CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 12 enrolled
Drug / intervention
Multiple daily injections using insulin glargine + rapid acting analog +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT00357890
NCT00357890N/ACompleted
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A Pilot Study of the Effect of Continuous Subcutaneous Insulin Infusion in Adolescents With Newly-diagnosed Type 1 Diabetes on Insulin Resistance, Beta-cell Function and the Honeymoon Period.

Nemours Children's Clinic·interventional·Posted Jul 28, 2006·Updated Jul 7, 2023

In Brief

A clinical study evaluating Insulin pump therapy and Multiple daily injections using insulin glargine + rapid acting analog for Diabetes Mellitus, Insulin-Dependent. Completed, enrolled 12 participants across 1 site.

Detailed Summary

Within 4 weeks after diagnosis of type 1 diabetes, 10 subjects (pubertal males, 12-17 years old) will be randomized to either receive multiple daily injection (MDI) using Lantus insulin, or continuous subcutaneous insulin infusion (CSII; pump therapy). The study evaluates how these modes of therapy affect insulin sensitivity (measured by the euglycemic-hyperinsulinemic clamp studies and adiponectin concentration changes) and beta cell function (measured by mixed meal tolerance testing).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus, Insulin-Dependent
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 28, 2006
Enrollment StartDec 1, 2005
Primary CompletionOct 1, 2014
TodayJul 2, 2026
Enrollment to primary: 8.8 yearsPosted 19.9 years ago

Interventions

Insulin pump therapydevice

CSII initiated within 1 month of diagnosis

Multiple daily injections using insulin glargine + rapid acting analogdrug

MDI as control