None listed
Conditions
Brief summary
This study is looking to find an optimal insulin-dosing strategy that effectively and safely controls blood glucose levels after meals in people with T1D on closed loop insulin pump therapy. The study involves 8 study days over the course of two weeks while the participant is using the currently available closed loop insulin pump system. The study will be split over two weeks with one week using the closed loop function and one week without. During this time the participant will test different insulin dosing strategies over two different meal types (4 meals will be high in carbohydrate, 4 meals will be high in fat and protein). Blood glucose will be measure through the cgm linked to the pump and this will be used to measure blood glucose levels and time in target after each meal. This will be used to determine the most effective insulin dosing strategy.
Interventions
This study involves the provision of 2 different test meals in the form of pancakes of different ingredients, a high carbohydrate (HC) meal or high fat, high protein (HFHP) meal on 8 occasions over 2 consecutive weeks. Test meals will be observed under different insulin dosing conditions. The HC test meal will be observed under 4 conditions; 1) standard bolus given in manual mode 15 minutes prior to meal delivery, 2) standard bolus (100% insulin to carbohydrate ratio) given in manual mode 25 min
This study involves the provision of 2 different test meals in the form of pancakes of different ingredients, a high carbohydrate (HC) meal or high fat, high protein (HFHP) meal on 8 occasions over 2 consecutive weeks. Test meals will be observed under different insulin dosing conditions. The HC test meal will be observed under 4 conditions; 1) standard bolus given in manual mode 15 minutes prior to meal delivery, 2) standard bolus (100% insulin to carbohydrate ratio) given in manual mode 25 minutes prior to meal delivery, 3) standard bolus given in auto mode 15 minutes prior to meal delivery and 4) standard bolus given in auto mode 25 minutes prior to meal delivery. The HFHP test meal will also be observed under 4 conditions; 5) dual wave bolus (70:30, 3 h) in manual mode given 15 minutes prior to meal delivery, 6) dual wave bolus using 130% ICR (70:30, 3h) in manual mode, 7) standard bolus given in auto mode 10 minutes prior to meal delivery and 8) split bolus given in auto mode with bolus 1, equivalent to 100% of the individual ICR given 15 minutes prior to meal delivery and bolus 2, equivalent to 30% of the individual ICR given 60 minutes post- meal delivery. Participants will be randomly allocated to receive both meal cohorts over the two weeks. Standard bolus refers to 100% of the participants insulin to carbohydrate ratio for that meal.. High Carbohydrate Meal= 90g carbohydrate, less than 10g protein. less than 10g of fat High Fat High Protein Meal= 30g carbohydrate, 50g of protein, 40g of fat All meals will be provided and made to exact measurements. The pump records insulin dosages that we can review to ensure patient compliance. Participants will have a face to face session at the Hunter Medical Research Institute where they will be provided with logbooks and all the meals prepared and frozen for them to take home and complete the study at home. A member of the study team will be in contact each day to ensure the study is going smoothly.
Sponsors
Australasian Paediatric Endocrine Group
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
12 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
Diagnosed with type 1 diabetes >1 year Using insulin pump therapy >6 months Glycated haemoglobin less than or equal to 10.0%
Exclusion criteria
Co-existing major medical condition Evidence of complications of diabetes
Outcome results
None listed