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

Nemours Children's Health

Status: Completed

Conditions: Diabetes Mellitus, Insulin-Dependent

Treatments: Device: Insulin pump therapy; Drug: Multiple daily injections using insulin glargine + rapid acting analog

Study type: Interventional

Funder types: Other

Identifiers

NCT00357890

16-03890-002

Details and patient eligibility

About

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).

Full 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.

Enrollment: 12 patients

Sex: All

Ages: 12 to 17 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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12 participants in 2 patient groups

Pump therapy (CSII)

Experimental group

Description:

Use of pump therapy

Treatment:

Device: Insulin pump therapy

Multiple daily injections (MDI)

Active Comparator group

Description:

Use of MDI (basal bolus therapy with glargine)

Treatment:

Drug: Multiple daily injections using insulin glargine + rapid acting analog