Type1diabetesNCT05044442
HIT on Hypoglycaemic Risk in T1D
A study testing moderate intensity continous training and high intensity interval 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?
- moderate intensity continous training and high intensity interval training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Oct 2018to 1 Aug 2019
- 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
- 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.
Read the detailed description
Recruitment 24 people with type 1 diabetes (T1D) will be recruited through local advertising, e.g. within the Liverpool Type 1 Diabetes (LIVT1D) Group.
Protocol The study will use a randomised counterbalanced crossover design, whereby participants will complete 3x 2-week intervention periods; control (no exercise), moderate intensity continous training (MICT) and high intensity interval training (HIT).
Intervention period Participants will complete 3x 2-week intervention periods identical in all respects except for the type of exercise completed.
The day before each intervention period participants will attend the lab at Liverpool John Moores University to have an Abbot Freestyle Libre® flash glucose monitor inserted. To access the data participants will be provide with a "Reader" in "masked" mode, ensuring the participant cannot see the data produced. The Reader will also be used to record time of exercise, insulin doses and blood glucose. Finally, participants will be provided with an activity monitor (Actigraph®) for the duration of the intervention. Participants will also be familiarised to the type of exercise being performed.
In Addition, before the first intervention period participants will also be asked to download MyFitnessPal® to record their daily food intake. An anonymous login email address and password will be given to the participant for access to this App and associated website. A 1ml finger prick blood sample will also be taken on this first visit.
Participants will then complete the 2-week intervention period. During this period participants will be asked to maintain their habitual lifestyle, but only complete the exercise prescribed by the research team (HIT or MICT), or no exercise during the control intervention. Participants will be asked to exercise on day 1, 3, 6, 8, 10 and 13 of the intervention period. Exercise will be completed at any time, but must not be performed following an overnight fast. Participants will be asked to record their blood glucose immediately before and after exercise and 2h post exercise using a finger stick blood sample and automated glucose reader. If participants need to take additional carbohydrates to adjust blood glucose following exercise the investigators will also ask for this to be recorded (what was consumed and time after exercise) using a note in the MyFitnessPal app. Participants will record all insulin doses, time of exercise and food intake for the duration of the intervention period.
Training MICT: Participants will be asked to complete 30 minutes of continuous exercise. Participants will be able to choose any form of exercise (e.g. running or cycling) as long as it is continous in nature. During exercise participants will be asked to maintain a heart rate between 60-70% of their predicted maximum (220-age).
HIT: Participants will be provided with a training guide containing information on the exercises. The programme involves repeated 1 minute bouts of simple on the spot movements interspersed with 1 minute of rest. During the intervals participants will be advised to reach a heart rate of approx. 80% of their predicted maximum heart rate (220-age). The 1 minute interval will be split between 2 consecutive 30 second exercises. The research team have a library of 18 exercises, with 9 suggested exercise pairs. Participants will be advised to complete 6 intervals during each session.
Participants will complete training in a place of their choosing. If requested participants will be able to train in the labs at LJMU.
Participants will be given a polar H7/10 Bluetooth heart rate monitor. Participants will be advised to wear this monitor during all training sessions. The monitor will provide a measure of training intensity and compliance with the suggested heart rate and training programme.
Participants will be asked to download the App PolarBeat to their smartphone. This App will be used to monitor heart rate during the training sessions. In addition, participants will be given a login email address and password for PolarFlow (www.polar.flow.com), a cloud storage site run by Polar for the storage and analysis of heart rate data. All heart rate data measured during training sessions will be uploaded to Polar Flow. This will allow the research team to investigate training intensity achieved during all sessions.
Safety Subjects will be asked to check their blood glucose level to ensure it is safe to exercise. The investigators will use the guidelines that are currently used in a national study of exercise for patients with type 1 diabetes (EXTOD - see attached leaflet). Blood glucose will be checked immediately following exercise and corrected with fast acting carbohydrates if low. The investigators will also advise the subjects to check their glucose level before bed, and if necessary in the early hours of the morning (through setting an alarm clock) if this is required.
Flash Glucose Monitoring Analysis 9 key metrics of glycaemic control will be assessed, reported in 3 time blocks (sleep 00:00-06:00, wake 06:00- 00:00 and 24h 00:00- 00:00): 1) mean glucose, 2) % of time in level 2 hypoglycaemia (<3.0mmol/L), 3) % of time in level 1 hypoglycaemia (3.0-3.9mmol/L), 4) % of time in target range (3.9-10.0mmol/L), 5) % of time in level 1 hyperglycaemia (10.0-13.9mmol/L), 6) % of time in level 2 hyperglycaemia (>13.9mmol/L), 7) glycaemic variability, reported as CV and SD, 8) episodes of hypoglycaemia and hyperglycaemia and 9) area under the curve of episodes of hypoglycaemia and hyperglycaemia.
