Prospective Study of Personalized Approach to Inpatient Patients With Hyperglycemia

What Was Tested

This registered early phase 1 trial tested Insulin (regular human).

It had two arms (groups): Basal-Prandial-Correctional Insulin Regimen (experimental) and Standard of Care Insulin Regimen (active comparator).

Participants hospitalized in the medical, hematologic, or bone marrow transplant units will begin with basal long-acting insulin glargine with correctional and prandial rapid-acting insulin that is personalized and precise, to achieve target blood glucose levels with daily assessments during hospitalization. Adjustments will be made in real time to reach the target range.

Participants hospitalized in the medical, hematologic, or bone marrow transplant units' blood sugar levels will be managed with sliding scale insulin or a combination of long- and short-acting insulin as per standard of care.

The registry classes the interventions as drug.

Who Took Part

The registry lists 9 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: Provision of signed and dated informed consent form. Stated willingness to comply with all study procedures and availability for the duration of the study. Provide race and ethnicity information. Male or female, aged 18 years or greater. Hospitalized at MCC in the medical, hematologic, or bone marrow transplant units.

The full record lists 8 inclusion and 11 exclusion criteria; among the exclusions: an individual who meets any of the following criteria will be excluded from participation in this study:; participants \< 18 years of age; participants at the end of life and/or with limited life expectancies (\< 6 months).

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 (regular human) and who got the comparison, which limits bias.

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

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

It started in 2019-04-04 with completion listed for 2020-10-14.

It ran at 1 site in United States.

Its stated primary purpose is supportive care.

What Was Measured

The main thing measured (primary outcome): Proportion of blood glucose values within normal range (time frame: During hospital admission, up to 30 days).

It also tracked 3 secondary outcomes, for example Proportion of high blood glucose levels, Proportion of low blood glucose levels and Duration of normal blood glucose level.

What This Means in Plain Language

Put simply, this is a early phase 1, randomized trial of Insulin (regular human) in 9 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.