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Hospital Insulin Protocol Aims for Glucose Control in Corticosteroid-induced Hyperglycemia
Plain-language guide to NCT01184014: phase 4 randomized trial of NPH Insulin (isophane), 72 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01184014
- Phase
- phase 4
- Status
- completed
- Start
- 2010-08
- Completion (planned or actual)
- 2012-08
- Participants
- 72 (actual)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Hyperglycemia
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
This registered phase 4 trial tested NPH Insulin (isophane).
It had two arms (groups): Experimental group (experimental) and Control group (active comparator).
The standard recommended care (Methodist Hospital Complete Insulin Orders).
The registry classes the interventions as drug.
Who Took Part
The registry lists 72 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: Have signed the consent form for the study. Are scheduled to be in hospital ≥ 2 days.
The full record lists 4 inclusion and 8 exclusion criteria; among the exclusions: unable to read or understand english; history of psychiatric disability affecting informed consent or compliance with drug intake; patients in hospice care.
How the Study Was Run
It was run as a randomized, parallel-group and open-label study.
The participants were allocated by chance, so the NPH Insulin (isophane) group and the comparison group should start out alike.
The NPH Insulin (isophane) group and the comparison group ran side by side rather than switching.
Everyone knew when NPH Insulin (isophane) was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.
It started in 2010-08 with completion listed for 2012-08.
It ran at 1 site in United States.
Its stated primary purpose is treatment.
What Was Measured
Researchers chose this as the main measure: Mean Blood Glucose of All Readings.
What This Means in Plain Language
Put simply, this is a phase 4, randomized trial of NPH Insulin (isophane) in 72 people.
The trial is marked completed; results are posted on the registry, and this page does not restate them.
More context: the NPH Insulin (isophane) compound page, all human trials.
Our Notes on the Compound
NPH Insulin (isophane): An intermediate-acting insulin made by combining insulin with protamine; also called isophane or NPH insulin (Humulin N, Novolin N).
Related Pages
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.