Regional variations in definitions and rates of hypoglycaemia: findings from the global HAT observational study of 27 585 people with Type 1 and insulin-treated Type 2 diabetes mellitus

K Khunti, M Cigrovski Berković, B Ludvik, E Moberg, J Barner Lekdorf, H Gydesen, U Pedersen-Bjergaard, K Khunti, M Cigrovski Berković, B Ludvik, E Moberg, J Barner Lekdorf, H Gydesen, U Pedersen-Bjergaard

Abstract

Aim: To determine participant knowledge and reporting of hypoglycaemia in the non-interventional Hypoglycaemia Assessment Tool (HAT) study.

Methods: HAT was conducted in 24 countries over a 6-month retrospective/4-week prospective period in 27 585 adults with Type 1 or insulin-treated Type 2 diabetes mellitus. Participants recorded whether hypoglycaemia was based on blood glucose levels, symptoms or both.

Results: Hypoglycaemia rates were consistently higher in the prospective compared with the retrospective period. Most respondents (96.8% Type 1 diabetes; 85.6% Type 2 diabetes) knew the American Diabetes Association/European Association for the Study of Diabetes hypoglycaemia definition, but there were regional differences in the use of blood glucose measurements and/or symptoms to define events. Confirmed symptomatic hypoglycaemia rates were highest in Northern Europe/Canada for Type 1 diabetes (63.9 events/year) and in Eastern Europe for Type 2 diabetes (19.4 events/year), and lowest in South East Asia (Type 1 diabetes: 6.0 events/year; Type 2 diabetes: 3.2 events/year). Unconfirmed symptomatic hypoglycaemia rates were highest in Eastern Europe for Type 1 diabetes (5.6 events/year) and South East Asia for Type 2 diabetes (4.7 events/year), and lowest for both in Russia (Type 1 diabetes: 2.1 events/year; Type 2 diabetes: 0.4 events/year). Participants in Latin America reported the highest rates of severe hypoglycaemia (Type 1 diabetes: 10.8 events/year; Type 2 diabetes 3.7 events/year) and severe hypoglycaemia requiring hospitalization (Type 1 diabetes: 0.56 events/year; Type 2 diabetes: 0.44 events/year). The lowest rates of severe hypoglycaemia were reported in South East Asia (Type 1 diabetes: 2.0 events/year) and Northern Europe/Canada (Type 2 diabetes: 1.3 events/year), and the lowest rates of severe hypoglycaemia requiring hospitalization were in Russia (Type 1 diabetes: 0.15 events/year; Type 2 diabetes: 0.09 events/year). The blood glucose cut-off used to define hypoglycaemia varied between regions (Type 1 diabetes: 3.1-3.6 mmol/l; Type 2 diabetes: 3.5-3.8 mmol/l).

Conclusions: Under-reporting of hypoglycaemia rates in retrospective recall and regional variations in participant definitions of hypoglycaemia may contribute to the global differences in reported rates. Discrepancies between participant definitions and guidelines may highlight a need to redefine hypoglycaemia criteria. (Clinical Trials Registry No: NCT01696266).

© 2018 The Authors. Diabetic Medicine published by John Wiley & Sons Ltd on behalf of Diabetes UK.

Figures

Figure 1
Figure 1
Definitions of hypoglycaemia used in the participant diary by participants with (a) Type 1 diabetes and (b) Type 2 diabetes. BG, blood glucose.

