Simple meal announcements and pramlintide delivery versus carbohydrate counting in type 1 diabetes with automated fast-acting insulin aspart delivery: a randomised crossover trial in Montreal, Canada

What Was Tested

This randomized controlled trial paper looks at Insulin Aspart and Amylin (Islet Amyloid Polypeptide).

In type 1 diabetes, carbohydrate counting is the standard of care to determine prandial insulin needs, but it can negatively affect quality of life.

Why It Was Studied

The researchers developed a novel insulin-and-pramlintide closed-loop system that replaces carbohydrate counting with simple meal announcements.

Who Took Part

The age groups tagged for this paper are children, teenagers, young adults, adults and middle-aged adults, both men and women.

The researchers performed a randomised crossover trial assessing 14 days of (1) insulin-and-pramlintide closed-loop system with simple meal announcements, (2) insulin-and-placebo closed-loop system with carbohydrate counting, and (3) insulin-and-placebo closed-loop system with simple meal announcements.

Participants were recruited at McGill University Health Centre (Montreal, QC, Canada).

How the Study Was Run

The design is described as randomized, placebo-controlled and crossover.

Because people in this Insulin Aspart study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Some participants received a placebo instead of Insulin Aspart, giving a reference point.

In the crossover set-up each of the participants took both Insulin Aspart and the comparison in turn, acting as their own control.

Eligible participants were adults (aged ≥18 years) and adolescents (aged 12-17 years) with type 1 diabetes for at least 1 year.

Participants were randomly assigned in a 1:1:1:1:1:1 ratio to a sequence of the three interventions, with faster insulin aspart used in all interventions.

Each intervention was separated by a 14-45-day wash-out period, during which participants reverted to their usual insulin.

During simple meal announcement interventions, participants triggered a prandial bolus at mealtimes based on a programmed fixed meal size, whereas during carbohydrate counting interventions, participants manually entered the carbohydrate content of the meal and an algorithm calculated the prandial bolus based on insulin-to-carbohydrate ratio.

Analyses were performed on a modified intention-to-treat basis, excluding participants who did not complete all interventions.

What Was Measured

Serious adverse events were assessed in all participants.

Topics PubMed links to this paper include Diabetes Mellitus, Type 1, Hypoglycemic Agents, Islet Amyloid Polypeptide, Insulin Aspart, Meals, Blood Glucose and Insulin Infusion Systems.

What This Means in Plain Language

The paper is a randomized, placebo-controlled and crossover study of Insulin Aspart and Amylin (Islet Amyloid Polypeptide).

Its findings take up roughly 7 sentences of the abstract and are left out here on purpose; the source paper is the place to read them.

The publication is from 2024 (The Lancet. Digital health), a journal based in England.

More context: the Insulin Aspart compound page and the Amylin (Islet Amyloid Polypeptide) compound page, all human trials.