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

Not Applicable

Completed

• Conditions: Diabetes Mellitus, Insulin-Dependent
• Interventions: Drug: Multiple daily injections using insulin glargine + rapid acting analog; Device: Insulin pump therapy

• Registration Number: NCT00357890
• Lead Sponsor: Nemours Children's Clinic

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.

Study Timeline

• Study Start: 2005-12
• Study First Submitted: 2006-07-26
• Study First Submitted QC: 2006-07-26
• Study First Posted: 2006-07-28
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Results First Submitted: 2023-05-06
• Status Verified: 2023-07
• Results First Submitted QC: 2023-07-06
• Last Update Submitted: 2023-07-06
• Results First Posted: 2023-07-07
• Last Update Posted: 2023-07-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Multiple daily injections (MDI)	Multiple daily injections using insulin glargine + rapid acting analog	Use of MDI (basal bolus therapy with glargine)
Pump therapy (CSII)	Insulin pump therapy	Use of pump therapy

Primary Outcome Measures

Name	Time	Method
Beta Cell Function	24 months	Beta cell function as assessed by peak c-peptide using mixed meal tolerance testing
Insulin Sensitivity	24 months	Insulin sensitivity - glucose infusion rate (GIR) obtained from hyperinsulinemic-euglycemic clamp. Higher GIR reflects higher insulin sensitivity, lower GIR reflects lower insulin sensitivity.

Secondary Outcome Measures

Name	Time	Method
Hemoglobin A1c	24 months	Hemoglobin A1c (HbA1c) (%)
Percent Body Fat	24 months	Percent body fat based on DEXA scan (%BF)

Trial Locations

Locations (1)

Nemours Children's Clinic; 🇺🇸 Jacksonville, Florida, United States