References

    1. Nathan DM, Buse JB, Davidson MB, Ferrannini E, Holman RR, Sherwin R et al Medical management of hyperglycemia in type 2 diabetes: a consensus algorithm for the initiation and adjustment of therapy: a consensus statement of the American Diabetes Association and the European Association for the Study of Diabetes. Diabetes Care 2009; 32: 193–203.
    1. Frier BM. How hypoglycaemia can affect the life of a person with diabetes. Diabetes Metab Res Rev 2008; 24: 87–92.
    1. Leiter LA, Boras D, Woo VC. Dosing irregularities and self‐treated hypoglycemia in type 2 diabetes: results from the Canadian cohort of an international survey of patients and healthcare professionals. Can J Diabetes 2014; 38: 38–44.
    1. Inzucchi SE, Bergenstal RM, Buse JB, Diamant M, Ferrannini E, Nauck M et al Management of hyperglycaemia in type 2 diabetes, 2015: a patient‐centred approach. Update to a Position Statement of the American Diabetes Association and the European Association for the Study of Diabetes. Diabetologia 2015; 58: 429–442.
    1. American Diabetes Association . Standards of Medical Care in Diabetes‐2017. Diabetes Care 2017; 40(Suppl 1): S48–S56.
    1. Frier BM. Defining hypoglycaemia: what level has clinical relevance? Diabetologia 2009; 52: 31–34.
    1. Canadian Diabetes Association Clinical Practice Guidelines Expert Committee . Canadian Diabetes Association 2013 clinical practice guidelines for the prevention and management of diabetes in Canada. Can J Diabetes 2013; 37(Suppl 1): S1–S212.
    1. Handelsman Y, Bloomgarden ZT, Grunberger G, Umpierrez G, Zimmerman RS, Bailey TS et al American Association of Clinical Endocrinologists and American College of Endocrinology – clinical practice guidelines for developing a diabetes mellitus comprehensive care plan – 2015. Endocr Pract 2015; 21(Suppl 1): 1–87.
    1. Seaquist ER, Anderson J, Childs B, Cryer P, Dagogo‐Jack S, Fish L et al Hypoglycemia and diabetes: a report of a workgroup of the American Diabetes Association and the Endocrine Society. Diabetes Care 2013; 36: 1384–1395.
    1. International Hypoglycaemia Study Group . Glucose concentrations of less than 3.0 mmol/L (54 mg/dL) should be reported in clinical trials: a joint position statement of the American Diabetes Association and the European Association for the Study of Diabetes. Diabetes Care 2017; 1: 155.
    1. Swinnen SG, Mullins P, Miller M, Hoekstra JB, Holleman F. Changing the glucose cut‐off values that define hypoglycaemia has a major effect on reported frequencies of hypoglycaemia. Diabetologia 2009; 52: 38–41.
    1. Edridge CL, Dunkley AJ, Bodicoat DH, Rose TC, Gray LJ, Davies MJ et al Prevalence and incidence of hypoglycaemia in 532,542 pople with type 2 diabetes on oral therapies and insulin: a systematic review and meta‐analysis of population based studies. PLoS ONE 2015; 10: e0126427.
    1. Khunti K, Alsifri S, Aronson R, Cigrovski Berkovic M, Enters‐Weijnen C, Forsen T et al Rates and predictors of hypoglycaemia in 27 585 people from 24 countries with insulin‐treated type 1 and type 2 diabetes: the global HAT study. Diabetes Obes Metab 2016; 18: 907–915.
    1. World Medical Association . Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects. Last amended by the 59th WMA Assembly Seoul, October 2008. Available at Last accessed 9 June 2017.
    1. International Conference on Harmonisation . ICH harmonised tripartite guideline: guideline for good clinical practice. J Postgrad Med 2001; 47: 199–203.
    1. American Diabetes Association . Defining and reporting hypoglycemia in diabetes: a report from the American Diabetes Association Workgroup on Hypoglycemia. Diabetes Care 2005; 28: 1245–1249.
    1. Pedersen‐Bjergaard U, Pramming S, Thorsteinsson B. Recall of severe hypoglycaemia and self‐estimated state of awareness in type 1 diabetes. Diabetes Metab Res Rev 2003; 19: 232–240.
    1. Östenson CG, Geelhoed‐Duijvestijn P, Lahtela J, Weitgasser R, Markert JM, Pedersen‐Bjergaard U. Self‐reported non‐severe hypoglycaemic events in Europe. Diabet Med 2014; 31: 92–101.

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