Dual-hormone Closed-loop Glucose Control in Type 1 Diabetes

What Was Tested

The trial (phase 4) is built around Glucagon.

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

FiAsp (R) - Saline.

FiAsp(R) - GlucaGen(R).

The registry classes the interventions as device and drug.

More on the Plan

The study aims to compare the glucose control achieved by DCL with their SCL.

Procedures: In this two-phase study 1) the researchers test the operability of their closed-loop systems and 2) compare glucose control by DCL with SCL.

The two studies are identical except for the blinding procedures.

In the first phase (pilot study), four participants are included, and the glucagon/saline pump is not masked.

Who Took Part

13 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. T1D ≥ 2 years. Insulin pump therapy ≥ 1. Currently treated with FiAsp® - insulin.

The full record lists 5 inclusion and 14 exclusion criteria; among the exclusions: pregnancy or nursing; inability and willingness to comply with all protocol procedures, e.g. exercise, sleeping, blood sampling, and meal consumption; plan to become pregnant or sexually active and not using adequate contraceptive methods (sterilization, intrauterine device, contraceptive pill, patch or injection).

How the Study Was Run

Design: randomized, crossover and single-blind.

Random assignment meant chance, not the researchers, decided who got Glucagon and who got the comparison, which limits bias.

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

Only one side, usually the participants, was kept unaware of whether Glucagon was given.

Those kept unaware of assignments: participant.

It started in 2019-07-16 with completion listed for 2021-03-19.

It ran at 1 site in Denmark.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Number of carbohydrate interventions to treat hypoglycemia (time frame: 33 hours).

It also tracked 32 secondary outcomes, for example Mean blood glucose value measured by glucose sensor and venous plasma glucose, Percentage of time with glucose values in the range > 13.9 measured by glucose sensor and venous plasma glucose, Nadir blood glucose value for each hypoglycemic episode as measured by glucose sensor and venous plasma glucose, Glucose sensor glycemic variability measured as SD and CV during overnight and during daytime, Low Blood Glucose Index (LBGI) overnight and during daytime by glucose sensor and venous plasma glucose and Mean Absolute Relative Difference (MARD) between glucose sensor and venous plasma glucose.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Glucagon in 13 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.