None listed
Conditions
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.
Interventions
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 bolu
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.
Sponsors
The University of Sydney
Study design
Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
16 Years to No maximum
Healthy volunteers
No
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.
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
Outcome results
None listed