None listed
Conditions
Brief summary
The proposed trial aims to determine if the use of a novel smartphone insulin bolus calculator, “OptimAAPP” which calculates insulin for carbohydrate, fat and protein in meals improves blood glucose levels in comparison to usual care (insulin dosing for carbohydrate only). We hypothesise that OptimAAPP will improve blood glucose control in people with Type 1 Diabetes (T1D) using multiple daily injection therapy, as measured by an increase in time spent in a blood glucose target range of 3.9-10.0mmol/L without an increase in time spent in hypoglycaemia compared to usual care.
Interventions
Participants on the intervention arm will use the insulin bolus calculator, OptimAAPP to calculate their mealtime insulin dose for all meals and snacks for a period of three months. Education on OptimAAPP use will be administered by a diabetes educator in conjuction with a dietician, technical support will be provided by the OptimAAPP developer in conjuction with members of the study team. OptimAAPP setup will be overseen by the nominated site endocrinologist. Participants will receive on- going
Participants on the intervention arm will use the insulin bolus calculator, OptimAAPP to calculate their mealtime insulin dose for all meals and snacks for a period of three months. Education on OptimAAPP use will be administered by a diabetes educator in conjuction with a dietician, technical support will be provided by the OptimAAPP developer in conjuction with members of the study team. OptimAAPP setup will be overseen by the nominated site endocrinologist. Participants will receive on- going support from the study team in the form of a phone call at the end of weeks 1, 3,5,7,9 and 11. Whilst participants will be instructed to use OptimAAPP for all meal bolus calculations this will not be monitored during the intervention. At the conclusion of the study OptimAAPP usage data will be exported in the form of a report. There will be a two- week washout period between study arms.
Sponsors
The University of Newcastle
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
12 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
Aged between 12- 50 years HbA1c less than or equal to 10% (86 mmol/mol) Type 1 Diabetes for more than 1 year Managed with multiple daily injections and insulin
Exclusion criteria
Complications of diabetes (e.g. gastroparesis) Any other major medical condition
Outcome results
None listed