None listed
Conditions
Brief summary
The aim of this study is to identify an insulin dosing strategy for people with T1D using MDI that will effectively control their blood glucose levels after eating meals high in fat and protein. Participation will involve consuming the same test meal for breakfast, a protein shake and a muesli bar on 4 mornings. Each morning participants will be allocated a different insulin dosing strategy. We hypothesise that increasing the insulin dose by 25% and extending the duration of insulin action by using regular human insulin will optimise blood glucose levels.
Interventions
Participants will consume the same high fat, high protein breakfast meal with insulin on 4 consecutive mornings in the same week. Each morning the total amount of insulin given and/ the type of used and/ the timing insulin delivery is varied depending on the dosing schedule allocated.
The test meal will consist of a vanilla flavoured whey protein shake and a chocolate muesli bar (Carman's brand) and will contain 30g of carbohydrate, 40g of fat and 50g of protein and have a total energy content
Participants will consume the same high fat, high protein breakfast meal with insulin on 4 consecutive mornings in the same week. Each morning the total amount of insulin given and/ the type of used and/ the timing insulin delivery is varied depending on the dosing schedule allocated. The test meal will consist of a vanilla flavoured whey protein shake and a chocolate muesli bar (Carman's brand) and will contain 30g of carbohydrate, 40g of fat and 50g of protein and have a total energy content of 2707 kj. Dosing conditions (1-4): 1. 100% of total rapid- acting insulin dose will be administered 15 minutes prior to test meal consumption via subcutaneous injection. 2. 125% of total rapid- acting insulin dose will be administered 15 minutes prior to test meal consumption via subcutaneous injection. 3. 125% of total short- acting insulin dose will be administered 15 minutes prior to test meal consumption via subcutaneous injection. 4. 100% of total rapid- acting insulin dose will be administered 15 minutes prior to test meal consumption via subcutaneous injection. An additional 25% of this dose will be administered 60 minutes post meal consumption. Each participant will receive all 4 dosing conditions in random order using a block design.
Sponsors
Diabetes Australia
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
8 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
Diagnosed with T1D for greater than 1 yr Treated with multiple daily insulin injection therapy ( 4 injections/ day) for greater than 6 mo Glycated haemoglobin less than or equal to 8.0% (64 mmol/mol) Non- Obese
Exclusion criteria
• Presence of any other major medical condition • Allergies/ intolerances to dairy, nuts, fructose, soy products • Evidence of complications of diabetes e.g. Gastroparesis • Oral glycaemic medications
Outcome results
None listed