Efficacy of Glucagon In the Prevention of Hypoglycemia During Mild Exercise

What Was Tested

This registered not phased trial tested Glucagon.

The study will consist of two study arms.

Each arm will include a 24-96 hour outpatient run-in period prior to their exercise visit wearing the bi-hormonal bionic pancreas.

In random order subjects will then complete two approximately 5-hour exercise visits, one wearing the bi-hormonal bionic pancreas and one wearing the insulin-only bionic pancreas.

It had two arms (groups): Bihormonal Bionic Pancreas (active comparator) and Insulin Only Bionic Pancreas (placebo comparator).

Bihormonal bionic pancreas exercise visit - subjects will participate in the outpatient bihormonal bionic pancreas run in period, and will use the bihormonal bionic pancreas for their exercise visit at the end of the run in. The glucagon pump of the bionic pancreas will be filled with glucagon.

Insulin-only bionic pancreas exercise visit - Bihormonal bionic pancreas exercise visit - subjects will participate in the outpatient bihormonal bionic pancreas run in period, and will use the insulin-only bionic pancreas for their exercise visit at the end of the run in. The glucagon pump of the bionic pancreas will be filled with placebo (normal saline).

The registry classes the interventions as device and drug.

More on the Plan

Twenty subjects will participate in two experimental periods.

Each will include a 24-96 hour outpatient run-in period prior to their exercise visit wearing the bi-hormonal bionic pancreas.

This will allow the bionic pancreas to adapt to their diabetes management needs.

After the run-in period is complete, the subjects will participate in an exercise visit during which they will arrive fasting and remain fasted until the visit is completed.

Who Took Part

22 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: Age ≥ 18 years and have had clinical type 1 diabetes for at least one year. Diabetes managed using an insulin pump for ≥ 6 months. Have used a CGM for ≥ 4 weeks over the last 12 months (usage does not need to be consecutive). Willing to spend the night prior to both exercise visits in a hotel and fast overnight prior to exercise. Have a mobile phone they will have access to at all times during the outpatient run-in period for making contact with study staff.

The full record lists 9 inclusion and 34 exclusion criteria; among the exclusions: unable to provide informed consent (e.g. impaired cognition or judgment); pregnancy (positive urine hcg), breast feeding, plan to become pregnant in the immediate future, or sexually active without use of contraception; subjects must use acceptable contraception for the two weeks prior to the study, throughout the study and for the two weeks following the study.

How the Study Was Run

It was run as a randomized, crossover and single-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.

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

In this single-blind Glucagon study one party knew the assignments and the other did not.

Those kept unaware of assignments: participant.

It started in 2017-08-18 with completion listed for 2018-03-09.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Number of Subjects With Plasma Glucose < [amount hidden]/dl.

It also tracked 4 secondary outcomes, for example Nadir Plasma Glucose.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Glucagon in 22 people.

Its size is small, so on its own it can only give an early look.

It ended early (terminated); results are posted on the registry, and this page does not restate them.

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