• National Collaborating Centre for Chronic Conditions. Type 1 diabetes in adults. National clinical guideline for diagnosis and management in primary and secondary care. London (UK): Royal College of Physicians; 2004. 171 p. [382 references]

This is the current release of the guideline.

Evidence categories (Ia–IV) and recommendation grades (A–D) are defined at the end of the "Major Recommendations" field.

In addition to evidence-based recommendations, the guideline development group (GDG) also identifies evidence from diagnostic studies (DS) and from the National Institute for Health and Clinical Excellence (NICE) guidelines or health technology appraisal programme (NICE).

Diagnosis

D - Diabetes should be confirmed by a single diagnostic laboratory glucose measurement in the presence of classical symptoms, or by a further laboratory glucose measurement. The diagnosis may be supported by a raised haemoglobin A_1c (HbA_1c).

D - Where diabetes is diagnosed, but Type 2 diabetes suspected, the diagnosis of Type 1 diabetes should be considered if:

• ketonuria is detected, or
• weight loss is marked, or
• the person does not have features of the metabolic syndrome or other contributing illness

D - When diabetes is diagnosed in a younger person, the possibility that the diabetes is not Type 1 diabetes should be considered if they are obese or have a family history of diabetes, particularly if they are of non-white ethnicity.

D - Tests to detect specific auto-antibodies or to measure C-peptide deficiency should not be regularly used to confirm the diagnosis of Type 1 diabetes. Their use should be considered if predicting the rate of decline of islet B-cell function would be useful in discriminating Type 1 from Type 2 diabetes.

Care Process and Support

Optimal Healthcare Processes

D - Advice to adults with Type 1 diabetes should be provided by a range of professionals with skills in diabetes care working together in a coordinated approach. A common environment (diabetes centre) is an important resource in allowing a diabetes multidisciplinary team to work and communicate efficiently while providing consistent advice.

C - Open-access services should be provided on a walk-in and telephone-request basis during working hours to adults with Type 1 diabetes, and a helpline staffed by people with specific diabetes expertise should be provided on a 24-hour basis. Adults with diabetes should be provided with contact information for these services.

D - An individual care plan should be set up and reviewed annually, modified according to changes in wishes, circumstances, and medical findings, and the details recorded. The plan should include aspects of:

• Diabetes education including nutritional advice (see sections below titled "Education Programmes for Adults with Type 1 Diabetes" and "Dietary Management")
• Insulin therapy (see sections below titled "Insulin Regimens" and "Insulin Delivery")
• Self-monitoring (see section below titled "Self-Monitoring of Blood Glucose")
• Arterial risk factor surveillance and management (see section below titled "Arterial Risk Control")
• Late complications surveillance and management (see sections below on late complications)
• Means and frequency of communication with the professional care team
• Follow-up consultations including next annual review

D - Population, practice-based, and clinic diabetes registers (as specified by the National Service Framework) should be used to assist programmed recall for annual review and assessment of complications and vascular risk.

A - Conventional technology (telephones), or newer technologies for high-density data transmission of images, should be used to improve process and outcomes.

D - The multidisciplinary team approach should be available to inpatients with diabetes, regardless of the reason for admission (see section titled "Inpatient Management).

Support Groups

C - At the time of diagnosis and periodically thereafter, adults with diabetes should be offered up-to-date information on the existence of and means of contacting diabetes support groups (local and national), and the benefits of membership.

Education, Programmes and Self-Care

Education Programmes for Adults with Type 1 Diabetes

Specific recommendations on patient education and information-giving in particular aspects of care are given in individual sections of this guideline.

A - A programme of structured diabetes education covering all major aspects of diabetes self-care and the reasons for it should be made available to all adults with Type 1 diabetes in the months after diagnosis, and periodically thereafter according to agreed need following yearly assessment.

D - Education programmes for adults with Type 1 diabetes should be flexible so that they can be adapted to specific educational, social, and cultural needs. These needs should be integrated with individual health needs as dictated by the impact of diabetes and other relevant health conditions on the individual.

D - Education programmes for adults with Type 1 diabetes should be designed and delivered by members of the multidisciplinary diabetes team in accordance with the principles of adult education.

D - Education programmes for adults with Type 1 diabetes should include modules designed to empower adults to participate in their own healthcare through:

• Enabling them to make judgments and choices about how they effect that care
• Obtaining appropriate input from the professionals available to advise them.

