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

Diabetes Mellitus, Insulin-Dependent Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00357890
• Other study ID #: 16-03890-002
• Status: Completed
• Phase: N/A
• Start date: December 2005
• Est. completion date: October 2014

Study information

• Verified date: July 2023
• Source: Nemours Children's Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Insulin-Dependent
• Diabetes Mellitus, Type 1

Intervention

Device:
• Insulin pump therapy
CSII initiated within 1 month of diagnosis

Drug:
• Multiple daily injections using insulin glargine + rapid acting analog
MDI as control

Locations

Country	Name	City	State
United States	Nemours Children's Clinic	Jacksonville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Nemours Children's Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insulin Sensitivity	Insulin sensitivity - glucose infusion rate (GIR) obtained from hyperinsulinemic-euglycemic clamp. Higher GIR reflects higher insulin sensitivity, lower GIR reflects lower insulin sensitivity.	24 months
Primary	Beta Cell Function	Beta cell function as assessed by peak c-peptide using mixed meal tolerance testing	24 months
Secondary	Hemoglobin A1c	Hemoglobin A1c (HbA1c) (%)	24 months
Secondary	Percent Body Fat	Percent body fat based on DEXA scan (%BF)	24 months