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HIT on Hypoglycemic Risk in Type 1 Diabetes (T1D)

Can High Intensity Interval Training Reduce Fear of Hypoglycaemia and Improve Glycaemic Control in People With Type 1 Diabetes?

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03598400
Enrollment
11
Registered
2018-07-26
Start date
2018-08-01
Completion date
2020-08-01
Last updated
2021-02-23

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

Conditions

Type1diabetes

Brief summary

There is clear evidence that regular exercise improves wellbeing and reduces the risk of diabetes related complications in people with type 1 diabetes. However, many people with type 1 diabetes do not exercise regularly. The primary reason for this is fear of hypoglycaemia and loss of glycaemic control associated with exercise. This loss of glycaemic control is associated with traditional moderate intensity continous aerobic exercise advocated in the guidelines for exercise in people with type 1 diabetes. Recent work (unpublished) from our lab suggests high intensity interval training (HIT) may reduce the risk of hypoglycaemia in people with type 1 diabetes, however stronger evidence is needed before firm conclusions can be drawn. Therefore, the aim of this study is to determine the effects of HIT on glycaemic control in people with type 1 diabetes compared to no exercise and traditional moderate intensity continous exercise. 24 people with type 1 diabetes will be recruited to complete a randomised counterbalanced cross over study comparing 3x 2-week interventions periods. During these intervention periods participant will maintain their habitual lifestyle but complete either no exercise (control), traditional moderate intensity continous exercise or high intensity interval training. Throughout the intervention periods participants glycaemic control will be monitored using a flash glucose monitor.

Interventions

BEHAVIORALhigh intensity interval training

Participants will complete 6 sessions of high intensity interval training during a 2 week intervention period. The programme involves repeated 1 minute bouts of simple on the spot movements interspersed with 1 minute of rest.

Participants will complete 6 sessions of moderate intensity continous training during a 2 week intervention period. Participants will be asked to complete 30 minutes of continuous exercise.

Sponsors

Society for Endocrinology
CollaboratorOTHER
Royal Liverpool University Hospital
CollaboratorOTHER_GOV
University of Birmingham
CollaboratorOTHER
University of Exeter
CollaboratorOTHER
Liverpool John Moores University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes

Inclusion criteria

* T1D diagnosis more than 6 months ago (to ensure participants are out of the honeymoon period), * Using a basal bolus insulin regime or insulin pump therapy * BMI ≤ 32 kg.m-2

Exclusion criteria

* Pregnancy (or planning pregnancy) * Disability preventing participation in an exercise regime * Angina * Autonomic neuropathy * Medication that affects heart rate (this will affect estimation of fitness) * Major surgery planned within 6 weeks of study * Uncontrolled blood pressure * Significant history of hyperglycaemia * History of severe hypoglycaemia requiring third party assistance within the last 3 months * Severe non-proliferative and unstable proliferative retinopathy

Design outcomes

Primary

MeasureTime frameDescription
Severe hypoglycaemia2 weeksNumber of severe hypoglycaemic events (\<3mmol/l) during the 2 week intervention period

Secondary

MeasureTime frameDescription
% of time in level 2 hypoglycaemia (<3.0mmol/L)2 weeks% of time in level 2 hypoglycaemia (\<3.0mmol/L) over 2 week recording period
% of time in level 1 hypoglycaemia (3.0-3.9mmol/L)2 weeks% of time in level 1 hypoglycaemia (3.0-3.9mmol/L) over 2 week recording period
% of time in target range (3.9-10.0mmol/L)2 weeks% of time in target range (3.9-10.0mmol/L) over 2 week recording period
Mean glucose2 weeksmean glucose level over 2 week recording period
% of time in level 2 hyperglycaemia (>13.9mmol/L)2 weeks% of time in level 2 hyperglycaemia (\>13.9mmol/L) over 2 week recording period
glycaemic variability (coefficient of variation and Standard Deviation)2 weeksglycaemic variability over 2 week recording period
area under the curve of episodes of hypoglycaemia and hyperglycaemia2 weeksarea under the curve of episodes of hypoglycaemia and hyperglycaemia 2 week recording period
% of time in level 1 hyperglycaemia (10.0-13.9mmol/L)2 weeks% of time in level 1 hyperglycaemia (10.0-13.9mmol/L) over 2 week recording period

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026