Testing State of the Art Remote Glucose Monitoring at Diabetes Camp

What Was Tested

This registered not phased trial tested Glucagon.

The timing of the overnight blood test is often arbitrary and it is unclear when the highest frequency of nocturnal hypoglycemic events at camp are occurring.

It is also unclear what the most appropriate treatment for nocturnal hypoglycemia is: simple carbohydrates, or mini-glucagon.

It had four arms (groups): Mini-Glucagon and Remote Monitoring (experimental), Carbohydrates and Remote Monitoring (other), Carbohydrates No Remote Monitoring (other) and Mini-Glucagon and No Remote Monitoring (other).

The registry classes the interventions as device, dietary supplement and drug.

More on the Plan

Study participants will be between the ages of 7-21 with type 1 diabetes.

This would allow for a counselor in training or a young counselor with a history of recent nocturnal hypoglycemia to be included.

It is these late adolescents and young adults who often have the most severe hypoglycemic events during a camp session.

Each night, 10 of the 20 campers will be randomly assigned to remote monitoring.

Who Took Part

57 actual participants took part.

It was open to people of any sex aged from 7 years up to 21 years.

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

Examples of who could join: Clinical diagnosis of type 1 diabetes and using daily insulin therapy for at least one year. Age 7-21 years. Attendee of Camp De Los Ninos or Conrad Chinnock. Using multiple daily insulin injections (Lantus) or on an insulin pump (any brand).

The full record lists 5 inclusion and 3 exclusion criteria; among the exclusions: cystic fibrosis; history of adhesive allergies which would interfere with sensor wear.

How the Study Was Run

The set-up was randomized, crossover and open-label.

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

In the crossover set-up each of the participants took both Glucagon and the comparison in turn, acting as their own control.

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

It started in 2012-05 with completion listed for 2012-09.

It ran at 1 site in United States.

Its stated primary purpose is supportive care.

What Was Measured

Primary outcome: Duration of Nocturnal Hypoglycemia (time frame: 8 hours).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Glucagon in 57 people.

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

More context: the Glucagon compound page, all human trials.