Delivery of G-Pump™ (Glucagon Infusion) From an OmniPod® to Prevent Hypoglycemia in Post-Bariatric Surgery Patients

What Was Tested

In this phase 2 trial, researchers set out to test Glucagon.

The primary objective of this study is to test an optimized control system for sensor-guided (physician administered) delivery of glucagon, and test Proof-of-Concept (POC) in a clinical setting in patients with severe hypoglycemia following bariatric surgery.

It had 1 arm (groups): G-Pump™ (glucagon infusion) (experimental).

The registry classes the interventions as drug.

More on the Plan

Participant on continuous glucose monitoring will arrive at the clinic and IV line will be inserted for venous access.

Boost® Nutritional Drink, over 10 minutes.

Blood samples will be collected for glucose and hormone measurement.

Sensors will be downloaded for subsequent analysis of appropriateness of alert timing and trigger for glucagon bolus delivery.

Who Took Part

Enrollment: 8 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: Willingness to provide informed consent and follow all study procedures, including attending all scheduled visits.

The full record lists 2 inclusion and 20 exclusion criteria; among the exclusions: documented hypoglycemia occurring in the fasting state (\> 12 hours fast);; congestive heart failure, new york heart association class ii, iii or iv;; history of myocardial infarction, unstable angina or revascularization within the past 6 months;.

How the Study Was Run

It was run as a single-group and open-label study.

Everyone knew when Glucagon was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2016-03 with completion listed for 2017-04-05.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Detection/Notification of Hypoglycemia.

It also tracked 3 secondary outcomes, for example Number of Subjects With Severe Hypoglycemia, Number of Subjects With Rebound Hyperglycemia and Glucose Time in Range.

What This Means in Plain Language

Put simply, this is a phase 2 trial of Glucagon in 8 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.