Closed-Loop Glucagon Administration For Hypoglycemia Treatment

What Was Tested

This registered not phased trial tested Glucagon.

It had two arms (groups): Glucagon-only Bionic Pancreas (active) (active comparator) and Glucagon-only Bionic Pancreas (placebo) (placebo comparator).

Glucagon-only Bionic Pancreas will deliver glucagon during 7 of the 14 days. The order of the glucagon days will be randomized in blocks of 2, with no more than 2 days in a row of glucagon.

Glucagon-only Bionic Pancreas will deliver placebo during 7 of the 14 days. The order of the placebo days will be randomized in blocks of 2, with no more than 2 days in a row of placebo.

The registry classes the interventions as device.

Who Took Part

The registry lists 31 actual participants took part.

It was open to people of any sex aged from 21 years with no upper age limit.

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

Examples of who could join: Age 21 years or older with type 1 diabetes for at least one year. Otherwise healthy (mild chronic disease such as asthma, hypertension, and depression will be allowed if well controlled).

The full record lists 4 inclusion and 17 exclusion criteria; among the exclusions: unable to provide informed consent; unable to comply with study procedures; current participation in another diabetes-related clinical trial other than one that is primarily observational in nature.

How the Study Was Run

The set-up was randomized, crossover and triple-blind.

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

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

Neither the participants nor the staff measuring them knew who was on Glucagon, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, investigator and outcomes assessor.

It started in 2014-11 with completion listed for 2015-06.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Continuous Glucose Monitor (CGM) Glucose Total Area Over the Curve and Less Than [amount hidden]/dl.

It also tracked 26 secondary outcomes, for example Mean CGMG During Exercise, Mean Absolute Relative Deviation (MARD) vs. Subset of BG Measurements Before Meals and at Bedtime, Mean Absolute Relative Deviation (MARD) Between Capillary Blood Glucose and CGM Glucose Values, Average BG as Determined From the Measurements Taken Before Meals and Before Bedtime, Mean BG During Exercise and • Fraction of BG Values < 70 During Exercise Fraction of BG Values < 70 During Exercise.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Glucagon in 31 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 Glucagon compound page, all human trials.