Continuous glucose monitoring and metrics for clinical trials: an international consensus statement
Tadej Battelino
(1, 2)
,
Charles Alexander
(3)
,
Stephanie Amiel
(4)
,
Guillermo Arreaza-Rubin
(5)
,
Roy Beck
(6)
,
Richard Bergenstal
(7)
,
Bruce Buckingham
(8)
,
James Carroll
(3)
,
Antonio Ceriello
(9)
,
Elaine Chow
(10)
,
Pratik Choudhary
(11)
,
Kelly Close
(3)
,
Thomas Danne
(12)
,
Sanjoy Dutta
(13)
,
Robert Gabbay
(14)
,
Satish Garg
(15, 16)
,
Julie Heverly
(3)
,
Irl Hirsch
(17)
,
Tina Kader
(18)
,
Julia Kenney
(3)
,
Boris Kovatchev
(19)
,
Lori Laffel
(14)
,
David Maahs
(20)
,
Chantal Mathieu
(21)
,
Dídac Mauricio
(22)
,
Revital Nimri
(23)
,
Rimei Nishimura
(24)
,
Mauro Scharf
,
Stefano del Prato
(25)
,
Eric Renard
(26, 27, 28)
,
Julio Rosenstock
(29)
,
Banshi Saboo
(30)
,
Kohjiro Ueki
(31)
,
Guillermo Umpierrez
(32)
,
Stuart Weinzimer
(33)
,
Moshe Phillip
(34, 23)
1
UMCL -
University Medical Centre Ljubljana [Ljubljana, Slovenia]
2 University of Ljubljana
3 The diaTribe Foundation
4 King‘s College London
5 National Institute of Diabetes and Digestive and Kidney Diseases [Bethesda]
6 Jaeb Center for Health Research
7 International Diabetes Center
8 Stanford School of Medicine [Stanford]
9 IRCCS - Istituti di Ricovero e Cura a Carattere Scientifico
10 CUHK - The Chinese University of Hong Kong [Hong Kong]
11 University of Leicester
12 Children's Hospital "Auf der Bult"
13 JDRF - Greater NYC Chapter
14 HMS - Harvard Medical School [Boston]
15 BDC - Barbara Davis Center for Childhood Diabetes
16 University of Colorado [Denver]
17 University of Washington [Seattle]
18 Jewish General Hospital
19 University of Virginia
20 Stanford University
21 KU-IBBT - FUTURE HEALTH DEPARTMENT [KU Leuven]
22 CIBERDEM - Centro de Investigación Biomédica en Red de Diabetes y Enfermedades Metabólicas Asociadas
23 SCMC - Schneider Children’s Medical Center [Petah Tikva, Israel]
24 The Jikei University School of Medicine
25 University of Pisa - Università di Pisa
26 CHRU Montpellier - Centre Hospitalier Régional Universitaire [Montpellier]
27 IGF - Institut de Génomique Fonctionnelle
28 CIC Montpellier
29 University of Texas Southwestern Medical Center [Dallas]
30 Ahmedabad University
31 NCGM - National Center for Global Health and Medicine [Japan]
32 Emory University School of Medicine
33 Yale University [New Haven]
34 Sackler Faculty of Medicine
2 University of Ljubljana
3 The diaTribe Foundation
4 King‘s College London
5 National Institute of Diabetes and Digestive and Kidney Diseases [Bethesda]
6 Jaeb Center for Health Research
7 International Diabetes Center
8 Stanford School of Medicine [Stanford]
9 IRCCS - Istituti di Ricovero e Cura a Carattere Scientifico
10 CUHK - The Chinese University of Hong Kong [Hong Kong]
11 University of Leicester
12 Children's Hospital "Auf der Bult"
13 JDRF - Greater NYC Chapter
14 HMS - Harvard Medical School [Boston]
15 BDC - Barbara Davis Center for Childhood Diabetes
16 University of Colorado [Denver]
17 University of Washington [Seattle]
18 Jewish General Hospital
19 University of Virginia
20 Stanford University
21 KU-IBBT - FUTURE HEALTH DEPARTMENT [KU Leuven]
22 CIBERDEM - Centro de Investigación Biomédica en Red de Diabetes y Enfermedades Metabólicas Asociadas
23 SCMC - Schneider Children’s Medical Center [Petah Tikva, Israel]
24 The Jikei University School of Medicine
