Diluted Insulin in Young Children: Bigger Volumes for Smaller Patients

• Status: Recruiting
• Trial end date: 2022-06-30
• Target enrollment: 0
• Participant gender: All

Summary

The aim of this study is to compare the pharmacokinetic (PK) profile of diluted insulin aspart (U25) with undiluted insulin aspart (U100) in school-aged children and adolescents with type 1 diabetes (T1D) utilizing the euglycemic clamp technique and a standardized meal in a controlled research environment.

The investigators hypothesize that dilution of insulin aspart (U25) will alter the PK properties as compared to undiluted aspart.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yale University
• Treatments: Insulin; Insulin Aspart; Insulin, Globin Zinc

Criteria

Inclusion Criteria:

• T1D of at least 6 months' duration

• Aged 9-15 years

• Continuous subcutaneous insulin therapy for at least 1 month;

• HbA1c ≤ 10%

• Normal hematocrit

• Able to give consent

Exclusion Criteria:

• Admission for DKA during the past 4 weeks

• Severe hypoglycemia during the past 4 weeks

• Other conditions/medications affecting insulin sensitivity (e.g. metformin)