Optimizing Insulin Absorption and Insulin Injection Technique in Older Adults

What Was Tested

This registered not phased trial tested Insulin Lispro.

To determine the injection technique which allows the most consistent subcutaneous injection of insulin (to pinch or to spread).

Hypothesis: Based on age-related changes in the amount of subcutaneous fat the researchers anticipate that the absorption of insulin from various anatomical sites will differ.

It had 1 arm (groups): 1 (experimental).

Each patient will receive 2 insulin injections in the abdomen: Once using a pinch method and once using a spread method. Injections will be given in a random order and the technician will be blinded to the injection. Each patient will evaluate the comfort of the injection by completing a visual analog scale.

The registry classes the interventions as procedure.

More on the Plan

The study will consist of 5 visits to the UBC VITALiTY Research Centre.

At the screening visit subjects will have the following information collected: height, weight, blood pressure, heart rate, BMI, medical history and concommitant medications.

The subjects will undergo 4 euglycemic clamp studies at least 30 days apart in random order.

Who Took Part

Enrollment: 20 actual participants took part.

It was open to people of any sex aged from 70 years with no upper age limit.

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

Examples of who could join: Male or female over the age of 70. Type 2 diabetes. Insulin naive - never have taken insulin with the exception of a short course during a hospitalization or illness. A1C between .065-.085. BMI between 25 and 35.

The full record lists 5 inclusion and 5 exclusion criteria; among the exclusions: taking medications that are known to interfere with glucose metabolism: systemic corticosteroids, non selective beta blockers; participation in another clinical trial within the past 30 days.

How the Study Was Run

Design: randomized, crossover and single-blind.

Random assignment meant chance, not the researchers, decided who got Insulin Lispro and who got the comparison, which limits bias.

Each person switched between Insulin Lispro and the comparison at some point, usually with a gap in between.

Only one side, usually the participants, was kept unaware of whether Insulin Lispro was given.

Those kept unaware of assignments: participant.

It started in 2010-09 with completion listed for 2012-07.

It ran at 1 site in Canada.

Its stated primary purpose is other.

What Was Measured

It also tracked 1 secondary outcome, for example Injection technique which allows the most comfortable method of inserting the needle subcutaneously.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Insulin Lispro in 20 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 Lispro compound page, all human trials.