Tameside and Glossop PCT Guidelines for Insulin Initiation and Adjustment of Insulin Therapy in Type 2 Diabetes in General

Practice May 2005

The Practice Nurse or GP may initiate insulin therapy within General Practice with relevant experience and qualifications. [Referrals for insulin therapy can be made directly to the Community Diabetes Nurse Team from Primary Care using referral form. Referrals will be received, acknowledged and distributed according to area for the Community Diabetes Nurse to arrange]. Initial Assessment of patient for Insulin Initiation Maximum tolerable oral hypoglycaemic agents Clinical history including review of complications Check previous HbA1c (Two above 7.5%, 3 months apart) and other relevant diagnostic tests Ensure lifestyle issues, treatment adherence and other alternatives to insulin therapy have been considered/discussed Has the patient become symptomatic or has signs of hyperglycaemia (thirst, nocturia, polyuria, malaise or recurrent infections) have they lost weight or are they overweight? Explore insulin regimen and treatment options that are suitable for each individual patient, taking into consideration the patients wishes, fears and aptitude

Agree Treatment Plan Discuss insulin and devices with patient. Taking into account the persons manual dexterity how heavy is the pen/device, how easy is it to push in the insulin, and the size of the dose they are ultimately to need. If the person is visually impaired, consider whether the pen has an audible click on dialling, the colour of the dial (background and number) and the number size, and whether appropriate magnifiers are available. Consider regimen: o Once daily medium/long acting insulin and oral hypoglycaemic agents o Twice daily fixed mixture o Basal bolus This is dependent on patient choice/safety aspects/lifestyle/ability to administer. Results of the full assessment will enable optimal decision-making. Within GP Surgery arrange prescription e.g. Pen device and spare, needles, sharps box, needle clipper and correct insulin presentation Discuss target blood glucose levels and frequency of testing. Advise patient on meter Quality Control and possible need for meter replacement 1

Agree start date and place. Dependent upon patients mobility/accessibility, insulin should be initiated either at a GP Surgery, locality health centre or as a domiciliary visit, to be decided by the health care professional at their discretion. Patients should be advised of the following prior to an appointment to start insulin therapy: o That the patient has the final choice in therapy; devices, frequency etc. o That the patient can choose to try insulin therapy for a few weeks/months and ultimately make a decision to return to oral agents. This should follow a further review with a doctor and a Nurse, should they wish so o That their nurses and doctors will support their decisions but will be explicit about potential issues in the future o It is important that the patient overcomes the fear of injections early, because otherwise it may interfere with further education o That on the day they are due to start insulin, they follow the full written instructions related to continuing/discontinuing their present diabetes treatment

Starting Dosage of Insulin For patients on Metformin, NICE recommends it to be continued unless clinically indicated to stop or if unable to tolerate. Local guidelines indicate if Creatinine is raised (130 or over) it should be stopped. Metformin has been found to reduce weight gain with insulin and decrease total insulin requirements. In some cases sulphonylureas may be continued initially. This is up to the individual practitioner who prescribes the treatment regimen. Glitazones are not licensed in this country to continue with insulin. Insulin start dose calculations vary in each Trust. Most are based on custom and practice. Once daily regimens often start with 10 units. Most twice daily regimens start with 6-10 units twice daily, dependent on the persons build. Starting low and working up will build the patients confidence and make hypoglycaemia less likely. Once Daily Regimen If starting with one injection per day an intermediate or long acting insulin (E.g. Insulatard, Humulin I, Levemir (not licensed), Lantus) should be used, in conjunction with oral hypoglycaemic agents. Insulin requirements approximately = 0.5 units/kg body weight For example 0.5 x 72kg =36 units of which 50% will be basal requirements (36 x 50 =18) 36 x 50% =18 units 100 Starting dose would be 560% of this for safety (18 x 60 = 11) 18 x 60 % = 11 units 100 2

So the safe once daily starting dose in this example would be 11 units, and then titrating up to individual insulin requirements. Twice Daily Regimens For Twice daily regimens the easiest option is a premixed combination of short/rapid acting and intermediate acting insulin. These can be an analogue mix (inject immediately before food) e.g. NovoMix 30, Humalog Mix 25, Humalog Mix 50, or Human Insulin mix (inject 20 -30 minutes prior to food) e.g. Mixtard 30, Humulin M3. Insulin requirements approximately = 0.5 units/kg bodyweight For example 0.5 units x 72kg = 36 units Take 60% of this dose for safety 36 x 60% = 22 units Split the safety dose between morning and evening (fifty/fifty) E.g. 22 is divided by 2 = 11 units BD

