Proposed minimum requirements for market approval of continuous glucose monitoring (CGM) systems: A viewpoint from the IFCC working group on CGM

Saved in:
Bibliographic Details
Published inDiabetes, obesity & metabolism Vol. 27; no. 7; pp. 4039 - 4042
Main Authors Pleus, Stefan, Eichenlaub, Manuel, Eriksson Boija, Elisabet, Diem, Peter, Fokkert, Marion, Hinzmann, Rolf, Jendle, Johan, Klonoff, David C., Makris, Konstantinos, Nichols, James H., Pemberton, John, Selvin, Elizabeth, Slingerland, Robbert J., Thomas, Andreas, Tran, Nam K., Witthauer, Lilian, Freckmann, Guido
Format Journal Article
LanguageEnglish
Published Oxford, UK Blackwell Publishing Ltd 01.07.2025
Wiley Subscription Services, Inc
Subjects
Online AccessGet full text
ISSN1462-8902
1463-1326
1463-1326
DOI10.1111/dom.16420

Cover

Loading…
Author Nichols, James H.
Pemberton, John
Klonoff, David C.
Selvin, Elizabeth
Slingerland, Robbert J.
Jendle, Johan
Diem, Peter
Eriksson Boija, Elisabet
Makris, Konstantinos
Witthauer, Lilian
Freckmann, Guido
Tran, Nam K.
Eichenlaub, Manuel
Pleus, Stefan
Fokkert, Marion
Hinzmann, Rolf
Thomas, Andreas
Author_xml – sequence: 1
  givenname: Stefan
  orcidid: 0000-0003-4629-7754
  surname: Pleus
  fullname: Pleus, Stefan
  email: stefan.pleus@idt-ulm.de
  organization: Institut für Diabetes‐Technologie, Forschungs‐ und Entwicklungsgesellschaft mbH an der Universität Ulm
– sequence: 2
  givenname: Manuel
  orcidid: 0000-0003-2150-3160
  surname: Eichenlaub
  fullname: Eichenlaub, Manuel
  organization: Institut für Diabetes‐Technologie, Forschungs‐ und Entwicklungsgesellschaft mbH an der Universität Ulm
– sequence: 3
  givenname: Elisabet
  surname: Eriksson Boija
  fullname: Eriksson Boija, Elisabet
  organization: Equalis AB
– sequence: 4
  givenname: Peter
  orcidid: 0000-0002-1190-9880
  surname: Diem
  fullname: Diem, Peter
  organization: Endokrinologie Diabetologie Bern
– sequence: 5
  givenname: Marion
  orcidid: 0000-0002-4687-1157
  surname: Fokkert
  fullname: Fokkert, Marion
  organization: Isala Clinics
– sequence: 6
  givenname: Rolf
  orcidid: 0000-0002-8419-4740
  surname: Hinzmann
  fullname: Hinzmann, Rolf
  organization: Working Group on Continuous Glucose Monitoring
– sequence: 7
  givenname: Johan
  orcidid: 0000-0003-1025-1682
  surname: Jendle
  fullname: Jendle, Johan
  organization: Örebro University
– sequence: 8
  givenname: David C.
  orcidid: 0000-0001-6394-6862
  surname: Klonoff
  fullname: Klonoff, David C.
  organization: Diabetes Research Institute of Mills‐Peninsula Medical Center
– sequence: 9
  givenname: Konstantinos
  orcidid: 0000-0002-7896-9028
  surname: Makris
  fullname: Makris, Konstantinos
  organization: KAT General Hospital
– sequence: 10
  givenname: James H.
  orcidid: 0000-0002-3652-1612
  surname: Nichols
  fullname: Nichols, James H.
  organization: Vanderbilt University Medical Center
– sequence: 11
  givenname: John
  orcidid: 0000-0002-0730-7879
  surname: Pemberton
  fullname: Pemberton, John
  organization: Birmingham Women's and Children's Foundation Trust
– sequence: 12
  givenname: Elizabeth
  orcidid: 0000-0001-6923-7151
  surname: Selvin
  fullname: Selvin, Elizabeth
  organization: Johns Hopkins Bloomberg School of Public Health
– sequence: 13
  givenname: Robbert J.
