Evidence map›Paper›PMID 32954812›Full record

ArticleJournal of diabetes science and technology2022

Accuracy of a 14-Day Factory-Calibrated Continuous Glucose Monitoring System With Advanced Algorithm in Pediatric and Adult Population With Diabetes.

Shridhara Alva, Timothy Bailey, Ronald Brazg, Erwin S Budiman, Kristin Castorino, Mark P Christiansen, Gregory Forlenza, Mark Kipnes, David R Liljenquist, Hanqing Liu

2 registry-linked trialsAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Journal of diabetes science and technology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 80 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
80citing papers in PubMed, 3 pooled it
–field-weighted citation impact
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.

NCT03607448 completednot on this map

Freestyle Libre Flash Glucose Monitoring System Accuracy Study

TypeobservationalSponsorAbbott Diabetes CareRan2018 to 2018Enrolled153ConditionsDiabetes MellitusArmsFreestyle Libre Flash Glucose Monitoring System
NCT03820050 completednot on this map

FreeStyle LIbre Flash Glucose Monitoring System Pediatric Accuracy Study

TypeobservationalSponsorAbbott Diabetes CareRan2019 to 2019Enrolled144ConditionsDiabetes MellitusArmsFreestyle LIbre Flash Glucose Monitoring System
3 · Its place in the literature

Who cites it

80 citing papers in PubMed, 3 syntheses or guidelines pooled it.

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20 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

10 authors.

Shridhara AlvaAbbott Diabetes Care, Alameda, CA, USA.ORCID 0000-0003-3596-2034
Timothy BaileyAMCR Institute, Escondido, CA, USA.
Ronald BrazgRainier Clinical Research Center, Renton, WA, USA.
Erwin S BudimanAbbott Diabetes Care, Alameda, CA, USA.
Kristin CastorinoSansum Diabetes Research Institute, Santa Barbara, CA, USA.
Mark P ChristiansenDiablo Clinical Research, Walnut Creek, CA, USA.
Gregory ForlenzaBarbara Davis Center for Diabetes, University of Colorado Denver, Aurora, CO, USA.
Mark KipnesDGD Clinic, San Antonio, TX, USA.
David R LiljenquistRocky Mountain Diabetes Center, Idaho Falls, ID, USA.
Hanqing LiuAbbott Diabetes Care, Alameda, CA, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIn this study, we evaluated the analytical performance of the second-generation factory-calibrated FreeStyle Libre Flash Glucose Monitoring (FreeStyle Libre 2) System compared to plasma venous blood glucose reference, Yellow Springs Instrument 2300 (YSI).

methodsThe study enrolled participants aged four and above with type 1 or type 2 diabetes at seven sites in the United States. Adult participants (18+ years) participated in three in-clinic sessions and pediatric participants (4-17 years) participated in up to two in-clinic sessions stratified to provide data for days 1, 2, 3, 7, 8, 9, 12, 13, or 14 of sensor wear. Participants aged 11+ underwent supervised glycemic manipulation during in-clinic sessions to achieve glucose levels across the measurement range of the System. Performance evaluation included accuracy measures such as the proportion of continuous glucose monitoring (CGM) values that were within ±20% or ±20 mg/dL of reference glucose values, and bias measures such as the mean absolute relative difference (MARD) between CGM and reference values.

resultsData from the 144 adults and 129 pediatric participants were analyzed. Percent of sensor results within ±20%/20 mg/dL of YSI reference were 93.2% and 92.1%, and MARD was 9.2% and 9.7% for the adults and pediatric participants, respectively. The System performed well in the hypoglycemic range, with 94.3% of the results for the adult population and 96.1% of the data for pediatric population being within 15 mg/dL of the YSI reference. The time lag was 2.4 ± 4.6 minutes for adults and 2.1 ± 5.0 minutes for pediatrics.

conclusionsThe System demonstrated improved analytical accuracy performance across the dynamic range during the 14-day sensor wear period as compared to the previous-generation device.NCT#: NCT03607448 and NCT03820050.

Indexed as

Diabetes Mellitus, Type 1Diabetes Mellitus, Type 2PediatricsAdultAgedAlgorithmsBlood GlucoseBlood Glucose Self-MonitoringChildGlucoseHumansReproducibility of ResultsBlood GlucoseGlucosecontinuous glucose monitoringfactory calibrationFreeStyle Libre 2optional alarm

Identifiers

PMID32954812
PMCPMC8875061

What OpenQuestion holds

Textmetadata
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Registered trials

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.