INSULIN INITIATION IN TYPE 2 DIABETES IN PRIMARY CARE We welcome feedback on this policy and the way it operates. We are interested to know of any possible or actual adverse impact that this policy/procedure may have on any groups in respect of gender or marital status, race, disability, sexual orientation, religion or belief, age or other characteristics. Document No. Version Date Approved 8 4.7.12 Last Review Review Date Equality Impact Assessed Screened, will need only a partial EIA Author/Contact Person Dr Weatherhead Approved By: For use in (clinical area) For use by (staff groups) For use for (patients/staff/public) Document Owner: Document Status: Primary care GPs and practice nurses Patients Dr Susan Weatherhead Final Document History Version Date Author Reason 8 June 2012 Dr Weatherhead Compliance with NICE guidelines Page 1 of 11
1.0 Introduction... 3 1.1 Policy Statement and aim... 3 1.2 Objectives... 3 2.0 Scope of document... 3 3.0 Roles and responsibilities... 3 4.0 Main body of document... 3 4.1 Initial assessment of patient requiring insulin therapy... 3 4.2 Oral hypoglycaemics and insulin initiation... 4 4.3 Choices of insulin regime and dose titration... 4 4.4 Patient education... 7 5.0 Audit and monitoring Criteria... 10 6.0 Statement of evidence/references and other associated documents... 10 7.0 Equality Impact Assessment... 10 8.0 Standards for Better Health... 10 9.0 Implementation and dissemination of document... 11 10.0 Overall responsibility for the document... 11-2 -
1.0 Introduction 1.1 Policy Statement and aim This guideline accompanies the local enhanced service (LES) for insulin use in primary care 1.2 Objectives To enable insulin to be started safely in general practice in patients with type 2 diabetes. 2.0 Scope of document This protocol covers the initiation of insulin in primary care in type 2 diabetes. 3.0 Roles and responsibilities This guidance has been produced by Dr Susan Weatherhead, the GPwSI in diabetes. It is intended for GPs and practice nurses working in primary care. 4.0 Main body of document 4.1 Initial assessment of patient requiring insulin therapy Insulin therapy should be considered: For those on maximal tolerated oral hypoglycaemic therapy whose glycaemic control is poor. Usually HbA1c >7.5% on the last two occasions 3 months apart. Ensure lifestyle issues including diet and adherence to medication, and alternatives to insulin have been assessed and discussed. For those intolerant to oral hypoglycaemics or in whom they are contraindicated (e.g. Metformin when creatinine is > 150µmol/l or egfr<30) For those who have symptomatic hyperglycaemia with thirst, polyuria and/or weight loss. In this group you should always test for ketones and consider could this be type 1 diabetes? Weight loss is a particularly important symptom and may be a sign of type 1 diabetes. These patients are insulin deficient, needing insulin at least twice daily. Insulin should be started without delay. Explore treatment options and insulin regime taking into consideration patients wishes, fears and aptitude. Remember while insulin may improve your patient s glycaemic control, it has two major disadvantages: hypoglycaemia and weight gain. The following may need insulin but will probably have this initiated under specialist care: Pre-pregnancy - 3 -
Gestational diabetes Children with type 2 diabetes Type 2 diabetes with complications e.g. MI, infected foot, renal failure. Newly diagnosed type 1 diabetes. People who may not be suitable for insulin therapy include: The very obese who will often gain more weight. The very elderly who are not worried about long term complications People who drive HGV or PSV (may lose licence, see new DVLA regulations 2012) Some people with mental health problems It is worth seeking expert advice in the above groups. GLP1 analogues In obese patients with inadequate blood glucose control and BMI>35 the GLP1 analogues Exenatide (Byetta), Exenatide prolonged release (Bydureon) or Liraglutide (Victoza) may be an option instead of insulin. Exenatide is given by twice daily injections, Exenatide prolonged release by weekly injection and Liraglutide is given by once daily injections. They are usually given with Metformin and Sulfonylureas, or Metformin and Thiazolidinedione. They can lower HbA1c by about 1% and cause weight loss. NICE recommends continuing with Exenatide or Liraglutide only if HbA1c reduction at 6 months is 1% or more, and weight loss at 6 months is 3% or more of body weight. (NICE 2009, NICE 2010) See MK local guidance. 