D - Professionals engaged in the delivery of diabetes care should consider incorporating educational interchange at all opportunities when in contact with a person with Type 1 diabetes. The professional should have the skills and training to make best use of such time.

D - More formal review of self-care and needs should be made annually in all adults with Type 1 diabetes, and the agenda addressed each year should vary according to the priorities agreed between the healthcare professional and the person with Type 1 diabetes.

Self-Monitoring of Blood Glucose

D - Self-monitoring of blood glucose levels should be used as part of an integrated package that includes appropriate insulin regimens and education to help choice and achievement of optimal diabetes outcomes.

D - Self-monitoring skills should be taught close to the time of diagnosis and initiation of insulin therapy.

D - Self-monitoring results should be interpreted in the light of clinically significant life events.

D - Self monitoring should be performed using meters and strips chosen by adults with diabetes to suit their needs, and usually with low blood requirements, fast analysis times, and integral memories.

D - Structured assessment of self-monitoring skills, the quality and use made of the results obtained, and the equipment used should be made annually. Self-monitoring skills should be reviewed as part of annual review, or more frequently according to need, and reinforced where appropriate.

D - Adults with Type 1 diabetes should be advised that the optimal frequency of self monitoring will depend on:

• The characteristics of an individual's blood glucose control
• The insulin treatment regimen
• Personal preference in using the results to achieve the desired lifestyle

D - Adults with Type 1 diabetes should be advised that the optimal targets for short-term glycaemic control are:

• A pre-prandial blood glucose level of 4.0 to 7.0 mmol/L and
• A post-prandial blood glucose level of less than 9.0 mmol/L

Note: These values are different than those given in the recommendations for children and young people with Type 1 diabetes because of clinical differences between these two age groups.

D - Monitoring using sites other than the fingertips (often the forearm, using meters that require small volumes of blood and devices to obtain those small volumes) cannot be recommended as a routine alternative to conventional self-blood glucose monitoring.

Dietary Management

D - Nutritional information sensitive to personal needs and culture should be offered from the time of diagnosis of Type 1 diabetes.

D - Nutritional information should be offered individually and as part of a diabetes education programme (see education recommendations above). Information should include advice from professionals with specific and approved training and continuing accredited education in delivering nutritional advice to people with health conditions. Opportunities to receive nutritional advice should be offered at intervals agreed between adults with Type 1 diabetes and their advising professionals.

A - The hyperglycaemic effects of different foods a person with Type 1 diabetes wishes to eat should be discussed in the context of the insulin preparations chosen to match those food choices.

A - Programmes should be available to adults with Type 1 diabetes to enable them to make:

• Optimal choices about the variety of foods they wish to consume
• Insulin dose changes appropriate to reduce glucose excursions when taking different quantities of those foods

D - The choice of content, timing, and amount of snacks between meals or at bedtime available to the person with Type 1 diabetes should be agreed on the basis of informed discussion about the extent and duration of the effects of consumption of different food types and the insulin preparations available to match them. Those choices should be modified on the basis of discussion of the results of self-monitoring tests.

D - Information should also be made available on:

• Effects of different alcohol-containing drinks on blood glucose excursions and calorie intake
• Use of high-calorie and high-sugar "treats"
• Use of foods of high glycaemic index

D - Information about the benefits of healthy eating in reducing arterial risk should be made available as part of dietary education in the period after diagnosis, and according to need and interest at intervals thereafter. This should include information about low glycaemic index foods, fruit and vegetables, and types and amounts of fat, and ways of making the appropriate nutritional changes.

D - Nutritional recommendations to individuals should be modified to take account of associated features of diabetes, including:

• Excess weight and obesity
• Underweight
• Eating disorders
• Raised blood pressure
• Renal failure

D - All healthcare professionals providing advice on the management of Type 1 diabetes should be aware of appropriate nutritional advice on common topics of concern and interest to adults living with Type 1 diabetes, and should be prepared to seek advice from colleagues with more specialised knowledge. Suggested common topics include:

• Glycaemic index of specific foods
• Body weight, energy balance, and obesity management
• Cultural and religious diets, feasts, and fasts
• Foods sold as "diabetic"
• Sweeteners
• Dietary fibre intake
• Protein intake
• Vitamin and mineral supplements
• Alcohol
• Matching carbohydrate, insulin, and physical activity
• Salt intake in hypertension
• Comorbidities including nephropathy and renal failure, coeliac disease, cystic fibrosis, or eating disorders
• Use of peer support groups

Physical Activity

C - Adults with Type 1 diabetes should be advised that physical activity can reduce their enhanced arterial risk in the medium and longer term.

D - Adults with Type 1 diabetes who choose to integrate increased physical activity into a more healthy lifestyle should be offered information about:

• Appropriate intensity and frequency of physical activity
• Role of self-monitoring of changed insulin and/or nutritional needs
• Effect of activity on blood glucose levels (likely fall) when insulin levels are adequate
• Effect of exercise on blood glucose levels when hyperglycaemic and hypoinsulinaemic (risk of worsening of hyperglycaemia and ketonaemia)
• Appropriate adjustments of insulin dosage and/or nutritional intake for exercise and post-exercise periods, and the next 24 hours
• Interactions of exercise and alcohol
• Further contacts and sources of information

Cultural and Individual Lifestyle

D - Each adult with Type 1 diabetes should be managed as an individual, rather than as a member of any cultural, economic, or health-affected group. Attention should be paid to the recommendations given elsewhere in this guideline with respect to the cultural preferences of individual adults with Type 1 diabetes.

Blood Glucose Control and Insulin Therapy

Clinical Monitoring of Blood Glucose

D - Clinical monitoring of blood glucose levels by high-precision Diabetes Control and Complications Trial (DCCT)-aligned methods of HbA1c should be performed every two to six months, depending on:

• Achieved level of blood glucose control
• Stability of blood glucose control
• Change in insulin dose or regimen

D - Site-of-care measurement or measurement before clinical consultation should be provided.

D - HbA_1c results should be communicated to the person with Type 1 diabetes after each measurement. The term "A1c" can be used for simplicity.

A - Total glycated haemoglobin (GHb) estimation or assessment of glucose profiles should be used where haemoglobinopathy or haemoglobin turnover invalidate HbA_1c measurement.

B - Fructosamine should not be used as a routine substitute for HbA_1c estimation.

B - Continuous glucose monitoring systems have a role in the assessment of glucose profiles in adults with consistent glucose control problems on insulin therapy, notably:

• Repeated hyper- or hypoglycaemia at the same time of day
• Hypoglycaemia unawareness, unresponsive to conventional insulin dose adjustment

Glucose Control Assessment Levels

B - Adults with Type 1 diabetes should be advised that maintaining a DCCT-harmonised HbA_1c below 7.5% is likely to minimise their risk of developing diabetic eye, kidney, or nerve damage in the longer term.

D - Adults with Type 1 diabetes who want to achieve an HbA_1c down to, or towards, 7.5% should be given all appropriate support in their efforts to do so.

NICE - Where there is evidence of increased arterial risk (identified by a raised albumin excretion rate, features of the metabolic syndrome, or other arterial risk factors), people with Type 1 diabetes should be advised that approaching lower HbA_1c levels (for example, 6.5% or lower) may be of benefit to them. Support should be given to approaching this target if so wished.

B - Where target HbA_1c levels are not reached in the individual, adults with Type 1 diabetes should be advised that any improvement is beneficial in the medium and long term, and that greater improvements towards the target level lead to greater absolute gains.

D - Undetected hypoglycaemia and an attendant risk of unexpected disabling hypoglycaemia or of hypoglycaemia unawareness should be suspected in adults with Type 1 diabetes who have:

• Lower HbA_1c levels, in particular levels in or approaching the normal reference range (DCCT harmonised <6.1%)
• HbA_1c levels lower than expected from self-monitoring results

D - Where experience or risk of hypoglycaemia is significant to an individual, or the effort needed to achieve target levels severely curtails other quality of life despite optimal use of current diabetes technologies, tighter blood glucose control should not be pursued without balanced discussion of the advantages and disadvantages.

Note: A new chemical standard for HbA_1c has been developed by the International Federation of Clinical Chemistry (IFCC). This reads lower by around 2.0% (units), and will be the basis of primary calibration of instruments from 2004 onwards. However, this does not preclude the use of DCCT-harmonised levels, and views from patient organisations and professional bodies at a recent Department of Health meeting (July 2003) are that all HbA_1c reports should be DCCT aligned, pending some internationally concerted policy change.

Insulin Regimens

A - Adults with Type 1 diabetes should have access to the types (preparation and species) of insulin they find allow them optimal well-being.

D - Cultural preferences need to be discussed and respected in agreeing the insulin regimen for a person with Type 1 diabetes.

