CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 16 enrolled
Drug / intervention
Microneedle +1 moredevice
Likely dose
Insulin delivered via microneedle at depth <900 micrometers or via subcutaneous catheter at 9 mm depth; Lispro insulin usedAI-extracted
Key inclusion· 6
  • ✓Age 8 to <19 years
  • ✓Type 1 Diabetes for at least 2 years
  • ✓Currently using a conventional, FDA-approved insulin pump for the past year
  • ✓Using Lispro insulin
Key exclusion· 8
  • ✕Type 2 Diabetes
  • ✕Acanthosis nigricans
  • ✕Clinically significant major organ system disease
  • ✕Current glucocorticoid therapy

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00837512
NCT00837512Phase 3Completed
CompareCT.gov

Insulin Delivery Using Microneedles in Type 1 Diabetes

Emory University·interventional·Posted Feb 5, 2009·Updated Jan 8, 2014

In Brief

A Phase 3 clinical trial evaluating Microneedle and Subcutaneous insulin catheter for Type 1 Diabetes Mellitus. Completed, enrolled 16 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 1 Diabetes Mellitus
CountriesUnited States
CollaboratorsThrasher Research Fund

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 5, 2009
Enrollment StartSep 1, 2008
Primary CompletionDec 1, 2012
Study CompletionJul 1, 2013
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 17.4 years ago

Interventions

Microneedledevice

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

Subcutaneous insulin catheterdevice

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