4.2 Oral hypoglycaemics and insulin initiation Metformin is always continued with insulin (as long as renal functions allow) as it limits weight gain and insulin doses. Thiazolidinediones are usually discontinued. Sulfonylureas are usually continued on a once daily insulin regime but discontinued on twice daily or basal bolus insulin regimes. 4.3 Choices of insulin regime and dose titration Once daily basal insulin. This is usually given as a bedtime injection of isophane insulin (e.g. Insulatard, - 4 -
Humulin I, Insuman basal). NICE guidance suggests using isophane insulin as first choice. A long acting analogue (e.g. Levemir or Lantus), which can be given at any time of day may be used if there are problems with nocturnal hypoglycaemia, if a person cannot use the delivery device for isophane insulin, or if they cannot inject themselves and a long acting analogue may be substituted for twice daily injections.. The usual starting dose is 10 units, although obese patients who are insulin resistant may require much higher doses. Metformin and sulfonylureas are continued with the insulin. (NICE 2009) Titration Insulin doses are titrated every 2-3 days according to pre-breakfast blood glucose. Patients are encouraged to self titrate if capable. Target pre-breakfast blood sugar is 4-7 mmol/l (individual targets agreed). Doses are usually increased by 2 units at a time, until blood glucose reaches the target range. If glucose levels are high, or insulin doses rise above 24 units more aggressive titration at 4-6 units at a time will speed up the titration process. If hypoglycaemia occurs cut doses by 10% or 4 units whichever is greater. Night time hypoglycaemia is an indication to switch from isophane insulin to a long acting analogue. This regime is a very simple introduction, which gets the patient used to insulin. Some patients manage well on this regime but many will find that while pre-breakfast blood glucose may be well controlled, the day time blood glucose readings are high and HbA1c fails to reach target. These patients will need an intensification of their regime to either a twice daily regime or a basal bolus regime. Patients needing a single dose of insulin above 50-60 units will often do better on a twice daily regime. While this regime is less likely to achieve target HbA1c than more intensive regimes, it is less likely to cause hypoglycaemia and weight gain is less. (Holman, 2007) Twice daily mixed insulin. This is a good option for those whose HbA1c>9%, or who are not achieving control on once daily insulin. It is suitable for people who have predictable lifestyles and regular meal times. A bedtime snack is usually advised to prevent night time hypoglycaemia. It lacks flexibility and dose titration can be more difficult. The simplest regime is to use a pre-mixed insulin, either human mix e.g. Humulin M3, Insuman Comb 25, (given 20-30 minutes before breakfast and evening meal) or an - 5 -
analogue mix e.g. Novomix 30, Humalog mix 25 (given just before breakfast and evening meal). Metformin is continued and sulfonylureas stopped. NICE recommend using human mixtures as a first line and only using analogue mixtures if hypoglycaemia after meals is a problem, there is marked post prandial hyperglycaemia or if the patient wants to inject immediately before meals. Starting doses would typically be 10 units twice daily (before breakfast and evening meal), with perhaps lower doses if not overweight. If transferring from a once daily regime simply divide the present dose by two, and give twice daily. Titration Doses are titrated every 3 days, with blood glucose readings before breakfast and evening meal. Titrate the morning dose of insulin up 2 units at a time until evening blood glucose levels reach a target of 4-7 mmol/l or individual agreed targets. Evening doses are titrated according to pre-breakfast glucose. Pre-lunch and pre-bed blood sugars may help with titration. If hypoglycaemia occurs reduce the appropriate insulin dose by 4 units or 10% of the