Evidence map›Paper›PMID 23911162›Full record

Trial reportJournal of diabetes science and technology2013

Evaluation of the performance of a novel system for continuous glucose monitoring.

Eva Zschornack, Christina Schmid, Stefan Pleus, Manuela Link, Hans-Martin Klötzer, Karin Obermaier, Michael Schoemaker, Monika Strasser, Gerhard Frisch, Günther Schmelzeisen-Redeker and 2 more

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 27 papers.

0numbers the graph read from it
0cells of the map it votes in
27citing papers in PubMed
4.1field-weighted citation impact, top 5% 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

27 citing papers in PubMed, 54 citations in OpenAlex.

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  16. A Review of the Current Challenges Associated with the Development of an Artificial Pancreas by a Double Subcutaneous Approach.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2017
    Review
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  18. Significance and Reliability of MARD for the Accuracy of CGM Systems.Journal of diabetes science and technology · 2017
    Article
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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

12 authors at 1 institution in 1 country.

Eva ZschornackInstitut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH, Ulm, Germany.
Christina Schmid
Stefan Pleus
Manuela Link
Hans-Martin Klötzer
Karin Obermaier
Michael Schoemaker
Monika Strasser
Gerhard Frisch
Günther Schmelzeisen-Redeker
Cornelia Haug
Guido Freckmann
Roche Pharma AG (Germany) · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe performance of a continuous glucose monitoring (CGM) system in the early stage of development was assessed in an inpatient setting that simulates daily life conditions of people with diabetes. Performance was evaluated at low glycemic, euglycemic, and high glycemic ranges as well as during phases with rapid glucose excursions.

methodsEach of the 30 participants with type 1 diabetes (15 female, age 47 ± 12 years, hemoglobin A1c 7.7% ± 1.3%) wore two sensors of the prototype system in parallel for 7 days. Capillary blood samples were measured at least 16 times per day (at least 15 times per daytime and at least once per night). On two subsequent study days, glucose excursions were induced. For performance evaluation, the mean absolute relative difference (MARD) between CGM readings and paired capillary blood glucose readings and precision absolute relative difference (PARD), i.e., differences between paired CGM readings were calculated.

resultsOverall aggregated MARD was 9.2% and overall aggregated PARD was 7.5%. During induced glucose excursions, MARD was 10.9% and PARD was 7.8%. Lowest MARD (8.5%) and lowest PARD (6.4%) were observed in the high glycemic range (euglycemic range, MARD 9.1% and PARD 7.4%; low glycemic range, MARD 12.3% and PARD 12.4%).

conclusionsThe performance of this prototype CGM system was, particularly in the hypoglycemic range and during phases with rapid glucose fluctuations, better than performance data reported for other commercially available systems. In addition, performance of this prototype sensor was noticeably constant over the whole study period. This prototype system is not yet approved, and performance of this CGM system needs to be further assessed in clinical studies.

Indexed as

AbdomenAdultBiosensing TechniquesBlood GlucoseBlood Glucose Self-MonitoringDiabetes Mellitus, Type 1FemaleHumansImplants, ExperimentalMaleMiddle AgedSensitivity and SpecificitySubcutaneous FatYoung AdultBlood Glucose

Identifiers

PMID23911162
PMCPMC3879745
OpenAlexW1896432491

What Socratic 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 Socratic graph.