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Insulin Delivery Using Microneedles in Type 1 Diabetes

Emory University logo

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)

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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