Clinical trial NCT00357890: Insulin Pump Therapy in Adolescents With Newly Diagnosed Type 1 Diabetes (T1D)
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Insulin-Dependent
Keywords: type 1 diabetes
diabetes
new onset
CSII
insulin sensitivity
beta cell function
beta cell preservation
Lead sponsor: Nemours Children's Clinic
Sponsor class: OTHER
First posted: 2006-07-28
Enrollment: 12
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Insulin Sensitivity
timeFrame: 24 months
measure: Beta Cell Function
timeFrame: 24 months
Secondary outcomes:
measure: Hemoglobin A1c
timeFrame: 24 months
measure: Percent Body Fat
timeFrame: 24 months
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Nemours Children's Clinic
state: Florida
Study officials:
affiliation: Nemours Chidlren's Clinic
name: Larry A Fox, MD
role: PRINCIPAL_INVESTIGATOR
References: