Is hypoglycemia an issue in type 2 diabetes?

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1 King s Diabetes Research Group Is hypoglycemia an issue in type 2 diabetes? Stephanie A Amiel RD Lawrence Professor of Diabetic Medicine King s College London

2 Conflicts of interest None! (Currently working for National Institute of Clinical Excellence)

3 Definitions Definitions: Hypoglycaemia Low blood glucose

4 Severe Documented symptomatic Asymptomatic Probable symptomatic Pdeudohypoglycemia Definitions requiring assistance of another person actively to treat.. Symptoms with a measured low blood glucose No typical symptoms but a measured low blood glucose Typical symptoms but no measured blood glucose Typical symptoms but glcuose only approaching low Seaquist et al., Diab Care 2013; 36:

5 Definitions 70 mg/dl (3.9 mmol/l) = an alert value = hypoglycemia EMA (2006) = 3.0 mmol/l (54 mg/dl) EMA (2012) = recommends ADA and ISPAD Seaquist et al., Diab Care 2013; 36:1384 CPMP/EWP/1080/00 Swinnen et al., Diabetologia. 2009;52:38

6 Does it matter? A trial of a new treatment in ~ 750 patients RR 21% 29% 41% P < 0.02 < < Hypo events per pt year Conventional New Severe Hypoglycaemia 14 in 9 (2.5%) pts 9 in 7 (1.8%) pts 0 Symptomatic Symts < 72 < 4 mm mg/dl < 56mg/dl < 3.1

7 Consequences of Hypoglycaemia Brain Musculo skeletal 1. Acute cognitive impairment, coma, focal neurological deficits 2. Impaired defences against next hypoglycaemia 3. Impaired memory formation 4. Fear of hypoglycaemia 5. Myocardial ischaemia 6. Arrythmias Heart & circulation 7. Coagulopathy & pro inflammatory 8. Falls, accidents (including while driving) 9. Fractures, dislocations Desouza et al. Diabetes Care 2003;26: Laitinen et al. Ann Noninvasive Electrocardiol 2008;13: Diabetes Metab. 2013;;39:63 70

8 Is hypoglycaemia Is hypoglycaemia an issue an issue? in T2MD? 10,000 admissions to UK hospitals per year: 50,000 bed days Hypoglycemic events (events per patient per year) SEVERE events 0.4 SEVERE events per patient per year per patient per year In type 70 1: In type 2: episodes/100 person years episodes/100 person years Type 1 Type 2 Holstein et al., Diabetes Care :2109; Macleod 1993; Shorr 1997; Leese et al., Diabetes Care 2003 ;26:1176. Donnelly et al. Diabetic Med 2005;22:749 55

9 Emergency calls for hypoglycemia Emergency How common calls is for hypoglycaemia? hypoglycemia 10,000 admissions to UK hospitals per year: 50,000 bed days % population requiring emergency Rx for severe hypoglycemia N= Holstein et al., Diabetes Care :2109; Macleod 1993; Shorr 1997; Leese et al., Diabetes Care 2003 ;26:1176. Donnelly et al. Diabetic Med 2005;22:749 55

10 Prospective study of hypoglycaemia Type 2 SUs T2 insulin T2 insulin T1 < 5 yrs T1 > 15 yrs Rx < 2yrs Rx > 5 yrs UK Hypoglycaemia Study group. Diabetolgia :

11 Diabetes β cell function, duration %B Can we predict risk? History of severe hypoglycaemia Loss of endogenous insulin secretion 60 Co morbidities 40 Awareness status 20 Proportion of patients (%) major episodes Ye Years UKPDS 16. Diabetes 1995; 44:

12 Can we predict risk? History of severe hypoglycaemia Age and diabetes duration Loss of endogenous insulin secretion Co morbidities Awareness status Intensive therapy/low HbA1c?

13 T2 diabetes end point trials Percentage of events(%) Intensive glucose lowering in advanced T2DM associated with 2 to 3 fold increase in SH ACCORD ADVANCE VADT ( 5.1 Intensive glucose control arm Standard glucose control arm Severe cognitive 24,000 patients with T2DM dysfunction and high associated cardiovascular with risk SH and with poorer randomly CV outcome assigned to 9.9 intensive glycemic control or standard therapy p<0.001 p<0.001 p< ADVANCE. N Engl J Med 2008;358: ; 2. ACCORD. N Engl J Med 2008;358; ; 3. VADT. N Engl J Med 2009;360: De Galan, Diabetologia (2009) 52:

14 Social factors contributing to severe hypoglycemia risk % people requiring emergency services for severe hypoglycemia Most affluent Most deprived Leese et al., Diabetes Care 2003 ;26:1176.

15 Severe hypoglycemia & adverse outcome, ADVANCE (2.1% patients in ~5 years) Risk factors Older age Longer duration of diabetes Higher creatinine levels Lower body mass index Lower cognitive Severe function hypoglycaemia is Use of a two marker or more oral glucose lowering lowering drugs History of smoking Microvascular disease Assignment to intensive glucose control Female gender* Lower education* African American* Insulin use at baseline* *from ACCORD marker for morbidity & mortality Zoungas et al., N Engl J Med 2010;363:

16 UK GPRD mortality by HbA1c Tablet treated Insulin treated Currie et al., Lancet 2010; 375:

17 Increased risk of severe hypoglycemia with RISING HbA1c in ACCORD female gender Lower education African American peripheral neuropathy lower BMI Higher urine ACR Higher creatinine Insulin use at baseline Miller et al. BMJ 2010;340:b5444

18 What about mild hypoglycemia? Impact of non severe NH on function next day 22.7% people reporting mild NH in a web based survey missed work time after it Brod et al., Value in health, :

19 Impact of non severe NH on function next day 22.7% people reporting mild NH in a web based survey missed work time after it % contacting health care professional % reducing doses Brod et al., Value in health, :

20 Summary & conclusions Good diabetes control is defined by HbA1c, and absence of clinically important hypoglycemia Hypoglycemia is important in type 2 diabetes It is a low risk for people with early onset disease and residual insulin secretion It is a marker for morbidity and mortality Risk for clinically important hypoglycemia should be assessed individually

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