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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00357890
Recruitment Status : Completed
First Posted : July 28, 2006
Last Update Posted : June 14, 2016
Information provided by (Responsible Party):
Larry Fox, Nemours Children's Clinic

July 26, 2006
July 28, 2006
June 14, 2016
December 2005
October 2014   (Final data collection date for primary outcome measure)
Hemoglobin A1c (HbA1c or A1c) [ Time Frame: 24 months ]
Complete list of historical versions of study NCT00357890 on Archive Site
  • insulin sensitivity [ Time Frame: 24 months ]
  • beta cell function [ Time Frame: 24 months ]
  • insulin sensitivity
  • beta cell function
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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.
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Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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
Sexes Eligible for Study: All
12 Years to 17 Years   (Child)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
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
June 2016

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