Evidence map›Paper›PMID 28745099›Full record

Trial reportJournal of diabetes science and technology2017

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

Mark Christiansen, Carmine Greene, Scott Pardo, Mary Ellen Warchal-Windham, Bern Harrison, Robert Morin, Timothy S Bailey

Open access · bronzeAbstract 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
7.4field-weighted citation impact, top 3% 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

13 citing papers in PubMed, 29 citations in OpenAlex.

  1. Article
  2. Article
  3. Co-designing Diabetes Care With Patients.Journal of diabetes science and technology · 2024
    Article
  4. Article
  5. Article
  6. Accuracy and User Performance of a New Blood Glucose Monitoring System.Journal of diabetes science and technology · 2021
    Article
  7. Article
  8. Article
  9. Article
  10. Disruption in the diabetic device care market.Medical devices (Auckland, N.Z.) · 2018
    Review
  11. Article
  12. Article
  13. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

7 authors at 3 institutions in 1 country.

Mark Christiansen1 Diablo Clinical Research, Walnut Creek, CA, USA.
Carmine Greene2 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.
Timothy S Bailey3 AMCR Institute Inc, Escondido, CA, USA.
Diabetes Care Center · USAMCR Institute · USDiablo Clinical Research · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThese studies investigated the accuracy of the new Contour

methodsA laboratory study tested fingertip capillary blood samples from 100 subjects in duplicate using 3 test strip lots, based on ISO 15197:2013 Section 6.3 analytical accuracy standards. A clinical study assessed accuracy per ISO 15197:2013 Section 8 criteria. Subjects with (n = 333) or without (n = 43) diabetes and who had not used the BGMS previously were enrolled. Each subject performed a self-test using the BGMS, which was repeated by a site staff member. Alternate site tests and venipunctures were also performed for analysis. A questionnaire was provided to assess user feedback on ease of use.

resultsIn the laboratory study, 100% (600/600) of combined results for all 3 test strip lots met ISO 15197:2013 Section 6.3 accuracy criteria. In the clinical study, among subjects with diabetes, 99.4% (327/329) of subject self-test results, 99.7% (331/332) of results obtained by study staff, 97.2% (309/318) of subject palm results, and 100% (330/330) of venous results met ISO 15197:2013 Section 8 accuracy criteria. Moreover, 97.6% (321/329) of subject self-test results were within ±10 mg/dl (±0.6 mmol/L) or ±10% of the YSI reference result. Questionnaire results indicated that most subjects considered the system easy to use.

conclusionsThe BGMS exceeded ISO 15197:2013 accuracy criteria in the laboratory and in a clinical setting.

Indexed as

SmartphoneAdolescentAdultAgedAged, 80 and overBlood GlucoseBlood Glucose Self-MonitoringComputers, HandheldData AccuracyDiabetes MellitusFemaleHumansMaleMiddle AgedWireless TechnologyYoung AdultBlood Glucoseaccuracyblood glucose monitoring systemISO 15197:2013mobile appself-monitoring of blood glucose

Identifiers

PMID28745099
PMCPMC5505433
OpenAlexW2590988789

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.