Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2/PHASE3
16 participants
INTERVENTIONAL
2008-09-30
2013-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Microneedle
Microneedle used to deliver insulin at a depth less than 900 micrometers
Microneedle
Microneedle used to deliver insulin at a depth less than 900 micrometers
Subcutaneous insulin catheter
Subcutaneous insulin catheter used to deliver insulin at a depth of 9 mm (9000 micrometers)
Subcutaneous insulin catheter
Subcutaneous insulin catheter used to deliver insulin at a depth of 9 mm (9000 micrometers)
Interventions
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Microneedle
Microneedle used to deliver insulin at a depth less than 900 micrometers
Subcutaneous insulin catheter
Subcutaneous insulin catheter used to deliver insulin at a depth of 9 mm (9000 micrometers)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* \<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
* 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).
8 Years
18 Years
ALL
No
Sponsors
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Thrasher Research Fund
OTHER
Emory University
OTHER
Responsible Party
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Eric Felner, MD, MSCR
Pediatric Endocrinology
Locations
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Emory University
Atlanta, Georgia, United States
Countries
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References
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Norman JJ, Brown MR, Raviele NA, Prausnitz MR, Felner EI. Faster pharmacokinetics and increased patient acceptance of intradermal insulin delivery using a single hollow microneedle in children and adolescents with type 1 diabetes. Pediatr Diabetes. 2013 Sep;14(6):459-65. doi: 10.1111/pedi.12031. Epub 2013 Mar 21.
Other Identifiers
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FWA00005792
Identifier Type: OTHER
Identifier Source: secondary_id
1348-2005
Identifier Type: -
Identifier Source: org_study_id
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