- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00837512
Insulin Delivery Using Microneedles in Type 1 Diabetes
November 20, 2013 updated by: Eric Felner, MD, MSCR, Emory University
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
16
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Georgia
-
Atlanta, Georgia, United States, 30322
- Emory University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
8 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Microneedle
Microneedle used to deliver insulin at a depth less than 900 micrometers
|
Microneedle used to deliver insulin at a depth less than 900 micrometers
|
Active Comparator: Subcutaneous insulin catheter
Subcutaneous insulin catheter used to deliver insulin at a depth of 9 mm (9000 micrometers)
|
Subcutaneous insulin catheter used to deliver insulin at a depth of 9 mm (9000 micrometers)
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2008
Primary Completion (Actual)
December 1, 2012
Study Completion (Actual)
July 1, 2013
Study Registration Dates
First Submitted
February 4, 2009
First Submitted That Met QC Criteria
February 4, 2009
First Posted (Estimate)
February 5, 2009
Study Record Updates
Last Update Posted (Estimate)
January 8, 2014
Last Update Submitted That Met QC Criteria
November 20, 2013
Last Verified
November 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1348-2005
- FWA00005792 (Other Identifier: Other)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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