Evidence mapPaperPMID 40607641Full record

ArticleJournal of diabetes science and technology2025

Comparative Performance Analysis of Manual and Updated Optional Calibration Algorithms for the CareSens Air CGM System.

Nina Jendrike, Manuel Eichenlaub, Manuela Link, Sükrü Öter, Anne Beltzer, Marta Gil Miró, Cornelia Haug, Jung Hee Seo, Moon Hwan Kim, Stefan Pleus and 1 more

Abstract read
In one paragraph

Article in Journal of diabetes science and technology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
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

4 citing papers in PubMed.

  1. Review
  2. Article
  3. Performance of a New Continuous Glucose Monitoring System in German Adults Living with Diabetes.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2026
    Article
  4. 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

11 authors.

Nina JendrikeInstitut für Diabetes-Technologie, Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm, Ulm, Germany.
Manuel EichenlaubInstitut für Diabetes-Technologie, Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm, Ulm, Germany.ORCID 0000-0003-2150-3160
Manuela LinkInstitut für Diabetes-Technologie, Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm, Ulm, Germany.
Sükrü ÖterInstitut für Diabetes-Technologie, Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm, Ulm, Germany.ORCID 0000-0002-3361-1313
Anne BeltzerInstitut für Diabetes-Technologie, Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm, Ulm, Germany.ORCID 0000-0002-8308-8540
Marta Gil MiróInstitut für Diabetes-Technologie, Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm, Ulm, Germany.ORCID 0009-0007-6314-3024
Cornelia HaugInstitut für Diabetes-Technologie, Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm, Ulm, Germany.
Jung Hee Seoi-SENS, Inc., Seoul, Korea.
Moon Hwan Kimi-SENS, Inc., Seoul, Korea.
Stefan PleusInstitut für Diabetes-Technologie, Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm, Ulm, Germany.ORCID 0000-0003-4629-7754
Guido FreckmannInstitut für Diabetes-Technologie, Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm, Ulm, Germany.ORCID 0000-0002-0406-9529

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe CE-marked CareSens Air continuous glucose monitoring (CGM) system (CSAir) features a 15-day sensor lifetime, a 2-hour warm-up period and mandatory manual calibrations. During subsequent product development, the algorithm was updated to reduce the warm-up period to 30 minutes and make user-entered calibrations optional. This study compared the CSAir's performance between the manual and updated algorithms.

methodsThirty adults with diabetes wore three CSAir sensors on their upper arms for 15 days. The study included three in-clinic sessions with capillary comparator measurements at 15-minute intervals over seven hours and glucose manipulation in the hypo- or hyperglycemic range. Point accuracy was assessed via mean absolute relative difference (MARD), 20/20 agreement rates (AR) stratified by BG range, and sensor wear time. Further evaluations included clinical point accuracy, alert reliability, technical reliability, safety and user satisfaction.

resultsThe CSAir's updated algorithm exhibited improved accuracy compared with the manual calibration algorithm, with a total 20/20 AR of 93.9% (vs 90.1%) and an MARD of 8.7% (vs 9.9%). Accuracy remained stable across measurement ranges and sensor lifetime. Diabetes Technology Society Error Grid analysis revealed high clinical accuracy, with 88.0% and 92.4% of data pairs in zone A for the manual and updated algorithms, respectively. The estimated survival probability was 88.8%. Participants reported positive user satisfaction. No safety concerns were identified.

conclusionsBoth algorithms of CSAir demonstrated robust performance and reliability with improved accuracy with the updated version. The study results of the CSAir suggest its suitability for nonadjunctive use.

Indexed as

accuracyalgorithmcontinuous glucose monitoringnonadjunctive useoptional calibrationperformance

Identifiers

PMID40607641
PMCPMC12226519

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.