Evidence mapPaperPMID 38701088Full record

ArticlePloS one2024

Early feasibility study with an implantable near-infrared spectroscopy sensor for glucose, ketones, lactate and ethanol.

Francesca De Ridder, Rie Braspenning, Juan S Ordonez, Gijs Klarenbeek, Patrick Lauwers, Kristien J Ledeganck, Danaë Delbeke, Christophe De Block

Registry-linked trialAbstract read
In one paragraph

Article in PloS one, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04782934 (Early Feasibility and First in Human Study of the YANG System for Continuous Monitoring of Glucose, Ketones and Lactate - The GLOW Study), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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.

NCT04782934 nacompletednot on this map

Early Feasibility and First in Human Study of the YANG System for Continuous Monitoring of Glucose, Ketones and Lactate - The GLOW Study

TypeinterventionalSponsorIndigo Diabetes NVRan2021 to 2021Enrolled7ConditionsDiabetes Mellitus, GlucoseArmsThe YANG SENSOR is an active implantable device, for Real Time Continuous Glucose, Lactate and Ketone Measurement
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. 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

8 authors.

Francesca De RidderDepartment of Endocrinology-Diabetology-Metabolism, Antwerp University Hospital, Antwerp, Belgium.ORCID https://orcid.org/0000-0002-5351-166X
Rie BraspenningDepartment of Endocrinology-Diabetology-Metabolism, Antwerp University Hospital, Antwerp, Belgium.
Juan S OrdonezIndigo Diabetes N.V., Ghent, Belgium.
Gijs KlarenbeekIndigo Diabetes N.V., Ghent, Belgium.
Patrick LauwersDepartment of Vascular & Thoracic Surgery, Antwerp University Hospital, Antwerp, Belgium.
Kristien J LedeganckFaculty of Medicine & Health Science, Laboratory of Experimental Medicine and Pediatrics, University of Antwerp, Antwerp, Belgium.
Danaë DelbekeIndigo Diabetes N.V., Ghent, Belgium.
Christophe De BlockDepartment of Endocrinology-Diabetology-Metabolism, Antwerp University Hospital, Antwerp, Belgium.ORCID https://orcid.org/0000-0002-0679-3203

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo evaluate the safety and performance of an implantable near-infrared (NIR) spectroscopy sensor for multi-metabolite monitoring of glucose, ketones, lactate, and ethanol. RESEARCH DESIGN AND

methodsThis is an early feasibility study (GLOW, NCT04782934) including 7 participants (4 with type 1 diabetes (T1D), 3 healthy volunteers) in whom the YANG NIR spectroscopy sensor (Indigo) was implanted for 28 days. Metabolic challenges were used to vary glucose levels (40-400 mg/dL, 2.2-22.2 mmol/L) and/or induce increases in ketones (ketone drink, up to 3.5 mM), lactate (exercise bike, up to 13 mM) and ethanol (4-8 alcoholic beverages, 40-80g). NIR spectra for glucose, ketones, lactate, and ethanol levels analyzed with partial least squares regression were compared with blood values for glucose (Biosen EKF), ketones and lactate (GlucoMen LX Plus), and breath ethanol levels (ACE II Breathalyzer). The effect of potential confounders on glucose measurements (paracetamol, aspartame, acetylsalicylic acid, ibuprofen, sorbitol, caffeine, fructose, vitamin C) was investigated in T1D participants.

resultsThe implanted YANG sensor was safe and well tolerated and did not cause any infectious or wound healing complications. Six out 7 sensors remained fully operational over the entire study period. Glucose measurements were sufficiently accurate (overall mean absolute (relative) difference MARD of 7.4%, MAD 8.8 mg/dl) without significant impact of confounders. MAD values were 0.12 mM for ketones, 0.16 mM for lactate, and 0.18 mM for ethanol.

conclusionsThe first implantable multi-biomarker sensor was shown to be well tolerated and produce accurate measurements of glucose, ketones, lactate, and ethanol.

trial registrationClinical trial identifier: NCT04782934.

Indexed as

EthanolFeasibility StudiesKetonesLactic AcidSpectroscopy, Near-InfraredAdultBiosensing TechniquesBlood GlucoseDiabetes Mellitus, Type 1FemaleGlucoseHumansMaleMiddle AgedBlood GlucoseEthanolGlucoseKetonesLactic Acid

Identifiers

PMID38701088
PMCPMC11068174

What Socratic holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

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.