NCT00837512
Completed
Phase 2
Insulin Delivery Using Microneedles in Type 1 Diabetes
ConditionsType 1 Diabetes Mellitus
Overview
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Emory University
- Enrollment
- 16
- Locations
- 1
- Primary Endpoint
- Onset Time (Tmax)
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 8 Years to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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).
Outcomes
Primary Outcomes
Onset Time (Tmax)
Time Frame: 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 Outcomes
No secondary outcomes reported
Investigators
Eric Felner, MD, MSCR
Pediatric Endocrinology
Emory University
Study Sites (1)
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