H.G. WELLS PROJECT Frailty and Type 2 Diabetes Guidelines for clinicians Victoria Ruszala victoria.ruszala@nhs.net H.G. Wells Project team Dugal T, Partington E. Kernow CCG Diabetes and Frailty Guideline 1 October 2015 Review date: October 2017
1. Introduction This guideline endorses a wider range of acceptable HbA1c targets in older patients. Treatment decisions can be based on the level of frailty and tolerability of hyperglycaemia and individualized treatment decisions can be made. Although acceptance of high HbA1c levels near 108 mmol/mol may be the exception, it is unnecessary to alter therapy if an individual has tolerated high HbA1c levels for many years, has limited life expectancy, and has no hyperglycaemia-associated symptoms. All patients with diabetes (including type 1 diabetes) who are older than 70 years should be assessed using a validated frailty scale. Younger individuals should also be assessed if clinically appropriate. The recommended scale is the Rockwood scale detailed in Appendix One. The following recommendations for treatment are based upon the use of the scale to assess the individual and their level of frailty. It should be remembered that patient conditions can vary and therefore a single time point assessment may need to be reviewed at a later date. 2. Treatment aims Treatment aims should be decided on an individual basis. The following guidance from ADA/EASD (American Diabetes Association and European Association for the Study of Diabetes) provides a treatment scale to determine patient and disease factors that may be used to determine optimal HbA1c targets. The ranges provided in Table 1 are idealised and therefore exceptions can be made where clinical necessity dictates. Where possible, such decisions should be made with the patient, reflecting his or her preferences, needs, and values. This scale is not designed to be applied rigidly but to be used as a broad construct to guide clinical decision making. 1
3. Approach to the management of hypoglycaemia NB. This algorithm is taken from Management of Hyperglycemia in Type 2 Diabetes: A Patient-Centered Approach Position Statement of the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD) Inzucchi et al. (2012) The IFCC units are not used in the US or across all of Europe therefore the aim of 7% is listed. This can be interpreted as 53mmol/mol for the purpose of UK practice. 2
Table 1. Treatment Aims The key aim of treatment in frail patients is avoidance of hypoglycaemia and hyperglycaemia which can increase hospital admissions, aggravate co-morbidities and reduce quality of life. Hypoglycaemia: Capillary blood glucose levels less than 4.0mmol/L (or HbA1c <50mmol/mol) can exacerbate dementia and confusion, increase likelihood of falls and cardiac arrhythmias Hyperglycaemia: Levels above 15.0mmol/L (or HbA1c >80mmol/mol) put patients at risk of dehydration, electrolyte abnormalities, urinary incontinence, dizziness and falls. Older patients with multiple co-morbidities are also at much higher risk of adverse drug reactions (ADRs) and these should be considered with every treatment review. Level of Frailty Rationale Therapeutic targets Blood Pressure and Lipids 1 Elderly (over 70 years) with life expectancy likely to be over 10 years None or mild complications Few co-existing chronic illnesses, intact cognitive and functional status Rockwood - Up to Mildly Frail Longer remaining life expectancy Prevention of deterioration of complications and comorbidities HbA1c: 53 to 58 mmol/mol (7%- 7.5%) Fasting or pre-prandial CBG: 5.0-7.5 mmol/l Bedtime CBG: 6.0-8.5mmol/L NB: CBG in this range will help to achieve HbA1c. However occasional deviations are not problematic. BP <140/80 if tolerated (avoid falls) Statin unless contraindicated or not tolerated In patients over the age of 70 controlling BP and lipids has a far greater beneficial effect than reducing HbA1c 2 Elderly (over 70 years) and life expectancy likely to be less than 10 years Multiple complications Multiple co-existing chronic illnesses or 2+ Activities of Daily Living (ADL) impairments or mild to moderate cognitive impairment Rockwood - Moderately Frail Intermediate remaining life expectancy High treatment burden Hypoglycaemia vulnerability Falls risk HbA1c: 60 to 69mmol/mol (7.6%- 8.5%) Fasting or pre-prandial CBG: 6.0-8.5 mmol/l Bedtime CBG: 6.0-10.0mmol/L NB: CBG in this range will help to achieve HbA1c. However occasional deviations are not problematic. BP <140/80 if tolerated Statin unless contraindicated or not tolerated. In patients over the age of 70 controlling BP and lipids has a far greater beneficial effect than reducing HbA1c 3
