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Performance Evaluation of Blood Glucose Monitoring Systems
Plain-language guide to NCT01504620: phase 4 non-randomized trial of Insulin (regular human), 106 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01504620
- Phase
- phase 4
- Status
- completed
- Start
- 2011-01
- Completion (planned or actual)
- 2011-04
- Participants
- 106 (actual)
- Design
- non-randomized, open label (everyone knows who gets what), diagnostic
- Conditions studied
- Diabetes Mellitus
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
In this phase 4 trial, researchers set out to test Insulin (regular human).
It had two arms (groups): Sugar infusion (other) and insulin infusion (experimental).
Diagnostic assessment of blood glucose by means of different devices.
Infusion of insulin to achieve low glucose levels.
The registry classes the interventions as drug and other.
Who Took Part
The registry lists 106 actual participants took part.
It was open to people of any sex aged from 18 years up to 75 years.
Healthy volunteers could join, not only people with the condition.
Examples of who could join: Healthy subjects or patients with type 1 or type 2 diabetes. Screening glucose levels fall into required glucose ranges.
The full record lists 3 inclusion and 6 exclusion criteria; among the exclusions: history of hypotension during blood draws; intake of drugs known to interfere with blood glucose readings; biochemical safety parameters outside of reference ranges.
How the Study Was Run
It was run as a non-randomized, single-group and open-label study.
Nothing was hidden in this open-label Insulin (regular human) study: the participants and staff both knew the treatment.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
It started in 2011-01 with completion listed for 2011-04.
It ran at 1 site in Germany.
Its stated primary purpose is diagnostic.
What Was Measured
Primary outcome: Accuracy of the blood glucose meter in comparison to a standard reference (time frame: within 10 min up to 300 min after start of experiment).
It also tracked 2 secondary outcomes, for example Intra-Assay precision and Hematocrit Interference (Helios).
What This Means in Plain Language
Put simply, this is a phase 4, non-randomized trial of Insulin (regular human) in 106 people.
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.
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.
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.