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Trial registered on ANZCTR


Registration number
ACTRN12617001651370
Ethics application status
Approved
Date submitted
10/11/2017
Date registered
22/12/2017
Date last updated
22/12/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Testing whether an on-line educational tool may reduce exercise-related hypoglycaemia in type 1 diabetes: the Type 1 Diabetes and Exercise Randomised Controlled Trial.
Scientific title
Testing whether an on-line educational tool may reduce exercise-related hypoglycaemia in type 1 diabetes: the Type 1 Diabetes and Exercise RCT of an online Educational Tool.
Secondary ID [1] 293204 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypoglycaemia 305209 0
Type 1 diabetes 305210 0
Condition category
Condition code
Metabolic and Endocrine 304523 304523 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Intervention, the educational online tool, www.ext1d.com.au contained 6 educational modules. The educational modules discussed the glycaemia secondary to exercise and suggested insulin adjustment and carbohydrate supplementation. Topics included: increased insulin sensitivity following an exercise session and the role of hormones regulating glucose levels around exercise; peak insulin action and timing of an exercise session in relation to insulin meal bolus and dose reduction of a meal bolus for exercise, temporary basal insulin rate and duration for a given exercise session, additional carbohydrate type and amount in relation to exercise.
The Intervention was an established online educational tool, developed by an accredited exercise physiologist (AEP) with concurrent certification as a diabetes educator and 20 years of experience.
Participants were granted access to the educational modules free of charge. They were provided with their individual login data following randomisation and accessed the Intervention, the internet based, educational online tool, individually from home.
Participants accessed the educational online tool, at their own convenience, following randomisation to the Intervention or Control groups. They varied the frequency and duration of exposure to the website according to their personal requirements. The Intervention group was given access to the intervention website for 12 weeks, whereas the Control group for 6 weeks. The anticipated duration of each module was approximately 35 - 60 minutes.
Number of times accessing each educational module as well as time spent reviewing each educational module by each participant was documented by online tracking. Participants were asked to complete knowledge quizzes following each module to document any change in knowledge. Participants were also assessed with regards to change in their behaviour including change in their exercise pattern, carbohydrate intake and insulin adjustment.
Intervention code [1] 299466 0
Prevention
Comparator / control treatment
Usual Care was defined as routine diabetes management and care provided by each participant's healthcare professionals that includes general practitioner as well as an endocrinologist, dietitian and/or diabetes educator. This is provided on at least 6 monthly basis and includes management of glycaemia as well as diabetes complications.
The Control group, a wait-list control group, was offered the exposure to the interventional website starting at week 8 of the trial for the following 6 weeks.
Control group
Active

Outcomes
Primary outcome [1] 303915 0
Change in the number of exercise-related hypoglycaemic events proportionally corrected for the number of exercise sessions undertaken between the Intervention and Control groups.
Hypoglycaemia was defined as exercise-related when it occurred within 24 hours of an onset of an exercise session, as documented by participant's heart rate monitor.
The number of hypoglycaemia was assessed from the data output derived from the continuous glucose monitoring system CGMS (iPro2 Medtronic). The hypoglycaemia was defined as glucose levels less or equal 3.9mmol/L according to American Diabetes Association guidelines at the time.
Timepoint [1] 303915 0
Change in the number of exercise-related hypoglycaemia events proportionally corrected for the number of exercise sessions undertaken, was assessed between the Intervention and Control groups at week 7 of the trial.
This is following 5 weeks of Usual Care for the Control group (baseline) as compared to 5 weeks of exposure to the interventional website for the Intervention group (following intervention).
Secondary outcome [1] 340454 0
Any change in the number of exercise-related hypoglycaemia events from baseline following exposure to the interventional website of the entire cohort.
Hypoglycaemia event was defined as exercise-related when it occurred within 24 hours of an onset of an exercise session, as documented by participant's heart rate monitor.
The presence of hypoglycaemia was assessed from the data output derived from the continuous glucose monitoring system CGMS (iPro2 Medtronic). The hypoglycaemia was defined as glucose levels less or equal 3.9mmol/L according to American Diabetes Association guidelines at the time.

