Phase 2 Study of Adaptive Insulin Meal Supervisor (AIMS) in Adults With Type 1 Diabetes Mellitus

What Was Tested

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

Pramlintide, a drug well recognized to help control hyperglycemia with meals, will be evaluated in both closed loop and open loop control.

It had two arms (groups): Closed Loop with Pramlintide (experimental) and Open Loop with Pramlintide (placebo comparator).

The registry classes the interventions as device.

More on the Plan

However, pramlintide treatment can result in post-prandial hypoglycemia primarily due to overbolusing with insulin.

Who Took Part

The registry lists 9 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: ≥21 and \<65 years old. Familiarity with a bolus calculator with the current insulin pump with pre-defined parameters for carbohydrate (CHO) ratio, insulin sensitivity factor (ISF), target glucose and active insulin. Not currently known to be pregnant, breast feeding, or intending to become pregnant (females). Willingness to avoid consumption of acetaminophen-containing products during the study interventions involving CGM use. Willingness to refrain from strenuous exercise for 2 days prior to admission. Non-strenuous walks of less than 15 minutes around the guest house will be permitted during the study.

The full record lists 11 inclusion and 34 exclusion criteria; among the exclusions: known hypersensitivity to pramlintide or any of its components, including metacresol; severe hypoglycemia resulting in seizure, loss of consciousness, or diabetic ketoacidosis (dka) within the 12 months prior to enrollment; pregnancy; breast feeding, or intention of becoming pregnant.

How the Study Was Run

Design: randomized, crossover and open-label.

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.

Nothing was hidden in this open-label Amylin (Islet Amyloid Polypeptide) study: the participants and staff both knew the treatment.

It started in 2013-07 with completion listed for 2013-11.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Percent of Glucose Measurements within Target Range (time frame: 13 days).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Amylin (Islet Amyloid Polypeptide) in 9 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 Amylin (Islet Amyloid Polypeptide) compound page, all human trials.