Three Way Crossover Closed Loop Study With Xeris Glucagon

What Was Tested

In this phase 1 trial, researchers set out to test Glucagon.

Closed-loop systems are an emerging technology that automate hormone delivery.

They are quickly paving the way to revolutionize the treatment of type 1 diabetes.

It had three arms (groups): Dual Hormone Closed-loop Arm (experimental), Single Hormone Closed-loop Arm (experimental) and Predictive Low Glucose Suspend Arm (experimental).

Subjects will undergo a 76 hour study with 9 hours inpatient and 67 hours outpatient using the closed-loop artificial pancreas controller in predictive low glucose suspend mode. The system will run through the closed-loop system but will utilize the patient's optimized basal rates, correction factors and carb ratios as they would normally run on their own insulin pump. But the mode will have the additional safety net of the pump suspending insulin when it predicts a hypoglycemic event.

The registry classes the interventions as device and drug.

More on the Plan

Subjects will undergo three approximately 76 hour studies.

During each of these intervention visits, subjects will wear an Omnipod to deliver insulin and a Dexcom G5 CGM to measure glucose.

The first day of intervention visit will be a 12 hour inpatient visit with the subsequent time spent as an outpatient.

The subject will come back to the research center on Day 4 in the morning to remove all devices.

Who Took Part

23 actual participants took part.

It was open to people of any sex aged from 21 years up to 50 years.

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

Examples of who could join: Diagnosis of type 1 diabetes mellitus for at least 1 year. Male or female subjects 21-50 years of age. Physically willing and able to perform 45 min of exercise. Current use of an insulin pump. Lives with another person age 18 or older who will be present while subject exercises at home and that can attend the training on using the system.

The full record lists 11 inclusion and 32 exclusion criteria; among the exclusions: liver failure, cirrhosis, or any other liver disease that compromises liver function as determined by the investigator; adrenal insufficiency; any active infection.

How the Study Was Run

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

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

Each person switched between Glucagon and the comparison at some point, usually with a gap in between.

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

It started in 2018-03-29 with completion listed for 2019-05-17.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Percent of Time With Sensed Glucose < [amount hidden]/dl.

It also tracked 6 secondary outcomes, for example Number of Carbohydrate Treatments, Mean Amount of Insulin Delivered in One Day and Mean Amount of Glucagon Delivered in One Day.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Glucagon in 23 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.