Lunch Time Insulin Injection by School Nurse for Poorly Controlled Diabetes

What Was Tested

The trial (phase 4) is built around Insulin Glargine.

The registry classes the interventions as drug.

More on the Plan

The researchers propose to use the school nurse to help with lunchtime blood sugar monitoring (BSM) and with a lunchtime insulin injection.

Who Took Part

The registry lists 36 actual participants took part.

It was open to people of any sex aged from 10 years up to 19 years.

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

Examples of who could join: Child with T1DM for at least 1 year. Age 10-19 years. School must have a school nurse.

The full record lists 4 inclusion and 2 exclusion criteria; among the exclusions: child who has type 2 diabetes; subject receiving home schooling.

How the Study Was Run

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

Because people in this Insulin Glargine study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Being open-label, the Insulin Glargine study did not mask who received what.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2006-06 with completion listed for 2007-06.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Hemoglobin A1c (time frame: At the start of the study and again in 3 months).

It also tracked 1 secondary outcome, for example Urine microalbumin.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Glargine in 36 people.

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

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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