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
  Purpose

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.


Condition Intervention Phase
Type 1 Diabetes Mellitus
Device: Microneedle
Device: Subcutaneous insulin catheter
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Insulin Delivery Using Microneedles in Type 1 Diabetes

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • 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


Enrollment: 16
Study Start Date: September 2008
Study Completion Date: July 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Microneedle
Microneedle used to deliver insulin at a depth less than 900 micrometers
Device: Microneedle
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)
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

  Eligibility

Ages Eligible for Study:   8 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00837512

Locations
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Thrasher Research Fund
  More Information

No publications provided by Emory University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Eric Felner, MD, MSCR, Pediatric Endocrinology, Emory University
ClinicalTrials.gov Identifier: NCT00837512     History of Changes
Other Study ID Numbers: 1348-2005, FWA00005792
Study First Received: February 4, 2009
Results First Received: August 13, 2013
Last Updated: November 20, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Emory University:
microneedle continuous subcutaneous insulin infusion

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 23, 2014