  orcidid: 0000-0002-8583-376X
  surname: Slingerland
  fullname: Slingerland, Robbert J.
  organization: Isala Clinics
– sequence: 14
  givenname: Andreas
  orcidid: 0000-0002-6549-2793
  surname: Thomas
  fullname: Thomas, Andreas
  organization: Independent Scientific Consulting
– sequence: 15
  givenname: Nam K.
  orcidid: 0000-0003-1565-0025
  surname: Tran
  fullname: Tran, Nam K.
  organization: University of California Davis Health
– sequence: 16
  givenname: Lilian
  orcidid: 0000-0001-9459-875X
  surname: Witthauer
  fullname: Witthauer, Lilian
  organization: Inselspital Bern, Bern University Hospital and University of Bern
– sequence: 17
  givenname: Guido
  orcidid: 0000-0002-0406-9529
  surname: Freckmann
  fullname: Freckmann, Guido
  organization: Institut für Diabetes‐Technologie, Forschungs‐ und Entwicklungsgesellschaft mbH an der Universität Ulm
BackLink https://www.ncbi.nlm.nih.gov/pubmed/40292701$$D View this record in MEDLINE/PubMed
https://urn.kb.se/resolve?urn=urn:nbn:se:oru:diva-120860$$DView record from Swedish Publication Index
BookMark eNp1kctu1DAUhi1URC-w4AWQJTbtIq0vScZhN0ovVGpVFsDW8iT24Db2Se24o3kLHhlPU7pAwpLlI-v7j85__kO058FrhD5SckrzOevBndK6ZOQNOqBlzQvKWb33XLNCNITto8MY7wkhJReLd2i_JKxhC0IP0O9vAUaIusfOeuuSw0E_Jhu0036K2EDAToUHPWE1jgGe1IDB4A78ZH2CFPF6SF3WYwfeThCsX-Pj9ur2BMdtnLSLX_ASP1m9GcH6CZsADk-_NL6-bFu8gfCwE6wDpBGDx1n4Hr01aoj6w8t7hH5cXnxvvxY3d1fX7fKm6LgQpFCaVl3ZEWJ0aSpBVqQ3vSpLVVFdM1FVfcPVIlvvTF_lf2No3Yu64asFZ6Kr-REq5r5xo8e0kmOw2ehWgrLy3P5cSgjrfJOkjIiaZP545vMWHpOOk3Q2dnoYlNd5D5LTJo9ByrrM6Od_0HtIwWc3kjMmmqoiza7hpxcqrZzuXwf4m00GTmagCxBj0OYVoUTucpc5d_mce2bPZnZjB739PyjP725nxR8Ooa7L
Cites_doi 10.1089/dia.2022.0331
10.1177/1932296816634356
10.1177/19322968221134639
10.1177/19322968251315459
10.2337/dci23‐0036
10.1177/19322968231190941
10.1177/19322968221133107
10.1089/dia.2023.0489
10.1089/dia.2023.0465
10.1111/dom.16153
10.1177/19322968251336221
ContentType Journal Article
Contributor Working Group on Continuous Glucose Monitoring of the IFCC Scientific Division, -
Contributor_xml – sequence: 1
  givenname: -
  surname: Working Group on Continuous Glucose Monitoring of the IFCC Scientific Division
  fullname: Working Group on Continuous Glucose Monitoring of the IFCC Scientific Division, -
Copyright 2025 John Wiley & Sons Ltd.
Copyright_xml – notice: 2025 John Wiley & Sons Ltd.
CorporateAuthor the Working Group on Continuous Glucose Monitoring of the IFCC Scientific Division
Working Group on Continuous Glucose Monitoring of the IFCC Scientific Division
CorporateAuthor_xml – name: the Working Group on Continuous Glucose Monitoring of the IFCC Scientific Division
– name: Working Group on Continuous Glucose Monitoring of the IFCC Scientific Division
DBID AAYXX
CITATION
NPM
7T5
7TK
H94
K9.
