Identifying the Brain Substrates of Hypoglycemia Unawareness in Type 1 Diabetes

What Was Tested

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

The purpose of this study is to investigate how the brain responds to low blood glucose in non-diabetic individuals.

The ultimate goal is to understand the brain substrates of hypoglycemia unawareness, a condition that can occur in patients with type1 diabetes undergoing insulin treatment.In the present study, the investigators focus on differences between two groups of non-diabetic subjects: one group who experienced two episodes of hypoglycemia the day prior to the study (and supposedly developed some level of unawareness to hypoglycemia), and one group who did not.

In this study, a 3 tesla MRI scanner is used to acquire brain images.

It had two arms (groups): Euglycemia pre-conditioning (experimental) and Hypoglycemia pre-conditioning (experimental).

The registry classes the interventions as drug.

More on the Plan

Hypoglycemia, also called low blood glucose or low blood sugar, occurs when blood glucose drops below normal levels.

When blood glucose starts to drop, the body reacts to this drop, trying to restore the blood glucose level.

Symptoms of hypoglycemia are usually easily recognized.

Hypoglycemia can be treated quickly and easily by eating or drinking a small amount of glucose-rich food.

Who Took Part

Enrollment: 27 actual participants took part.

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

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

Examples of who could join: Are evaluated as not contraindicated (based on.

The full record lists 2 inclusion and 10 exclusion criteria; among the exclusions: have any type of bio-implant activated by mechanical, electronic, or magnetic means (e.g. cochlear implants, pacemakers, neurostimulators, bio stimulators, electronic infusion pumps); have any type of ferromagnetic bio-implant that could potentially be displaced or damaged, such as aneurysm clips, metallic skull plates, etc; have any retained metal in their body, either from a medical procedure or an injury.

How the Study Was Run

Design: randomized, parallel-group and double-blind.

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.

The Insulin (regular human) group and the comparison group ran side by side rather than switching.

Neither the participants nor the staff measuring them knew who was on Insulin (regular human), so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and outcomes assessor.

It started in 2016-11 with completion listed for 2019-09-30.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

The main thing measured (primary outcome): Change from baseline (i.e., normal glucose levels) functional connectivity, measured as a dimensionless correlation coefficient of MRI signals among brain areas, at hypoglycemia (time frame: Baseline and immediately as hypoglycemia starts).

What This Means in Plain Language

Put simply, this is a early phase 1, randomized trial of Insulin (regular human) in 27 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 Insulin (regular human) compound page, all human trials.