Diluted Insulin in Young Children: Bigger Volumes for Smaller Patients

Study Design: participants age 9-15 y/o will be enrolled in a randomized cross-over trial, in which each participant will undergo two 24-hour admissions. Each admission will include a meal-study on the evening of admission followed by a euglycemic clamp study performed the following morning. During one of the admissions, participants will use undiluted insulin aspart (U100) while on the other the participants will receive diluted insulin aspart (U25).

(Figure 1)

Participants. 12 participants will be recruited between the ages of 9-15 years, who have had diabetes for at least 6 months' duration, on continuous subcutaneous insulin therapy for at least 1 month and have an HbA1c ≤ 10%. Those with a history of diabetes ketoacidosis (DKA) or severe hypoglycemia in the month prior to enrollment and those with other conditions/medications affecting insulin sensitivity (e.g. metformin) will be excluded from the study.

Study drugs: Diluted insulin U25 will be formulated by adding diluent, which will be obtained from Novo Nordisk, with insulin aspart. The diluted insulin will be formulated by the investigational pharmacy.

Study procedures: