Co-administration of Pramlintide and Insulin Via an Automated Dual-hormone Artificial Pancreas System in Adults With Type 1 Diabetes

What Was Tested

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

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

Amylin is a gluco-regulatory beta-cell hormone that is co-secreted with insulin in response to nutrient stimuli, and is deficient in patients with type 1 diabetes.

It had two arms (groups): Rapid Insulin-Plus-Pramlintide (experimental) and Rapid Insulin-Plus-Placebo (placebo comparator).

Rapid insulin and pramlintide infusion in two insulin pumps.

Rapid insulin and placebo (saline) infusion in two insulin pumps.

The registry classes the interventions as device and drug.

Who Took Part

Enrollment: 26 planned participants were the target.

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: Signed and dated written informed consent. Males and females ≥ 18 years of age. Insulin pump use for at least 6 months and actively performing carbohydrate counting.

The full record lists 6 inclusion and 26 exclusion criteria; among the exclusions: current or ≤ 1 month use of other antihyperglycemic agents (sglt2 inhibitors, glp-1 agonists, metformin, acarbose, etc.…); anticipated need to use acetaminophen during study participation; use of medication that alters gastrointestinal motility.

How the Study Was Run

Design: randomized, crossover and open-label.

Random assignment meant chance, not the researchers, decided who got Amylin (Islet Amyloid Polypeptide) and who got the comparison, which limits bias.

Each person switched between Amylin (Islet Amyloid Polypeptide) and the comparison at some point, usually with a gap in between.

Being open-label, the Amylin (Islet Amyloid Polypeptide) study did not mask who received what.

It started in 2021-11-12 with completion listed for 2024-04.

It ran at 1 site in Canada.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Time in target range (time frame: 4 weeks).

It also tracked 8 secondary outcomes, for example Mean glucose level, Total insulin delivery, Standard deviation and coefficient of variance, Gastrointestinal symptoms and Number of hypoglycemia events.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Amylin (Islet Amyloid Polypeptide) in 26 people.

Its size is small, so on its own it can only give an early look.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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