Glucose Control In Hematopoetic Stem Cell Transplant

Plain-language guide to NCT00582036: not phased randomized trial of Insulin (regular human), 11 participants. Who took part, design and what was measured.

Key Facts

Registry ID: NCT00582036
Phase: not phased
Status: terminated early
Start: 2007-02
Completion (planned or actual): 2009-05
Participants: 11 (actual)
Design: randomized, open label (everyone knows who gets what), treatment
Conditions studied: Hyperglycemia; Hematopoietic Stem Cell Transplantation
Results posted: yes

What This Study Did, in Plain Language

What Was Tested

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

It had two arms (groups): Arm 1 (active comparator) and Arm 2 (experimental).

Regular Sliding Scale Insulin administration for hyperglycemia.

MiniMed Paradigm monitoring device for hyperglycemia.

The registry classes the interventions as device and drug.

Who Took Part

11 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: Patients older than 18. Must meet standard criteria for HSCT. If patient is known diabetic at admit the may be maintained on home sulfonylurea and insulin if randomized to the conventional arm.

The full record lists 3 inclusion and 1 exclusion criteria; among the exclusions: if on intensive arm patient must stop all oral hyperglycemic meds.

How the Study Was Run

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

Random assignment meant chance, not the researchers, decided who got Insulin (regular human) and who got the comparison, which limits bias.

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

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

It started in 2007-02 with completion listed for 2009-05.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Intensive Control of Glucose Effects on Mortality in Allogenic Hematopoietic Stem Cell Transplant (HSCT) (time frame: 100 days).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Insulin (regular human) in 11 people.

Its size is small, so on its own it can only give an early look.

It ended early (terminated); results are posted on the registry, and this page does not restate them.

More context: the Insulin (regular human) compound page, all human trials.

Our Notes on the Compound

Insulin (regular human): The 51-amino-acid pancreatic hormone that lowers blood glucose; this page covers regular (short-acting) insulin studied in human trials.

Insulin (regular human) in the library

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.