dose whichever is greater. This regime is more likely to reach target HbA1c than once daily regime but more likely to give hypoglycaemia and cause weight gain. (Holman 2007) Basal bolus regime. A four times a day insulin regime consists of a rapid acting insulin before each meal (e.g. Novorapid, Humalog or Apidra) and a basal insulin (e.g. Levemir or Lantus) which is usually given at bedtime. It mimics physiological insulin production and is very flexible. It is unusual to start people with type 2 diabetes on this regime but it can be a good choice for those who do physical exercise, or eat erratically. It requires motivation and skill to check blood glucose frequently and alter insulin doses. If transferring a patient from once daily insulin simply add a rapid acting insulin (e.g. Novorapid or Humalog) pre-meal times. One dose at a time can be introduced by starting with the meal with highest post prandial glucose. If switching from a twice daily regime take the total daily dose less 10% for safety, and give 50% as basal insulin and the other 50% divided between the three meals as rapid acting insulin. - 6 -
When titrating basal bolus regimes titrate the long acting dose first (i.e.get pre-breakfast blood glucose to target), then titrate the main meal dose next, then the other doses. Choice of devices Consider the patients manual dexterity, how hard it is to push insulin in, and the likely size of dose. Devices with easy read dials and audible clicks are suitable for the visually impaired. The patient should be able to handle a range of devices and choose the most suitable. Choice of insulin may be dictated by device choice. 4.4 Patient education Injecting Insulin Injection sites are buttocks, outer thighs, or abdomen (upper outer arms can be used if taught correctly). Absorption is quickest from the abdomen and slower from thighs and buttocks. 4, 5 or 6mm needles are normally recommended. The needle should be inserted at a 90 degree angle, and the full length of the needle should be inserted. When the insulin is injected, the needle should be kept in place for 10 seconds to ensure the full dose is delivered and to reduce the risk of insulin leaking from the injection site. Injection sites should be moved regularly to avoid lipohypertrophy developing. Cloudy insulins containing isophane (e.g. Insulatard, Novomix 30 and Humulin M3) need to be resuspended before use by gentle rotation of the pen or vial. Large doses of insulin are not well absorbed and doses much over 60 units are often better split into two separate injections. Insulin storage Unopened insulin supplies should be kept in the fridge but not frozen. Insulin is stable at room temperature for 30 days, so insulin pens in use can be kept out of the fridge, although extremes of temperature should be avoided (e.g. sunlight, hot radiator). For travelling cool bags such as Frio products are recommended. Sharps disposal A sharps box should be obtained on prescription. - 7 -
Full sharps bins should be returned with the lid closed to the GP surgery for disposal. Carbohydrate awareness and timing of injections People should understand when their insulin will be working. Insulins containing rapid acting insulin (e.g. Novomix 30, Novorapid, and Humalog) are usually given just before a meal. Human insulins (e.g. Actrapid, Humilin M3 and Insuman Comb 25) are given 20 minutes before food. Twice daily mixed insulin usually require snacks mid morning and pre bed to ensure that hypoglycaemia does not occur when the insulin is working at a peak. Longer acting insulin (Levemir and Lantus) do not have to be given with food but need to be given at the same time of day. They are usually given at bedtime. Blood glucose monitoring Blood glucose levels of 4-7mmol/l or individual agreed targets before meals are usually aimed for. If there are problems with hypoglycaemia a higher target can be agreed. For once daily long acting insulin given at bedtime, pre-breakfast blood glucose levels will help assess dose. For twice a day mixed insulin, pre-meal and pre-bedtime blood glucose levels will help assess dose. Additional monitoring will be needed before driving and to assess the effects of physical exercise or illness.( See DVLA advice) Hypoglycaemia All blood glucose levels below 4mmol/l should be considered as hypoglycaemia, whether there are symptoms or not. Patients need to be aware of the symptoms of hypoglycaemia Treatment should be with 10-20g of fast acting carbohydrate either as 3-4 glucose tablets (e.g. Glucose tabs) or with a sugary drink e.g. 50mls of Lucozade, or 150mls of ordinary lemonade or coke. This should be followed up with some longer-acting carbohydrate such as a sandwich, fruit, biscuit, bowl of cereal or eat a meal if due. - 8 -
