Metabolic Adaptation to High-frequent Hypoglycaemia in Type 1 Diabetes

What Was Tested

This registered not phased trial tested Insulin (regular human) and Glucagon.

The knowledge to be obtained may feed into experimental hypoglycaemic clamp studies to further elucidate the effect of the adaptations during acute hypoglycaemia.

It had two arms (groups): one (experimental) and Healthy Controls (active comparator).

Healthy Controls.

The registry classes the interventions as device, drug and procedure.

More on the Plan

Severe hypoglycaemia is the main barrier in achieving the recommended glycaemic targets and may indirectly be the main driver for late diabetic complications and related morbidity, mortality and health care costs.

Who Took Part

The registry lists 60 planned participants were the target.

It was open to people of any sex aged from 18 years up to 70 years.

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

Examples of who could join: Ability to provide written informed consent. Male or female aged 18-70 years. In insulin treatment regimen. The subject must be willing and able to comply with trial protocol.

The full record lists 7 inclusion and 9 exclusion criteria; among the exclusions: history of severe psychological condition; history of severe heart disease; history of epilepsy, former apoplexies and dementia.

How the Study Was Run

The set-up was non-randomized, parallel-group and open-label.

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

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

It started in 2019-12-16 with completion listed for 2023-12.

It ran at 2 sites in Denmark (2).

Its stated primary purpose is basic science.

What Was Measured

The main thing measured (primary outcome): Metabolite- and lipid profiling (time frame: 5 minutes). Brain lactate concentration (time frame: 20 minutes). Brain adenosine triphosphate (ATP) concentration (time frame: 20 minutes).

It also tracked 29 secondary outcomes, for example Estimated glucose production during glucagon stimulation, Estimated glucose production during epinephrine stimulation, Indirect calorimetry, Thermography, Plasma lactate during glucagon injections and Plasma free fatty acids during glucagon injections.

What This Means in Plain Language

Put simply, this is a not phased, non-randomized trial of Insulin (regular human) and Glucagon in 60 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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