Insulin Delivery Using Microneedles in Type 1 Diabetes

Type 1 Diabetes Mellitus Clinical Trial

Official title:

Insulin Delivery Using Microneedles in Type 1 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00837512
• Other study ID #: 1348-2005
• Secondary ID: FWA00005792
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: February 4, 2009
• Last updated: November 20, 2013
• Start date: September 2008
• Est. completion date: July 2013

Study information

• Verified date: November 2013
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: July 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years to 18 Years

Eligibility

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).

Study Design

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

Device:
• Microneedle
Microneedle used to deliver insulin at a depth less than 900 micrometers
• Subcutaneous insulin catheter
Subcutaneous insulin catheter used to deliver insulin at a depth of 9 mm (9000 micrometers)

Locations

Country	Name	City	State
United States	Emory University	Atlanta	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Emory University	Thrasher Research Fund

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Onset Time (Tmax)	Average time to peak insulin concentration	0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4 hours	No