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Completed

NCT Number: NCT00837512

Insulin Delivery Using Microneedles in Type 1 Diabetes

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.

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Key information

Conditions

Type 1 Diabetes Mellitus Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

8 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Emory University

Atlanta, Georgia, 30322, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Microneedle

Device

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

Subcutaneous insulin catheter

Device

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

Other names: subcutaneous insulin infusion catheter

Primary outcomes

  1. Onset Time (Tmax)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Emory University

Other

Collaborators

  • Thrasher Research Fund

Registry information

Important dates

Study start
2008
Primary completion
2012
Study completion
2013
First posted
Feb 5, 2009
Registry last updated
Jan 8, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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