Pramlintide Combined With Model Predictive Control Algorithm

What Was Tested

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

Pramlintide is approved by the Food and Drug Administration (FDA) and is given as an injection (subcutaneous) that works with insulin to lower blood sugar.

It had three arms (groups): Closed loop with pramlintide (experimental), Closed loop without pramlintide (experimental) and Open loop with pramlintide (experimental).

Pramlintide will be provided to study subjects who will subsequently be admitted for inpatient testing with the closed loop system. The term closed loop refers to insulin adjustment automatically regulated by computer input to the insulin pump based on monitoring (often a combination of patient blood glucose (BG) testing and/or continuous glucose monitoring (CGM)).

This visit is necessary to assess how well the closed loop system works without the pramlintide (how well it protects from hypoglycemia and hyperglycemia). It will be the exact protocol as for the closed loop with pramlintide but without the medication.

The term open loop refers to insulin infusions regulated in their delivery based on patient self-monitoring and adjustment. The study subject will be in charge of their insulin treatment while also receiving pramlintide.

The registry classes the interventions as device and drug.

More on the Plan

The closed-loop system-recommended insulin will replace (in a clinical setting) the basal rate insulin that the patient would normally use.

The patients' meal insulin needs will be estimated using an insulin-to-carbohydrate ratio as per standard clinical practice and will be optimized prior to admission to the Clinical Research Unit.

For example, based upon their work in animal models, one secondary goal is to explore whether moderate inhibition of α-cell glucagon, known to occur with pramlintide administration in the early postprandial period, has the potential to repair inadequate glucagon counterregulation.

Who Took Part

2 actual participants took part.

It was open to people of any sex aged from 21 years up to 65 years.

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

Examples of who could join: Age 21 to 65 years. For females, not currently known to be pregnant. An understanding of the protocol and a willingness to follow it. Hematocrit \>36 (females); \>38 (males).

The full record lists 7 inclusion and 35 exclusion criteria; among the exclusions: known hypersensitivity to symlin or any of its components, including metacresol; poor compliance with current insulin regimen; poor compliance with prescribed self-blood glucose monitoring.

How the Study Was Run

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

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 2011-02 with completion listed for 2012-02.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Percent of Blood glucose tests within target range of [amount hidden]/dl.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Amylin (Islet Amyloid Polypeptide) in 2 people.

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

It ended early (terminated); 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.