HIT on Hypoglycaemic Risk in T1D
Condition: Type1diabetes
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional

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 Recent work (unpublished) from our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.
    

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.
    

Intervention name(s): moderate intensity continous training; high intensity interval training
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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.; 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.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care