Type1diabetesNCT03598400
HIT on Hypoglycemic Risk in Type 1 Diabetes (T1D)
A study testing high intensity interval training and moderate intensity continous training in people with Type1diabetes, run by Liverpool John Moores University at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Type1diabetes
- What is being tested?
- high intensity interval training and moderate intensity continous training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Aug 2018to 1 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Type1diabetes
- Being tested
- high intensity interval training, moderate intensity continous training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high intensity interval trainingBehavioural
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.
moderate intensity continous trainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Participants will continue with their habitual lifestyle but perform no exercise for 2 weeks |
| Moderate intensity continous training | Active comparator | Participants will complete moderate intensity continous training during a 2 week intervention period Receives: Behavioral: moderate intensity continous training |
| high intensity interval training | Experimental | Participants will complete high intensity interval training during a 2 week intervention period Receives: Behavioral: high intensity interval training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severe hypoglycaemia
Number of severe hypoglycaemic events (<3mmol/l) during the 2 week intervention period
Measured: 2 weeks
Secondary outcomes (8)
Mean glucose
mean glucose level over 2 week recording period
Measured: 2 weeks
% of time in level 2 hypoglycaemia (<3.0mmol/L)
% of time in level 2 hypoglycaemia (<3.0mmol/L) over 2 week recording period
Measured: 2 weeks
% of time in level 1 hypoglycaemia (3.0-3.9mmol/L)
% of time in level 1 hypoglycaemia (3.0-3.9mmol/L) over 2 week recording period
Measured: 2 weeks
% of time in target range (3.9-10.0mmol/L)
% of time in target range (3.9-10.0mmol/L) over 2 week recording period
Measured: 2 weeks
% of time in level 1 hyperglycaemia (10.0-13.9mmol/L)
% of time in level 1 hyperglycaemia (10.0-13.9mmol/L) over 2 week recording period
Measured: 2 weeks
% of time in level 2 hyperglycaemia (>13.9mmol/L)
% of time in level 2 hyperglycaemia (>13.9mmol/L) over 2 week recording period
Measured: 2 weeks
glycaemic variability (coefficient of variation and Standard Deviation)
glycaemic variability over 2 week recording period
Measured: 2 weeks
area under the curve of episodes of hypoglycaemia and hyperglycaemia
area under the curve of episodes of hypoglycaemia and hyperglycaemia 2 week recording period
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start1 Aug 2018
- Primary completion1 Aug 2020
- Study completion1 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type1diabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Liverpool John Moores University
- Sponsor type
- University, hospital or other
- Collaborators
- Society for Endocrinology, Royal Liverpool University Hospital, University of Birmingham, University of Exeter
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03598400
- Sponsor's protocol ID
- T1D1
- Status last verified
- Feb 2020
- First submitted
- 16 Jul 2018
- Last updated
- 23 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual participant data will be shared outside the research team. Anonymised group data will be presented in research articles and presentations
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can High Intensity Interval Training Reduce Fear of Hypoglycaemia and Improve Glycaemic Control in People With Type 1 Diabetes?
- ClinicalTrials.gov ID
- NCT03598400
- Acronym / sponsor ID
- T1D1
- Conditions
- Type1diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Liverpool John Moores UniversityUniversity, hospital or other
- Collaborators
- Society for Endocrinology, Royal Liverpool University Hospital, University of Birmingham, University of Exeter
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 1 Aug 2020 (actual)
- Study completion
- 1 Aug 2020 (actual)
- First posted
- 26 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Participants will continue with their habitual lifestyle but perform no exercise for 2 weeks |
| Moderate intensity continous training | Active comparator | Behavioral: moderate intensity continous trainingParticipants will complete moderate intensity continous training during a 2 week intervention period |
| high intensity interval training | Experimental | Behavioral: high intensity interval trainingParticipants will complete high intensity interval training during a 2 week intervention period |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| high intensity interval trainingParticipants 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. | Behavioural | high intensity interval training |
| moderate intensity continous trainingParticipants 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. | Behavioural | Moderate intensity continous training |
Primary outcome
Severe hypoglycaemia
Time frame: 2 weeks
Number of severe hypoglycaemic events (<3mmol/l) during the 2 week intervention period
8 secondary outcomes
Mean glucose
Time frame: 2 weeks
% of time in level 2 hypoglycaemia (<3.0mmol/L)
Time frame: 2 weeks
% of time in level 1 hypoglycaemia (3.0-3.9mmol/L)
Time frame: 2 weeks
% of time in target range (3.9-10.0mmol/L)
Time frame: 2 weeks
% of time in level 1 hyperglycaemia (10.0-13.9mmol/L)
Time frame: 2 weeks
% of time in level 2 hyperglycaemia (>13.9mmol/L)
Time frame: 2 weeks
glycaemic variability (coefficient of variation and Standard Deviation)
Time frame: 2 weeks
area under the curve of episodes of hypoglycaemia and hyperglycaemia
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2021.
- Individual participant dataSharing planned: No. No individual participant data will be shared outside the research team. Anonymised group data will be presented in research articles and presentations
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing high intensity interval training and moderate intensity continous training in people with Type1diabetes, run by Liverpool John Moores University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severe hypoglycaemia (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2021.