Evidence map›Paper›PMID 30073864›Full record

ArticleJournal of diabetes science and technology2019

In Vitro Sugar Interference Testing With Amperometric Glucose Oxidase Sensors.

Ryan Boehm, John Donovan, Disha Sheth, Andrew Durfor, Jason Roberts, Irada Isayeva

Open access · bronzeAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Journal of diabetes science and technology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
0.4field-weighted citation impact, top 37% 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

11 citing papers in PubMed, 19 citations in OpenAlex.

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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

6 authors at 3 institutions in 1 country.

Ryan Boehm1 Division of Biology, Chemistry, and Material Science (DBCMS), Office of Science and Engineering Laboratories (OSEL), Center for Devices and Radiological Health (CDRH), Food and Drug Administration (FDA), Silver Spring, MD, USA.
John Donovan1 Division of Biology, Chemistry, and Material Science (DBCMS), Office of Science and Engineering Laboratories (OSEL), Center for Devices and Radiological Health (CDRH), Food and Drug Administration (FDA), Silver Spring, MD, USA.
Disha Sheth1 Division of Biology, Chemistry, and Material Science (DBCMS), Office of Science and Engineering Laboratories (OSEL), Center for Devices and Radiological Health (CDRH), Food and Drug Administration (FDA), Silver Spring, MD, USA.
Andrew Durfor4 Office of Compliance, CDRH/FDA, Silver Spring, MD, USA.
Jason Roberts5 Office of Device Evaluation, CDRH/FDA, Silver Spring, MD, USA.
Irada Isayeva1 Division of Biology, Chemistry, and Material Science (DBCMS), Office of Science and Engineering Laboratories (OSEL), Center for Devices and Radiological Health (CDRH), Food and Drug Administration (FDA), Silver Spring, MD, USA.
Office of Science · USCenter for Devices and Radiological Health · USDexcom (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundElectrochemical enzymatic glucose sensors are intended to measure blood or interstitial fluid glucose concentrations. One class of these glucose sensors are continuous glucose monitors (CGMs), indicated for tracking and trending of glucose concentrations in interstitial fluid and as an adjunct to blood glucose testing. Currently approved CGMs employ a glucose oxidase (GOx) electrochemical detection scheme. Potential interfering agents can impact the accuracy of results obtained by glucose sensors, including CGMs.

methodsSeven sugars, seven sugar alcohols, and three artificial sweeteners were in vitro screened for interference with amperometric glucose oxidase (GOx) sensors at concentrations greater than physiologic concentrations. Galactose was investigated further at physiologically relevant concentrations using a custom amperometric system. Furthermore, glucose and galactose calibration experiments were conducted to facilitate multiple enzyme kinetic analysis approaches (Michaelis-Menten and Hill equation) to understand the potential source and mechanism of interference from galactose.

resultsUnder in vitro testing, except for galactose, xylose and mannose, all screened compounds exhibited interference bias, expressed in mean absolute relative difference (MARD), of ⩽ 20% even at concentrations significantly higher than normal physiologic concentrations. Galactose exhibited, CGM-dependent, MARD of 47-72% and was subjected to further testing. The highest recorded mean relative difference (MRD) was 6.9 ± 1.3% when testing physiologically relevant galactose concentrations (0.1-10 mg/dL). Enzyme kinetic analysis provided calculations of maximum reaction rates (

conclusionUnder the conditions of in vitro screening, 14 of the 17 compounds did not exhibit measuarable interference. Galactose exhibited the highest interference during screening, but did not substantially interfere with CGMs under the conditions of in vitro testing at physiologically relevant concentrations. Enzyme kinetic analysis conducted with galactose supported the notion that (1) the reactivity of GOx enzyme toward nonglucose sugars and (2) the presence of enzymatic impurities (such as galactose oxidase) are two potential sources for sugar interference with GOx glucose sensors, and thus, should be considered during device development.

Indexed as

Biosensing TechniquesBlood GlucoseBlood Glucose Self-MonitoringElectrochemistryGalactoseGlucoseGlucose OxidaseHumansIn Vitro TechniquesKineticsLinear ModelsReproducibility of ResultsSugarsBlood GlucoseGalactoseGlucoseGlucose OxidaseSugarscontinuous glucose monitorsenzyme kineticsglucose oxidaseglucose sensorsinterferencesin vitro testing

Identifiers

PMID30073864
PMCPMC6313278
OpenAlexW2886482461

What OpenQuestion holds

Textmetadata
Read underepoch 390

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 OpenQuestion graph.