Insulin Delivery Using Microneedles in Type 1 Diabetes

Phase 2

Completed

• Conditions: Type 1 Diabetes Mellitus
• Interventions: Device: Microneedle; Device: Subcutaneous insulin catheter

• Registration Number: NCT00837512
• Lead Sponsor: Emory University

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 available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2009-02-04
• Study First Submitted QC: 2009-02-04
• Study First Posted: 2009-02-05
• Primary Completion: 2012-12
• Study Completion: 2013-07
• Results First Submitted: 2013-08-13
• Status Verified: 2013-11
• Results First Submitted QC: 2013-11-20
• Last Update Submitted: 2013-11-20
• Results First Posted: 2014-01-08
• Last Update Posted: 2014-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

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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).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Microneedle	Microneedle	Microneedle used to deliver insulin at a depth less than 900 micrometers
Subcutaneous insulin catheter	Subcutaneous insulin catheter	Subcutaneous insulin catheter used to deliver insulin at a depth of 9 mm (9000 micrometers)

Primary Outcome Measures

Name	Time	Method
Onset Time (Tmax)	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

Trial Locations

Locations (1)

Emory University; 🇺🇸 Atlanta, Georgia, United States