Evidence map›Paper›PMID 28585874›Full record

Trial reportDiabetes technology & therapeutics2017

Stability, Accuracy, and Risk Assessment of a Novel Subcutaneous Glucose Sensor.

Jonathan Hughes, John B Welsh, Naresh C Bhavaraju, Stephen J Vanslyke, Andrew K Balo

Abstract readClinical Trial
In one paragraph

Trial report in Diabetes technology & therapeutics, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 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.

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

5 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Review
  3. Article
  4. Review
  5. The Future of Continuous Glucose Monitoring.Diabetes technology & therapeutics · 2017
    Article
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

5 authors.

Jonathan Hughes1 Dexcom, Inc. , San Diego, California.
John B Welsh1 Dexcom, Inc. , San Diego, California.
Naresh C Bhavaraju1 Dexcom, Inc. , San Diego, California.
Stephen J Vanslyke1 Dexcom, Inc. , San Diego, California.
Andrew K Balo1 Dexcom, Inc. , San Diego, California.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundUsers of continuous glucose monitoring (CGM) systems are concerned with the frequency of inserting and calibrating new sensors, with sensor accuracy and reliability throughout the sensor's functional life, and with the risks associated with inaccurate sensor readings.

methodsA sensor for our next-generation CGM system was tested for accuracy by comparison with self-monitored blood glucose (SMBG) values throughout 10 days of wear. Fifty subjects (49 with type 1 diabetes, 1 with type 2 diabetes, 20 male, mean ± standard deviation [SD] age 32.5 ± 18.7 years) enrolled. Subjects wore one sensor each, calibrated it once per day, and obtained multiple daily SMBG values for comparison. A total of 2739 paired CGM-SMBG values were analyzed to arrive at standard accuracy statistics and plotted on the surveillance error grid (SEG) to estimate the risk of SMBG-CGM discrepancies.

resultsThe overall mean and median absolute relative difference (ARD) values were 9.6% and 7.2%, respectively. The median ARD values ranged from 8.9% on Day 1 to 6.5% on Day 10. SEG analysis categorized 2727 points (99.6%) as "no" or "slight" risk and 12 points (0.4%) as "moderate" or "great" risk. Thirty-nine (79.6%) of the 49 systems worked through the end of Day 10. Sensors and adhesives were well tolerated, with minimal erythema and induration.

conclusionsThis new CGM system's accuracy throughout its 10-day functional life, the convenience associated with once-daily calibrations, and the high proportion of measurements in the "no risk" zone of the SEG support its nonadjunctive use in diabetes management and closed-loop insulin delivery systems.

Indexed as

AdultBlood GlucoseBlood Glucose Self-MonitoringCalibrationFemaleHumansMaleMiddle AgedReproducibility of ResultsYoung AdultBlood GlucoseContinuous glucose monitoringGlucose sensorsSelf-monitored blood glucoseSensor accuracy

Identifiers

PMID28585874
PMCPMC5467111

What OpenQuestion holds

Textmetadata
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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.