Insulin Delivery Using Microneedles in Type 1 Diabetes
Primary Purpose
Type 1 Diabetes Mellitus
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Microneedle
Subcutaneous insulin catheter
Sponsored by
About this trial
This is an interventional treatment trial for Type 1 Diabetes Mellitus focused on measuring microneedle continuous subcutaneous insulin infusion
Eligibility Criteria
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).
Sites / Locations
- Emory University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Microneedle
Subcutaneous insulin catheter
Arm Description
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)
Outcomes
Primary Outcome Measures
Onset Time (Tmax)
Average time to peak insulin concentration
Secondary Outcome Measures
Full Information
NCT ID
NCT00837512
First Posted
February 4, 2009
Last Updated
November 20, 2013
Sponsor
Emory University
Collaborators
Thrasher Research Fund
1. Study Identification
Unique Protocol Identification Number
NCT00837512
Brief Title
Insulin Delivery Using Microneedles in Type 1 Diabetes
Official Title
Insulin Delivery Using Microneedles in Type 1 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
July 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University
Collaborators
Thrasher Research Fund
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes Mellitus
Keywords
microneedle continuous subcutaneous insulin infusion
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Microneedle
Arm Type
Experimental
Arm Description
Microneedle used to deliver insulin at a depth less than 900 micrometers
Arm Title
Subcutaneous insulin catheter
Arm Type
Active Comparator
Arm Description
Subcutaneous insulin catheter used to deliver insulin at a depth of 9 mm (9000 micrometers)
Intervention Type
Device
Intervention Name(s)
Microneedle
Intervention Description
Microneedle used to deliver insulin at a depth less than 900 micrometers
Intervention Type
Device
Intervention Name(s)
Subcutaneous insulin catheter
Other Intervention Name(s)
subcutaneous insulin infusion catheter
Intervention Description
Subcutaneous insulin catheter used to deliver insulin at a depth of 9 mm (9000 micrometers)
Primary Outcome Measure Information:
Title
Onset Time (Tmax)
Description
Average time to peak insulin concentration
Time Frame
0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Facility Information:
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
23517449
Citation
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.
Results Reference
derived
Learn more about this trial
Insulin Delivery Using Microneedles in Type 1 Diabetes
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