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.

INTERVENTION: 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. CONDITION: Hypoglycaemia Type 1 diabetes PRIMARY OUTCOME: 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. ; SECONDARY OUTCOME: 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. ; ; 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.