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

NCT ID: NCT00357890

Last Updated: 2023-07-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-12-31
• Study Completion Date: 2014-10-31

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.

Conditions

Diabetes Mellitus, Insulin-Dependent

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pump therapy (CSII)

Use of pump therapy

Group Type: EXPERIMENTAL

Insulin pump therapy

Intervention Type: DEVICE

CSII initiated within 1 month of diagnosis

Multiple daily injections (MDI)

Use of MDI (basal bolus therapy with glargine)

Group Type: ACTIVE_COMPARATOR

Multiple daily injections using insulin glargine + rapid acting analog

Intervention Type: DRUG

MDI as control

Interventions

Insulin pump therapy

CSII initiated within 1 month of diagnosis

Intervention Type: DEVICE

Multiple daily injections using insulin glargine + rapid acting analog

MDI as control

Intervention Type: DRUG

Other Intervention Names

Continuous subcutaneous insulin infusion (CSII); MDI using glargine plus a rapid acting analog

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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nemours Children's Clinic

OTHER

Sponsor Role: lead

Responsible Party

Larry A. Fox, MD

Pediatric Endocrinologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Larry A Fox, MD

Role: PRINCIPAL_INVESTIGATOR

Nemours Chidlren's Clinic

Locations

Nemours Children's Clinic

Jacksonville, Florida, United States

Countries

United States

Other Identifiers

16-03890-002

Identifier Type: -

Identifier Source: org_study_id