- Conditions
- Type1diabetes
- Being tested
- moderate intensity continous training, high intensity interval training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| 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 (using continuous glucose monitoring)
Number of severe hypoglycaemic events (<3mmol/l) during the 2 week intervention period
Measured: Over a 2 week intervention period
Secondary outcomes (8)
Mean glucose (using continuous glucose monitoring)
mean glucose level over 2 week recording period
Measured: Over a 2 week intervention period
% of time in level 2 hypoglycaemia (<3.0mmol/L) (using continuous glucose monitoring)
% of time in level 2 hypoglycaemia (<3.0mmol/L) over 2 week recording period
Measured: Over a 2 week intervention period
% of time in level 1 hypoglycaemia (3.0-3.9mmol/L) (using continuous glucose monitoring)
% of time in level 1 hypoglycaemia (3.0-3.9mmol/L) over 2 week recording period
Measured: Over a 2 week intervention period
% of time in target range (3.9-10.0mmol/L) (using continuous glucose monitoring)
% of time in target range (3.9-10.0mmol/L) over 2 week recording period
Measured: Over a 2 week intervention period
% of time in level 1 hyperglycaemia (10.0-13.9mmol/L) (using continuous glucose monitoring)
% of time in level 1 hyperglycaemia (10.0-13.9mmol/L) over 2 week recording period
Measured: Over a 2 week intervention period
% of time in level 2 hyperglycaemia (>13.9mmol/L) (using continuous glucose monitoring)
% of time in level 2 hyperglycaemia (>13.9mmol/L) over 2 week recording period
Measured: Over a 2 week intervention period
glycaemic variability (using continuous glucose monitoring)
Standard deviation in glucose concentrations obtained over a 2 week period using a continuous glucose monitoring device.
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: Over a 2 week intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2021
- Study start1 Oct 2018
- Primary completion1 Aug 2019
- Study completion1 Aug 2019
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
- 24 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
- Principal investigator, Sam Shepherd, Liverpool John Moores University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05044442
- Sponsor's protocol ID
- SB_T1D_V1
- Status last verified
- Sep 2021
- First submitted
- 25 Jun 2018
- Last updated
- 14 Sep 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 14 Sep 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
- NCT05044442
- Acronym / sponsor ID
- SB_T1D_V1
- Conditions
- Type1diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 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 Oct 2018 (actual)
- Primary completion
- 1 Aug 2019 (actual)
- Study completion
- 1 Aug 2019 (actual)
- First posted
- 14 Sep 2021 (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.
Detailed description
Recruitment 24 people with type 1 diabetes (T1D) will be recruited through local advertising, e.g. within the Liverpool Type 1 Diabetes (LIVT1D) Group.
Protocol The study will use a randomised counterbalanced crossover design, whereby participants will complete 3x 2-week intervention periods; control (no exercise), moderate intensity continous training (MICT) and high intensity interval training (HIT).
Intervention period Participants will complete 3x 2-week intervention periods identical in all respects except for the type of exercise completed.
The day before each intervention period participants will attend the lab at Liverpool John Moores University to have an Abbot Freestyle Libre® flash glucose monitor inserted. To access the data participants will be provide with a "Reader" in "masked" mode, ensuring the participant cannot see the data produced. The Reader will also be used to record time of exercise, insulin doses and blood glucose. Finally, participants will be provided with an activity monitor (Actigraph®) for the duration of the intervention. Participants will also be familiarised to the type of exercise being performed.
In Addition, before the first intervention period participants will also be asked to download MyFitnessPal® to record their daily food intake. An anonymous login email address and password will be given to the participant for access to this App and associated website. A 1ml finger prick blood sample will also be taken on this first visit.
Participants will then complete the 2-week intervention period. During this period participants will be asked to maintain their habitual lifestyle, but only complete the exercise prescribed by the research team (HIT or MICT), or no exercise during the control intervention. Participants will be asked to exercise on day 1, 3, 6, 8, 10 and 13 of the intervention period. Exercise will be completed at any time, but must not be performed following an overnight fast. Participants will be asked to record their blood glucose immediately before and after exercise and 2h post exercise using a finger stick blood sample and automated glucose reader. If participants need to take additional carbohydrates to adjust blood glucose following exercise the investigators will also ask for this to be recorded (what was consumed and time after exercise) using a note in the MyFitnessPal app. Participants will record all insulin doses, time of exercise and food intake for the duration of the intervention period.
