Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000583448
Ethics application status
Approved
Date submitted
15/01/2016
Date registered
5/05/2016
Date last updated
5/05/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of short sprints during exercise on blood glucose management in Type 1 Diabetes Mellitus.
Scientific title
The benefits of sprinting for improving blood glucose management in individuals with Type 1 Diabetes Mellitus
Secondary ID [1] 288276 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 1 Diabetes Mellitus 297228 0
Condition category
Condition code
Metabolic and Endocrine 297440 297440 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study will follow a randomised crossover design. On three occasions, the participants will wear a continuous glucose monitoring system (CGMS), and an exercise watch for 14 days under free-living conditions. On one occasion, the participants will follow their normal diabetes management during periods of physical activity. In the alternate conditions, the participants will incorporate shorts sprints with their normal diabetes management to any period of sustained physical activity.The participants will be instructed that sprints should be performed with maximum effort. However as this is a "real-life" study we will not be measuring the intensity of the sprint.

We will investigate two different sprinting protocols to be performed during sustained (greater than 30 minutes) moderate intensity exercise. Participants will be asked to partake in moderate intensity exercise (running or cycling) at least 3 times a week for at least 30 minutes. This will take place in a real-life, free living setting.

Intervention 1: Moderate intensity exercise with a 10 seconds sprint at the start, every 20 minutes during, and at the end of the exercise.
Intervention 2: Moderate intensity exercise with a 4 second sprint every 2 minutes, followed by a 10 second sprint at the end of the exercise.
We will monitor adherence to sprinting protocols using a GPS exercise watch (worn during exercise) and an exercise diary.
All participants will complete intervention 1, intervention 2 and control arms of the study, There will be a 1-2 week washout period between each arm,
Intervention code [1] 293571 0
Treatment: Other
Comparator / control treatment
Participants will be asked to partake in moderate intensity exercise (running or cycling) at least 3 times a week for at least 30 minutes. This will take place in a real-life, free living setting. Participants will be instructed to follow their normal diabetes management and will NOT be given additional instructions regarding exercise management including insulin and/or carbohydrate adjustment.

Control group
Active

Outcomes
Primary outcome [1] 296992 0
The incidence of hypoglycaemia (defined as glucose sensor readings <3.5 mmol/L for greater than or equal to 20 minutes); or treated symptomatic hypoglycaemia.

Treated symptomatic hypoglycaemia will be assessed using self reported episodes in the participant study diary.
Timepoint [1] 296992 0
Hypoglycaemia will be assessed using continuous glucose monitoring (CGM) throughout the three (control, intervention 1 and intervention 2), two week study periods- i.e over 6 weeks.
Secondary outcome [1] 319814 0
Time spent with sensor glucose levels between 3.5 and 8mmol/L, between 8 and 10mmol/L and above 10mmol/L

This will be assessed using continuous glucose monitoring
Timepoint [1] 319814 0
This will be assessed using continuous glucose monitoring (CGM) throughout the three (control, intervention 1 and intervention 2), two week study periods- i.e over 6 weeks.
Secondary outcome [2] 319815 0
Compliance with the exercise guidelines. This will be assessed using the exercise watch and the participant's exercise diary.
Timepoint [2] 319815 0
This will be assessed using the exercise watch and the participant's exercise diary throughout the three (control, intervention 1 and intervention 2), two week study periods- i.e over 6 weeks.
Secondary outcome [3] 319816 0
The incidence of hypoglycaemia (defined as glucose sensor readings <3.9 mmol/L)

This will be assessed using continuous glucose monitoring.
Timepoint [3] 319816 0
This will be assessed using continuous glucose monitoring (CGM) throughout the three (control, intervention 1 and intervention 2), two week study periods- i.e over 6 weeks.
Secondary outcome [4] 319817 0
Carbohydrate intake before, during and after exercise.

This will be assessed using the participant's food diary.
Timepoint [4] 319817 0
This will be assessed using the participant's food diary throughout the three (control, intervention 1 and intervention 2), two week study periods- i.e over 6 weeks.

