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

Sponsor

Nemours Children's Clinic (Other)

Overall Status

Completed

CT.gov ID

NCT00357890

Collaborator

(none)

Enrollment

Location

Arms

106

Duration (Months)

0.1

Patients Per Site Per Month

Study Details

Study Description

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 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 or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Insulin-Dependent	Device: Pump therapy (CSII) Drug: Multiple daily injections (MDI) using insulin glargine + rapid acting analog	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

12 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (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.

Study Start Date :

Dec 1, 2005

Actual Primary Completion Date :

Oct 1, 2014

Actual Study Completion Date :

Oct 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

Hemoglobin A1c (HbA1c or A1c) [24 months]

Secondary Outcome Measures

insulin sensitivity [24 months]
beta cell function [24 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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