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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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Diabetes Mellitus, Insulin-Dependent

Intervention / Treatment
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* Device: Insulin pump therapy
* Drug: Multiple daily injections using insulin glargine + rapid acting analog


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pump therapy (CSII)<br>Use of pump therapy | Device: Insulin pump therapy<br>* CSII initiated within 1 month of diagnosis<br>* Other names: Continuous subcutaneous insulin infusion (CSII);|
| Active Comparator: Multiple daily injections (MDI)<br>Use of MDI (basal bolus therapy with glargine) | Drug: Multiple daily injections using insulin glargine + rapid acting analog<br>* MDI as control<br>* Other names: MDI using glargine plus a rapid acting analog;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Beta Cell Function | Beta cell function as assessed by peak c-peptide using mixed meal tolerance testing | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin A1c | Hemoglobin A1c (HbA1c) (%) | 24 months | 
| Percent Body Fat | Percent body fat based on DEXA scan (%BF) | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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type 1 diabetes, diabetes, new onset, CSII, insulin sensitivity, beta cell function, beta cell preservation