Try and find out the reason for the hypoglycaemic episode. Consider cutting doses of insulin. Physical activity Physical activity will cause blood glucose levels to drop. Everyday activities such as gardening, housework and shopping all count as physical activity. Blood glucose monitoring can provide information on how much blood glucose levels are affected by different activities. Extra carbohydrate is likely to be needed to avoid hypoglycaemia. If activity is planned, insulin doses can be reduced before exercise to avoid the need for extra carbohydrates. Prolonged intense exercise may need a dosage reduction after the activity. Insulin doses or carbohydrate intake should be decided on an individual basis and the effectiveness of any action assessed using blood glucose monitoring. Driving Anyone starting to use insulin must inform the DVLA and their motor insurance company. People using insulin can only hold a 1, 2, or 3 year licence. A 3 year licence is issued unless there are concerns about hypoglycaemic unawareness or loss of sight. People using insulin should be encouraged to check blood glucose before driving and every 2 hours on long journeys. Carbohydrate snacks should be carried in the car. Illness Illness is likely to cause blood glucose levels to rise, and insulin doses may need to be increased. Insulin should never be stopped completely although doses may need to be reduced if someone is unable to eat. Anyone experiencing vomiting or diarrhoea for 24hrs or more should seek medical help. Alcohol Alcohol can cause blood sugar to rise initially (for carbohydrate containing drinks such as beer or lager), but in excess of 2 units is likely to cause hypoglycaemia a few hours later. - 9 -
Additional food should be taken if alcohol is drunk especially at bedtime. 5.0 Audit and monitoring Criteria Document Audit and Monitoring Table Monitoring Practices participating in the Insulin LES will be expected to complete requirements an audit of patients they have commenced on insulin Monitoring Method: Monitoring prepared by :- Monitoring presented to:- Frequency of presentation:- The number of patients commenced on insulin, and for each patient their HbA1c, and weight before and after commencement of insulin Individual GP practices GPwSI in diabetes or Lead Diabetes Specialist Nurse. Annual 6.0 Statement of evidence/references and other associated documents References Holman RR, Thorne KI, Farmer AJ, Davies MJ, Keenan JF, Paul S, Levy JC; 4-T Study Group: (2007) Addition of biphasic, prandial, or basal insulin to oral therapy in type 2 diabetes. N Engl J Med, 357, 1716-1730 NICE(2009) CG87 Type 2 diabetes - newer agents (a partial update of CG66): quick reference guide http://guidance.nice.org.uk/cg87/quickrefguide/pdf/english accessed 4.4.12 NICE (2010) TA203 Diabetes (type 2) - liraglutide: quick reference guide. http://guidance.nice.org.uk/ta203/quickrefguide/pdf/english Accessed 4.4.2012 7.0 Equality Impact Assessment This document has been screened for its equality impact; it does not differentiate between individuals or groups on the grounds of age, ethnicity, religious beliefs, gender, disability or sexual orientation. It will therefore need only a partial EIA. 8.0 Standards for Better Health This document is relevant to the following HCC domains: Domain Safety Definition/Evidence C3 Using NICE evidence - 10 -
Clinical and Cost Effectiveness C4d, safe handling of medicines C5a: Using NICE evidence 9.0 Implementation and dissemination of document The document will form an appendix to the insulin local enhanced services document. It will be placed on the MKPCT website and MK Diabetes Care Website. Health professionals will be informed of the document at relevant educational meetings. 10.0 Overall responsibility for the document Dr S.M Weatherhead - 11 -