Do continuous glucose monitoring (CGM) metrics predict macrovascular and microvascular complications in diabetes? The FACULTY protocol of a retrospective real-world cohort study
Introduction Glycated haemoglobin (HbA1c) is currently the gold standard for assessing glycaemic control in diabetes, given the established relationship with microvascular and macrovascular complications in this condition. However, HbA1c is affected by non-glycaemic factors, while also failing to pr...
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BMJ Publishing Group
2025-01-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/15/1/e085961.full |
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| author | Eric Vicaut Ramzi A Ajjan J Seufert Gérard de Pouvourville Emmanuel Cosson Laure Carcaillon-Bentata Tadej Battelino Patrick Blin Fleur Levrat-Guillen Michael Joubert |
| author_facet | Eric Vicaut Ramzi A Ajjan J Seufert Gérard de Pouvourville Emmanuel Cosson Laure Carcaillon-Bentata Tadej Battelino Patrick Blin Fleur Levrat-Guillen Michael Joubert |
| author_sort | Eric Vicaut |
| collection | DOAJ |
| description | Introduction Glycated haemoglobin (HbA1c) is currently the gold standard for assessing glycaemic control in diabetes, given the established relationship with microvascular and macrovascular complications in this condition. However, HbA1c is affected by non-glycaemic factors, while also failing to provide data on hypoglycaemic exposure and glucose variability, which are associated with adverse vascular outcomes. Continuous glucose monitoring (CGM)-derived glucose metrics provide a more comprehensive assessment of glycaemia, but their role in predicting future vascular complications remains unclear. Here, we present the protocol for a real-world cohort study, aiming to establish the relationship between CGM-derived glycaemic metrics and the incidence of macrovascular and/or microvascular complications in people with diabetes.Methods and analysis This cohort study will use data from all CGM new users (FreeStyle Libre system) in France who uploaded their glycaemic values onto the LibreView cloud-based system, linked with data from the French nationwide Système National des Données de Santé claims database. The study is expected to include a minimum of 70 000 individuals with diabetes with a first date of glucose data upload to the LibreView platform after 1 January 2018 and with a 6-year follow-up period. The primary outcomes are the first occurrence of new macrovascular or microvascular complications, analysed as a composite outcome and separately. Secondary outcomes will include all-cause mortality and hospital admissions for any cause. This longitudinal study will provide key data on the relationship between CGM-derived glycaemic metrics and micro/macrovascular complications in diabetes. This will have an impact on routine clinical practice by setting targets for the different glycaemic markers, based on robust outcome data, thus helping to optimise glucose management in diabetes.Ethics and dissemination The study data-collection protocol is approved by the French National Commission for Informatics and Liberties, including approval from the Comité Ethique et Scientifique pour les Recherches, les Etudes et les Evaluations dans le domaine de la Santé. This study complies with French and European regulations, including those relating to the General Data Protection Regulation. This study uses pseudonymous information, not requiring informed consent. Dissemination plans include full publication of the study outcomes in peer-reviewed journal(s) with open access and presentations at national and international diabetes and cardiovascular conferences. |
| format | Article |
| id | doaj-art-c7abd20d364d4d5ca637ffe2efac61fc |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2025-01-01 |
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| series | BMJ Open |
| spelling | doaj-art-c7abd20d364d4d5ca637ffe2efac61fc2025-01-09T10:45:11ZengBMJ Publishing GroupBMJ Open2044-60552025-01-0115110.1136/bmjopen-2024-085961Do continuous glucose monitoring (CGM) metrics predict macrovascular and microvascular complications in diabetes? The FACULTY protocol of a retrospective real-world cohort studyEric Vicaut0Ramzi A Ajjan1J Seufert2Gérard de Pouvourville3Emmanuel Cosson4Laure Carcaillon-Bentata5Tadej Battelino6Patrick Blin7Fleur Levrat-Guillen8Michael Joubert9Clinical Research Unit, Fernand Vidal Hospital, Paris, FranceThe LIGHT Laboratories, Leeds Institute of Cardiovascular and Metabolic Medicine, University of Leeds, Leeds, UKDepartment of Endocrinology and Diabetology, Department of Medicine II, Medical Centre, University of Freiburg, Freiburg, GermanyDepartment of Economics, ESSEC Business School, Cergy-Pontoise, FranceDepartment of