Reducing the Risk of Metabolic Decompensation in Diabetic Adolescents by Supervised School Administration of Insulin

What Was Tested

In this early phase 1 trial, researchers set out to test Insulin Glargine.

It had two arms (groups): subjects receiving insulin degludec (experimental) and Subjects receiving insulin glargine (active comparator).

The registry classes the interventions as drug.

More on the Plan

To remove variability due to potential non-compliance during the school week, this study will utilize their routine clinical practice of supervised insulin administration and monitoring of blood glucose and ketones during the school day.

Who Took Part

32 actual participants took part.

It was open to people of any sex aged from 8 years up to 18 years.

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

Examples of who could join: Clinical diagnosis of T1D, diagnosed at least 12 months prior to enrollment. Taking no medications known to affect blood glucose levels other than insulin. Ability to provide participant written informed consent if age 18 years, or parental written informed consent and participant assent if participant is \< age 18 before any trial-related activities. Current regimen includes insulin detemir or I-glar, as long acting insulin. Willingness to use either I-glar or I-deg pens as basal insulin, and have school personnel supervise administration.

The full record lists 8 inclusion and 6 exclusion criteria; among the exclusions: female participants who are pregnant, breast-feeding or planning on becoming pregnant; participant (and parent if age \<18) unable to read, write, and speak english; adolescents who are home schooled or no longer attending secondary school.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

Random assignment meant chance, not the researchers, decided who got Insulin Glargine and who got the comparison, which limits bias.

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 2017-10-01 with completion listed for 2021-06-07.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Lower beta hydroxybutyrate levels (time frame: 4 months).

It also tracked 2 secondary outcomes, for example Control of HbA1c levels and Measure of beta hydroxybutyrate levels between the 2 groups.

What This Means in Plain Language

Put simply, this is a early phase 1, randomized trial of Insulin Glargine in 32 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.