Insulin Delivery Using Microneedles in Type 1 Diabetes



Status:Completed
Conditions:Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:8 - 18
Updated:1/1/2014
Start Date:September 2008
End Date:July 2013
Contact:Nicholas Raviele, BS
Email:nicholas.raviele@emory.edu
Phone:404-727-3189

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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.


Inclusion Criteria:

- ≥ 8 years of age

- <19 years of age

- T1D 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:

- T2D

- 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).
We found this trial at
1
site
201 Dowman Dr
Atlanta, Georgia 30308
404.727.6123
Emroy University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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mi
from
Atlanta, GA
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