Timepoint [1] 340454 0
Comparison of the number of exercise-related hypoglycaemia events was assessed for each participant, from baseline following 5 weeks of exposure to the interventional website. In this longitudinal study each participant served as his own control.
Therefore for the Intervention group, number of exercise-related hypoglycaemia events was compared from Week 1 ( baseline) till Week 7 (following intervention), whereas for the Control group, comparison was made from Week 7 (baseline) till Week 13 (following intervention).


Eligibility
Key inclusion criteria
1. Type 1 diabetes of at least 12 months duration.
2. Minimum of 2 sessions/week or at least 60min/week of usual cardiovascular, resistance or combined exercise regimen, as planned activity.
3. Using insulin to carbohydrate ratios.
4. Using continuous subcutaneous insulin infusion (CSII) or basal-bolus insulin therapy.
5. Willing to undertake regular multiple times daily fingerprick blood glucose levels monitoring.

Minimum age
16 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Pre-mixed insulin therapy regimen.
2. One or more episodes of severe hypoglycaemia within the previous 6 months.
3. Previous learning of the exT11D online tool.
4. Pregnancy


Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software ie computer sequence generation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Parallel design is used in the RCT part of the study and examines the primary endpoint ie difference between the Control and Intervention groups.
Then, in the longitudinal part of the study, all study subjects received Intervention in a partial crossover design, where the Intervention group continued with the Intervention and the Control group gained access to the Intervention. Therefore, all participants served as their own controls.

Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
The power calculation was derived from a Type 1 Diabetes and Exercise Pilot Study data. The power calculation was based on the proportion of exercise-related hypoglycaemia number to exercise session number with a proposed 50% reduction in the proportion for the Intervention group compared with the parallel Control group.
We required 15 participants in the Intervention group and 15 participants in the Control group, to undertake a minimum of 45 exercise sessions per week in each group, to demonstrate 50% reduction in the number of exercise-related hypoglycaemia between the Control and Intervention groups giving a power of 87%.
The number of exercise-related hypoglycaemia in the Control and Intervention groups was compared using the unpaired Mann–Whitney test.
From baseline to intervention the number of exercise-related hypoglycaemia was compared using the paired the Mann–Whitney test.


Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 9380 0
Royal Prince Alfred Hospital - Camperdown
Recruitment postcode(s) [1] 18071 0
2050 - Camperdown

Funding & Sponsors
Funding source category [1] 297836 0
University
Name [1] 297836 0
The University of Sydney, Endocrinology & Diabetes Research Foundation.
Address [1] 297836 0
The University of Sydney,
Level 3W, Charles Perkins Centre D17,
The University of Sydney, NSW 2006
Country [1] 297836 0
Australia
Funding source category [2] 297959 0
Charities/Societies/Foundations
Name [2] 297959 0
Juvenile Diabetes Research Foundation, Australia
Address [2] 297959 0
4/80-84 Chandos St, St Leonards NSW 2065
Country [2] 297959 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
The University of Sydney,
Level 3W, Charles Perkins Centre D17,
The University of Sydney, NSW 2006
Country
Australia
Secondary sponsor category [1] 296871 0
Government body
Name [1] 296871 0
Sydney Local Health District RPAH Zone
Address [1] 296871 0
Diabetes Centre, Royal Prince Alfred Hospital
Level 6, West Wing Missenden Road Camperdown Sydney Australia 2050
Sydney Local Health District,
RPAH Zone
Country [1] 296871 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298883 0
Ethics Review Committe (RPAH Zone)
Ethics committee address [1] 298883 0
Research Development Office
Royal Prince Alfred Hopsital
Camperdown NSW 2050
Ethics committee country [1] 298883 0
Australia
Date submitted for ethics approval [1] 298883 0
30/01/2013
Approval date [1] 298883 0
11/03/2013
Ethics approval number [1] 298883 0
Ethics committee name [2] 299004 0
Human Research Ethics Committee, The University of Sydney
Ethics committee address [2] 299004 0
Ethics committee country [2] 299004 0
Australia
Date submitted for ethics approval [2] 299004 0
Approval date [2] 299004 0
15/08/2013
Ethics approval number [2] 299004 0

