Safety of Overestimation of a Meal Insulin Bolus in the Context of Dual-hormone Closed-loop Operation

What Was Tested

The trial (phase 2) is built around Insulin (regular human) and Glucagon.

With this strategy, the patient would only have to evaluate the size of the meal in terms of carbohydrate (snack, regular, large or very large) It is however important to establish safety of this simplified meal bolus approach.

The safety of overestimating a meal insulin bolus in the context of single and dual-hormone CLS with the simplified meal strategy needs to be determined.

It had two arms (groups): Dual-hormone CL with overestimation of meal size category (active comparator) and Dual-hormone CL with adequate estimation of meal size category (active comparator).

The registry classes the interventions as device, drug and other.

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: Males and females ≥ 18 years old. Clinical diagnosis of type 1 diabetes for at least one year. The subject will have been on insulin pump therapy for at least 3 months and currently using a fast actin insulin analog (Lispro, Aspart or Guilisine).

The full record lists 5 inclusion and 8 exclusion criteria; among the exclusions: recent (\< 3 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery; severe hypoglycemic episode within 1 month of screening.

How the Study Was Run

The set-up was randomized, crossover and single-blind.

Because people in this Insulin (regular human) 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 Insulin (regular human) and the comparison in turn, acting as their own control.

In this single-blind Insulin (regular human) study one party knew the assignments and the other did not.

Those kept unaware of assignments: participant.

It started in 2016-01 with completion listed for 2016-06.

It ran at 1 site in Canada.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Percentage of time below [amount hidden]/L.

It also tracked 11 secondary outcomes, for example Mean glucose, Number of patients with at least one hypoglycemic event with or without symptoms, Total carbohydrate intake for hypoglycemia correction, Total insulin delivery and Total glucagon delivery.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Insulin (regular human) and Glucagon in 10 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 Insulin (regular human) compound page and the Glucagon compound page, all human trials.