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

Effect of exercise on hypoglycaemia awareness in individuals with type 1 diabetes and IAH under free-living conditions: A pilot study

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12622000828729
Enrollment
7
Registered
2022-06-14
Start date
2021-03-18
Completion date
2023-03-25
Last updated
2024-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

People with both Type 1 diabetes (T1D) and impaired awareness of hypoglycaemia (IAH) have a diminished ability to respond to hypoglycaemia and are hence more susceptible to severe hypoglycaemia. IAH occurs in at least 20-25% of individuals with T1D, and adds to the burden of the disease. The novel concept that IAH develops as a result of an adaptive learning response referred to as habituation. This theory suggests that the progressive diminishment of the counterregulatory responses (CRR) to hypoglycaemia following repeated exposure to hypoglycaemia is consistent with the principal features of a habituated response, and provides an explanation for IAH. Importantly, a habituated response can also be, at least temporarily, reversed. Presentation of another (usually strong) stimulus results in recovery of the habituated response by the introduction of a novel (heterotypic) stimulus, a process known as Dishabituation. High-intensity exercise (HIE) was shown to provide an effective dishabituation stimulus in a rodent model of IAH. In this pilot study, we seek to assess the acceptability and feasibility of HIE as a home-based intervention for people with IAH. The study will also aim to provide preliminary evidence of whether regular exposure to HIE can be used as a home-based therapeutic intervention to restore hypoglycaemia awareness in individuals with IAH.

Interventions

This is a pilot, single-centre, randomised, cross-over study in participants with both Type 1 diabetes and impaired awareness of hypoglycaemia (IAH) under free living conditions. Participants will be screened for IAH over the phone by our study doctor using the Clarke questionnaire. Once eligibility is confirmed, there will be a 2-week run in period where participants continue with their usual lifestyle. Participants will then be randomised into a 4-week period of either a tri-weekly low-intensi

This is a pilot, single-centre, randomised, cross-over study in participants with both Type 1 diabetes and impaired awareness of hypoglycaemia (IAH) under free living conditions. Participants will be screened for IAH over the phone by our study doctor using the Clarke questionnaire. Once eligibility is confirmed, there will be a 2-week run in period where participants continue with their usual lifestyle. Participants will then be randomised into a 4-week period of either a tri-weekly low-intensity exercise or tri-weekly high-intensity exercise, with a 8-week wash-out in between the two exercise regimens after which, participants will be exposed to the alternative exercise programme for 4 weeks. A logbook will be provided to participants to enable them to record hypoglycaemia for 2 weeks. Logbooks will be used during the 2-week run in period and then in study weeks 5-7, 13-15 and 17-19. This will include a record of both autonomic and neuroglycopenic symptoms (Edinburg hypoglycaemia scale), with the severity of these symptoms being rated on a Likert scale from 1 to 7. (Appendix 6) All participants will be encouraged to record hypoglycaemia symptoms and glucose level in the logbook when at least one of the following conditions is met. a. Notification of urgent low alarm (3.1 mmol/l). b. Symptoms of hypoglycaemia as perceived by the participant c. Any time hypoglycaemia treatment (fast-acting carbohydrates) is instituted by the participant with glucose. Participants will be provided with an activity tracker watch (Garmin Forerunner 735xt) and Dexcom continuous glucose monitoring sensors if they do not have their own. Participants will be required to wear the Dexcom continuous glucose monitoring sensor for the whole study period. Participants will be given the option to wear the activity tracker for the whole study period or only when performing the exercise regimens. Research staff will conduct a home visit to the participant's house to deliver and set up a cycle ergometer (MaXx KH-805 Programmable Upright Exercise Bike). Under the supervision of the research staff members, participants will perform a 10 second sprint test to determine their maximum power output generated (in Watts). Low-intensity exercise for 4 weeks, 3 times a week. Participants will be required to cycle for 16 minutes at a low intensity corresponding to 15% of their peak power (measured during their peak power assessment at the familiarisation visit). High-intensity exercise for 4 weeks, 3-times a week. After a 2-min warm up performed at an intensity equivalent to 15% peak power, participants will be required to engage in four 15-second maximal sprint efforts each separated by a 4-min period of light cycling at 15% peak power, finishing with 2-min of light cycling at 15% peak power. Exercise to be performed at least 3 hours after the last insulin bolus and before the evening meal (dinner). The primary outcome is the acceptability and feasibility of HIE as a home-based intervention. This outcome will be determined by the semi-structured interview at the end of the study. Weekly text messages and when needed, phone calls will be made to each participant to monitor adherence to the intervention.

Sponsors

Telethon Kids Institute
Lead SponsorOther Collaborative groups

Study design

Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
14 Years to 35 Years
Healthy volunteers
No

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026