A - Multiple insulin injection regimens, in adults who prefer them, should be used as part of an integrated package of which education, food, and skills training should be integral parts.

D - Appropriate self-monitoring and education should be used as part of an integrated package to help achieve optimal diabetes outcomes.

D - Meal-time insulin injections should be provided by injection of unmodified ("soluble") insulin or rapid-acting insulin analogues before main meals.

A - Rapid-acting insulin analogues should be used as an alternative to meal-time unmodified insulin:

• Where nocturnal or late inter-prandial hypoglycaemia is a problem
• In those in whom they allow equivalent blood glucose control without use of snacks between meals and this is needed or desired

D - Basal insulin supply (including nocturnal insulin supply) should be provided by the use of isophane (NPH) insulin or long-acting insulin analogues (insulin glargine). Isophane (NPH) insulin should be given at bedtime. If rapid-acting insulin analogues are given at meal times or the midday insulin dose is small or lacking, the need to give isophane (NPH) insulin twice daily (or more often) should be considered.

D - Long-acting insulin analogues (insulin glargine) should be used when:

• Nocturnal hypoglycaemia is a problem on isophane (NPH) insulin
• Morning hyperglycaemia on isophane (NPH) insulin results in difficult daytime blood glucose control
• Rapid-acting insulin analogues are used for meal-time blood glucose control

D - Twice-daily insulin regimens should be used by those adults who consider number of daily injections an important issue in quality of life.

• Biphasic insulin preparations (pre-mixes) are often the preparations of choice in this circumstance.
• Biphasic rapid-acting insulin analogue pre-mixes may give an advantage to those prone to hypoglycaemia at night.

Such twice daily regimens may also help:

• Those who find adherence to their agreed lunch-time insulin injection difficult
• Adults with learning difficulties who may require assistance from others

D - Adults whose nutritional and physical activity patterns vary considerably from day to day, for vocational or recreational reasons, may need careful and detailed review of their self-monitoring and insulin injection regimen(s). This should include all the appropriate preparations (see recommendations above regarding use of rapid-acting insulin analogues, isophane [NPH] insulin, and long-acting insulin analogues [insulin glargine]) and consideration of unusual patterns and combinations.

D - For adults undergoing periods of fasting or sleep following eating (such as during religious feasts and fasts or after night-shift work), a rapid-acting insulin analogue before the meal (provided the meal is not prolonged) should be considered.

D - For adults with erratic and unpredictable blood glucose control (hyper- and hypoglycaemia at no consistent times), rather than a change in a previously optimised insulin regimen, the following should be considered:

• Resuspension of insulin and injection technique
• Injection sites
• Self-monitoring skills
• Knowledge and self-management skills
• Nature of lifestyle
• Psychological and psychosocial difficulties
• Possible organic causes such as gastroparesis

NICE - Continuous subcutaneous insulin infusion (or insulin pump therapy) is recommended as an option for people with Type 1 diabetes provided that:

• Multiple-dose insulin therapy (including, where appropriate, the use of insulin glargine) has failed;* and
• Those receiving the treatment have the commitment and competence to use the therapy effectively.

  *Note: People for whom multiple-dose therapy has failed are considered to be those for whom it has been impossible to maintain an HbA_1c level no greater than 7.5% (or 6.5% in the presence of microalbuminuria or adverse features of the metabolic syndrome) without disabling hypoglycaemia occurring, despite a high level of self care of their diabetes. "Disabling hypoglycaemia," for the purpose of this guidance, means the repeated and unpredicted occurrence of hypoglycaemia requiring third-party assistance that results in continuing anxiety about recurrence and is associated with significant adverse effect on quality of life.

D - Partial insulin replacement to achieve blood glucose control targets (basal insulin only, or just some meal-time insulin) should be considered for adults starting insulin therapy, until such time as islet B-cell deficiency progresses further.

D - Clear guidelines and protocols ("sick-day rules") should be given to all adults with Type 1 diabetes to assist them in adjusting insulin doses appropriately during intercurrent illness.

D - Oral glucose-lowering drugs should generally not be used in the management of adults with Type 1 diabetes.

Insulin Delivery

D - Adults with Type 1 diabetes who inject insulin should have access to the insulin injection delivery device they find allows them optimal well-being, often using one or more types of insulin injection pen.

D - Adults with Type 1 diabetes who have special visual or psychological needs should be provided with injection devices or needle-free systems that they can use independently for accurate dosing.

