Comparison of the HAT study, the largest global hypoglycaemia study to date, with similar large real-world studies

Ulrik Pedersen-Bjergaard; Saud Alsifri; Ronnie Aronson; Maja Cigrovski Berković; Gagik Galstyan; Helge Gydesen; Jesper Barner Lekdorf; Bernhard Ludvik; Erik Moberg; Ambady Ramachandran; Kamlesh Khunti

doi:10.1111/dom.13588

Comparison of the HAT study, the largest global hypoglycaemia study to date, with similar large real-world studies

Ulrik Pedersen-Bjergaard^*, Saud Alsifri, Ronnie Aronson, Maja Cigrovski Berković, Gagik Galstyan, Helge Gydesen, Jesper Barner Lekdorf, Bernhard Ludvik, Erik Moberg, Ambady Ramachandran, Kamlesh Khunti

^*Corresponding author for this work

Department of Clinical Medicine

3 Citations (Scopus)

38 Downloads (Pure)

Abstract

Aims: Optimal diabetes care requires clear understanding of the incidence of hypoglycaemia in real-world clinical practice. Current data on hypoglycaemia are generally limited to those reported from randomised controlled clinical trials. The Hypoglycaemia Assessment Tool (HAT) study, a non-interventional real-world study of hypoglycaemia, assessed hypoglycaemia in 27 585 individuals across 24 countries. The present study compared the incidence of hypoglycaemia from the HAT study with other similarly designed, large, real-world studies. Materials and Methods: A literature search of PubMed (1995-2017) for population-based studies of insulin-treated patients with type 1 or type 2 diabetes (T1D, T2D), excluding clinical trials and reviews, identified comparable population-based studies reporting the incidence of hypoglycaemia. Results: The 24 comparative studies, including more than 24 000 participants with T1D and more than 160 000 participants with T2D, varied in design, size, inclusion criteria, definitions of hypoglycaemia and method of recording hypoglycaemia. Reported rates (events per patient-year [PPY]) of hypoglycaemia were higher in patients with T1D than in those with T2D (overall T1D, 21.8-73.3 and T2D, 1.3-37.7; mild/non-severe T1D, 29.0-126.7 and T2D, 1.3-41.5; severe T1D, 0.7-5.8 and T2D, 0.0-2.5; nocturnal T1D, 2.6-11.3 and T2D, 0.38-9.7) and were similar to the ranges found in the HAT study. Conclusions: The HAT data on hypoglycaemia incidence were comparable with those from other real-world studies and indicate a high incidence of hypoglycaemia among insulin-treated patients. Differences in rates among studies are mostly explained by differences in patient populations and study methodology. The goal of reducing hypoglycaemia should be a target for continued educational and evidence-based pharmacological interventions.

Original language	English
Journal	Diabetes, Obesity and Metabolism
Volume	21
Issue number	4
Pages (from-to)	844-853
Number of pages	10
ISSN	1462-8902
DOIs	https://doi.org/10.1111/dom.13588
Publication status	Published - 2019

Keywords

hypoglycaemia
insulin therapy
observational study
systematic review
type 1 diabetes
type 2 diabetes

UN SDGs

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

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Comparison of the HAT study, the largest global hypoglycaemia study to date, with similar large real‐world studiesFinal published version, 799 KBLicence: CC BY-NC

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Pedersen-Bjergaard, U., Alsifri, S., Aronson, R., Berković, M. C., Galstyan, G., Gydesen, H., Lekdorf, J. B., Ludvik, B., Moberg, E., Ramachandran, A., & Khunti, K. (2019). Comparison of the HAT study, the largest global hypoglycaemia study to date, with similar large real-world studies. Diabetes, Obesity and Metabolism, 21(4), 844-853. https://doi.org/10.1111/dom.13588

Pedersen-Bjergaard, U, Alsifri, S, Aronson, R, Berković, MC, Galstyan, G, Gydesen, H, Lekdorf, JB, Ludvik, B, Moberg, E, Ramachandran, A & Khunti, K 2019, 'Comparison of the HAT study, the largest global hypoglycaemia study to date, with similar large real-world studies', Diabetes, Obesity and Metabolism, vol. 21, no. 4, pp. 844-853. https://doi.org/10.1111/dom.13588

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title = "Comparison of the HAT study, the largest global hypoglycaemia study to date, with similar large real-world studies",

abstract = "Aims: Optimal diabetes care requires clear understanding of the incidence of hypoglycaemia in real-world clinical practice. Current data on hypoglycaemia are generally limited to those reported from randomised controlled clinical trials. The Hypoglycaemia Assessment Tool (HAT) study, a non-interventional real-world study of hypoglycaemia, assessed hypoglycaemia in 27 585 individuals across 24 countries. The present study compared the incidence of hypoglycaemia from the HAT study with other similarly designed, large, real-world studies. Materials and Methods: A literature search of PubMed (1995-2017) for population-based studies of insulin-treated patients with type 1 or type 2 diabetes (T1D, T2D), excluding clinical trials and reviews, identified comparable population-based studies reporting the incidence of hypoglycaemia. Results: The 24 comparative studies, including more than 24 000 participants with T1D and more than 160 000 participants with T2D, varied in design, size, inclusion criteria, definitions of hypoglycaemia and method of recording hypoglycaemia. Reported rates (events per patient-year [PPY]) of hypoglycaemia were higher in patients with T1D than in those with T2D (overall T1D, 21.8-73.3 and T2D, 1.3-37.7; mild/non-severe T1D, 29.0-126.7 and T2D, 1.3-41.5; severe T1D, 0.7-5.8 and T2D, 0.0-2.5; nocturnal T1D, 2.6-11.3 and T2D, 0.38-9.7) and were similar to the ranges found in the HAT study. Conclusions: The HAT data on hypoglycaemia incidence were comparable with those from other real-world studies and indicate a high incidence of hypoglycaemia among insulin-treated patients. Differences in rates among studies are mostly explained by differences in patient populations and study methodology. The goal of reducing hypoglycaemia should be a target for continued educational and evidence-based pharmacological interventions.",