Training MICT: Participants will be asked to complete 30 minutes of continuous exercise. Participants will be able to choose any form of exercise (e.g. running or cycling) as long as it is continous in nature. During exercise participants will be asked to maintain a heart rate between 60-70% of their predicted maximum (220-age).
HIT: Participants will be provided with a training guide containing information on the exercises. The programme involves repeated 1 minute bouts of simple on the spot movements interspersed with 1 minute of rest. During the intervals participants will be advised to reach a heart rate of approx. 80% of their predicted maximum heart rate (220-age). The 1 minute interval will be split between 2 consecutive 30 second exercises. The research team have a library of 18 exercises, with 9 suggested exercise pairs. Participants will be advised to complete 6 intervals during each session.
Participants will complete training in a place of their choosing. If requested participants will be able to train in the labs at LJMU.
Participants will be given a polar H7/10 Bluetooth heart rate monitor. Participants will be advised to wear this monitor during all training sessions. The monitor will provide a measure of training intensity and compliance with the suggested heart rate and training programme.
Participants will be asked to download the App PolarBeat to their smartphone. This App will be used to monitor heart rate during the training sessions. In addition, participants will be given a login email address and password for PolarFlow (www.polar.flow.com), a cloud storage site run by Polar for the storage and analysis of heart rate data. All heart rate data measured during training sessions will be uploaded to Polar Flow. This will allow the research team to investigate training intensity achieved during all sessions.
Safety Subjects will be asked to check their blood glucose level to ensure it is safe to exercise. The investigators will use the guidelines that are currently used in a national study of exercise for patients with type 1 diabetes (EXTOD - see attached leaflet). Blood glucose will be checked immediately following exercise and corrected with fast acting carbohydrates if low. The investigators will also advise the subjects to check their glucose level before bed, and if necessary in the early hours of the morning (through setting an alarm clock) if this is required.
Flash Glucose Monitoring Analysis 9 key metrics of glycaemic control will be assessed, reported in 3 time blocks (sleep 00:00-06:00, wake 06:00- 00:00 and 24h 00:00- 00:00): 1) mean glucose, 2) % of time in level 2 hypoglycaemia (<3.0mmol/L), 3) % of time in level 1 hypoglycaemia (3.0-3.9mmol/L), 4) % of time in target range (3.9-10.0mmol/L), 5) % of time in level 1 hyperglycaemia (10.0-13.9mmol/L), 6) % of time in level 2 hyperglycaemia (>13.9mmol/L), 7) glycaemic variability, reported as CV and SD, 8) episodes of hypoglycaemia and hyperglycaemia and 9) area under the curve of episodes of hypoglycaemia and hyperglycaemia.
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
- 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 |
|---|---|---|
| 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 |
| 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 |
Primary outcome
Severe hypoglycaemia (using continuous glucose monitoring)
Time frame: Over a 2 week intervention period
Number of severe hypoglycaemic events (<3mmol/l) during the 2 week intervention period
8 secondary outcomes
Mean glucose (using continuous glucose monitoring)
Time frame: Over a 2 week intervention period
% of time in level 2 hypoglycaemia (<3.0mmol/L) (using continuous glucose monitoring)
Time frame: Over a 2 week intervention period
% of time in level 1 hypoglycaemia (3.0-3.9mmol/L) (using continuous glucose monitoring)
Time frame: Over a 2 week intervention period
% of time in target range (3.9-10.0mmol/L) (using continuous glucose monitoring)
Time frame: Over a 2 week intervention period
% of time in level 1 hyperglycaemia (10.0-13.9mmol/L) (using continuous glucose monitoring)
Time frame: Over a 2 week intervention period
% of time in level 2 hyperglycaemia (>13.9mmol/L) (using continuous glucose monitoring)
Time frame: Over a 2 week intervention period
glycaemic variability (using continuous glucose monitoring)
Time frame: 2 weeks
area under the curve of episodes of hypoglycaemia and hyperglycaemia
Time frame: Over a 2 week intervention period
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 14 Sep 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 moderate intensity continous training and high intensity interval 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 14 Sep 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 (using continuous glucose monitoring) (time frame: Over a 2 week intervention period). 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 14 Sep 2021.