Alleviating Carbohydrate Counting for Patients With Type 1 Diabetes Using a Novel Insulin-plus-pramlintide Artificial Pancreas

What Was Tested

The trial (not phased) is built around Insulin Aspart and Amylin (Islet Amyloid Polypeptide).

One of the main challenges in maintaining tight glucose control in a closed-loop system occurs at meal times.

It had three arms (groups): Fiasp-plus-Placebo with Full Carbohydrate Counting (experimental), Fiasp-plus-placebo with Simple Meal Announcement (placebo comparator) and Fiasp-plus-Pramlintide with Simple Meal Announcement (active comparator).

Fiasp insulin and placebo insulin infusion in two insulin pumps with full carbohydrate counting.

Fiasp insulin and placebo (saline) insulin infusion in two insulin pumps using the simple meal announcement system.

Fiasp insulin and pramlintide insulin infusion in two insulin pumps using the simple meal announcement system.

The registry classes the interventions as device and drug.

Who Took Part

Enrollment: 36 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: Signed and dated written informed consent. Males and females ≥ 12 years of age. Insulin pump use for at least 3 months.

The full record lists 6 inclusion and 17 exclusion criteria; among the exclusions: current or ≤ 1 month use of other antihyperglycemic agents (sglt2 inhibitors, glp-1 agonists, 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 triple-blind study.

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

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

As a double-blind Insulin Aspart study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider and investigator.

It started in 2020-02-14 with completion listed for 2022-01-30.

It ran at 1 site in Canada.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Each participant's time in target range (time frame: 12 days).

It also tracked 9 secondary outcomes, for example Each participant's mean glucose level, Each participant's standard deviation of glucose levels as a measure of glucose variability, Each participant's number of Gastrointestinal symptoms and Each participant's total insulin delivery.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Insulin Aspart and Amylin (Islet Amyloid Polypeptide) in 36 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.