Point-of-Care Glucose Testing and Insulin Supplementation

What Was Tested

The trial (not phased) is built around Insulin Aspart.

Capillary point-of-care (POC) testing is advocated as a valuable aid in the management of diabetes and hyperglycemia in the hospital setting.

It had two arms (groups): Bedtime supplementation (active comparator) and no bedtime supplementation (no intervention).

Patients in this arm will have acqhs (before meals and at bedtime) and 3 am blood glucose testing and will receive sliding scale insulin supplementation as needed.

Patients in this arm will have ac (before meals), qhs (at bedtime) and 3 am blood glucose testing; however, subjects in this group will NOT receive sliding scale insulin bedtime supplementation.

The registry classes the interventions as drug.

Who Took Part

235 actual participants took part.

It was open to people of any sex aged from 18 years up to 80 years.

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

Examples of who could join: Male and female patients with a known history of T2DM for \> 3 months. Age 18-80 years. Home treatment with either diet alone, any combination of oral antidiabetic agents, non-insulin injectables or insulin therapy.

The full record lists 4 inclusion and 8 exclusion criteria; among the exclusions: hyperglycemia without a history of diabetes; acute critical illness admitted to the icu or expected to require icu admission; receiving continuous insulin infusion.

How the Study Was Run

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

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

Groups ran in parallel: each of the participants stayed in one arm throughout.

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

It started in 2012-05 with completion listed for 2013-12.

It ran at 2 sites in United States (2).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Mean Fasting Blood Glucose (time frame: up to 10 days).

It also tracked 12 secondary outcomes, for example Mean Daily BG, Length of Hospital Stay, Hospital Mortality, Nosocomial Infections (CDC), Pneumonia and Bacteremia.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Insulin Aspart in 235 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Insulin Aspart compound page, all human trials.