Level of Frailty Rationale Therapeutic targets Blood Pressure and Lipids 3 Elderly (over 70 years) and life expectancy likely to be much less than 10 years Multiple or end-stage co-morbidities Long term care facility 2+ ADL dependencies or moderate to severe cognitive impairment Limited life expectancy makes benefits uncertain HbA1c: 60 to 75mmol/mol (7.6%- 9%). Higher levels are acceptable as long as patients have no hyperglycaemic symptoms and have tolerated these levels for a long period of time and do not have risk factors for HHS. BP <150/90 if tolerated Consider likelihood of benefit with statin (secondary prevention more likely to benefit than primary prevention) Rockwood Severely Frail or Very severely Frail Fasting or pre-prandial CBG: 6.0-15.0mmol/L Bedtime CBG: 7.0-15.0mmol/L Includes: Moderately frail patients requiring paramedic for hypo management or admitted to hospital with hyper- or hypo glycaemia. NB: CBG in this range will help to achieve HbA1c. However occasional deviations are not problematic. NB. CBG: Capillary Blood Glucose 4
Table 2. Treatment choices Frailty level 1 2 3 Suggested actions and therapeutic options. NICE guidance and BNSSG formulary should be followed where possible to determine first line choices 1. Metformin remains first line treatment. 2. Avoid starting sulphonylureas in elderly. Review existing sulphonylurea use. 3. Appropriate to use DPP4 inhibitors for second line therapy. Consider SGLT-2 inhibitors if renal function is sufficient. 4. Pioglitazone should be avoided due to risk of heart failure. 5. Weight loss associated with GLP-1 agonists should be monitored carefully. 6. First choice of insulin remains NPH insulin. 7. Combination of all of these agents with insulin is appropriate to minimise insulin doses required. 8. Ensure appropriate CV risk reduction medication is maintained. 9. Reassess/Reduce if worsening frailty or hypoglycaemia occurs. 1. Main treatment aim is hypoglycaemia avoidance and hyperglycaemic symptoms. 2. Assess renal function regularly. Caution with metformin (and other drugs) if egfr 30-60 ml/min/1.73m 2. Reduce or stop drugs as necessary. (egfr is known to over-estimate renal function in frail elderly patients and creatinine clearance should be calculated using the Cockroft Gault equation) 3. Consider insulin treatment to control hyperglycaemia with symptoms. NPH insulin remains first line. Analogue insulin should be considered where hypoglycaemia has occurred or if patient requires assistance with administration. Combination with other products to minimise doses required and/or weight gain is appropriate. 4. Do not restrict diet if low or losing weight. GLP-1 agonist use should be reviewed regularly. 5. Review blood pressure regularly. Minimise number of agents used and decrease targets if patient is at risk of falls or lives alone. ACE inhibitors remain first line choice although will need review in worsening renal impairment. 6. Reassess/Reduce if worsening frailty or hypoglycaemia occurs. 1. De-escalate treatment Reduce drug doses and treatments. 2. Consider whether oral or injectable diabetes therapies can be stopped. 3. Consider whether possible to stop insulin (seek advice) or minimise doses given. 4. Stop metformin (and caution with other drugs) if egfr is deteriorating, consistently below 30 ml/min/1.73m 2, or acute kidney injury has occurred recently. 5. Stop lipid lowering drugs. 6. Review and possibly stop diuretics (increases risks of falls, dehydration and HHS). 7. Stop /reduce other drugs likely to cause adverse effects. 5
References 1. Sinclair AJ et al on behalf of European Diabetes Working Party for Older People. Clinical Guidelines for Type 2 Diabetes Mellitus. Diabetes Metab, 2011; 37(Suppl 3):S27-38 2. Kirkman MS, Briscoe VJ, Clark N et al. Consensus Report: Diabetes in Older Adults. Diabetes Care, 2012; 35:2650-2664 3. Meneilly GS, Knip A, Tessier D on behalf of the Canadian Diabetes Association Clinical Practice Guidelines Expert Committee. Clinical Practice Guidelines: Diabetes in the Elderly. Can J Diabetes, 2013; 37:S184-S190 4. Inzucchi SE, Bergenstal RM, Buse JB et al. Management of hyperglycemia in type 2 diabetes, 2015: a patient-centered approach: update to a position statement of the American Diabetes Association and the European Association for the Study of Diabetes. Diabetes Care, 2015; 38(1):140-9. This paper has been reviewed and commented on by the following: North Bristol Trust Diabetes Team Jarrod Richards (Consultant, NBT Complex Adult Liason Service) UHBristol Diabetes Team Simon Croxon (Consultant, elderly care and diabetes specialist) Bristol CCG Meds Optimisation Team Bristol Community Health Diabetes Specialist Nurses H.G. Wells Project Team The paper was also sent to the Weston Diabetes Team. 6
Appendix One: Rockwood Frailty Scale Figure 1.Clinical frailty scale.adapted with permission from Moorhouse P, Rockwood K. Frailty and its quantitative clinical evaluation.j R Coll Physicians Edinb. 2012;42:333-340. 7