Insulin-based Strategies to Prevent Hypoglycemia During Exercise

What Was Tested

The trial (not phased) is built around Insulin (regular human).

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

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

Who Took Part

The registry lists 20 planned participants were the target.

It was open to people of any sex aged from 14 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Males and females ≥ 14 years of old. Clinical diagnosis of type 1 diabetes for at least two years. The subject will have been on insulin pump therapy for at least 3 months.

The full record lists 4 inclusion and 7 exclusion criteria; among the exclusions: recent (\< 3 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery; abnormal blood panel and/or anemia; ongoing pregnancy.

How the Study Was Run

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

Random assignment meant chance, not the researchers, decided who got Insulin (regular human) and who got the comparison, which limits bias.

Each person switched between Insulin (regular human) and the comparison at some point, usually with a gap in between.

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 2018-05-18 with completion listed for 2019-01.

It ran at 2 sites in Canada (2).

Its stated primary purpose is treatment.

What Was Measured

It also tracked 26 secondary outcomes, for example Decremental area under the curve of glucose levels, Number of patients requiring an oral treatment for hypoglycemia, Total number of hypoglycemia episodes requiring treatment, Mean time (minutes) to the first hypoglycemic event, Amount of carbohydrates needed to treat a hypoglycemic event and Muscle blood flow.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Insulin (regular human) in 20 people.

Its size is small, so on its own it can only give an early look.

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, all human trials.