Timing of Meal Insulin Boluses for Optimal Postprandial Glycemic Control in Type 1 Diabetes

What Was Tested

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

Blood glucose levels in patients with type 1 diabetes tend to peak after eating a meal due to the delayed action of insulin when compared to carbohydrate absorption from food.

It is the hypothesis of the investigator that administering the insulin for a meal 20 minutes before the meal will result in lower blood glucose peaks compared to administration of insulin immediately before or 20 minutes after starting to eat.

All subjects will eat the same meal on three different occasions.

It had three arms (groups): -20 minute insulin (experimental), 0 minute insulin (experimental) and +20 minute insulin (experimental).

Insulin for the meal is given 20 minutes prior to starting the meal.

Insulin for the meal is given immediately before starting to eat.

Insulin is given 20 minutes after the start of the meal.

The registry classes the interventions as other.

More on the Plan

Subjects enrolled in this study will be between the ages of 12 and 30 years inclusive.

Subjects in this study will complete three study visits lasting from approximately 8:30am until 1:30pm.

At each visit, the subject will eat the same frozen breakfast meal.

Subjects will be supplied with the same insulin to maintain consistency between visits and between subjects.

Who Took Part

23 actual participants took part.

It was open to people of any sex aged from 12 years up to 30 years.

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

Examples of who could join: 12 to 30 years of age, inclusive. Clinical diagnosis of T1D and using daily insulin therapy for at least 1 year. Using CSII therapy for diabetes management for at least three months. Able and willing to give informed consent/assent to participate. No expectation that the subject will be moving out of the area of the clinical center during the study.

The full record lists 8 inclusion and 4 exclusion criteria; among the exclusions: being unable or unwilling to give informed consent; having documented hypoglycemia unawareness; an episode of severe hypoglycemia (seizure or loss of consciousness) or of ketoacidosis in the past six months.

How the Study Was Run

It was run as a randomized, crossover and open-label 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.

In the crossover set-up each of the participants took both Insulin (regular human) and the comparison in turn, acting as their own control.

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

It started in 2007-08 with completion listed for 2009-05.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Blood glucose area under the curve (time frame: 9:00am until 1:30pm).

It also tracked 2 secondary outcomes, for example Glucose values one hour after the meal and Glucose values two hours after the beginning of the meal.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Insulin (regular human) in 23 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.