Pramlintide and Fiasp Closed-Loop With a Simple Meal Announcement

What Was Tested

In this not phased trial, researchers set out to test Insulin Aspart and Amylin (Islet Amyloid Polypeptide).

The aim of this pilot study is to generate preliminary data of (i) Fiasp-plus-Pramlintide closed-loop system with a simple meal announcement, compared to (ii) Fiasp-alone closed-loop system with full carbohydrate counting, in preparation for an outpatient study over two weeks.

It had two arms (groups): Simple Meal Announcement (experimental) and Full Carbohydrate counting (active comparator).

Before every meal, the meal will be simply announced to the algorithm by a member of the study team. Meal bolus computation will be independent of the carbohydrate content of the meal.

The registry classes the interventions as combination product and device.

Who Took Part

The registry lists 8 actual participants took part.

It was open to people of any sex aged from 12 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 ≥ 12 years of age. Insulin pump therapy for at least 6 months.

The full record lists 5 inclusion and 17 exclusion criteria; among the exclusions: current or ≤ 1 month use of other antihyperglycemic agents (sglt2 (sodium-glucose cotransporter-2), glp-1 (glucagon-like peptide 1), metformin, acarbose, etc.…); current use of glucocorticoid medication; use of medication that alters gastrointestinal motility.

How the Study Was Run

It was run as a randomized, crossover and open-label study.

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

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

Nothing was hidden in this open-label Insulin Aspart study: the participants and staff both knew the treatment.

It started in 2019-03-01 with completion listed for 2019-08-06.

It ran at 1 site in Canada.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Time in target (time frame: 24 hours). Time in hypoglycemia (time frame: 24 hours). Time in hyperglycemia (time frame: 24 hours).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Insulin Aspart and Amylin (Islet Amyloid Polypeptide) in 8 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 Aspart compound page and the Amylin (Islet Amyloid Polypeptide) compound page, all human trials.