1.1 Policy Statement and Aim 3

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.

Last Equality Document Date Review Author/Contact Version Review Impact No. Approved Date Person Assessed Screened, will need Dr Weatherhead 1 only a partial EIA

Approved By:

For use in (clinical Primary care area) For use by (staff GPs and practice nurses groups) For use for Patients (patients/staff/public) Document Owner: Dr Susan Weatherhead Document Status: DRAFT

Document History

Version Date Author Reason 1 (this version) Oct 08. Dr Weatherhead Compliance with NICE guidelines 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: Initial assessment of patient requiring insulin therapy Oral hypoglycaemics and insulin initiation, Choices of insulin regime and dose titration Patient education, 5.0 Audit and monitoring Criteria...... 9

6.0 Statement of evidence/references...... 10

7.0 Equality Impact Assessment...... 10

8.0 Standards for Better Health...... 10

9.0 Implementation and dissemination of document...... 10

10.0 Overall responsibility for the document...... 10

of 10 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  Gestational diabetes  Children with type 2 diabetes Page 3 of 10  Type 2 diabetes with complications e.g. MI, infected foot, renal failure.

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 (will lose licence)  Some people with mental health problems

It is worth seeking expert advice in the above groups.

Exenatide In obese patients with inadequate blood glucose control and BMI>35 the incretin mimetic exenatide may be an option instead of insulin. Exenatide is given by twice daily injections. It is usually given with metformin and sulphonylureas but is not licensed to be given with thiazolidinediones which must be stopped. It can lower HbA1c by about 1% and cause weight loss. NICE recommends continuing with exenatide only if HbA1c reduction at 6 months is 1% or more, and weight loss at 12 months is 5% or more of body weight.

4.2 Oral hypoglycaemics and insulin initiation

Metformin is always continued with insulin as it limits weight gain and insulin doses. Thiazolidinediones are usually discontinued. Sulphonylureas 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, Humulin I) or a long acting analogue (e.g. Levemir or Lantus), which can be given at any time of day. NICE guidance suggests using isophane insulin as first choice. The usual starting dose is 10 units, although obese patients who are insulin resistant may require much higher doses. Metformin and sulphonylureas are continued with the insulin.

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. Doses are usually increased by 2 units at a time, until blood glucose reaches

of 10 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. Mixtard 30 (given 20-30 minutes before breakfast and evening meal) or an analogue mix e.g. Novomix 30, Humalog mix 25 (given just before breakfast and evening meal). Metformin is continued and sulphonylureas stopped.

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.

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. 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.

of 10 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 or Humalog) 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.

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 arms are no longer recommended). Absorption is quickest from the abdomen and slower from thighs and buttocks.  8mm needles are normally recommended, but 6mm needles may be required for thin people.

of 10  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, Mixtard 30) 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.  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 insulins (e.g. Novomix, Novorapid, and Humalog) are usually given just before a meal. Human insulins (e.g. Actrapid, Mixtard 30 ) are given 20 minutes before food.  Twice daily mixed insulins 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 insulins (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.

of 10 Blood glucose monitoring

 Blood glucose levels of 4-7mmol/l before meals should be 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 insulins, 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.

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 tablets of Glucotabs or similar, 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 or bowl of cereal.  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.

of 10 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 (for carbohydrate containing drinks such as beer or lager), but in excess of 2 units is likely to cause hypoglycaemia a few hours later.  Additional food should be taken if alcohol is drunk.

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: The number of patients commenced on insulin, and for each patient their HbA1c, and weight before and after commencement of insulin Monitoring Individual GP practices prepared by :-

Monitoring GPwSI in diabetes, or diabetes primary care facilitator diabetes presented to:- specialist nurse.

Frequency of Annual presentation:-

6.0 Statement of evidence/references and other associated documents

of 10 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 (2008) Type 2 diabetes. Nice Clinical Guidance 66, quick reference guide. NICE, London. Available from www.nice.org.uk/ accessed 29.10.08

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 Definition/Evidence Safety C3 Using NICE evidence C4d, safe handling of medicines Clinical and Cost C5a: Using NICE evidence Effectiveness

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. Health professionals will be informed of the document at relevant educational meetings.

10.0 Overall responsibility for the document

Dr S.M Weatherhead