HIT on Hypoglycemic Risk in Type 1 Diabetes (T1D)

February 22, 2021 updated by: Liverpool John Moores University

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

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 Recent work (unpublished) from our lab suggests high intensity interval training (HIT) may reduce the risk of hypoglycaemia in people with type 1 diabetes, however stronger evidence is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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Liverpool, United Kingdom, L33AF
        • Liverpool John Moores University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Participants will continue with their habitual lifestyle but perform no exercise for 2 weeks
Active Comparator: Moderate intensity continous training
Participants will complete moderate intensity continous training during a 2 week intervention period
Behavioral: moderate intensity continous training
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.
Experimental: high intensity interval training
Participants will complete high intensity interval training during a 2 week intervention period
Behavioral: high 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Severe hypoglycaemia
Time Frame: 2 weeks
Number of severe hypoglycaemic events (<3mmol/l) during the 2 week intervention period
2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean glucose
Time Frame: 2 weeks
mean glucose level over 2 week recording period
2 weeks
% of time in level 2 hypoglycaemia (<3.0mmol/L)
Time Frame: 2 weeks
% of time in level 2 hypoglycaemia (<3.0mmol/L) over 2 week recording period
2 weeks
% of time in level 1 hypoglycaemia (3.0-3.9mmol/L)
Time Frame: 2 weeks
% of time in level 1 hypoglycaemia (3.0-3.9mmol/L) over 2 week recording period
2 weeks
% of time in target range (3.9-10.0mmol/L)
Time Frame: 2 weeks
% of time in target range (3.9-10.0mmol/L) over 2 week recording period
2 weeks
% of time in level 1 hyperglycaemia (10.0-13.9mmol/L)
Time Frame: 2 weeks
% of time in level 1 hyperglycaemia (10.0-13.9mmol/L) over 2 week recording period
2 weeks
% of time in level 2 hyperglycaemia (>13.9mmol/L)
Time Frame: 2 weeks
% of time in level 2 hyperglycaemia (>13.9mmol/L) over 2 week recording period
2 weeks
glycaemic variability (coefficient of variation and Standard Deviation)
Time Frame: 2 weeks
glycaemic variability over 2 week recording period
2 weeks
area under the curve of episodes of hypoglycaemia and hyperglycaemia
Time Frame: 2 weeks
area under the curve of episodes of hypoglycaemia and hyperglycaemia 2 week recording period
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Liverpool John Moores University

Collaborators

Royal Liverpool University Hospital
University of Birmingham
University of Exeter
Society for Endocrinology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2018

Primary Completion (Actual)

August 1, 2020

Study Completion (Actual)

August 1, 2020

Study Registration Dates

First Submitted

July 16, 2018

First Submitted That Met QC Criteria

July 24, 2018

First Posted (Actual)

July 26, 2018

Study Record Updates

Last Update Posted (Actual)

February 23, 2021

Last Update Submitted That Met QC Criteria

February 22, 2021

Last Verified

February 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • T1D1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

No individual participant data will be shared outside the research team. Anonymised group data will be presented in research articles and presentations

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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