes.; Impaired awareness of hypoglycaemia; Metabolic and Endocrine - Diabetes

• Registration Number: ACTRN12622000828729
• Lead Sponsor: Telethon Kids Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-06-14
• Study Completion: 2023-09-25
• Last Update Posted: 3 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 7

Inclusion Criteria

Participant inclusion criteria.
1. Type 1 diabetes
2. Age 14 to 35 years
3. Impaired awareness of hypoglycaemia (Clarke score greater than or equal to 4 OR Gold Score greater than or equal to 4)
4. No clinical contraindication to exercise
5. HIE naïve or not participating in competitive team sports/sprints less than or equal to 1 /week
6. No expected participation in high intensity exercise other than the study-prescribed exercise for
the duration of the study
7. Willing to follow study instructions and attend visits
8. Willing to wear real-time CGM
9. Willing to wear a wrist-warn physical activity monitor (Garmin Forerunner)
10. Able to carry out exercise tasks

Exclusion Criteria

1. Any clinical evidence of microvascular, macrovascular or neurological complications associated with T1D
2. Any clinical evidence of cardiovascular disease
3. Individuals not able to perform high-intensity exercise
4. Individuals with severe hypoglycaemia (coma, convulsion or requiring third-party assistance for treatment) in the last six months
5. Pregnancy or planned pregnancy within the study period
6. Another serious chronic illness or concomitant medication impacting one’s ability to perform the
exercise testing or study participation
7. Commenced new treatment (insulin pump or sensor) during or in the three months preceding the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome is the acceptability of high intensity exercise as a home-based intervention. This outcome will be determined by the semi-structured interview at the end of the study[ At the end of the 19 week study];The feasibility of the high intensity exercise regimens as a home-based intervention determined by a semi-structured end of study interview. [ At the end of the 19 week study ]