Integration of Continuous Glucose Monitoring Into a BiHormonal Closed-Loop Artificial Pancreas

What Was Tested

This registered not phased trial tested Glucagon.

It had two arms (groups): Bi-hormonal with meal-priming bolus (experimental) and Bi-hormonal without meal-priming bolus (experimental).

The insulin controller was entirely reactive to CGMG; there were no meal priming boluses and no meal announcements.

The registry classes the interventions as device.

More on the Plan

Experiments will be 51 hours in length incorporating 6 meals and two (night) sleep periods.

In order to evaluate the effect of exercise on BG control, the last 48 hours of the experiment will be divided into two 24 hour blocks, the second of which will contain a period of structured exercise near the beginning of the block.

Who Took Part

The registry lists 24 actual participants took part.

It was open to people of any sex aged from 12 years with no upper age limit.

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

Examples of who could join: Weight \> 41 kg. Otherwise healthy (mild chronic disease allowed if well controlled). Prescription medication regimen stable for 1 month.

The full record lists 9 inclusion and 34 exclusion criteria; among the exclusions: unable to provide informed consent for subjects \> 18 years of age or unable to provide assent if \< 18 years of age; unable to comply with study procedures; anemia (hct less than normal for age and sex).

How the Study Was Run

Design: randomized, parallel-group and open-label.

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.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Nothing was hidden in this open-label Glucagon study: the participants and staff both knew the treatment.

It started in 2010-07 with completion listed for 2012-12.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Mean Plasma Blood Glucose Achieved by the Bionic Pancreas (mg/dl) (time frame: 48 hours).

It also tracked 7 secondary outcomes, for example Number of Carbohydrate Interventions for Hypoglycemia and Nadir Blood Glucose in Each Arm.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Glucagon in 24 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.