Eligibility
Key inclusion criteria
Type 1 Diabetes duration >1y.
- Male and female participants aged between 14 and 35 years old;
- Mean (over last 12 months) glycated haemoglobin levels <9%;
- Participate in sustained aerobic exercise at least 3 times per week;
- Free from any clinical evidence of macrovascular, microvascular or neurological complications associated with Type 1 Diabetes.
- Hypoglycaemia aware, as assessed by the Modified Clarke’s Hypoglycaemia Awareness Questionnaire.
Minimum age
14 Years
Maximum age
35 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Musculoskeletal injuries;
- Other medical conditions where exercise is contraindicated.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealed through central randomisation using a computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
All participants will complete all three experimental conditions (control, intervention 1 and intervention 2) following a crossover study design and the order of these conditions will be randomised. We will use a counterbalanced design in which participants will be allocated to one of six ‘Sequences’ based on the order in which they receive the conditions. Participants will be evenly distributed across the ‘Sequences’. To allocate participants to a ‘sequence’, adaptive randomization (specifically, minimization) will be used. The following stratifying factors will be used in the minimisation: age group, and gender. This will be done using the computer program ‘MinimPy’.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Fifty subjects (50 completed studies) will be enrolled in this study. We have previously shown, using a similar experimental design, an average of 1.4 low glucose events (sensor glucose readings <3.5 mmol/L) per day with a standard deviation of 1.0 in free-living individuals with Type 1 Diabates. Since a 30% reduction in this incident rate to 1.0 event per day would represent a statistically significant change with an alpha set at 0.05, we have calculated that a sample size of 45 participants will provide us with enough statistical power (Beta = 0.85) to test our hypothesis. We will recruit 50 participants to account for an approximate 10% loss to follow-up based on previous studies of this nature.

Generalized linear mixed models with a Negative Binomial distribution and log link will be used to determine whether, compared to the control condition sprinting reduces the incidence of hypoglycaemic episodes associated with exercise in individuals with Type 1 Diabetes.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
29/01/2016
Date of last participant enrolment
Anticipated
1/07/2017
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 5013 0
Princess Margaret Hospital - Subiaco
Recruitment hospital [2] 5355 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment hospital [3] 5356 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [4] 5357 0
Royal Perth Hospital - Perth

Funding & Sponsors
Funding source category [1] 292655 0
Government body
Name [1] 292655 0
NHMRC research grant
Country [1] 292655 0
Australia
Primary sponsor type
Hospital
Name
Princess Margaret Hospital
Address
Princess Margaret Hospital
99 Roberts Road
Subiaco, 6008
Perth
Western Australia
Country
Australia
Secondary sponsor category [1] 291419 0
None
Name [1] 291419 0
Address [1] 291419 0
Country [1] 291419 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294170 0
Princess Margaret Hospital for Children HREC
Ethics committee address [1] 294170 0
Ethics committee country [1] 294170 0
Australia
Date submitted for ethics approval [1] 294170 0
03/10/2014
Approval date [1] 294170 0
17/03/2015
Ethics approval number [1] 294170 0
2014109EP

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 62530 0
Prof Tim Jones
Address 62530 0
Department Endocrinology and Diabetes
Princess Margaret Hospital
99 Roberts Road
Subiaco, 6008
Perth
Western Australia
Country 62530 0
Australia
Phone 62530 0
+618 9340 8090
Fax 62530 0
Email 62530 0
[email protected]
Contact person for public queries
Name 62531 0
Tarini Chetty
Address 62531 0
Department Endocrinology and Diabetes
Princess Margaret Hospital
99 Roberts Road
Subiaco, 6008
Perth
Western Australia
Country 62531 0
Australia
Phone 62531 0
+618 9340 8090
Fax 62531 0
Email 62531 0
[email protected]
Contact person for scientific queries
Name 62532 0
Tarini Chetty
Address 62532 0
Department Endocrinology and Diabetes
Princess Margaret Hospital
99 Roberts Road
Subiaco, 6008
Perth
Western Australia
Country 62532 0
Australia
Phone 62532 0
+618 9340 8090
Fax 62532 0
Email 62532 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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