Post Bariatric Closed Loop Glucagon Trial

What Was Tested

This registered not phased trial tested Glucagon.

It had two arms (groups): Glucagon-only bionic pancreas - glucagon (experimental) and Glucagon-only bionic pancreas - placebo (placebo comparator).

The registry classes the interventions as device.

Who Took Part

The registry lists 10 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 a gastric bypass for more than 1 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 23 exclusion criteria; among the exclusions: unable to provide informed consent; unable to comply with study procedures; current participation in another hypoglycemia related clinical trial other than one that is primarily observational in nature.

How the Study Was Run

It was run as a randomized, crossover and quadruple-blind study.

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

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

As a double-blind Glucagon study, the assignments were hidden from both participants and investigators until the end.

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

It started in 2016-09 with completion listed for 2017-12.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Area Over the Curve and <[amount hidden]/dl (CGM) Measured in mg/dl *Min.

It also tracked 15 secondary outcomes, for example Mean Continuous Glucose Monitor (CGM) Glucose, Mean Absolute Relative Deviation (MARD) of CGM vs. All StatStrip Xpress BG Measurements, Number of Carbohydrate Interventions for Hypoglycemia Per Day, Total Number of Grams of Carbohydrate Taken for Hypoglycemia Per Day, Number of Symptomatic Hypoglycemia Events Per Day and Percentage of Days When Participants Correctly Guessed Intervention (Glucagon vs Placebo) Out of a Total of 14 Days.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Glucagon in 10 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.