So the safe twice-daily starting dose in this example would be 11 units at breakfast time and 11 units at teatime and then titrating up to individual insulin requirements. Basal Bolus Regimens For basal bolus regimens, rapid acting analogues (e.g. NovoRapid, Humalog) or soluble human insulin (e.g. Actrapid, Humulin S,) may be given with meals (bolus) and a background insulin (basal) for example Levemir or Lantus would be given once a day. This can be increased to twice a day, dependent on insulin license and patient insulin requirements. Basal insulin can be given in the morning or evening, again dependent on patient choice and concordance. Insulin requirements = 0.5 units/kg bodyweight For example 0.5 units x 72kg = 36 units of which 50% will be basal requirements (36 x 50 = 18) 36 x 50% = 18 units 100 Other 50% will be bolus requirements = 18 units 60% of these doses for safety Basal 60 x 18 = 11 units 100 (Patient to choose bedtime or morning for basal injection) Bolus 60 x 18 = 18 units 100 Bolus to be divided up over three meals, dependent on carbohydrate intake for each meal. 3

E.g.

Breakfast 3 units Lunchtime 4 units Evening meal 5 units

Patients starting on basal bolus regimen should ideally have an appointment with a dietician to discuss carbohydrate counting and bolus adjustment. Education Education should be given as per Community Insulin Education Protocol Frequency of appointments is agreed on an individual basis with the patient Ensure as far as possible that the patient can manage the new regime until the next arranged contact. Contingency plans should be arranged and made clear to the patient If the patient is unable to cope initially or long term with insulin therapy independently, then liaise and refer to District Nursing service or discuss with patient and appropriate carer.

Titration of Insulin The aim is to encourage all patients to self adjust their insulin dosage according to blood glucose levels, activity and dietary intake Aim to increase the dosage by 2 units on each dose every 4 days until target blood glucose levels are achieved. When insulin dose is above 40 units, insulin dose may need to be adjusted by 4 units until targets are achieved. Remember that some patients may be insulin sensitive and will require smaller insulin dose adjustments Pitfalls to avoid are changing doses too frequently before a pattern has emerged. Avoid adjusting the insulin dose immediately after an unsatisfactory glucose result rather than adjusting the insulin dose that was predominantly responsible for the glycaemic control in the period, which the glucose was measured Care needs to be taken when adjusting doses. Think about which blood glucose that the insulin will affect, especially when adjusting/titrating biphasic insulin. For example, to lower the lunchtime blood glucose when on a mixed insulin, you increase the morning dose of insulin. This however, because of the increase in both types of insulin in the mix, will affect the blood glucose in the afternoon and before evening meal. Other pitfalls include relentlessly increasing the insulin doses in excess of the patients body weight in Kg, without checking other confounding factors such as dietary habits etc. Injection technique should be regularly examined. For insulin Glargine and Levemir please see individual recommendation charts for insulin dose titration (as per charts). However, these are just a guide and basal insulin should be initiated and adjusted individually.

Titrating Levemir Pre breakfast or pre dinner Blood Glucose (mmol/l) 5.1 6.5 mmol/l >6.5 10 mmol/l >10 15 mmol/l >15 mmol/l Change in Basal dose (Units) No adjustment + 10% + 20% + 25%

If the desired pre dinner target cannot be reached, consider splitting the total daily dose of Levemir into 2 injections (morning and evening), according to individual needs. Titrating Lantus (Greater than 100kg) Fasting blood glucose (FBG) mmol/l >8.9 7.1 8.9 6.1 7.0 5.1 6.0 Increase in Insulin Dose 8 6 4 2

(Less than 100kg) Titration of Lantus following results of fasting blood glucose, adjust to no more frequently than 2 units at 48 hour intervals. The overall aim being to improve glycaemic control to a level, which is safe for the individual patient.