D - Insulin injection should be made into the deep subcutaneous fat. To achieve this, needles of a length appropriate to the individual should be made available.

D - Adults with Type 1 diabetes should be informed that the abdominal wall is the therapeutic choice for mealtime insulin injections.

D - Adults with Type 1 diabetes should be informed that extended-acting suspension insulin (for example isophane [NPH] insulin) may give a longer profile of action when injected into the subcutaneous tissue of the thigh rather than the arm or abdominal wall.

D - Adults with Type 1 diabetes should be recommended to use one anatomical area for the injections given at the same time of day, but to move the precise injection site around in the whole of the available skin within that area.

D - Adults with Type 1 diabetes should be provided with suitable containers for the collection of used needles. Arrangements should be available for the suitable disposal of these containers.

D - Injection site condition should be checked annually, and if new problems with blood glucose control occur.

Hypoglycaemia: Prevention of Hypoglycaemia, Problems Related to Hypoglycaemia, and Management of Symptomatic Hypoglycaemia

A - Adults with Type 1 diabetes should be informed that any available glucose/sucrose-containing fluid is suitable for the management of hypoglycaemic symptoms or signs in people who are able to swallow. Glucose-containing tablets or gels are also suitable for those able to dissolve or disperse these in the mouth and swallow the products.

D - When a more rapid-acting form of glucose is required, purer glucose-containing solutions should be given.

D - Adults with decreased level of consciousness due to hypoglycaemia who are unable to take oral treatment safely should be:

• Given intramuscular glucagon by a trained user (intravenous glucose may be used by professionals skilled in obtaining intravenous access)
• Monitored for response at 10 minutes, and then given intravenous glucose if the level of consciousness is not improving significantly
• Then given oral carbohydrate when it is safe to administer it, and placed under continued observation by a third party who has been warned of the risk of relapse

B - Adults with Type 1 diabetes should be informed that some hypoglycaemic episodes are an inevitable consequence of insulin therapy in most people using any insulin regimen, and that it is advisable that they should use a regimen that avoids or reduces the frequency of hypoglycaemic episodes while maintaining as optimal a level of blood glucose control as is feasible. Advice to assist in obtaining the best such balance from any insulin regimen should be available to all adults with Type 1 diabetes. (See sections above titled "Insulin regimens" and "Insulin delivery").

D - When hypoglycaemia becomes unusually problematic or of increased frequency, review should be made of the following possibly contributory causes:

• Inappropriate insulin regimens (incorrect dose distributions and insulin types)
• Meal and activity patterns, including alcohol
• Injection technique and skills, including insulin resuspension
• Injection site problems
• Possible organic causes including gastroparesis
• Changes in insulin sensitivity (the latter including drugs affecting the renin-angiotensin system and renal failure)
• Psychological problems
• Previous physical activity
• Lack of appropriate knowledge and skills for self management

D - Hypoglycaemia unawareness should be assumed to be secondary to undetected periods of hypoglycaemia (<3.5 mmol/litre, often for extended periods, commonly at night) until these are excluded by appropriate monitoring techniques. If present, such periods of hypoglycaemia should be ameliorated.

D - Specific education on the detection and management of hypoglycaemia in adults with problems of hypoglycaemia awareness should be offered.

D - Nocturnal hypoglycaemia (symptomatic or detected on monitoring) should be managed by:

• Reviewing knowledge and self-management skills
• Reviewing current insulin regimen and evening eating habits and previous physical activity
• Choosing an insulin type and regimen with less propensity to induce low glucose levels in the night hours, such as:
  • Isophane (NPH) insulin at bedtime
  • Rapid-acting analogue with the evening meal
  • Long-acting insulin analogues (insulin glargine)
  • Insulin pump

D - Adults with Type 1 diabetes should be informed that late post-prandial hypoglycaemia may be managed by appropriate inter-prandial snacks or the use of rapid-acting insulin analogues before meals.

D - Where early cognitive decline occurs in adults on long-term insulin therapy, normal investigations should be supplemented by the consideration or investigation of possible brain damage due to overt or covert hypoglycaemia, and the need to ameliorate this.

Arterial Risk Control

Identification of Arterial Risk

C - Arterial risk factors should be assessed annually, and the assessment should include:

• Albumin excretion rate
• Smoking
• Blood glucose control
• Blood pressure
• Full lipid profile (including high-density lipoprotein [HDL] and low-density lipoprotein [LDL] cholesterol and triglycerides)
• Age
• Family history of arterial disease (CVD)
• Abdominal adiposity

DS - Arterial risk tables, equations, or engines for calculation of arterial risk should not be used because they underestimate risk in adults with Type 1 diabetes.

