Insulin Delivery Using Microneedles in Type 1 Diabetes
2 other identifiers
interventional
16
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Sep 2008
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2008
CompletedFirst Submitted
Initial submission to the registry
February 4, 2009
CompletedFirst Posted
Study publicly available on registry
February 5, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2013
CompletedResults Posted
Study results publicly available
January 8, 2014
CompletedJanuary 8, 2014
November 1, 2013
4.3 years
February 4, 2009
August 13, 2013
November 20, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Onset Time (Tmax)
Average time to peak insulin concentration
0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4 hours
Study Arms (2)
Microneedle
EXPERIMENTALMicroneedle used to deliver insulin at a depth less than 900 micrometers
Subcutaneous insulin catheter
ACTIVE COMPARATORSubcutaneous insulin catheter used to deliver insulin at a depth of 9 mm (9000 micrometers)
Interventions
Microneedle used to deliver insulin at a depth less than 900 micrometers
Subcutaneous insulin catheter used to deliver insulin at a depth of 9 mm (9000 micrometers)
Eligibility Criteria
You may qualify if:
- ≥ 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
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Emory Universitylead
- Thrasher Research Fundcollaborator
Study Sites (1)
Emory University
Atlanta, Georgia, 30322, United States
Related Publications (1)
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.
PMID: 23517449DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Eric Felner
- Organization
- Emory University School of Medicine
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Pediatric Endocrinology
Study Record Dates
First Submitted
February 4, 2009
First Posted
February 5, 2009
Study Start
September 1, 2008
Primary Completion
December 1, 2012
Study Completion
July 1, 2013
Last Updated
January 8, 2014
Results First Posted
January 8, 2014
Record last verified: 2013-11