7X8
ADTPV
AOWAS
BTSUP
D91
DOI 10.1111/dom.16420
DatabaseName CrossRef
PubMed
Immunology Abstracts
Neurosciences Abstracts
AIDS and Cancer Research Abstracts
ProQuest Health & Medical Complete (Alumni)
MEDLINE - Academic
SwePub
SwePub Articles
SwePub Editorial
SWEPUB Örebro universitet
DatabaseTitle CrossRef
PubMed
AIDS and Cancer Research Abstracts
ProQuest Health & Medical Complete (Alumni)
Immunology Abstracts
Neurosciences Abstracts
MEDLINE - Academic
Database_xml – sequence: 1
  dbid: NPM
  name: PubMed
  url: https://proxy.k.utb.cz/login?url=http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed
  sourceTypes: Index Database
DeliveryMethod fulltext_linktorsrc
Discipline Medicine
EISSN 1463-1326
EndPage 4042
ExternalDocumentID oai_DiVA_org_oru_120860
40292701
10_1111_dom_16420
DOM16420
Genre letter
Letter
Commentary
Editorial
Correspondence
GrantInformation_xml – fundername: Diabetes Center Berne
GroupedDBID ---
.3N
.GA
.GJ
.Y3
05W
0R~
10A
1OC
29F
31~
33P
36B
3SF
4.4
50Y
50Z
51W
51X
52M
52N
52O
52P
52R
52S
52T
52U
52V
52W
52X
53G
5GY
5HH
5LA
5VS
66C
702
7PT
8-0
8-1
8-3
8-4
8-5
8UM
930
A01
A03
AAESR
AAEVG
AAHHS
AAHQN
AAIPD
AAKAS
AAMNL
AANHP
AANLZ
AAONW
AASGY
AAXRX
AAYCA
AAZKR
ABCQN
ABCUV
ABEML
ABPVW
ABQWH
ABXGK
ACAHQ
ACBWZ
ACCFJ
ACCZN
ACGFS
ACGOF
ACMXC
ACPOU
ACPRK
ACRPL
ACSCC
ACXBN
ACXQS
ACYXJ
ADBBV
ADBTR
ADEOM
ADIZJ
ADKYN
ADMGS
ADNMO
ADOZA
ADXAS
ADZCM
ADZMN
ADZOD
AEEZP
AEIGN
AEIMD
AENEX
AEQDE
AEUYR
AEYWJ
AFBPY
AFEBI
AFFPM
AFGKR
AFWVQ
AFZJQ
AGHNM
AGQPQ
AGYGG
AHBTC
AHMBA
AIACR
AITYG
AIURR
AIWBW
AJBDE
ALAGY
ALMA_UNASSIGNED_HOLDINGS
ALUQN
ALVPJ
AMBMR
AMYDB
ASPBG
ATUGU
AVWKF
AZBYB
AZFZN
AZVAB
BAFTC
BDRZF
BFHJK
BHBCM
BMXJE
BROTX
BRXPI
BY8
C45
CAG
COF
CS3
D-6
D-7
D-E
D-F
DCZOG
DPXWK
DR2
DRFUL
DRMAN
DRSTM
DU5
EBS
EJD
EMOBN
EX3
F00
F01
F04
F5P
FEDTE
FUBAC
G-S
G.N
GODZA
H.X
HF~
HGLYW
HVGLF
HZI
HZ~
IHE
IX1
J0M
K48
KBYEO
LATKE
LC2
LC3
LEEKS
LH4
LITHE
LOXES
LP6
LP7
LUTES
LW6
LYRES
MEWTI
MK4
MRFUL
MRMAN
MRSTM
MSFUL
MSMAN
MSSTM
MXFUL
MXMAN
MXSTM
N04
N05
N9A
NF~
O66
O9-
OIG
OVD
P2W
P2X
P2Z
P4B
P4D
PQQKQ
Q.N
Q11
QB0
R.K
ROL
RX1
SUPJJ
TEORI
UB1
W8V
W99
WBKPD
WHWMO
WIH
WIJ
WIK
WOHZO
WOW
WQJ
WVDHM
WXI
WXSBR
XG1
YFH
ZZTAW
~IA
~KM
~WT
AAMMB
AAYXX
AEFGJ
AGXDD
AIDQK
AIDYY
CITATION
NPM
7T5
7TK
H94
K9.
