Reducing the burden of hypoglycaemia in people with diabetes through increased understanding: design of the Hypoglycaemia Redefining Solutions for Better Lives (Hypo-RESOLVE) project

B. E. de Galan; R. J. McCrimmon; M. Ibberson; S. R. Heller; P. Choudhary; F. Pouwer; J. Speight; J. Carlton; T. R. Pieber; M. Rosilio; C. J. Tack; M. Müllenborn; Hypo-RESOLVE Consortium

doi:10.1111/dme.14240

Reducing the burden of hypoglycaemia in people with diabetes through increased understanding: design of the Hypoglycaemia Redefining Solutions for Better Lives (Hypo-RESOLVE) project

B. E. de Galan (Lead / Corresponding author), R. J. McCrimmon, M. Ibberson, S. R. Heller, P. Choudhary, F. Pouwer, J. Speight, J. Carlton, T. R. Pieber, M. Rosilio, C. J. Tack, M. Müllenborn, Hypo-RESOLVE Consortium

Research output: Contribution to journal › Article › peer-review

27 Citations (Scopus)

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Abstract

Background: Hypoglycaemia is the most frequent complication of treatment with insulin or insulin secretagogues in people with diabetes. Severe hypoglycaemia, i.e. an event requiring external help because of cognitive dysfunction, is associated with a higher risk of adverse cardiovascular outcomes and all-cause mortality, but underlying mechanism(s) are poorly understood. There is also a gap in the understanding of the clinical, psychological and health economic impact of ‘non-severe’ hypoglycaemia and the glucose level below which hypoglycaemia causes harm.

Aim: To increase understanding of hypoglycaemia by addressing the above issues over a 4-year period. Methods: Hypo-RESOLVE is structured across eight work packages, each with a distinct focus. We will construct a large, sustainable database including hypoglycaemia data from >100 clinical trials to examine predictors of hypoglycaemia and establish glucose threshold(s) below which hypoglycaemia constitutes a risk for adverse biomedical and psychological outcomes, and increases healthcare costs. We will also investigate the mechanism(s) underlying the antecedents and consequences of hypoglycaemia, the significance of glucose sensor-detected hypoglycaemia, the impact of hypoglycaemia in families, and the costs of hypoglycaemia for healthcare systems.

Results: The outcomes of Hypo-RESOLVE will inform evidence-based definitions regarding the classification of hypoglycaemia in diabetes for use in daily clinical practice, future clinical trials and as a benchmark for comparing glucose-lowering interventions and strategies across trials. Stakeholders will be engaged to achieve broadly adopted agreement.

Conclusion: Hypo-RESOLVE will advance our understanding and refine the classification of hypoglycaemia, with the ultimate aim being to alleviate the burden and consequences of hypoglycaemia in people with diabetes.

Original language	English
Pages (from-to)	1066-1073
Number of pages	8
Journal	Diabetic Medicine
Volume	37
Issue number	6
Early online date	22 Jan 2020
DOIs	https://doi.org/10.1111/dme.14240
Publication status	Published - 22 May 2020

ASJC Scopus subject areas

Internal Medicine
Endocrinology, Diabetes and Metabolism
Endocrinology

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.1111/dme.14240Licence: CC BY-NC-ND

Final Published VersionFinal published version, 602 KBLicence: CC BY-NC-ND

Cite this

de Galan, B. E., McCrimmon, R. J., Ibberson, M., Heller, S. R., Choudhary, P., Pouwer, F., Speight, J., Carlton, J., Pieber, T. R., Rosilio, M., Tack, C. J., Müllenborn, M., & Hypo-RESOLVE Consortium (2020). Reducing the burden of hypoglycaemia in people with diabetes through increased understanding: design of the Hypoglycaemia Redefining Solutions for Better Lives (Hypo-RESOLVE) project. Diabetic Medicine, 37(6), 1066-1073. https://doi.org/10.1111/dme.14240

@article{2661ab28adfa4579947007af3677267f,

title = "Reducing the burden of hypoglycaemia in people with diabetes through increased understanding: design of the Hypoglycaemia Redefining Solutions for Better Lives (Hypo-RESOLVE) project",

