MedPath

Insulin Delivery Using Microneedles in Type 1 Diabetes

Phase 2
Completed
Conditions
Type 1 Diabetes Mellitus
Registration Number
NCT00837512
Lead Sponsor
Emory University
Brief Summary

The goal of this study is to determine if microneedles can effectively and painlessly deliver insulin to children and young adults with type 1 diabetes.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
16
Inclusion Criteria
  • ≥ 8 years of age
  • <19 years of age
  • Type 1 Diabetes for at least 2 years
  • Uses a conventional, FDA-approved insulin pump for the past year
  • Uses Lispro insulin
  • Mean hemoglobin A1C ≤ 8.5 % for the past year
  • Body mass index ≤ 85th percentile for age
  • Understand and be willing to adhere to the study protocol
Exclusion Criteria
  • Type 2 Diabetes
  • Acanthosis nigricans
  • Clinically significant major organ system disease
  • On glucocorticoid therapy
  • Insulin requirement ≥ 150 U/day
  • Illness on the day of the study
  • Cognitive impairment (IQ < 85 or > 2 grades behind age-appropriate grade)
  • Pregnant or breast-feeding (if female).

Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Primary Outcome Measures
NameTimeMethod
Onset Time (Tmax)0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4 hours

Average time to peak insulin concentration

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Emory University

🇺🇸

Atlanta, Georgia, United States

Emory University
🇺🇸Atlanta, Georgia, United States

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