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Insulin Therapy

Pump therapy (CSII) for Type 1 Diabetes

N/A
Waitlist Available
Led By Larry A Fox, MD
Research Sponsored by Nemours Children's Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
No Placebo-Only Group

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).

Eligible Conditions
  • Type 1 Diabetes

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Beta Cell Function
Insulin Sensitivity
Secondary study objectives
Hemoglobin A1c
Percent Body Fat

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Pump therapy (CSII)Experimental Treatment1 Intervention
Use of pump therapy
Group II: Multiple daily injections (MDI)Active Control1 Intervention
Use of MDI (basal bolus therapy with glargine)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Insulin pump therapy
2021
Completed Phase 2
~270

Find a Location

Who is running the clinical trial?

Nemours Children's ClinicLead Sponsor
127 Previous Clinical Trials
18,411 Total Patients Enrolled
Larry A Fox, MDPrincipal InvestigatorNemours Chidlren's Clinic
4 Previous Clinical Trials
47 Total Patients Enrolled
~1 spots leftby Nov 2025
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