Insulin Delivery Using Microneedles in Type 1 Diabetes

This study has been completed.
Sponsor:
Collaborator:
Thrasher Research Fund
Information provided by (Responsible Party):
Eric Felner, MD, MSCR, Emory University
ClinicalTrials.gov Identifier:
NCT00837512
First received: February 4, 2009
Last updated: November 20, 2013
Last verified: November 2013

February 4, 2009
November 20, 2013
September 2008
December 2012   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Average time to peak insulin concentration
Difference in glycemic control between the subcutaneous insulin catheter (SIC) and microneedle for bolus delivery of insulin. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00837512 on ClinicalTrials.gov Archive Site
Not Provided
Difference in pain with insulin delivery through a microneedle (MN) as compared to a subcutaneous insulin catheter (SIC). [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Insulin Delivery Using Microneedles in Type 1 Diabetes
Insulin Delivery Using Microneedles in Type 1 Diabetes

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.

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Type 1 Diabetes Mellitus
  • Device: Microneedle
    Microneedle used to deliver insulin at a depth less than 900 micrometers
  • Device: Subcutaneous insulin catheter
    Subcutaneous insulin catheter used to deliver insulin at a depth of 9 mm (9000 micrometers)
    Other Name: subcutaneous insulin infusion catheter
  • Experimental: Microneedle
    Microneedle used to deliver insulin at a depth less than 900 micrometers
    Intervention: Device: Microneedle
  • Active Comparator: Subcutaneous insulin catheter
    Subcutaneous insulin catheter used to deliver insulin at a depth of 9 mm (9000 micrometers)
    Intervention: Device: Subcutaneous insulin catheter
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
July 2013
December 2012   (final data collection date for primary outcome measure)

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).
Both
8 Years to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00837512
1348-2005, FWA00005792
Yes
Eric Felner, MD, MSCR, Emory University
Emory University
Thrasher Research Fund
Not Provided
Emory University
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP