Mechanisms for Restoration of Hypoglycemia Awareness

What Was Tested

In this early phase 1 trial, researchers set out to test Insulin (regular human).

In particular, T1DM patients who are aware of hypoglycemia (T1DM-Aware) have greater activity in sensory integration brain regions (e.g. parietal lobe and caudate nucleus) in response to hypoglycemia, whereas hypoglycemia unaware T1DM patients (T1DM-Unaware) show no detectable changes in brain reward regions during hypoglycemia.

It had three arms (groups): one (experimental), Aim 1: Impact of hypoglycemia on brain connectivity Type 1 (experimental) and Aim 2: Impact of hypoglycemia on brain glucose transports in Type 1 (experimental).

Continuous Glucose Monitor for 3 months duration.

Healthy controls, T1 aware, and T1 unawares.

Healthy controls, T1 aware, and T1 unawares.

The registry classes the interventions as device and drug.

Who Took Part

Enrollment: 55 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Ages \> 18 years. Healthy, non-diabetic control or T1DM. BMI \> 18.0.

The full record lists 3 inclusion and 15 exclusion criteria; among the exclusions: ALT \> 2.5 X ULN; untreated thyroid disease; uncontrolled hypertension.

How the Study Was Run

It was run as a randomized, parallel-group and single-blind study.

Because people in this Insulin (regular human) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Only one side, usually the participants, was kept unaware of whether Insulin (regular human) was given.

Those kept unaware of assignments: participant.

It started in 2018-11-07 with completion listed for 2023-08-14.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Brain Glucose Levels (time frame: 3 months).

What This Means in Plain Language

Put simply, this is a early phase 1, randomized trial of Insulin (regular human) in 55 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Insulin (regular human) compound page, all human trials.