Closed-Loop Glucagon Pump for Treatment of Post-Bariatric Hypoglycemia

What Was Tested

The trial (phase 1, phase 2) is built around Glucagon.

It had two arms (groups): Study drug (glucagon) first, placebo second (other) and Placebo first, study drug (glucagon) second (other).

The registry classes the interventions as device and drug.

More on the Plan

A control system for sensor-guided delivery was previously developed and tested in a Proof-of-Concept (POC) study in a clinical research setting during 9 mixed meal tolerance tests in 8 unique patients with severe hypoglycemia following bariatric surgery.

This optimized algorithm will now be implemented to deliver stable glucagon in a closed-loop system.

Who Took Part

The registry lists 18 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

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

Examples of who could join: Age 18-65 years of age, inclusive, at screening. Willingness to provide informed consent and follow all study procedures, including attending all scheduled visits.

The full record lists 3 inclusion and 24 exclusion criteria; among the exclusions: documented hypoglycemia occurring in the fasting state (\> 12 hours fast);; congestive heart failure, new york heart association (nyha )class ii, iii or iv;; history of cardiac arrhythmia or arrhythmia detected by ekg during the screening visit;.

How the Study Was Run

It was run as a randomized, crossover and quadruple-blind study.

The participants were allocated by chance, so the Glucagon group and the comparison group should start out alike.

Each person switched between Glucagon and the comparison at some point, usually with a gap in between.

Neither the participants nor the staff measuring them knew who was on Glucagon, so expectations could not easily colour the readings.

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

It started in 2017-09-19 with completion listed for 2018-08-22.

It ran at 1 site in United States.

Its stated primary purpose is prevention.

What Was Measured

The main thing measured (primary outcome): Number of Participants With Meal-provoked Hypoglycemia, Defined as Sensor Glucose <[amount hidden]/dL. Number of Participants With Meal-provoked Hypoglycemia, Defined as Plasma Glucose <[amount hidden]/dL.

It also tracked 20 secondary outcomes, for example Number of Participants With Hypoglycemia Rescue Administered, Meal Provoked Nadir Plasma Glucose, Meal Provoked Nadir Sensor Glucose, Time to Nadir Plasma Glucose After Mixed Meal (Min), Time to Nadir Sensor Glucose After Mixed Meal (Min) and Time to Alarm During Mixed Meal Testing (Minutes).

What This Means in Plain Language

Put simply, this is a phase 1, phase 2, randomized trial of Glucagon in 18 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 Glucagon compound page, all human trials.