D - Adults with raised albumin excretion rate (microalbuminuria), or two or more features of the metabolic syndrome (see table below) should be managed as the highest risk category (as though they had Type 2 diabetes or declared arterial disease).

Table: Features of the Metabolic Syndrome Suggesting High Arterial Risk in Adults with Type 1 Diabetes

Table Notes:

• Raised albumin excretion rate is not included, because in Type 1 diabetes it is a marker of developing nephropathy, and nephropathy alone is associated with extreme risk of ischaemic heart disease.
• Glucose intolerance cannot be assessed in adults with Type 1 diabetes, but higher insulin doses in adults >20 years (>1.0 U/kg/day) suggest insulin insensitivity.

D - Adults with Type 1 diabetes who are not in the highest risk category but who have other arterial risk factors (increasing age over 35 years, family history of premature heart disease, of ethnic group with high risk, or with more severe abnormalities of blood lipids or blood pressure) should be managed as a moderately-high-risk group.

D - Where there is no evidence of additional arterial risk, the management of lipids and blood pressure should follow normal procedures for the non-diabetes population, using appropriate clinical guidelines.

Interventions to Reduce Risk and to Manage Arterial Disease

These recommendations assume that arterial risk has been assessed according to the recommendations in the section above titled "Identification of Arterial Risk." Blood glucose control, blood pressure control, and education programmes for adults with Type 1 diabetes are considered elsewhere in this guideline.

D - Adults with Type 1 diabetes who smoke should be given advice on smoking cessation and use of smoking cessation services, including NICE guidance-recommended therapies. The messages should be reinforced in continuing smokers yearly if pre-contemplative of stopping, and at all clinical contacts if there is a prospect of their stopping.

D - Young adult non-smokers should be advised never to start smoking.

B - Aspirin therapy (75 mg daily) should be recommended in adults in the highest and moderately-high risk categories.

B - A standard dose of a statin should be recommended for adults in the highest risk and moderately-high risk groups. Therapy should not be stopped if alanine aminotransferase (ALT) is raised to less than three times the upper limit of reference range.

D - If several statins are not tolerated, fibrates and other lipid-lowering drugs should be considered as indicated according to assessed arterial disease risk status.

D - Fibrates should be recommended for adults with hypertriglyceridaemia according to local lipid-lowering guidelines and arterial disease risk status.

D - Responses to therapy should be monitored by assessment of lipid profile. If the response is unsatisfactory, the following causes should be considered: non-concordance, inappropriate drug choice, and the need for combination therapy.

D - Adults who have had myocardial infarction or stroke should be managed intensively, according to relevant non-diabetes guidelines. In the presence of angina or other ischaemic heart disease, beta-adrenergic blockers should be considered. (For use of insulin in these circumstances, see section below titled "Inpatient Management").

Blood Pressure

D - Intervention levels for recommending blood pressure management should be 135/85 mmHg unless the person with Type 1 diabetes has abnormal albumin excretion rate or two or more features of the metabolic syndrome (see Table above), in which case it should be 130/80 mmHg. See also the recommendation regarding blood pressure treatment in the section below titled "Kidney Damage."

D - To allow informed choice by the person with the condition, the following should be discussed:

• Reasons for choice of intervention level
• Substantial potential gains from small improvements in blood pressure control
• Possible negative consequences of therapy

See also the recommendation regarding blood pressure treatment in the section below titled "Kidney Damage."

D - A trial of a low-dose thiazide diuretic should be started as first-line therapy for raised blood pressure, unless the person with Type 1 diabetes is already taking a renin-angiotensin system blocking drug for nephropathy (see the section below titled "Kidney Damage"). Multiple drug therapy will often be required.

D - Adults with Type 1 diabetes should be offered information on the potential for lifestyle changes to improve blood pressure control and associated outcomes, and offered assistance in achieving their aims in this area.

D - Concerns over potential side effects should not be allowed to inhibit advising and offering the necessary use of any class of drugs, unless the side effects become symptomatic or otherwise clinically significant. In particular:

• Selective beta-adrenergic blockers should not be avoided in adults on insulin.
• Low-dose thiazides may be combined with beta-blockers.
• When calcium channel antagonists are prescribed, only long-acting preparations should be used.
• Direct questioning should be used to detect the potential side effects of erectile dysfunction, lethargy, and orthostatic hypotension with different drug classes.

