Insulin Delivery Using Microneedles in Type 1 Diabetes

Emory University

Status and phase: Completed; Phase 3; Phase 2

Conditions: Type 1 Diabetes Mellitus

Treatments: Device: Microneedle; Device: Subcutaneous insulin catheter

Study type: Interventional

Funder types: Other

Identifiers

NCT00837512

FWA00005792 (Other Identifier)

1348-2005

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: All

Ages: 8 to 18 years old

Volunteers: No 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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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16 participants in 2 patient groups

Microneedle

Experimental group

Description:

Microneedle used to deliver insulin at a depth less than 900 micrometers

Treatment:

Device: Microneedle

Subcutaneous insulin catheter

Active Comparator group

Description:

Subcutaneous insulin catheter used to deliver insulin at a depth of 9 mm (9000 micrometers)

Treatment:

Device: Subcutaneous insulin catheter