keywords = "hypoglycaemia, insulin therapy, observational study, systematic review, type 1 diabetes, type 2 diabetes",

author = "Ulrik Pedersen-Bjergaard and Saud Alsifri and Ronnie Aronson and Berkovi{\'c}, {Maja Cigrovski} and Gagik Galstyan and Helge Gydesen and Lekdorf, {Jesper Barner} and Bernhard Ludvik and Erik Moberg and Ambady Ramachandran and Kamlesh Khunti",

year = "2019",

doi = "10.1111/dom.13588",

language = "English",

volume = "21",

pages = "844--853",

journal = "Diabetes, Obesity and Metabolism",

issn = "1462-8902",

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T1 - Comparison of the HAT study, the largest global hypoglycaemia study to date, with similar large real-world studies

AU - Pedersen-Bjergaard, Ulrik

AU - Alsifri, Saud

AU - Aronson, Ronnie

AU - Berković, Maja Cigrovski

AU - Galstyan, Gagik

AU - Gydesen, Helge

AU - Lekdorf, Jesper Barner

AU - Ludvik, Bernhard

AU - Moberg, Erik

AU - Ramachandran, Ambady

AU - Khunti, Kamlesh

PY - 2019

Y1 - 2019

N2 - Aims: Optimal diabetes care requires clear understanding of the incidence of hypoglycaemia in real-world clinical practice. Current data on hypoglycaemia are generally limited to those reported from randomised controlled clinical trials. The Hypoglycaemia Assessment Tool (HAT) study, a non-interventional real-world study of hypoglycaemia, assessed hypoglycaemia in 27 585 individuals across 24 countries. The present study compared the incidence of hypoglycaemia from the HAT study with other similarly designed, large, real-world studies. Materials and Methods: A literature search of PubMed (1995-2017) for population-based studies of insulin-treated patients with type 1 or type 2 diabetes (T1D, T2D), excluding clinical trials and reviews, identified comparable population-based studies reporting the incidence of hypoglycaemia. Results: The 24 comparative studies, including more than 24 000 participants with T1D and more than 160 000 participants with T2D, varied in design, size, inclusion criteria, definitions of hypoglycaemia and method of recording hypoglycaemia. Reported rates (events per patient-year [PPY]) of hypoglycaemia were higher in patients with T1D than in those with T2D (overall T1D, 21.8-73.3 and T2D, 1.3-37.7; mild/non-severe T1D, 29.0-126.7 and T2D, 1.3-41.5; severe T1D, 0.7-5.8 and T2D, 0.0-2.5; nocturnal T1D, 2.6-11.3 and T2D, 0.38-9.7) and were similar to the ranges found in the HAT study. Conclusions: The HAT data on hypoglycaemia incidence were comparable with those from other real-world studies and indicate a high incidence of hypoglycaemia among insulin-treated patients. Differences in rates among studies are mostly explained by differences in patient populations and study methodology. The goal of reducing hypoglycaemia should be a target for continued educational and evidence-based pharmacological interventions.

AB - Aims: Optimal diabetes care requires clear understanding of the incidence of hypoglycaemia in real-world clinical practice. Current data on hypoglycaemia are generally limited to those reported from randomised controlled clinical trials. The Hypoglycaemia Assessment Tool (HAT) study, a non-interventional real-world study of hypoglycaemia, assessed hypoglycaemia in 27 585 individuals across 24 countries. The present study compared the incidence of hypoglycaemia from the HAT study with other similarly designed, large, real-world studies. Materials and Methods: A literature search of PubMed (1995-2017) for population-based studies of insulin-treated patients with type 1 or type 2 diabetes (T1D, T2D), excluding clinical trials and reviews, identified comparable population-based studies reporting the incidence of hypoglycaemia. Results: The 24 comparative studies, including more than 24 000 participants with T1D and more than 160 000 participants with T2D, varied in design, size, inclusion criteria, definitions of hypoglycaemia and method of recording hypoglycaemia. Reported rates (events per patient-year [PPY]) of hypoglycaemia were higher in patients with T1D than in those with T2D (overall T1D, 21.8-73.3 and T2D, 1.3-37.7; mild/non-severe T1D, 29.0-126.7 and T2D, 1.3-41.5; severe T1D, 0.7-5.8 and T2D, 0.0-2.5; nocturnal T1D, 2.6-11.3 and T2D, 0.38-9.7) and were similar to the ranges found in the HAT study. Conclusions: The HAT data on hypoglycaemia incidence were comparable with those from other real-world studies and indicate a high incidence of hypoglycaemia among insulin-treated patients. Differences in rates among studies are mostly explained by differences in patient populations and study methodology. The goal of reducing hypoglycaemia should be a target for continued educational and evidence-based pharmacological interventions.

KW - hypoglycaemia

KW - insulin therapy

KW - observational study

KW - systematic review

KW - type 1 diabetes

KW - type 2 diabetes

U2 - 10.1111/dom.13588

DO - 10.1111/dom.13588

M3 - Journal article

C2 - 30456887

AN - SCOPUS:85058676200

SN - 1462-8902

VL - 21

SP - 844

EP - 853

JO - Diabetes, Obesity and Metabolism

JF - Diabetes, Obesity and Metabolism

IS - 4

ER -

Comparison of the HAT study, the largest global hypoglycaemia study to date, with similar large real-world studies

Abstract

Keywords

UN SDGs

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