Clinical Trials Logo
  1. Home
  2. Other
  3. NCT00357890

Insulin Pump Therapy in Adolescents With Newly Diagnosed Type 1 Diabetes (T1D)

Diabetes Mellitus, Insulin-Dependent Clinical Trial

Official title:
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.

Clinical Trial 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).

Clinical Trial Description

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 proposed protocol compares the changes in diabetes control between pump therapy and MDI treatment groups. More importantly, however, the study evaluates how these modes of therapy may affect the honeymoon period and glycemic control, specifically focusing on changes in insulin sensitivity (measured by the euglycemic-hyperinsulinemic clamp studies and adiponectin concentration changes) and beta cell function (measured by mixed meal tolerance testing). Demonstrating that pump therapy at the time of diagnosis of type 1 diabetes prolongs the honeymoon phase by improving insulin sensitivity and beta cell function may have important therapeutic implications that could influence the standard of care in pediatric diabetes. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00357890
Study type Interventional
Source Nemours Children's Clinic
Contact
Status Completed
Phase N/A
Start date December 2005
Completion date October 2014
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT01322789 - Safety and Efficacy of Mesenchymal Stem Cells in Newly-diagnosed Type 1 Diabetic Patients Phase 1/Phase 2
Completed NCT00035750 - Risk Factors for Atherogenesis in Type 1 Diabetes N/A
Completed NCT00005754 - Coronary Artery Calcification in Type 1 Diabetes N/A
Completed NCT00005474 - Markers and Mechanisms of Macrovascular Disease in IDDM N/A
Completed NCT01236365 - Statins in Children With Type 1 Diabetes and Hypercholesterolemia Phase 3
Completed NCT01216618 - Evaluation of the Effect of the InsuPatch Device on Insulin Pharmacokinetics in Clamp Studies Phase 3
Completed NCT00071409 - Safety and Efficacy of INGAP-Peptide in Patients With Type 1 Diabetes Phase 2
Completed NCT00069537 - Continuous Glucose Monitors for Children With Diabetes Mellitus Phase 4
Completed NCT05168657 - Feasibility of Closed-loop Automated Insulin Delivery System by Primary Care & Endocrinology, in Person & Via Telehealth N/A
Withdrawn NCT00297635 - Telemetric Glucose Data Acquisition During Initiation of Insulin Pump Therapy Phase 2
Completed NCT00184821 - Ischemic Injury and Ischemic Preconditioning in Diabetes N/A
Completed NCT00073255 - Safety and Pharmacokinetics (PK) of hOKT3g1 (Ala-Ala) in Type 1 Diabetes Mellitus (T1DM) Phase 1
Completed NCT00690066 - PROCHYMAL® (Human Adult Stem Cells) for the Treatment of Recently Diagnosed Type 1 Diabetes Mellitus (T1DM) Phase 2
Active, not recruiting NCT04078308 - Mesenchymal Stem Cells Transplantation in Newly Diagnosed Type-1 Diabetes Patients Phase 1/Phase 2
Completed NCT00069628 - Randomized Clinical Trial to Assess the Effectiveness of the GlucoWatch Biographer Phase 4
Completed NCT00044408 - Treatment for Symptomatic Peripheral Neuropathy in Patients With Diabetes Phase 3
Completed NCT00044395 - Treatment for Symptomatic Peripheral Neuropathy in Patients With Diabetes Phase 3
Completed NCT00069615 - Pilot Study of the GlucoWatch G2 Biographer for the Management of Type 1 Diabetes in Children Phase 4
Completed NCT00005539 - Wisconsin Epidemiological Study of Cardiovascular Disease in Type 1 Diabetes N/A
Completed NCT04689685 - The RADAR Study - Wearable-Based Dysglycemia Detection and Warning in Diabetes