Continuing Care Community DSN/Healthcare Professional initiating insulin to monitor the effect of treatment and potential side effects and establish a plan for review. Initially regular contact by telephone may be required for support and guidance. When blood glucose levels are stable and education checklist completed the patient can then maintain telephone contact with their Community Diabetes Specialist Nurse Team, Practice Nurse or General practitioner. If involved District Nurses to contact the insulin initiator with any problems by fax or by telephone. In the case of the Community DSN initiating insulin, once stabilised, care is then transferred back to the referring healthcare professional, unless patient is staying on the long term Community Diabetes Specialist Nurse caseload. If in the future the glycaemic control is not acceptable then referral back to the Community Diabetes Specialist Nurse can be made either by the patient themselves or the healthcare professional managing their diabetes.

Diabetes Management Flow Chart for Adjusting Insulin in Clinical Activity Are changes to Insulin therapy necessary today to achieve target?

Yes

No

Which insulin? Decide by reviewing; General well being Symptoms. Change to routine? Hypoglycaemic episodes? Blood glucose monitoring-range and pattern. Meter function and testing technique. HbA1c Changes to medication. Check date and storage of insulin. Needle length, injection technique and condition of sites.

Is a change of formulation needed? Decide which by considering: Safety Patient preference and choice. Lifestyle implications.

Discuss at next contact

Adjustment by how much? Decide by considering total daily dose and proportions. Eating habits. Lifestyle exercise, work patterns. Past history of sensitivity to dose changes, if any. Timing of hypos, frequency.

Is a change of injection device needed? If so, decide which by: Patients ability to use device Patient preference Required insulin formulation.

Agree plans if control deteriorates. Insulin dose adjustments. Blood glucose monitoring. Ketone testing required? Who to contact and when.

Self Management Where appropriate teach self-adjustment of insulin. Agree appropriate blood glucose monitoring plan. Ketone testing Review suitable record keeping with the patient.

Agree and arrange next contact clinic/telephone/home visit/GP visit. Agree target and timescales. Ensure patient has telephone contact and DSN name.

Rationale for Insulin dose/ regime adjustments When patients are being encouraged to self adjust insulin they are normally advised to adjust by 2-4 units per injection. Further adjustments on each subsequent day are not recommended because a true response will only be noted over 2-3 days. In this way, panic adjusting will not occur and hypoglycaemia is avoided. Variances to the guidelines are required when grossly elevated blood glucose levels or severe hypoglycaemia occur. Patients will need correspondingly higher or lower doses to ensure safety and well-being. Dose adjustments of 15 - 20 % of the total daily dose may be required to achieve these stated aims. Ketone testing (in some cases where type 1 is suspected) and intensive blood glucose monitoring will be advised. Most patients would not self adjust to this extent, but would seek nursing or medical advise to support treatment changes. Insulin Dose adjustments in Hypoglycaemia Before adjusting insulin doses it is sometimes wise to explore reasons for altered blood glucose levels. Questions/Prompts How high? Did you wash, rinse and dry your hands before checking? Which area was used for testing? Meter working OK? Usual blood glucose levels, recent blood glucose readings? How long have they been high? Well or unwell? How do you feel? Are you stressed about anything? Intercurrent illness being managed appropriately. Following sick day rules What have you eaten in the last few hours, have you eaten anything which might have a high sugar content? Any likely precipitating factors: missed doses/ lack of exercise/ illness? Are you taking new medication? Check insulin appears ok, is it in date and has been stored correctly. When was the needle last changed? Correct insulin? Injection site problems? Earlier hypoglycaemic episode? Severity and frequency/ Rebound hypoglycaemia? Have they been using unrecognised hypos? IF THE PATIENT IS UNWELL, BLOOD GLUCOSE >20MMOL/L AND/OR VOMITING THEY MUST BE REFERRED TO ACCIDENT AND EMERGENCY

