A Fully-closed Loop, Pramlintide and Insulin, Artificial Pancreas Clinical Trial for Adults With Type 1 Diabetes

What Was Tested

This registered not phased trial tested Insulin Aspart and Amylin (Islet Amyloid Polypeptide).

The investigators aim to assess the glycemic outcomes of a fully automated insulin-and-pramlintide artificial pancreas and a comparator insulin-alone artificial pancreas with carbohydrate matched boluses.

It had five arms (groups): one (experimental), Fiasp-alone with carbohydrate-matched boluses (active comparator), one (experimental), one (experimental) and one (experimental).

The registry classes the interventions as device and drug.

More on the Plan

The aim of this pilot study is to generate additional data of (i) a Fiasp-alone artificial pancreas with carbohydrate-matched boluses, compared to (ii) a Fiasp-plus-Pramlintide fully automated artificial pancreas with no meal announcement in an outpatient free-living setting.

Design The investigators will undertake a randomized crossover study to compare the following strategies: 1.

Insulin-alone artificial pancreas with carbohydrate-matched boluses 2.

Fiasp and pramlintide artificial pancreas with no meal announcement.

Who Took Part

The registry lists 12 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: Females and males ≥ 18 years of age. Use of insulin pump therapy for at least 3 months.

The full record lists 4 inclusion and 11 exclusion criteria; among the exclusions: current or ≤ 1 month use of other antihyperglycemic agents (sglt2i (sodium-glucose transporter), glp-1(glucagon-like peptide), metformin, etc.); current use of glucocorticoid medication (except low, stable does and inhaled steroids); individuals with confirmed gastroparesis.

How the Study Was Run

Design: randomized, crossover and open-label.

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.

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

Being open-label, the Insulin Aspart study did not mask who received what.

It started in 2022-02-21 with completion listed for 2023-03-25.

It ran at 1 site in Canada.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Each participant's percentage of time glucose levels spent in the target range (time frame: 42 +/- 28 hours).

It also tracked 13 secondary outcomes, for example Each participant's mean glucose levels, Each participant's standard deviation of glucose levels, Each participant's coefficient of variance of glucose levels, Total pramlintide delivery for each participant, Total insulin delivery for each participant and Total basal insulin delivery for each participant.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Insulin Aspart and Amylin (Islet Amyloid Polypeptide) in 12 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.