Insulin Delivery Using Microneedles in Type 1 Diabetes

This study is currently recruiting participants.

Verified March 2012 by Emory University

Sponsor:

Collaborator:

Emory University

Information provided by (Responsible Party):

Eric Felner, MD, MSCR, Emory University

ClinicalTrials.gov Identifier:

NCT00837512

First received: February 4, 2009

Last updated: March 19, 2012

Last verified: March 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

February 4, 2009

Last Updated Date

March 19, 2012

Start Date ^ICMJE

September 2008

Estimated Primary Completion Date

December 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00837512 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Insulin Delivery Using Microneedles in Type 1 Diabetes

Official Title ^ICMJE

Insulin Delivery Using Microneedles in Type 1 Diabetes

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2
Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Type 1 Diabetes Mellitus

Intervention ^ICMJE

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

Study Arm (s)

Experimental: Microneedle
Intervention: Device: Microneedle
Active Comparator: Subcutaneous insulin catheter
Intervention: Device: Subcutaneous insulin catheter

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

July 2013

Estimated Primary Completion Date

December 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

≥ 8 years of age
<19 years of age
T1D 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:

T2D
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).

Gender

Both

Ages

8 Years to 18 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Nicholas Raviele, BS	404-727-3189	nicholas.raviele@emory.edu
Contact: Eric Felner, MD, MSCR	404-727-9811	efelner@emory.edu

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00837512

Other Study ID Numbers ^ICMJE

FWA00005792

Has Data Monitoring Committee

Yes

Responsible Party

Eric Felner, MD, MSCR, Emory University

Study Sponsor ^ICMJE

Eric Felner, MD, MSCR

Collaborators ^ICMJE

Emory University

Investigators ^ICMJE

Not Provided

Information Provided By

Emory University

Verification Date

March 2012

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

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