25 University of Pisa - Università di Pisa
26 CHRU Montpellier - Centre Hospitalier Régional Universitaire [Montpellier]
27 IGF - Institut de Génomique Fonctionnelle
28 CIC Montpellier
29 University of Texas Southwestern Medical Center [Dallas]
30 Ahmedabad University
31 NCGM - National Center for Global Health and Medicine [Japan]
32 Emory University School of Medicine
33 Yale University [New Haven]
34 Sackler Faculty of Medicine
Tadej Battelino
Connectez-vous pour contacter l'auteur
- Fonction : Auteur correspondant
- PersonId : 1201961
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Mauro Scharf
- Fonction : Auteur
Résumé
Randomised controlled trials and other prospective clinical studies for novel medical interventions in people with diabetes have traditionally reported HbA1c as the measure of average blood glucose levels for the 3 months preceding the HbA1c test date. The use of this measure highlights the long-established correlation between HbA1c and relative risk of diabetes complications; the change in the measure, before and after the therapeutic intervention, is used by regulators for the approval of medications for diabetes. However, with the increasing use of continuous glucose monitoring (CGM) in clinical practice, prospective clinical studies are also increasingly using CGM devices to collect data and evaluate glucose profiles among study participants, complementing HbA1c findings, and further assess the effects of therapeutic interventions on HbA1c. Data is collected by CGM devices at 1-5 min intervals, which obtains data on glycaemic excursions and periods of asymptomatic hypoglycaemia or hyperglycaemia (ie, details of glycaemic control that are not provided by HbA1c concentrations alone that are measured continuously and can be analysed in daily, weekly, or monthly timeframes). These CGM-derived metrics are the subject of standardised, internationally agreed reporting formats and should, therefore, be considered for use in all clinical studies in diabetes. The purpose of this consensus statement is to recommend the ways CGM data might be used in prospective clinical studies, either as a specified study endpoint or as supportive complementary glucose metrics, to provide clinical information that can be considered by investigators, regulators, companies, clinicians, and individuals with diabetes who are stakeholders in trial outcomes. In this consensus statement, we provide recommendations on how to optimise CGM-derived glucose data collection in clinical studies, including the specific glucose metrics and specific glucose metrics that should be evaluated. These recommendations have been endorsed by the American Association of Clinical Endocrinologists, the American Diabetes Association, the Association of Diabetes Care and Education Specialists, DiabetesIndia, the European Association for the Study of Diabetes, the International Society for Pediatric and Adolescent Diabetes, the Japanese Diabetes Society, and the Juvenile Diabetes Research Foundation. A standardised approach to CGM data collection and reporting in clinical trials will encourage the use of these metrics and enhance the interpretability of CGM data, which could provide useful information other than HbA1c for informing therapeutic and treatment decisions, particularly related to hypoglycaemia, postprandial hyperglycaemia, and glucose variability.
