Evidence map›Paper›PMID 23439156›Full record

Trial reportJournal of diabetes science and technology2013

First clinical evaluation of a new percutaneous optical fiber glucose sensor for continuous glucose monitoring in diabetes.

Achim Josef Müller, Monika Knuth, Katharina Sibylle Nikolaus, Roland Krivánek, Frank Küster, Christoph Hasslacher

Open access · bronzeAbstract readClinical Trial
In one paragraph

Trial report in Journal of diabetes science and technology, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
1.8field-weighted citation impact, top 14% 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

11 citing papers in PubMed, 32 citations in OpenAlex.

  1. Article
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  9. Performance assessment of a closed-loop system for diabetes management.Medical & biological engineering & computing · 2015
    Article
  10. Review
  11. 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

6 authors at 2 institutions in 1 country.

Achim Josef MüllerEyesense GmbH, Grossostheim, Germany. achim.mueller@eyesense.com
Monika Knuth
Katharina Sibylle Nikolaus
Roland Krivánek
Frank Küster
Christoph Hasslacher
Eyesense (Germany) · DEDiabetesinstitut Heidelberg · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThis article describes a new fiber-coupled, percutaneous fluorescent continuous glucose monitoring (CGM) system that has shown 14 days of functionality in a human clinical trial.

methodThe new optical CGM system (FiberSense) consists of a transdermal polymer optical fiber containing a biochemical glucose sensor and a small fluorescence photometer optically coupled to the fiber. The glucose-sensitive optical fiber was implanted in abdominal and upper-arm subcutaneous tissue of six diabetes patients and remained there for up to 14 days. The performance of the system was monitored during six visits to the study center during the trial. Blood glucose changes were induced by oral carbohydrate intake and insulin injections, and capillary blood glucose samples were obtained from the finger tip. The data were analyzed using linear regression and the consensus error grid analysis.

resultsThe FiberSense worn at the upper arm exhibited excellent results during 14 wearing days, with an overall mean absolute relative difference (MARD) of 8.3% and 94.6% of the data in zone A of the consensus error grid. At the abdominal application site, FiberSense resulted in a MARD of 11.4 %, with 93.8% of the data in zone A.

conclusionsThe FiberSense CGM system provided consistent, reliable measurements of subcutaneous glucose levels in human clinical trial patients with diabetes for up to 14 days.

Indexed as

Biosensing TechniquesBlood GlucoseBlood Glucose Self-MonitoringDiabetes MellitusFemaleFluorescence Resonance Energy TransferHumansMaleMiddle AgedMonitoring, AmbulatoryBlood Glucose

Identifiers

PMID23439156
PMCPMC3692212
OpenAlexW2104632781

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.