7X8
ADTPV
AOWAS
BTSUP
D91
ID FETCH-LOGICAL-c3880-ae15c4c00fe4f580b0dfda44a51e62855d93a7902cfd5a44ff16d8693b7328c63
IEDL.DBID DR2
ISSN 1462-8902
1463-1326
IngestDate Wed Aug 27 04:12:20 EDT 2025
Fri Jul 11 18:32:07 EDT 2025
Sat Jul 12 03:25:48 EDT 2025
Tue Jun 10 01:31:07 EDT 2025
Thu Jul 03 08:34:56 EDT 2025
Mon Jun 09 09:20:18 EDT 2025
IsDoiOpenAccess false
IsOpenAccess true
IsPeerReviewed true
IsScholarly true
Issue 7
Language English
LinkModel DirectLink
MergedId FETCHMERGED-LOGICAL-c3880-ae15c4c00fe4f580b0dfda44a51e62855d93a7902cfd5a44ff16d8693b7328c63
Notes SourceType-Scholarly Journals-1
content type line 14
ObjectType-Editorial-2
ObjectType-Commentary-1
content type line 23
ObjectType-Correspondence-1
ORCID 0000-0002-4687-1157
0000-0001-6394-6862
0000-0001-9459-875X
0000-0003-4629-7754
0000-0002-7896-9028
0000-0002-6549-2793
0000-0002-0406-9529
0000-0002-0730-7879
0000-0003-1565-0025
0000-0003-2150-3160
0000-0002-1190-9880
0000-0001-6923-7151
0000-0002-8419-4740
0000-0002-3652-1612
0000-0003-1025-1682
0000-0002-8583-376X
OpenAccessLink https://onlinelibrary.wiley.com/doi/pdfdirect/10.1111/dom.16420
PMID 40292701
PQID 3228955090
PQPubID 1006516
PageCount 4
ParticipantIDs swepub_primary_oai_DiVA_org_oru_120860
proquest_miscellaneous_3195800464
proquest_journals_3228955090
pubmed_primary_40292701
crossref_primary_10_1111_dom_16420
wiley_primary_10_1111_dom_16420_DOM16420
PublicationCentury 2000
PublicationDate July 2025
PublicationDateYYYYMMDD 2025-07-01
PublicationDate_xml – month: 07
  year: 2025
  text: July 2025
PublicationDecade 2020
PublicationPlace Oxford, UK
PublicationPlace_xml – name: Oxford, UK
– name: England
– name: Oxford
PublicationTitle Diabetes, obesity & metabolism
PublicationTitleAlternate Diabetes Obes Metab
PublicationYear 2025
Publisher Blackwell Publishing Ltd
Wiley Subscription Services, Inc
Publisher_xml – name: Blackwell Publishing Ltd
– name: Wiley Subscription Services, Inc
References e_1_2_1_6_10_1
e_1_2_1_6_12_1
e_1_2_1_6_11_1
e_1_2_1_6_7_1
e_1_2_1_6_6_1
e_1_2_1_6_9_1
e_1_2_1_6_8_1
e_1_2_1_6_3_1
e_1_2_1_6_2_1
e_1_2_1_6_13_1
e_1_2_1_6_5_1
e_1_2_1_6_4_1
References_xml – ident: e_1_2_1_6_13_1
  doi: 10.1089/dia.2022.0331
– ident: e_1_2_1_6_3_1
– ident: e_1_2_1_6_9_1
  doi: 10.1177/1932296816634356