Insulin Dose Adjustment in Hypoglycaemia Before adjusting insulin doses it is sometimes wise to explore reasons for altered blood glucose levels. Always consider extra carbohydrate as an alternative to insulin dose reduction. Do not normally adjust insulin on the basis of one hypoglycaemic episode (unless severe) or low reading. Make small adjustments and monitor blood glucose for 2-3 days before making further changes. Adjustment to Lantus (Glargine) should be made no more frequently than weekly. Questions/Prompts Where was patient? Ensure safety. (May need driving advise re cap) What symptoms? Severity and frequency of hypos. Any unrecognised hypos? What doses of insulin are they on? Have they taken an incorrect dose? Have they taken the wrong insulin at the right time? E.g. in basal bolus regimen Usual blood glucose levels, recent history of blood glucose results Values of concern, how low has blood glucose been recorded and for how long? A symptom present, or was it from a reading on the meter. Was that reading double-checked? Quality control of meter? Any likely precipitating factors? Missed meal (fasting. Ramadam) exercise, alcohol, (deliberate overdose) injection site problem (lipophypertrophy) or renal impairment failure. Treatment taken. Time to recover. Treatment afterwards? Was a third party involved? Paramedics needed? DISCLAIMERr Within the text it has not been feasible to avoid individual names of products. In none of these instances should the appearance of such a name be taken as a recommendation. These guidelines are for use by health professionals with experience of adjusting insulin regimens in people with diabetes. They are not intended for use by any other person since the guidelines cannot describe and provide assistance with every conceivable situation. If unsure about any change in treatment, please contact the Community Diabetes Specialist Nurse Team at Selbourne House 0161 368 4242 References RCN (2004) starting insulin treatment in adults with Type 2 diabetes. RCN guidance for nurses. Department of Health (2002) National service framework for Diabetes. www.dh.gov.uk NICE (2002) Management of Type 2 Diabetes blood glucose (guideline G) NICE London.

Tameside and Glossop Primary Care Trust May 2005

Education Protocol for Patients with Type 2 Diabetes Requiring Insulin Therapy Insulin Therapy should be offered to people with diabetes whose current treatment is not enabling the achievement of agreed well being/glycaemic targets (HbA1c>7.5%) or any person with type 2 diabetes who has developed complications and/or symptoms which may benefit from a change to insulin therapy. Education is commenced either in a GP Surgery, Primary Care Clinic or in the patients own home, dependent upon access and mobility. The Healthcare professional initiating the insulin should decide this on an individual basis with the patient. The pace at which the education is delivered depends on each individual, involving as required the education needs of the carer also. Insulin Education Survival Skills This is the minimal amount of information required to allow the patient to manage independently. Brief explanation of Insulin Therapy and why it is needed Review/teach self blood glucose monitoring including recording and interpreting of results Teach insulin injection technique and storage of insulin Basic dietary advice (refer to dietician) Management of hypoglycaemia Need to carry identification and glucose at all times Driving restrictions and insurance How to obtain prescriptions and supplies The patient must also have the following (leaflets are only written backup to verbal advice already given) How to Treat Hypos Leaflet Driving Advice Leaflet Diabetes and Insulin Leaflet Correct instructions for insulin device chosen ID Card Enough supplies for at least 1 week Prescription list A follow up appointment Contact arrangements to be made for insulin titration Contact number for DSN (Novo Nordisk insulin only out of hours Help Line number available) District Nurse Referral as appropriate

The health professional should document in the patient records and complete the education checklist (see attached) on an on going basis. Continuing Education Utilizing the Education checklist, continuing education will take place in the contact made between the patient and the health professional according to the patient needs. Education should be paced to suit the individual needs and appointments negotiated with the patient. Diabetes education should be planned documented, monitored and evaluated. Mode of Education and Resources One to one teaching backed up with appropriate literature Group education patients within Primary Care Clinics Education given with Practice Nurse Diabetes UK membership Audio/visual tapes available Education Content Changes to our current medication explain to the patient about oral medication, diabetes progression and the need to start insulin therapy. Explain which oral medication is to continue and advise (with GP) which is to be discontinued and when. Advise on the name of the insulin. Pen Devise/Syringe Educate the patient on how to use their chosen device safely. How to change the cartridge (if appropriate) and preparation of the devise prior to each injection. Give written back up as reference from appropriate company. Injection technique/Timing/Dose Demonstrate 90 degree injection and show pinch up of skin for injection. Advise after injection to count slowly to 10 allowing insulin to finish coming out of the needle. Advise patient about time of day injection depending on the time action profile of the insulin prescribed. Inform patient of their dose and provide clear instructions on time and dose. Site and rotation of injection Demonstrate areas on body suitable for insulin injection. Lower abdomen, upper/outer thighs, upper/outer buttocks and top of arms (not always recommended). Advise patient on site rotation to prevent lipohypertrophy and lipoatrophy. Sites should be rotated, from rotating between injection sites and rotating within injection sites. Patients should be informed that insulin is absorbed at different speeds depending on where you inject. Needle Change/sharps Disposal Recommend that needles should be changed following each injection as per manufacturers guidelines. Used needles must be disposed of safely, either using a BD safeclip to remove the

