Early Glargine (Lantus) in DKA Management in Children With Type 1 Diabetes

What Was Tested

This registered phase 4 trial tested Insulin Glargine.

Participants will also have the option to wear a continuous glucose monitor (CGM) during the study to help them understand blood glucose control during and after DKA.

It had two arms (groups): Early glargine (Lantus) (experimental) and Control group (other).

The registry classes the interventions as device and drug.

More on the Plan

The investigators will do this by randomizing participants in DKA to either receive glargine early in the management of DKA (study group) or after resolution of DKA (control group); the latter is currently standard-of-care.

These devices measure blood sugar levels every 5 minutes and provide a great deal of information about blood sugar control patterns over many days.

Not only will the use of CGM in this study provide meaningful information regarding blood sugar patterns during DKA treatment, it will also broaden the investigators knowledge of whether CGM is a feasible and accurate tool to use in this setting.

Who Took Part

61 actual participants took part.

It was open to people of any sex aged from 6 years up to 18 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Age 6-17.9 years at time of enrollment. Known history of type 1 diabetes or presumed new-onset type 1 diabetes. Evidence of ketonemia or ketonuria).

The full record lists 5 inclusion and 23 exclusion criteria; among the exclusions: participants who present in dka with conditions that affect neurological function such as:; suspected alcohol or drug use,; severe head trauma,.

How the Study Was Run

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

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.

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 2017-07-21 with completion listed for 2021-03-13.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Rate of Rebound Hyperglycemia (time frame: Within 12 hours after discontinuation of IV insulin).

It also tracked 3 secondary outcomes, for example Rate of Recurrent Ketogenesis, Risk of Hypoglycemia Between Those Given Early Administration of Glargine Versus Those Given Standard-of-care Management and Evaluation of CGM and POC Glucose Monitoring During DKA Treatment in Children.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Glargine in 61 people.

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.