– ident: e_1_2_1_6_4_1
  doi: 10.1177/19322968221134639
– ident: e_1_2_1_6_8_1
  doi: 10.1177/19322968251315459
– ident: e_1_2_1_6_11_1
  doi: 10.2337/dci23‐0036
– ident: e_1_2_1_6_5_1
  doi: 10.1177/19322968231190941
– ident: e_1_2_1_6_10_1
  doi: 10.1177/19322968221133107
– ident: e_1_2_1_6_7_1
  doi: 10.1089/dia.2023.0489
– ident: e_1_2_1_6_6_1
  doi: 10.1089/dia.2023.0465
– ident: e_1_2_1_6_2_1
  doi: 10.1111/dom.16153
– ident: e_1_2_1_6_12_1
  doi: 10.1177/19322968251336221
SSID ssj0004387
Score 2.458943
SourceID swepub
proquest
pubmed
crossref
wiley
SourceType Open Access Repository
Aggregation Database
Index Database
Publisher
StartPage 4039
SubjectTerms Glucose monitoring
Title Proposed minimum requirements for market approval of continuous glucose monitoring (CGM) systems: A viewpoint from the IFCC working group on CGM
URI https://onlinelibrary.wiley.com/doi/abs/10.1111%2Fdom.16420
https://www.ncbi.nlm.nih.gov/pubmed/40292701
https://www.proquest.com/docview/3228955090
https://www.proquest.com/docview/3195800464
https://urn.kb.se/resolve?urn=urn:nbn:se:oru:diva-120860
Volume 27
hasFullText 1
inHoldings 1
isFullTextHit
isPrint
link http://utb.summon.serialssolutions.com/2.0.0/link/0/eLvHCXMwnV3di9QwEA_HPRy-6J2fq6eMInI-dOlHkm30adl1PYVVEU_uQShpk8gibY_tFsG_wj_ZmfRDTxHEh0JpGpomM5OZycxvGHssjZBcuTjQLi8CLkwaaFEYXBCndew0j73Dbf1Gnp7x1-fifI89H3JhOnyI0eFGnOHlNTG4zptfmNzU5RR1_Zjs9SiRhJu_fP8TOoonvjgeCgLkeEVRPIdDFM_Y8_Je9IeCOaKHXlZc_c6zusY-DWPuAk6-TNtdPi2-_Qbn-J8_dciu9hopzDsSOmJ7trrODtb9mfsN9v0dFVJorAGCISnbEraWwoe9X7EBVHqh9KnT4PHJkXKhdkAh8JuqrdsG-qh4KL34ID8inCxerp9ChyLdPIM50AHFRb2pdkD5LoBaKbxaLRbwtfPlg08-gboC7HiTna1efFicBn0dh6AgqJlA20gUvAhDZ7kTaZiHxhnNuRaRpQxOYVSiZ7hGhTMCnzsXSZNKleSEJFTI5Bbbr-rK3mGgolRbI3KnUsejMNFo4KbS8lk4kwR1N2GPhhXNLjq4jmwwc3BuMz-3E3Y8rHXWc2yToWBLFZprCpsfjs3Ia3SAoiuL85UlhMzjD4Mn7HZHI-NX0A5X8SyMJuxJRzRjCwF4Lzcf51m9_YwXgXejHYmfOfGU8PdxZsu3a39z999fvceuxFSh2AcUH7P93ba191Ft2uUPPH_8ADTAE-Q
linkProvider Wiley-Blackwell
