Dual-Hormone Closed-Loop Glucose Control in Adolescents With Type 1 Diabetes

What Was Tested

The trial (phase 4) is built around Glucagon.

It had two arms (groups): Dual-hormone Closed-loop (active comparator) and Single-Hormone Closed-loop (placebo comparator).

FiAsp® and GlucaGen®.

FiAsp® and isotonic saline.

The registry classes the interventions as device and drug.

More on the Plan

For dual-hormone control, the study pumps will be filled with FiAsp® and GlucaGen®.

For single-hormone control, the study pumps have been filled with FiAsp® and isotonic saline.

In addition, participants are provided with a blinded wearable activity and sleep monitoring device (ActiGraph GT9X Link, Pensacola, FL) for activity level estimation and sleep assessment during study participation.

The Actigraph is connected to a Bluetooth® Polar heart rate monitors during the exercise session.

Who Took Part

Enrollment: 11 actual participants took part.

It was open to people of any sex aged from 13 years up to 17 years.

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

Examples of who could join: Age = 13-17 years. T1D duration ≥ 2 years. Insulin pump therapy ≥ 1 year. Using CGM or isCGM (Flash Libre). Using carbohydrate counting.

The full record lists 6 inclusion and 8 exclusion criteria; among the exclusions: allergy to glucagon or lactose; allergy to faster insulin aspart (fiasp); inability to follow study procedures, e.g. exercise, sleeping, blood sampling, and meal intake.

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.

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 2021-05-20 with completion listed for 2022-04-26.

It ran at 2 sites in Denmark (2).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Percentage of time with glucose values < [amount hidden]/l as measured by the continuous glucose monitor.

It also tracked 21 secondary outcomes, for example Number of carbohydrate interventions to treat hypoglycemia, Mean blood glucose value measured by continuous glucose monitor and plasma glucose, Continuous glucose monitored glycemic variability measured as SD, Continuous glucose monitored glycemic variability measured as CV, Number of manual insulin boluses and Number of adverse events - Nausea.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Glucagon in 11 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.