Why the New FDA Glucose Meter POCT Guidance Is Disappointing.

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

Who cites it

4 citing papers in PubMed.

1. Glucose biosensors in clinical practice: principles, limits and perspectives of currently used devices.Theranostics · 2022
   Review
2. Evaluation of Precision and Bias Specifications Required to Achieve the 2018 FDA Guidance Criteria for Glucose Meter Performance Using Simulation Models.Journal of diabetes science and technology · 2020
   Article
3. Postmarket Surveillance of Blood Glucose Monitor Systems Is Needed for Safety of Subjects and Accurate Determination of Effectiveness in Clinical Trials of Diabetes Drugs and Devices.Journal of diabetes science and technology · 2019
   Article
4. Do the New FDA Guidance Documents Help Improving Performance of Blood Glucose Monitoring Systems Compared With ISO 15197?Journal of diabetes science and technology · 2017
   Article

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

Authors and funding

1 author.

Funding

No grant is acknowledged in the PubMed record.

Abstract

PubMed holds no abstract for this paper.

Indexed as