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needle before throwing the hub in the household waste, protected by a plastic bottle or by obtaining a sharps box from their GP. Blood Glucose monitoring it is advisable that patients on insulin should monitor their blood glucose. Meters are available via chemists or possibly through their GP practice. Check that monitoring is correct and that technique is safe. Ensure that meter is up to date and that the Quality Control has been done regularly. Advise patients on their blood testing times over the day e.g. pre meal or pre and post meal. Supply patient with a monitoring diary as required. Regular carbohydrate intake Advise patients about regular meals and in some cases the need for a supper prior to bed. Explain carbohydrate and need to include at each mealtime. Refer to dietician as appropriate. Snacks - Advise as necessary, dependent on insulin action profile and weight, suitable snacks to have between meals. Eating Out Advise again about insulin timing, snacks and also probable need for increase in insulin dose dependent on insulin regime and type of insulin e.g. NovoRapid, to deal with meal, dependent on content. Hypoglycaemia Signs and Treatment Explain hypo signs and also treatment. Give written back up to give patient reference at a later date. Ensure patient is able to discuss hypos and their treatment. High light importance of this advice. Exercise Dependent on patients general health and risk to feet/lower limbs advise about appropriate exercise and the benefits that can be gained. Explain about effects on blood glucose control and possibility of hypoglycaemia. Alcohol Discuss effects of alcohol on diabetes control and weight. Advise on hypoglycaemic risk associated with alcohol and also if they are going to consume alcohol, how to minimise the risk of hypoglycaemia. Advise on weekly recommended limit 14 units for females and 21 units for males. Advise on harmful effects of binge drinking and discuss measures for altering present drinking habits if appropriate. ID Card Provide identity card for purse/wallet to show that person holding this card has diabetes and is on insulin therapy. Holidays/Travel advise patients about holiday and preparation with insulin therapy. If on long haul flight advise on injection timing with their travel outbound and inbound flights. Advise on storage of insulin in hand luggage, due to hold temperature. Advise on insulin storage abroad and how to obtain further supplies in case of an emergency. Advise on letter required to allow travel with insulin device and injection on plane, provide same. Advise on general holiday advice, such as foot care, insulin reduction due to probability of hypos in hot weather, meal times, sick day rules, insulin storage etc. Sick day Rules Advise patient about sick day rules and give written back up for future reference.

1. Never stop taking your insulin, even if you are ill and cannot eat. 2. Measure your blood glucose levels more frequently, at least 4 times a day, and adjust your insulin dose if necessary. 3. Try to drink plenty of liquids such as water or sugar free drinks. At least 3 4 litres should be sipped through the day if possible. 4. If you dont feel like eating solid foods, try alternatives like milk, soup, cereals, ice cream, pudding, fruit juice or fizzy drinks. 11

5. Test your urine for ketones and glucose frequently as it will give you the first warning of either a lack of insulin or carbohydrates. 6. Contact Diabetes Clinic or GP if you are unsure what to do, you are vomiting, you dont improve quickly, your glucose level remains high or adversely low, you are worrying. Contact Numbers Give contact number of Community Diabetes Specialist Nurses. If on Novo Nordisk products, give out of hours help line number in addition. Driving/DVLA/Insurance Advise that by law, the patient must inform the DVLA when starting on insulin, and that they will then have a 3 year driving license. Advise the patient that they must inform their Insurance Company or else their insurance is void if they have an accident. Explain also that it is vitally important that they do not go hypo whilst driving and explain fully the risks involved. 1. 2. 3. 4. 5. Keep glucose tablets/lucozade and snack in the car Stop every 2 hours Dont miss a meal or snack Check blood glucose before, during and after driving Do not drive if blood glucose is less than 4 mmol/l. Take glucose tablets (3) followed by an extra snack. Wait until blood glucose level above 8mmol/l 6. If blood glucose level is 5mmol/ have snack prior to setting off 7. If patient has a hypo whilst driving then: Pull over when safe to do so Park safely Take the keys out of the ignition Change seats Have fast acting carbohydrate and something else to eat Check that the blood glucose level is greater than 8mmol/l before setting off again

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