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
  Purpose

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.


Condition Intervention
Diabetes Mellitus, Insulin-Dependent
Device: Pump therapy (CSII)
Drug: Multiple daily injections (MDI) using insulin glargine + rapid acting analog

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Nemours Children's Clinic:

Primary Outcome Measures:
  • Hemoglobin A1c (HbA1c or A1c) [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • insulin sensitivity [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • beta cell function [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 12
Study Start Date: December 2005
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pump therapy (CSII)
Use of pump therapy
Device: Pump therapy (CSII)
CSII initiated within 1 month of dx
Active Comparator: Multiple daily injections (MDI)
Use of MDI (basal bolus therapy with glargine)
Drug: Multiple daily injections (MDI) using insulin glargine + rapid acting analog
MDI as control

  Eligibility

Ages Eligible for Study:   12 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00357890

Locations
United States, Florida
Nemours Children's Clinic
Jacksonville, Florida, United States, 32207
Sponsors and Collaborators
Nemours Children's Clinic
Investigators
Principal Investigator: Larry A Fox, MD Nemours Chidlren's Clinic
  More Information

No publications provided

Responsible Party: Larry Fox, Pediatric Endocrinologist, Nemours Children's Clinic
ClinicalTrials.gov Identifier: NCT00357890     History of Changes
Other Study ID Numbers: 16-03890-002
Study First Received: July 26, 2006
Last Updated: September 25, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Nemours Children's Clinic:
type 1 diabetes
diabetes
new onset
CSII
insulin glargine
insulin sensitivity
beta cell function
beta cell preservation

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin, Globin Zinc
Glargine
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 01, 2014