Evidence map›Paper›PMID 28617617›Full record

Trial reportJournal of diabetes science and technology2017

Accuracy and User Performance Evaluation of a New, Wireless-enabled Blood Glucose Monitoring System That Links to a Smart Mobile Device.

Timothy S Bailey, Jane F Wallace, Scott Pardo, Mary Ellen Warchal-Windham, Bern Harrison, Robert Morin, Mark Christiansen

Abstract readClinical Trial
In one paragraph

Trial report in Journal of diabetes science and technology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed
–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.

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

13 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
  4. Article
  5. Review
  6. Accuracy and User Performance of a New Blood Glucose Monitoring System.Journal of diabetes science and technology · 2021
    Article
  7. New and Emerging Technologies in Type 1 Diabetes.Endocrinology and metabolism clinics of North America · 2020
    Review
  8. Article
  9. Article
  10. Article
  11. Article
  12. Article
  13. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

7 authors.

Timothy S Bailey1 AMCR Institute Inc., Escondido, CA, USA.
Jane F Wallace2 Ascensia Diabetes Care, Parsippany, NJ, USA.
Scott Pardo2 Ascensia Diabetes Care, Parsippany, NJ, USA.
Mary Ellen Warchal-Windham2 Ascensia Diabetes Care, Parsippany, NJ, USA.
Bern Harrison2 Ascensia Diabetes Care, Parsippany, NJ, USA.
Robert Morin2 Ascensia Diabetes Care, Parsippany, NJ, USA.
Mark Christiansen3 Diablo Clinical Research, Walnut Creek, CA, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe new Contour

methodsThe accuracy of the new BGMS was assessed in 2 studies according to ISO 15197:2013 criteria. In Study 1 (laboratory study), fingertip capillary blood samples from 100 subjects were tested in duplicate using 3 test strip lots. In Study 2 (clinical study), 134 subjects with type 1 or type 2 diabetes enrolled at 2 clinical sites. BGMS results and YSI analyzer (YSI) reference results were compared for fingertip blood obtained by untrained subjects' self-testing and for study staff-obtained fingertip, subject palm, and venous results.

resultsIn Study 1, 99.0% (594/600) of combined results for all 3 test strip lots fulfilled ISO 15197:2013 Section 6.3 accuracy criteria. In Study 2, 99.2% (133/134) of subject-obtained capillary fingertip results, 99.2% (133/134) of study staff-obtained fingertip results, 99.2% (125/126) of subject-obtained palm results, and 100% (132/132) of study staff-obtained venous results met ISO 15197:2013 Section 8 accuracy criteria. Moreover, 95.5% (128/134) of subject-obtained fingertip self-test results were within ±10 mg/dl (±0.6 mmol/L) or ±10% of the YSI reference result. Questionnaire results showed that most subjects found the BGMS easy to use.

conclusionsThe BGMS exceeded ISO 15197:2013 accuracy criteria both in the laboratory and in a clinical setting when used by untrained subjects with diabetes.

Indexed as

SmartphoneAdolescentAdultAgedBlood GlucoseBlood Glucose Self-MonitoringDiabetes MellitusFemaleHumansMaleMiddle AgedYoung AdultBlood Glucoseaccuracyblood glucose monitoring systemISO 15197:2013mobile appself-monitoring of blood glucose

Identifiers

PMID28617617
PMCPMC5588817

What OpenQuestion holds

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Registered trials

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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.