Low-dose Glucagon for Prevention of Exercise-Induced Hypoglycemia in People With Type 1 Diabetes

What Was Tested

This registered not phased trial tested Glucagon.

The secondary aim is to compare the accuracy of three continuous glucose monitors (CGM) during and after exercise in inpatient and outpatient settings.

It had three arms (groups): one (experimental), one (experimental) and Saline as placebo (active comparator).

Saline as placebo will be administered in the same amount as glucagon before and after exercise.

The registry classes the interventions as drug.

More on the Plan

During the visits and in an outpatient period the participants will have 3 different CGM devices installed and the values will be compared with self-monitored blood glucose values.

Who Took Part

Enrollment: 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. T1D ≥ 2 years. Use of insulin pump or MDI therapy for ≥ 6 months. Current use of insulin aspart. Body mass index (BMI) ≤ 30 kg/m2.

The full record lists 7 inclusion and 10 exclusion criteria; among the exclusions: professional athletes or highly active individuals ( ≥ 5 hours of exercise per week); known or suspected allergies to glucagon or related products; history of hypersensitivity or allergic reaction to glucagon or lactose.

How the Study Was Run

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

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.

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 2021-11-23 with completion listed for 2023-08-08.

It ran at 1 site in Denmark.

Its stated primary purpose is prevention.

What Was Measured

The main thing measured (primary outcome): Incidence rate of hypoglycemia (PG < [amount hidden]/l).

It also tracked 17 secondary outcomes, for example Percentage of time below range (PG < 3.9), Change in plasma glucose levels, Nadir plasma glucose concentration, Peak plasma glucose concentration, Incremental peak in plasma glucose concentration and Mean plasma glucose concentration.

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.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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