abstract = "Background: Hypoglycaemia is the most frequent complication of treatment with insulin or insulin secretagogues in people with diabetes. Severe hypoglycaemia, i.e. an event requiring external help because of cognitive dysfunction, is associated with a higher risk of adverse cardiovascular outcomes and all-cause mortality, but underlying mechanism(s) are poorly understood. There is also a gap in the understanding of the clinical, psychological and health economic impact of {\textquoteleft}non-severe{\textquoteright} hypoglycaemia and the glucose level below which hypoglycaemia causes harm.Aim: To increase understanding of hypoglycaemia by addressing the above issues over a 4-year period. Methods: Hypo-RESOLVE is structured across eight work packages, each with a distinct focus. We will construct a large, sustainable database including hypoglycaemia data from >100 clinical trials to examine predictors of hypoglycaemia and establish glucose threshold(s) below which hypoglycaemia constitutes a risk for adverse biomedical and psychological outcomes, and increases healthcare costs. We will also investigate the mechanism(s) underlying the antecedents and consequences of hypoglycaemia, the significance of glucose sensor-detected hypoglycaemia, the impact of hypoglycaemia in families, and the costs of hypoglycaemia for healthcare systems.Results: The outcomes of Hypo-RESOLVE will inform evidence-based definitions regarding the classification of hypoglycaemia in diabetes for use in daily clinical practice, future clinical trials and as a benchmark for comparing glucose-lowering interventions and strategies across trials. Stakeholders will be engaged to achieve broadly adopted agreement.Conclusion: Hypo-RESOLVE will advance our understanding and refine the classification of hypoglycaemia, with the ultimate aim being to alleviate the burden and consequences of hypoglycaemia in people with diabetes.",

author = "{de Galan}, {B. E.} and McCrimmon, {R. J.} and M. Ibberson and Heller, {S. R.} and P. Choudhary and F. Pouwer and J. Speight and J. Carlton and Pieber, {T. R.} and M. Rosilio and Tack, {C. J.} and M. M{\"u}llenborn and {Hypo-RESOLVE Consortium}",

note = "Hypo-RESOLVE has received funding from the Innovative Medicines Initiative 2 Joint Undertaking (JU) under grant agreement No 777460. The JU receives support from the European Union{\textquoteright}s Horizon 2020 research and innovation programme and EFPIA and T1D Exchange, JDRF, International Diabetes Federation (IDF) and The Leona M. and Harry B. Helmsley Charitable Trust. The industry partners supporting the JU include Abbott Diabetes Care, Eli Lilly, Medtronic, Novo Nordisk and Sanofi-Aventis. 2020 Diabetes UK.",

year = "2020",

month = may,

day = "22",

doi = "10.1111/dme.14240",

language = "English",

volume = "37",

pages = "1066--1073",

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de Galan, BE, McCrimmon, RJ, Ibberson, M, Heller, SR, Choudhary, P, Pouwer, F, Speight, J, Carlton, J, Pieber, TR, Rosilio, M, Tack, CJ, Müllenborn, M & Hypo-RESOLVE Consortium 2020, 'Reducing the burden of hypoglycaemia in people with diabetes through increased understanding: design of the Hypoglycaemia Redefining Solutions for Better Lives (Hypo-RESOLVE) project', Diabetic Medicine, vol. 37, no. 6, pp. 1066-1073. https://doi.org/10.1111/dme.14240

Reducing the burden of hypoglycaemia in people with diabetes through increased understanding: design of the Hypoglycaemia Redefining Solutions for Better Lives (Hypo-RESOLVE) project. / de Galan, B. E. (Lead / Corresponding author); McCrimmon, R. J.; Ibberson, M. et al.
In: Diabetic Medicine, Vol. 37, No. 6, 22.05.2020, p. 1066-1073.

Research output: Contribution to journal › Article › peer-review

TY - JOUR

T1 - Reducing the burden of hypoglycaemia in people with diabetes through increased understanding

T2 - design of the Hypoglycaemia Redefining Solutions for Better Lives (Hypo-RESOLVE) project

AU - de Galan, B. E.

AU - McCrimmon, R. J.

AU - Ibberson, M.

AU - Heller, S. R.

AU - Choudhary, P.

AU - Pouwer, F.

AU - Speight, J.

AU - Carlton, J.

AU - Pieber, T. R.

AU - Rosilio, M.

AU - Tack, C. J.

AU - Müllenborn, M.

AU - Hypo-RESOLVE Consortium

N1 - Hypo-RESOLVE has received funding from the Innovative Medicines Initiative 2 Joint Undertaking (JU) under grant agreement No 777460. The JU receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA and T1D Exchange, JDRF, International Diabetes Federation (IDF) and The Leona M. and Harry B. Helmsley Charitable Trust. The industry partners supporting the JU include Abbott Diabetes Care, Eli Lilly, Medtronic, Novo Nordisk and Sanofi-Aventis. 2020 Diabetes UK.

