None listed
Conditions
Brief summary
In this within-subject crossover study in individuals with type 1 diabetes, we will compare two methods of adjusting the dose of insulin to match the nutrients in a meal. One method, known as carbohydrate counting, uses an algorithm (= formula) that matches the dose of insulin to the carbohydrate content of the meal. The second method uses a novel algorithm based on the food’s normal insulin response in healthy subjects (the Food Insulin Index or FII). Participants who are experienced users of insulin pumps will consume three breakfast meals and apply different insulin to food algorithms on 3 consecutive test days. Their blood glucose levels will be monitored using a continuous glucose monitoring system (CGMS) and finger-prick blood testings with a blood monitor over the next 3 hours. We hypothesize that using the novel FII to adjust mealtime insulin dose will improve blood glucose readings (ie reduce hyperglycaemia) without increasing the risk of hypoglycaemia, compared with carbohydrate counting.
Interventions
In this within-subject crossover study, two methods of adjusting the dose of insulin to match the nutrients in a meal will be compared on measures of postprandial glycemia control in adults with type 1 diabetes. One method, known as carbohydrate counting, uses an algorithm (= formula) that matches the bolus insulin dose to the carbohydrate content of the meal. The other method uses a novel algorithm based on the food’s normal insulin response in healthy subjects (DAFII algorithm). Three meal and
In this within-subject crossover study, two methods of adjusting the dose of insulin to match the nutrients in a meal will be compared on measures of postprandial glycemia control in adults with type 1 diabetes. One method, known as carbohydrate counting, uses an algorithm (= formula) that matches the bolus insulin dose to the carbohydrate content of the meal. The other method uses a novel algorithm based on the food’s normal insulin response in healthy subjects (DAFII algorithm). Three meal and bolus-dose algorithm combined conditions will be administered in a random order to each participant who is an experienced insulin pump user on three consecutive days. The three test conditions are as follows: 1) meal A (54 g grain bread, 23 ml raspberry jam and 177 g canned peach in syrup), containing 83 g of carbohydrate + bolus algorithm using carbohydrate counting; 2) meal B (59 g croissant, 96 g yogurt and 48 g poached egg), containing 41 g of carbohydrate + bolus algorithm using carbohydrate counting; 3) meal B + bolus using DAFII algorithm. According to DAFII algorithm, meal A and B have the same bolus insulin dose because of the same insulin demand. Therefore only 3 test conditions will be in randomization. The blood glucose levels after meal will be monitored using both a continuous glucose monitoring system (CGMS) and finger-prick blood testings with a blood monitor at regular intervals over the next 3 hours.
Sponsors
The University of Sydney
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Prevention
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
Adult patients with type I diabetes diagnosed for more than 1 year, age 18 - 70 years; use of insulin pump therapy, for more than 3 months; recent glycated haemoglobin (HbA1C) less than 9.0 % and reliably performing self-monitoring of blood glucose at least four times daily.
Exclusion criteria
Eating disorders; individuals using medication that may influence blood glucose profiles.
Outcome results
None listed