Endocrinology-Diabetology-Nutrition, CINFO, Bobigny, FranceUniversity of Bordeaux, INSERM CIC-P 1401, Bordeaux PharmacoEpi, Bordeaux, FranceDepartment of Endocrinology, Diabetes and Metabolism, University Children`s Hospital, University Medical Center Ljubljana and Faculty of Medicine, University of Lubljana, Ljubljana, SloveniaUniversity of Bordeaux, INSERM CIC-P 1401, Bordeaux PharmacoEpi, Bordeaux, FranceAbbott Laboratories, Maidenhead, Berkshire, UKDiabetes Care Unit, Caen University Hospital, Caen cedex 09, FranceIntroduction Glycated haemoglobin (HbA1c) is currently the gold standard for assessing glycaemic control in diabetes, given the established relationship with microvascular and macrovascular complications in this condition. However, HbA1c is affected by non-glycaemic factors, while also failing to provide data on hypoglycaemic exposure and glucose variability, which are associated with adverse vascular outcomes. Continuous glucose monitoring (CGM)-derived glucose metrics provide a more comprehensive assessment of glycaemia, but their role in predicting future vascular complications remains unclear. Here, we present the protocol for a real-world cohort study, aiming to establish the relationship between CGM-derived glycaemic metrics and the incidence of macrovascular and/or microvascular complications in people with diabetes.Methods and analysis This cohort study will use data from all CGM new users (FreeStyle Libre system) in France who uploaded their glycaemic values onto the LibreView cloud-based system, linked with data from the French nationwide Système National des Données de Santé claims database. The study is expected to include a minimum of 70 000 individuals with diabetes with a first date of glucose data upload to the LibreView platform after 1 January 2018 and with a 6-year follow-up period. The primary outcomes are the first occurrence of new macrovascular or microvascular complications, analysed as a composite outcome and separately. Secondary outcomes will include all-cause mortality and hospital admissions for any cause. This longitudinal study will provide key data on the relationship between CGM-derived glycaemic metrics and micro/macrovascular complications in diabetes. This will have an impact on routine clinical practice by setting targets for the different glycaemic markers, based on robust outcome data, thus helping to optimise glucose management in diabetes.Ethics and dissemination The study data-collection protocol is approved by the French National Commission for Informatics and Liberties, including approval from the Comité Ethique et Scientifique pour les Recherches, les Etudes et les Evaluations dans le domaine de la Santé. This study complies with French and European regulations, including those relating to the General Data Protection Regulation. This study uses pseudonymous information, not requiring informed consent. Dissemination plans include full publication of the study outcomes in peer-reviewed journal(s) with open access and presentations at national and international diabetes and cardiovascular conferences.https://bmjopen.bmj.com/content/15/1/e085961.full |
| spellingShingle | Eric Vicaut Ramzi A Ajjan J Seufert Gérard de Pouvourville Emmanuel Cosson Laure Carcaillon-Bentata Tadej Battelino Patrick Blin Fleur Levrat-Guillen Michael Joubert Do continuous glucose monitoring (CGM) metrics predict macrovascular and microvascular complications in diabetes? The FACULTY protocol of a retrospective real-world cohort study BMJ Open |
| title | Do continuous glucose monitoring (CGM) metrics predict macrovascular and microvascular complications in diabetes? The FACULTY protocol of a retrospective real-world cohort study |
| title_full | Do continuous glucose monitoring (CGM) metrics predict macrovascular and microvascular complications in diabetes? The FACULTY protocol of a retrospective real-world cohort study |
| title_fullStr | Do continuous glucose monitoring (CGM) metrics predict macrovascular and microvascular complications in diabetes? The FACULTY protocol of a retrospective real-world cohort study |
| title_full_unstemmed | Do continuous glucose monitoring (CGM) metrics predict macrovascular and microvascular complications in diabetes? The FACULTY protocol of a retrospective real-world cohort study |
| title_short | Do continuous glucose monitoring (CGM) metrics predict macrovascular and microvascular complications in diabetes? The FACULTY protocol of a retrospective real-world cohort study |
| title_sort | do continuous glucose monitoring cgm metrics predict macrovascular and microvascular complications in diabetes the faculty protocol of a retrospective real world cohort study |
| url | https://bmjopen.bmj.com/content/15/1/e085961.full |
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