Type 1 Diabetes Clinical Trial
Official title:
Timing of Meal Insulin Boluses to Achieve Optimal Postprandial Glycemic Control in Patients With Type 1 Diabetes
Blood glucose levels in patients with type 1 diabetes tend to peak after eating a meal due
to the delayed action of insulin when compared to carbohydrate absorption from food. It is
the hypothesis of the investigator that administering the insulin for a meal 20 minutes
before the meal will result in lower blood glucose peaks compared to administration of
insulin immediately before or 20 minutes after starting to eat.
All subjects will eat the same meal on three different occasions. Insulin will be
administered at one of the three times at each visit.
Subjects enrolled in this study will be between the ages of 12 and 30 years inclusive. All
subjects will be on an insulin pump and use carbohydrate counting as their method for
insulin dosing at a meal.
Subjects in this study will complete three study visits lasting from approximately 8:30am
until 1:30pm. At each visit, the subject will eat the same frozen breakfast meal. Subjects
will be supplied with the same insulin to maintain consistency between visits and between
subjects.
Insulin will be administered at different times, depending upon the randomization group
assigned to the participant. The three different times the insulin will be given is either
20 minutes before the meal, immediately before the meal and 20 minutes after the meal. All
subjects will complete all three insulin bolus times. Blood glucose will be measured by
fingerstick every 30 minutes until the completion of the visit.
;
Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
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