Format du dépôt | Notice |
---|---|
Type de dépôt | Article dans une revue (data paper) |
Titre |
en
Continuous glucose monitoring and metrics for clinical trials: an international consensus statement
|
Résumé |
en
Randomised controlled trials and other prospective clinical studies for novel medical interventions in people with diabetes have traditionally reported HbA1c as the measure of average blood glucose levels for the 3 months preceding the HbA1c test date. The use of this measure highlights the long-established correlation between HbA1c and relative risk of diabetes complications; the change in the measure, before and after the therapeutic intervention, is used by regulators for the approval of medications for diabetes. However, with the increasing use of continuous glucose monitoring (CGM) in clinical practice, prospective clinical studies are also increasingly using CGM devices to collect data and evaluate glucose profiles among study participants, complementing HbA1c findings, and further assess the effects of therapeutic interventions on HbA1c. Data is collected by CGM devices at 1-5 min intervals, which obtains data on glycaemic excursions and periods of asymptomatic hypoglycaemia or hyperglycaemia (ie, details of glycaemic control that are not provided by HbA1c concentrations alone that are measured continuously and can be analysed in daily, weekly, or monthly timeframes). These CGM-derived metrics are the subject of standardised, internationally agreed reporting formats and should, therefore, be considered for use in all clinical studies in diabetes. The purpose of this consensus statement is to recommend the ways CGM data might be used in prospective clinical studies, either as a specified study endpoint or as supportive complementary glucose metrics, to provide clinical information that can be considered by investigators, regulators, companies, clinicians, and individuals with diabetes who are stakeholders in trial outcomes. In this consensus statement, we provide recommendations on how to optimise CGM-derived glucose data collection in clinical studies, including the specific glucose metrics and specific glucose metrics that should be evaluated. These recommendations have been endorsed by the American Association of Clinical Endocrinologists, the American Diabetes Association, the Association of Diabetes Care and Education Specialists, DiabetesIndia, the European Association for the Study of Diabetes, the International Society for Pediatric and Adolescent Diabetes, the Japanese Diabetes Society, and the Juvenile Diabetes Research Foundation. A standardised approach to CGM data collection and reporting in clinical trials will encourage the use of these metrics and enhance the interpretability of CGM data, which could provide useful information other than HbA1c for informing therapeutic and treatment decisions, particularly related to hypoglycaemia, postprandial hyperglycaemia, and glucose variability.
|
Auteur(s) |
Tadej Battelino
1, 2
, Charles Alexander
3
, Stephanie Amiel
4
, Guillermo Arreaza-Rubin
5
, Roy Beck
6
, Richard Bergenstal
7
, Bruce Buckingham
8
, James Carroll
3
, Antonio Ceriello
9
, Elaine Chow
10
, Pratik Choudhary
11
, Kelly Close
3
, Thomas Danne
12
, Sanjoy Dutta
13
, Robert Gabbay
14
, Satish Garg
15, 16
, Julie Heverly
3
, Irl Hirsch
17
, Tina Kader
18
, Julia Kenney
3
, Boris Kovatchev
19
, Lori Laffel
14
, David Maahs
20
, Chantal Mathieu
21
, Dídac Mauricio
22
, Revital Nimri
23
, Rimei Nishimura
24
, Mauro Scharf
, Stefano del Prato
25
, Eric Renard
26, 27, 28
, Julio Rosenstock
29
, Banshi Saboo
30
, Kohjiro Ueki
31
, Guillermo Umpierrez
32
, Stuart Weinzimer
33
, Moshe Phillip
34, 23
1
UMCL -
University Medical Centre Ljubljana [Ljubljana, Slovenia]
