Dual-hormone Artificial Pancreas Versus Single-hormone Under Exercise and a Meal Challenge

What Was Tested

In this not phased trial, researchers set out to test Glucagon.

This system offers two configurable options: a single-hormone configuration with automatic rescue carbohydrate recommendations (sHC) and a dual-hormone configuration with subcutaneously administered glucagon boluses (dHmG).

The main question addressed in this study focuses on determining whether the dHmG outperforms the sHC in terms of minimizing the time spent below the target range and number of hypoglycemic events.

It had two arms (groups): Dual-hormone configuration system (insulin and glucagon) (experimental) and Single-hormone configuration (insulin) with carbohydrate recommendations system (active comparator).

12-hour inpatient study that will include an unannounced 30-min aerobic exercise session and a meal challenge. Automated insulin and glucagon delivery will be performed using a dual-hormone configuration system for glucose control .

12-hour inpatient study that will include an unannounced 30-min aerobic exercise session and a meal challenge. Automated insulin delivery will be performed using a single-hormone configuration system with carbohydrate recommendations if needed for glucose control .

The registry classes the interventions as device.

More on the Plan

RATIONALE OF THE STUDY Automated insulin delivery (AID), commonly referred to as artificial pancreas, represents the most advanced treatment for individuals with type 1 diabetes (T1D).

AID is recognized for its ability to optimize insulin treatment, thereby maximizing the time spent within the target range (TIR) while minimizing instances of blood glucose levels falling below or exceeding the target range.

Overestimation of carbohydrate intake and physical activity are the primary drivers contributing to postprandial and episodic hypoglycemia, respectively, with potential consequences during the overnight period.

This system offers two configurable options: a single-hormone configuration with automatic rescue carbohydrate recommendations and a dual-hormone configuration with subcutaneously administered glucagon boluses.

Who Took Part

Enrollment: 15 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

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

Examples of who could join: Age between 18 and 65 years. CSII treatment for a minimum of 6 months prior to Visit 1. Body mass index between 18 and 30 kg/m2.

The full record lists 5 inclusion and 12 exclusion criteria; among the exclusions: postmenopausal women or women of childbearing age who have a negative urine pregnancy test during the screening visit; pregnancy or breastfeeding; hypoglycemia unawareness (as indicated by a clarke test score greater than 3).

How the Study Was Run

The set-up was randomized, crossover and open-label.

The participants were allocated by chance, so the Glucagon group and the comparison group should start out alike.

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

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 2024-05-15 with completion listed for 2025-05-30.

It ran at 1 site in Spain.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): % time below range (<[amount hidden]/dL). Number of Level 1 (<[amount hidden]/dL) and Level 2 (<[amount hidden]/dL) hypoglycemic events.

It also tracked 13 secondary outcomes, for example Coefficient of variation (CV) of CGM values, Average glucose, Standard deviation, Total insulin, Total glucagon and Number of automatic rescue carbohydrate recommendations.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Glucagon in 15 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.