Glucagon and Advanced HCL System to Prevent Exercise-Induced Hypoglycaemia in People With Type 1 Diabetes

What Was Tested

The trial (not phased) is built around Glucagon.

It had two arms (groups): one (experimental) and Control (no intervention).

No glucagon will be administered before exercise.

The registry classes the interventions as drug.

More on the Plan

The study consists of a screening visit (visit A) and two additional study visits (visit B and visit C) completed in a sequential order.

During study visit C the exact same procedures will be followed with the omission of glucagon.

Who Took Part

10 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. Use of Novorapid for ≥ 1 week.

The full record lists 4 inclusion and 8 exclusion criteria; among the exclusions: allergies to lactose or glucagon; 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 non-randomized, sequential and open-label study.

Everyone knew when Glucagon was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2022-09-21 with completion listed for 2024-05-13.

It ran at 1 site in Denmark.

Its stated primary purpose is prevention.

What Was Measured

The main thing measured (primary outcome): Difference in Percentage of Time in Target Glucose Range (PG: [amount hidden]/l) During and for 1-hour After Dynamic Physical Exercise Between Visit B and C.

It also tracked 12 secondary outcomes, for example Difference in Nadir PG Concentration Between Visit B and C, Difference in Peak PG Concentration Between Visit B and C, Difference in Incremental Peak PG Concentration Between Visit B and C, Difference in Mean PG Concentration Between Visit B and C, Difference in PG Area Under the Curve (AUC) Between Visit B and C and Difference in Standard Deviation in PG Concentrations Between Visit B and C.

What This Means in Plain Language

Put simply, this is a not phased, non-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.