Evidence map›Paper›PMID 26171659›Full record

ArticleDiabetes technology & therapeutics2015

The Performance and Usability of a Factory-Calibrated Flash Glucose Monitoring System.

Timothy Bailey, Bruce W Bode, Mark P Christiansen, Leslie J Klaff, Shridhara Alva

Registry-linked trialOpen access · hybridAbstract readEvaluation StudyMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Article in Diabetes technology & therapeutics, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04060732 (Feasibility and Safety of "Flash Glucose Monitoring-FGM" in an Adult and Selected Pediatric Population.), which is not on this map. Cited by 341 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
341citing papers in PubMed, 2 pooled it
42.0field-weighted citation impact, top 1% 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.

NCT04060732 completednot on this mapstarted 2017, after this paper: background citation

Feasibility and Safety of "Flash Glucose Monitoring-FGM" in an Adult and Selected Pediatric Population.

TypeobservationalSponsorAzienda Ospedaliero-Universitaria di ParmaRan2017 to 2020Enrolled350ConditionsDiabetes Mellitus, Type 1ArmsFlash Glucose Monitoring-FGM
3 · Its place in the literature

Who cites it

341 citing papers in PubMed, 2 syntheses or guidelines pooled it, 672 citations in OpenAlex.

  1. Pooled it
  2. Guideline
  3. Trial
  4. Trial
  5. Trial
  6. Trial
  7. Trial
  8. Trial
  9. Trial
  10. Trial
  11. Trial
  12. Trial
  13. Trial
  14. Trial
  15. Trial
  16. Trial
  17. Trial
  18. Trial
  19. Trial
  20. Trial

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

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

5 authors at 5 institutions in 2 countries.

Timothy Bailey1 AMCR Institute , Escondido, California.
Bruce W Bode2 Atlanta Diabetes Associates , Atlanta, Georgia .
Mark P Christiansen3 Diablo Clinical Research , Walnut Creek, California.
Leslie J Klaff4 Rainier Clinical Research Center , Renton, Washington.
Shridhara Alva5 Clinical Affairs, Abbott Diabetes Care , Alameda, California.
Abbott (Canada) · CAAMCR Institute · USAtlanta Diabetes Associates · USDiablo Clinical Research · USRainier Clinical Research Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThe purpose of the study was to evaluate the performance and usability of the FreeStyle(®) Libre™ Flash glucose monitoring system (Abbott Diabetes Care, Alameda, CA) for interstitial glucose results compared with capillary blood glucose results. MATERIALS AND

methodsSeventy-two study participants with type 1 or type 2 diabetes were enrolled by four U.S. clinical sites. A sensor was inserted on the back of each upper arm for up to 14 days. Three factory-only calibrated sensor lots were used in the study. Sensor glucose measurements were compared with capillary blood glucose (BG) results (approximately eight per day) obtained using the BG meter built into the reader (BG reference) and with the YSI analyzer (Yellow Springs Instrument, Yellow Springs, OH) reference tests at three clinic visits (32 samples per visit). Sensor readings were masked to the participants.

resultsThe accuracy of the results was demonstrated against capillary BG reference values, with 86.7% of sensor results within Consensus Error Grid Zone A. The percentage of readings within Consensus Error Grid Zone A on Days 2, 7, and 14 was 88.4%, 89.2%, and 85.2%, respectively. The overall mean absolute relative difference was 11.4%. The mean lag time between sensor and YSI reference values was 4.5±4.8 min. Sensor accuracy was not affected by factors such as body mass index, age, type of diabetes, clinical site, insulin administration, or hemoglobin A1c.

conclusionsInterstitial glucose measurements with the FreeStyle Libre system were found to be accurate compared with capillary BG reference values, with accuracy remaining stable over 14 days of wear and unaffected by patient characteristics.

Indexed as

AdolescentAdultAgedBlood GlucoseBlood Glucose Self-MonitoringCalibrationCapillariesDiabetes Mellitus, Type 1Diabetes Mellitus, Type 2FemaleHumansMaleMiddle AgedReference ValuesReproducibility of ResultsTime FactorsBlood Glucose

Identifiers

PMID26171659
PMCPMC4649725
OpenAlexW1599923190

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.