Sensor-Augmented Insulin Delivery: Insulin Plus Glucagon Versus Insulin Alone

What Was Tested

The trial (phase 2) is built around Glucagon.

This combined glucose sensing/hormone delivery approach is a step on the way to eventual development of an artificial (or automated) pancreas.

The insulin and glucagon delivery algorithm is based on the difference between the current blood glucose and the target glucose (proportional error) and the rate of change in blood glucose (derivative error), both adjusted for the recent glucose history.

It had three arms (groups): Insulin + Placebo (placebo comparator), Insulin + Glucagon (active comparator) and Pilot Study (experimental).

The registry classes the interventions as drug.

More on the Plan

Subjects will undergo two 28-hour sensor-augmented glycemic control studies.

These catheters will allow for SC delivery of insulin and glucagon (or insulin plus a glucagon placebo).

The accuracy of the wire sensors will be verified every 10 minutes with a venous blood glucose test.

For the first 4 hours, the insulin and glucagon delivery will be controlled by venous blood in order to assess and compare the accuracy of the two sensors, after which the more accurate sensor (if it remains accurate) will control the FMPD algorithm.

Who Took Part

14 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: For menopausal women or those who have undergone surgical sterilization, no pregnancy test or contraception will be required. Willingness to attend all clinic visits and participate in two 28-hour studies or one 9-hour study. Body mass index of 19-35.

The full record lists 7 inclusion and 39 exclusion criteria; among the exclusions: pregnancy, lactation or refusal to use contraception; use of any investigational drug during the 30 days prior to screening; current alcohol abuse, substance abuse, or severe mental illness (as judged by the principal investigator (pi)).

How the Study Was Run

The set-up was randomized, crossover and single-blind.

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

In the crossover set-up each of the participants took both Glucagon and the comparison in turn, acting as their own control.

Only one side, usually the participants, was kept unaware of whether Glucagon was given.

Those kept unaware of assignments: participant.

It started in 2008-11 with completion listed for 2009-09.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Glucagon in 14 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.