( 562611 )
- Ljubljana
- Slovénie
2
University of Ljubljana
( 302844 )
- Kongresni trg 12, 1000 Ljubljana
- Slovénie
3
The diaTribe Foundation
( 1097143 )
- 776 Haight Street
San Francisco, CA 94117
- États-Unis
4
King‘s College London
( 327716 )
- Strand Campus, London WC2R 2LS
- Royaume-Uni
5
National Institute of Diabetes and Digestive and Kidney Diseases [Bethesda]
( 306976 )
- Bethesda, MD 20892
- États-Unis
6
Jaeb Center for Health Research
( 1057138 )
- États-Unis
7
International Diabetes Center
( 1084845 )
- 3800 Park Nicollet Blvd,
St Louis Park,
MN 55416
- États-Unis
8
Stanford School of Medicine [Stanford]
( 179626 )
- Stanford University, Stanford Medicine, 291 Campus Drive, Stanford, CA 94305
- États-Unis
9
IRCCS -
Istituti di Ricovero e Cura a Carattere Scientifico
( 363961 )
- Italie
10
CUHK -
The Chinese University of Hong Kong [Hong Kong]
( 93116 )
- Shatin, NT, Hong Kong SAR
- Chine
11
University of Leicester
( 300751 )
- University Rd, Leicester LE1 7RH
- Royaume-Uni
12
Children's Hospital "Auf der Bult"
( 199605 )
- Allemagne
13
JDRF -
Greater NYC Chapter
( 1078852 )
- JDRF
200 Vesey Street, 28th Floor
New York, NY 10281
- États-Unis
14
HMS -
Harvard Medical School [Boston]
( 130467 )
- 25 Shattuck Street Boston, MA 02115
- États-Unis
15
BDC -
Barbara Davis Center for Childhood Diabetes
( 241707 )
- Anschutz Medical Campus, Aurora, CO, USA
- États-Unis
16
University of Colorado [Denver]
( 475301 )
- 1250 14th Street, Denver, Colorado 303-315-5969
- États-Unis
17
University of Washington [Seattle]
( 300433 )
- Seattle, Washington 98105
- États-Unis
18
Jewish General Hospital
( 264903 )
- 3755 Côte Ste-Catherine Road, Montreal, Quebec H3T 1E2
- Canada
19
University of Virginia
( 329139 )
- P.O. Box 400229, Charlottesville, VA 22904-4229
- États-Unis
20
Stanford University
( 73500 )
- 450 Serra Mall, Stanford, CA 94305-2004
- États-Unis
21
KU-IBBT -
FUTURE HEALTH DEPARTMENT [KU Leuven]
( 478873 )
- Belgique
22
CIBERDEM -
Centro de Investigación Biomédica en Red de Diabetes y Enfermedades Metabólicas Asociadas
( 207806 )
- Passeig de la Bonanova, 69, 6a Planta 08017 Barcelona
- Espagne
23
SCMC -
Schneider Children’s Medical Center [Petah Tikva, Israel]
( 1123719 )
- Petah Tiqwa
- Israël
24
The Jikei University School of Medicine
( 416726 )
- 3-25-8, Nishi-Shimbashi, Minato-ku,Tokyo, 105-8461
- Japon
25
University of Pisa - Università di Pisa
( 366408 )
- Lungarno Pacinotti 43 - 56126 Pisa
- Italie
26
CHRU Montpellier -
Centre Hospitalier Régional Universitaire [Montpellier]
( 258773 )
- 191 avenue du doyen Gaston Giraud 34295 Montpellier
- France
27
IGF -
Institut de Génomique Fonctionnelle
( 1100822 )
- 141, Rue de la Cardonille 34094 Montpellier cedex 5
- France
28
CIC Montpellier
( 417877 )
- 80 Avenue Augustin Fliche 34295 Montpellier Cedex 5
- France
29
University of Texas Southwestern Medical Center [Dallas]
( 142536 )
- 5323 Harry Hines Boulevard Dallas, Texas, 75390
- États-Unis
30
Ahmedabad University
( 438737 )
- Inde
31
NCGM -
National Center for Global Health and Medicine [Japan]
( 458502 )
- 〒162-8655, 1-21-1 Toyama, Shinjuku-ku, Tokyo
- Japon
32
Emory University School of Medicine
( 142636 )
- États-Unis
33
Yale University [New Haven]
( 46674 )
- 157 Church Street, New Haven, CT 06510-2100
- États-Unis
34
Sackler Faculty of Medicine
( 425188 )
- Tel Aviv 69978
- Israël
|
Date de publication |
2023-01
|
Date de publication électronique |
2022-12
|
Volume |
11
|
Numéro |
1
|
Page/Identifiant |
42-57
|
Nom de la revue |
|
Langue du document |
Anglais
|
Vulgarisation |
Non
|
Comité de lecture |
Oui
|
Audience |
Internationale
|
Domaine(s) |
|
DOI | 10.1016/S2213-8587(22)00319-9 |
Pubmed Id | 36493795 |
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