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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Larry Fox, Nemours Children's Clinic
ClinicalTrials.gov Identifier:
NCT00357890
First received: July 26, 2006
Last updated: September 25, 2014
Last verified: September 2014

July 26, 2006
September 25, 2014
December 2005
October 2014   (final data collection date for primary outcome measure)
Hemoglobin A1c (HbA1c or A1c) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
HbA1c
Complete list of historical versions of study NCT00357890 on ClinicalTrials.gov Archive Site
  • insulin sensitivity [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • beta cell function [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • insulin sensitivity
  • beta cell function
Not Provided
Not Provided
 
Insulin Pump Therapy in Adolescents With Newly Diagnosed Type 1 Diabetes (T1D)
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.

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Diabetes Mellitus, Insulin-Dependent
  • Device: Pump therapy (CSII)
    CSII initiated within 1 month of dx
  • Drug: Multiple daily injections (MDI) using insulin glargine + rapid acting analog
    MDI as control
  • Experimental: Pump therapy (CSII)
    Use of pump therapy
    Intervention: Device: Pump therapy (CSII)
  • Active Comparator: Multiple daily injections (MDI)
    Use of MDI (basal bolus therapy with glargine)
    Intervention: Drug: Multiple daily injections (MDI) using insulin glargine + rapid acting analog
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
12
October 2014
October 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male or female patient between the age of 12 and 17 years inclusive at time of entry into study (i.e., after their 12th but before their 18th birthday)
  • Type 1 diabetes mellitus for no more than 10 days
  • pubertal (Tanner stage 2 or above)
  • The patient and parents or guardians should be able to do simple math calculations (necessary for pump management)
  • Parent or legal guardian must give signed informed consent

Exclusion Criteria:

  • No other chronic medical conditions (well-controlled thyroid disease is OK, and mild asthma is OK if the patient is not on chronic inhaled or oral daily corticosteroids)
  • Exceptional psychological stress, more than expected for circumstances of having the new diagnosis of diabetes
  • Inability or unwillingness to comply with requirements of the protocol
Both
12 Years to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00357890
16-03890-002
No
Larry Fox, Nemours Children's Clinic
Nemours Children's Clinic
Not Provided
Principal Investigator: Larry A Fox, MD Nemours Chidlren's Clinic
Nemours Children's Clinic
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP