Best Timing of Insulin Bolus Before Meals of Different Contents

What Was Tested

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

Post-meal glucose excursions may contribute to the development of diabetes-related complications.

These glucose excursions are affected by the food content of the meal and the timing of insulin injection (or insulin pump-bolus) before meal.

The best timing for insulin bolus (by pump) is controversial.

It had 1 arm (groups): Timing of insulin administration (experimental).

The registry classes the interventions as drug.

Who Took Part

24 planned participants were the target.

It was open to people of any sex aged from 8 years up to 30 years.

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

Examples of who could join: Type 1 diabetes. Age 8 to 20 years. Age 18 to 30 years.

The full record lists 5 inclusion and 5 exclusion criteria; among the exclusions: less than a year from the diagnosis of type 1 diabetes; less than 6 months from the time of insulin pump introduction; any diagnosed or suspected chronic diseases.

How the Study Was Run

It was run as a randomized, single-group and open-label study.

The participants were allocated by chance, so the Insulin (regular human) group and the comparison group should start out alike.

Nothing was hidden in this open-label Insulin (regular human) study: the participants and staff both knew the treatment.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2011-08 with completion listed for 2013-10.

It ran at 1 site in Israel.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Post-prandial blood glucose excursions following three different meals and three different timings of insulin bolus.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Insulin (regular human) in 24 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.