linkToHtml http://utb.summon.serialssolutions.com/2.0.0/link/0/eLvHCXMwnV3da9RAEF9KBfVF6_dp1VFE6kOOfOzmEvHluPO8alNF2tIXCZvsbjlKknK5IPhX-Cc7s_nQKoL4EAjZLNnszszOzM78hrEXoRIhj43vSJPlDhcqcqTIFS6IkdI3kvvW4ZYchstj_v5UnG6xN30uTIsPMTjciDOsvCYGJ4f0L1yuqmKMyr6PBvsVjooGmV7zzz_Bo3hgy-OhKECejymOZ6eP4xm6Xt6N_lAxB_zQy6qr3XsWN9mXftRtyMn5uNlk4_zbb4CO__tbO-xGp5TCtKWiW2xLl7fZ1aQ7dr_Dvn-iWgq1VkBIJEVTwFpTBLF1LdaAei8UNnsaLEQ5Ei9UBigKflU2VVNDFxgPhZUg5EqEvdm75BW0QNL1a5gCnVFcVKtyA5TyAqiYwv5iNoOvrTsfbP4JVCVgx7vsePH2aLZ0ulIOTk5oM47Unsh57rpGcyMiN3OVUZJzKTxNSZxCxYGc4CLlRgl8bowXqiiMg4zAhPIwuMe2y6rUDxjEXiS1EpmJI8M9N5Bo40ah5hN3EhLa3Yg975c0vWgRO9Le0sG5Te3cjthuv9hpx7R1irItitFii7H52dCM7EZnKLLUOF9pQOA89jx4xO63RDJ8BU3x2J-43oi9bKlmaCEM7_nqZJpW6zO8CL8bTUn8zJ4lhb-PM51_TOzNw39_9Sm7tjxKDtKD_cMPj9h1nwoW2_jiXba9WTf6MWpRm-yJZZYfaSwYAw
linkToPdf http://utb.summon.serialssolutions.com/2.0.0/link/0/eLvHCXMwnV3di9QwEA_HCYcven6vnjqKyPnQpR9Jt9WnZdf1Tt3zEE_uQQhpk8gibZftFsG_wj_ZmfRDTxHEh0JpGpomM8lvJjO_MPYk1iLmqQ09ZbPc40InnhK5xgGxSoVW8dA53JYn8dEZf30uznfYiz4XpuWHGBxupBluviYFX2v7i5Lrqhgj1g_RXr_EY0QShIje_-SO4pE7HQ9nAlT5lMJ49vswnqHqxcXoD4Q50IdeRK5u6VlcZZ_6RrcRJ1_GzTYb599-43P8z7_aZ1c6SArTVoausR1TXmd7y27T_Qb7fkonKdRGA_GQFE0BG0Pxw86xWAOiXihc7jQ4gnIUXagsUAz8qmyqpoYuLB4KN3-QIxEOZ6-Wz6Clka6fwxRoh2JdrcotUMILICyF48VsBl9bZz647BOoSsCKN9nZ4uWH2ZHXHeTg5cQ14ykTiJznvm8NtyLxM19brThXIjCUwil0GqkJjlFutcDn1gaxTuI0yohKKI-jW2y3rEpzh0EaJMpokdk0sTzwI4UWbhIbPvEnMXHdjdjjfkTluuXrkL2dg30rXd-O2EE_1rJT2VrizJakaK-lWPxoKEZlox0UVRrsLxkRNY_bDR6x262MDF9BQzwNJ34wYk9boRlKiMF7vvo4ldXmM17E3o2GJH7m0EnC39sp5--W7ubuv7_6kO2dzhfy7fHJm3vsckinFbvg4gO2u9005j5CqG32wKnKDxS6FrI
openUrl ctx_ver=Z39.88-2004&ctx_enc=info%3Aofi%2Fenc%3AUTF-8&rfr_id=info%3Asid%2Fsummon.serialssolutions.com&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=Proposed+minimum+requirements+for+market+approval+of+continuous+glucose+monitoring+%28+CGM+%29+systems%3A+A+viewpoint+from+the+IFCC+working+group+on+CGM&rft.jtitle=Diabetes%2C+obesity+%26+metabolism&rft.au=Pleus%2C+Stefan&rft.au=Eichenlaub%2C+Manuel&rft.au=Eriksson+Boija%2C+Elisabet&rft.au=Diem%2C+Peter&rft.date=2025-07-01&rft.issn=1462-8902&rft.eissn=1463-1326&rft.volume=27&rft.issue=7&rft.spage=4039&rft.epage=4042&rft_id=info:doi/10.1111%2Fdom.16420&rft.externalDBID=n%2Fa&rft.externalDocID=10_1111_dom_16420
thumbnail_l http://covers-cdn.summon.serialssolutions.com/index.aspx?isbn=/lc.gif&issn=1462-8902&client=summon
thumbnail_m http://covers-cdn.summon.serialssolutions.com/index.aspx?isbn=/mc.gif&issn=1462-8902&client=summon
thumbnail_s http://covers-cdn.summon.serialssolutions.com/index.aspx?isbn=/sc.gif&issn=1462-8902&client=summon