Evidence map›Paper›PMID 22920814›Full record

Trial reportJournal of diabetes science and technology2012

First clinical evaluation of a new long-term subconjunctival glucose sensor.

Achim Josef Müller, Monika Knuth, Katharina Sibylle Nikolaus, Peter Herbrechtsmeier

Open access · bronzeAbstract readClinical Trial
In one paragraph

Trial report in Journal of diabetes science and technology, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
1.0field-weighted citation impact, top 24% 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

5 citing papers in PubMed, 11 citations in OpenAlex.

  1. Trial
  2. Trial
  3. In-Vivo Microsystems: A Review.Sensors (Basel, Switzerland) · 2020
    Review
  4. Review
  5. 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

4 authors at 1 institution in 1 country.

Achim Josef MüllerEyesense GmbH, Grossostheim, Germany. achim.mueller@eyesense.com
Monika Knuth
Katharina Sibylle Nikolaus
Peter Herbrechtsmeier
Eyesense (Germany) · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTo evaluate the feasibility of an implantable subconjunctival glucose monitoring system (SGMS) for glucose monitoring in humans, we investigated the in vivo performance of the sensor in a clinical trial with five patients.

methodsThe new SGMS consists of an implantable ocular mini implant (OMI) and a hand-held fluorescence photometer. The implantable subconjunctival glucose sensor is composed of a fluorescence resonance energy transfer system based on Concanavalin A chemistry, embedded in a nelfilcon polymer hydrogel disk. Blood glucose changes in humans were induced by oral glucose intake and insulin injections.

resultsThe in vivo response of the new SGMS was tested in a first human clinical study with five diabetes patients. The OMI was well tolerated in the eyes of the patients. The SGMS exhibited high correlation coefficients (>0.88) with blood glucose changes and a good stability of the sensor response to glucose for the study period of 2 weeks. Lag times were in the range of 5-10 min. A total of 98% of all data pairs was in the clinical acceptable ranges A and B of the consensus error grid.

conclusionsFor the first time, the possibility to measure glucose in vivo in the subconjunctival interstitial fluid for a period of 2 weeks was demonstrated in a human clinical trial.

Indexed as

ConjunctivaImplants, ExperimentalAdultBiosensing TechniquesBlood GlucoseBlood Glucose Self-MonitoringCircadian RhythmConcanavalin ADiabetes MellitusFeasibility StudiesFemaleFluorescence Resonance Energy TransferHumansMaleMiddle AgedModels, BiologicalBlood GlucoseConcanavalin A

Identifiers

PMID22920814
PMCPMC3440159
OpenAlexW2048135118

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.