Summary
Brief summary
Exercise in type 1 diabetes may lead to increased variability in glucose levels and hypoglycaemia. Glucose management around exercise may be therefore challenging for people living with in type 1 diabetes and prevent them from undertaking exercise. At the same time, there was deficiency of easily accessible information to help stabilise glycaemia around exercise and prevent hypoglycaemia in type 1 diabetes.
The aim of the trial was to establish whether educational online tool: ext1d may reduce hypoglycaemia following exercise.
This educational website was developed specifically for people with type 1 diabetes and was based on current literature recommendations. It consists of several learning modules. The educational modules discussed the glycaemia secondary to exercise and suggested insulin adjustment and carbohydrate supplementation. Topics included: increased insulin sensitivity following exercise and the role of hormones regulating glucose levels around exercise; dose reduction and timing of meal bolus and/or temporary basal insulin for a given exercise, additional carbohydrate type and amount in relation to exercise.
Participants were asked to review the learning modules on glucose management in type 1 diabetes in relation to exercise. Participants chose recommendations related to exercise and stabilising glucose, that best suited them and then incorporated those recommendations into their usual exercise routine. Participants were encouraged to utilise the online tool ‘dashboard’ which suggests possible individualised insulin dose tailoring, typically an exercise-related reduction, as well as carbohydrate supplementation amount for a given exercise regimen.
The study design was a prospective randomised controlled trial with crossover of the Control group into the Intervention.
Following a baseline CGM Study Period (CGM1) participants underwent computer randomisation and were assigned to either the Control or the Intervention group. During the following 5-week period participants in the Intervention group accessed the website and the Control group continued with usual care. Subsequently, all participants underwent a second CGM Study Period (CGM2). This was followed by the second 5-week period during which the Intervention group continued with the website viewing and education and the Control group gained access to the website, in the partial cross-over design. The second five-week period concluded the trial with CGM Study Period (CGM3). During each CGM period participants wore continuous glucose monitoring system (Medtronic iPro2) to monitor for exercise and non- exercise related hypoglycaemia.
Hypoglycaemia data was based on continuous glucose monitoring system output.
For a primary outcome, the exercise-related hypoglycaemia data, was compared between the Intervention group which already had access to the educational modules for 5 weeks and the Control group, which did not have access to the educational modules in the past 5 weeks.
Trial website
Trial related presentations / publications
Presentations:

Piotrowicz AK, McGill MJ, Overland JE, Molyneaux L., Twigg SM. An On-line Support Tool That Reduces Exercise-Related Hypoglycaemia in Type 1 Diabetes. World Diabetes Congress, International Diabetes Federation Congress, November 2015.

Piotrowicz AK, McGill MJ, Overland JE, Molyneaux L., Twigg SM. An On-line Support Tool Reduces Exercise-Related Hypoglycaemia and Improves Confidence to Exercise in Type 1 Diabetes' oral presentation at the Annual Scientific Meeting of the Australian Diabetes Society, August 2015.

McGill MJ, Overland JE, Molyneaux L., Twigg SM. An On-line Support Tool for Type 1 Diabetes that Reduces Exercise-related Hypoglycaemia including Nocturnal Episodes, 76th Scientific Sessions, American Diabetes Association, June 2016.
Public notes

Contacts
Principal investigator
Name 78550 0
Prof Stephen Twigg
Address 78550 0
The University of Sydney,
Level 3W, Charles Perkins Centre D17,
The University of Sydney, NSW 2006
Country 78550 0
Australia
Phone 78550 0
+61 418 637 715
Fax 78550 0
+61 2 8627 1604
Email 78550 0
stephen.twigg@sydney.edu.au
Contact person for public queries
Name 78551 0
Prof Stephen Twigg
Address 78551 0
The University of Sydney,
Level 3W, Charles Perkins Centre D17,
The University of Sydney, NSW 2006
Country 78551 0
Australia
Phone 78551 0
+61 418 637 715
Fax 78551 0
+61 2 8627 1604
Email 78551 0
stephen.twigg@sydney.edu.au
Contact person for scientific queries
Name 78552 0
Prof Stephen Twigg
Address 78552 0
The University of Sydney,
Level 3W, Charles Perkins Centre D17,
The University of Sydney, NSW 2006
Country 78552 0
Australia
Phone 78552 0
+61 418 637 715
Fax 78552 0
+61 2 8627 1604
Email 78552 0
stephen.twigg@sydney.edu.au

No data has been provided for results reporting
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary