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

What Was Tested

The trial (not phased) is built around Insulin Glargine.

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).

It had two arms (groups): Pump therapy (CSII) (experimental) and Multiple daily injections (MDI) (active comparator).

Use of pump therapy.

Use of MDI (basal bolus therapy with glargine).

The registry classes the interventions as device and drug.

More on the Plan

The proposed protocol compares the changes in diabetes control between pump therapy and MDI treatment groups.

Who Took Part

Enrollment: 12 actual participants took part.

It was open to people of any sex aged from 12 years up to 17 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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.

The full record lists 5 inclusion and 3 exclusion criteria; among the exclusions: 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.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

The participants were allocated by chance, so the Insulin Glargine group and the comparison group should start out alike.

The Insulin Glargine group and the comparison group ran side by side rather than switching.

Nothing was hidden in this open-label Insulin Glargine study: the participants and staff both knew the treatment.

It started in 2005-12 with completion listed for 2014-10.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Insulin Sensitivity (time frame: 24 months). Beta Cell Function (time frame: 24 months).

It also tracked 2 secondary outcomes, for example Hemoglobin A1c and Percent Body Fat.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Insulin Glargine in 12 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Insulin Glargine compound page, all human trials.