PY - 2020/5/22

Y1 - 2020/5/22

N2 - Background: Hypoglycaemia is the most frequent complication of treatment with insulin or insulin secretagogues in people with diabetes. Severe hypoglycaemia, i.e. an event requiring external help because of cognitive dysfunction, is associated with a higher risk of adverse cardiovascular outcomes and all-cause mortality, but underlying mechanism(s) are poorly understood. There is also a gap in the understanding of the clinical, psychological and health economic impact of ‘non-severe’ hypoglycaemia and the glucose level below which hypoglycaemia causes harm.Aim: To increase understanding of hypoglycaemia by addressing the above issues over a 4-year period. Methods: Hypo-RESOLVE is structured across eight work packages, each with a distinct focus. We will construct a large, sustainable database including hypoglycaemia data from >100 clinical trials to examine predictors of hypoglycaemia and establish glucose threshold(s) below which hypoglycaemia constitutes a risk for adverse biomedical and psychological outcomes, and increases healthcare costs. We will also investigate the mechanism(s) underlying the antecedents and consequences of hypoglycaemia, the significance of glucose sensor-detected hypoglycaemia, the impact of hypoglycaemia in families, and the costs of hypoglycaemia for healthcare systems.Results: The outcomes of Hypo-RESOLVE will inform evidence-based definitions regarding the classification of hypoglycaemia in diabetes for use in daily clinical practice, future clinical trials and as a benchmark for comparing glucose-lowering interventions and strategies across trials. Stakeholders will be engaged to achieve broadly adopted agreement.Conclusion: Hypo-RESOLVE will advance our understanding and refine the classification of hypoglycaemia, with the ultimate aim being to alleviate the burden and consequences of hypoglycaemia in people with diabetes.

AB - Background: Hypoglycaemia is the most frequent complication of treatment with insulin or insulin secretagogues in people with diabetes. Severe hypoglycaemia, i.e. an event requiring external help because of cognitive dysfunction, is associated with a higher risk of adverse cardiovascular outcomes and all-cause mortality, but underlying mechanism(s) are poorly understood. There is also a gap in the understanding of the clinical, psychological and health economic impact of ‘non-severe’ hypoglycaemia and the glucose level below which hypoglycaemia causes harm.Aim: To increase understanding of hypoglycaemia by addressing the above issues over a 4-year period. Methods: Hypo-RESOLVE is structured across eight work packages, each with a distinct focus. We will construct a large, sustainable database including hypoglycaemia data from >100 clinical trials to examine predictors of hypoglycaemia and establish glucose threshold(s) below which hypoglycaemia constitutes a risk for adverse biomedical and psychological outcomes, and increases healthcare costs. We will also investigate the mechanism(s) underlying the antecedents and consequences of hypoglycaemia, the significance of glucose sensor-detected hypoglycaemia, the impact of hypoglycaemia in families, and the costs of hypoglycaemia for healthcare systems.Results: The outcomes of Hypo-RESOLVE will inform evidence-based definitions regarding the classification of hypoglycaemia in diabetes for use in daily clinical practice, future clinical trials and as a benchmark for comparing glucose-lowering interventions and strategies across trials. Stakeholders will be engaged to achieve broadly adopted agreement.Conclusion: Hypo-RESOLVE will advance our understanding and refine the classification of hypoglycaemia, with the ultimate aim being to alleviate the burden and consequences of hypoglycaemia in people with diabetes.

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U2 - 10.1111/dme.14240

DO - 10.1111/dme.14240

M3 - Article

C2 - 31970814

SN - 0742-3071

VL - 37

SP - 1066

EP - 1073

JO - Diabetic Medicine

JF - Diabetic Medicine

IS - 6

ER -

Reducing the burden of hypoglycaemia in people with diabetes through increased understanding: design of the Hypoglycaemia Redefining Solutions for Better Lives (Hypo-RESOLVE) project

Abstract

ASJC Scopus subject areas

UN SDGs

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Other files and links

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Hypoglycaemia - REdefining SOLutions for better liVEs (Hypo-RESOLVE) (Joint with Stichting Katholieke Universiteit, King's College London, Medizinische Universitat Graz and 19 others)

Cite this

Reducing the burden of hypoglycaemia in people with diabetes through increased understanding: design of the Hypoglycaemia Redefining Solutions for Better Lives (Hypo-RESOLVE) project

Abstract

ASJC Scopus subject areas

UN SDGs

Access to Document

Other files and links

Fingerprint

Projects

Hypoglycaemia - REdefining SOLutions for better liVEs (Hypo-RESOLVE) (Joint with Stichting Katholieke Universiteit, King's College London, Medizinische Universitat Graz and 19 others)

Cite this