Two Way Crossover Closed Loop Study Insulin vs Insulin and Pramlintide

What Was Tested

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

The purpose of this study is to test how well a new investigational closed loop system manages your blood sugar with the ability to deliver insulin and pramlintide.

It had two arms (groups): Insulin Only Arm (experimental) and Insulin and Pramlintide Arm (experimental).

Participants will use the closed loop system with insulin only for managing blood sugar during the 12.5 hour study. Insulin will be administered by an Omnipod. Sensor glucose will be measured by a Dexcom G6 CGM. Participants will eat two meals while in clinic.

Participants will use the closed loop system with insulin and pramlintide for managing blood sugar during the 12.5 hour study. Insulin and pramlintide will be administered by two Omnipods. Sensor glucose will be measured by a Dexcom G6 CGM. Participants will eat two meals while in clinic.

The registry classes the interventions as device.

More on the Plan

Participants will undergo two 12.5 hour clinic visits.

Participants will complete a training on how to start the Dexcom G6 sensor at home.

Participants will start the G6 sensor the day before each study visit.

For one visit, the system will use insulin only for managing blood sugar.

Who Took Part

Enrollment: 33 actual participants took part.

It was open to people of any sex aged from 18 years up to 70 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Participants 18 to 70 years of age. Willingness to follow all study procedures, including attending all clinic visits. Willingness to sign informed consent and HIPAA documents.

The full record lists 8 inclusion and 24 exclusion criteria; among the exclusions: liver failure, cirrhosis, or any other liver disease that compromises liver function as determined by the investigator; adrenal insufficiency; any active infection requiring treatment (example soft tissue infection requiring antibiotics).

How the Study Was Run

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

Because people in this Amylin (Islet Amyloid Polypeptide) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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 2024-07-12 with completion listed for 2025-01-04.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Incremental Area Under the Curve of Postprandial Glucose Following the First Meal (time frame: 6 hours following first meal).

It also tracked 46 secondary outcomes, for example Incremental Area Under the Curve of Postprandial Glucose Following the Second Meal, Net Area Under the Curve of Postprandial Glucose Following the First Meal, Net Area Under the Curve of Postprandial Glucose Following the Second Meal, Net Area Under the Curve of Postprandial Glucose, Mean Sensed Glucose Following First Meal and Mean Sensed Glucose Following Second Meal.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Amylin (Islet Amyloid Polypeptide) in 33 people.

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

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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