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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
Emory University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 1 Diabetes Mellitus focused on measuring microneedle continuous subcutaneous insulin infusion

Eligibility Criteria

8 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

First Posted
February 4, 2009
Last Updated
November 20, 2013
Sponsor
Emory University
Collaborators
Thrasher Research Fund
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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

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Insulin Delivery Using Microneedles in Type 1 Diabetes

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