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Insulin Delivery Using Microneedles in Type 1 Diabetes

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00837512
First Posted: February 5, 2009
Last Update Posted: January 8, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Thrasher Research Fund
Information provided by (Responsible Party):
Eric Felner, MD, MSCR, Emory University
  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
Intervention Model: Crossover Assignment
Masking: None (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 Eric Felner, MD, MSCR, 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 ]
    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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   8 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00837512


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

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 ( Other Identifier: Other )
First Submitted: February 4, 2009
First Posted: February 5, 2009
Results First Submitted: August 13, 2013
Results First Posted: January 8, 2014
Last Update Posted: January 8, 2014
Last Verified: November 2013

Keywords provided by Eric Felner, MD, MSCR, 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, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs