Evidence map›Paper›PMID 34486429›Full record

ArticleJournal of diabetes science and technology2023

Post-Market Surveillance of a Blood Glucose Test Strip Demonstrates No Evidence of Interference on Clinical Accuracy in a Large Cohort of People with Type 1 or Type 2 Diabetes.

Stuart Phillips, Steven Setford, Mike Grady, Zuifang Liu, Hilary Cameron

Open access · hybridAbstract read
In one paragraph

Article in Journal of diabetes science and technology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.6field-weighted citation impact, top 32% of its field
1 · What the graph read from it

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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 6 citations in OpenAlex.

  1. Review
  2. Article
4 · The record

Corrections and comments

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

5 · Who and what money

Authors and funding

5 authors.

Stuart PhillipsLifeScan Scotland Ltd, Inverness, UK.ORCID 0000-0003-2399-9016
Steven SetfordLifeScan Scotland Ltd, Inverness, UK.ORCID 0000-0003-1983-0461
Mike GradyLifeScan Scotland Ltd, Inverness, UK.ORCID 0000-0002-8006-1844
Zuifang LiuLifeScan Scotland Ltd, Inverness, UK.
Hilary CameronLifeScan Scotland Ltd, Inverness, UK.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundRegulations and industry guidance relating to testing for interference in blood glucose monitoring (BGM) systems continue to focus on in vitro laboratory bench tests. Post-market surveillance (PMS) in a clinical setting allows for BGM accuracy assessments to evaluate the impact of real-world exposure to polypharmacy in people with diabetes. This study evaluated the OneTouch Select Plus® BGM test-strip accuracy with respect to polypharmacy using a clinical registry dataset.

methodsMedication profiles were analysed for 1023 subjects (425 with type 1 (T1D) and 598 with type 2 diabetes (T2D)) attending 3 UK hospitals. Blood samples were analysed to determine clinical accuracy of the BGM test-strip against a laboratory comparator.

results538 different medications (48 diabetes and 490 non-diabetes) were recorded across the 1023 subjects. Patients took on average 6.9 (

conclusionsClinical performance for the test strip under assessment demonstrated no evidence of interference from over 500 prescription medications, with clinical accuracy maintained across a range of polypharmacy conditions in people with diabetes.

Indexed as

Diabetes Mellitus, Type 2Blood GlucoseBlood Glucose Self-MonitoringHospitalsHumansLaboratoriesBlood Glucoseaccuracyblood glucose monitoring (BGM)medicationspost market surveillance (PMS)regulations

Identifiers

PMID34486429
PMCPMC9846393
OpenAlexW3198219273

What Socratic holds

Textmetadata
LicenceCC BY-NC
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.