Management of Late Complications: Diabetic Eye Disease

Retinopathy Surveillance Programmes

A - Eye surveillance for adults newly diagnosed with Type 1 diabetes should be started from diagnosis.

B - Depending on the findings, structured eye surveillance should be followed by:

• Routine review in one year, or
• Earlier review, or
• Referral to an ophthalmologist

A - Structured eye surveillance should be at one-year intervals.

C - The reasons and success of eye surveillance systems should be properly conveyed to adults with Type 1 diabetes, so that attendance is not reduced by ignorance of need or fear of outcome.

Screening Tests for Retinopathy

B - Digital retinal photography should be implemented for eye surveillance programmes for adults with Type 1 diabetes.

B - Mydriasis with tropicamide should be used when photographing the retina,
D - after prior agreement with the person with Type 1 diabetes following discussion of the advantages and disadvantages, including appropriate precautions for driving.

D - Visual acuity testing should be a routine part of eye surveillance programmes.

Referral

D - Emergency review by an ophthalmologist should occur for:

• Sudden loss of vision
• Rubeosis iridis
• Pre-retinal or vitreous haemorrhage
• Retinal detachment

D - Rapid review by an ophthalmologist should occur for new vessel formation.

D - Referral to an ophthalmologist should occur for:

• Referable maculopathy:
  • Exudate or retinal thickening within one disc diameter of the centre of the fovea
  • Circinate or group of exudates within the macula (the macula is defined here as a circle centred on the fovea, of a diameter the distance between the temporal border of the optic disc and the fovea)
  • Any microaneurysm or haemorrhage within one disc diameter of the centre of the fovea, only if associated with a best visual acuity of 6/12 or worse
• Referable pre-proliferative retinopathy:
  • Any venous beading
  • Any venous loop or reduplication
  • Any intraretinal microvascular abnormalities (IRMA)
  • Multiple deep, round or blot haemorrhages
• Any unexplained drop in visual acuity

Management of Late Complications: Diabetic Kidney Disease

Kidney Damage

See also recommendations for "blood pressure" above.

D - All adults with Type 1 diabetes with or without detected nephropathy should be asked to bring in a first-pass morning urine specimen once a year. This should be sent for estimation of albumin:creatinine ratio. Estimation of urine albumin concentration alone is a poor alternative. Serum creatinine should be measured at the same time.

DS - If an abnormal surveillance result is obtained (in the absence of proteinuria/urinary tract infection) the test should be repeated at each clinic visit or at least every three to four months, and the result taken as confirmed if a further specimen (out of two more) is also abnormal (>2.5 mg/mmol for men, >3.5 mg/mmol for women).

DS - Other renal disease should be suspected:

• In the absence of progressive retinopathy
• If blood pressure is particularly high
• If proteinuria develops suddenly
• If significant haematuria is present
• In the presence of systemic ill health

D - The significance of a finding of abnormal albumin excretion rate should be discussed with the person concerned.

A - Angiotensin-converting enzyme (ACE) inhibitors should be started and (with the usual precautions) titrated to full dose in all adults with confirmed nephropathy (including those with microalbuminuria alone) and Type 1 diabetes.

B - If ACE inhibitors are not tolerated, angiotensin 2 receptor antagonists should be substituted. Combination therapy is not recommended at present.

D - Blood pressure should be maintained below 130/80 mmHg by addition of other anti-hypertensive drugs if necessary.

B - Adults with Type 1 diabetes and nephropathy should be advised about the advantages of not following a high protein diet.

D - Referral criteria for tertiary care should be agreed between local diabetes specialists and nephrologists.

Management of Late Complications: Diabetes Foot Problems

Screening and Surveillance of Diabetic Foot Problems

D - Structured foot surveillance should be at one-year intervals, and should include educational assessment and education input commensurate with the assessed risk.

D - The reasons for and success of foot surveillance systems should be properly conveyed to adults with Type 1 diabetes, so that attendance is not reduced by ignorance of need.

D - Inspection and examination of feet should include:

• Skin condition
• Shape and deformity
• Shoes
• Impaired sensory nerve function
• Vascular supply (including peripheral pulses)

DS - Use of a 10-g monofilament plus non-traumatic pin prick is advised for detection of impairment of sensory nerve function sufficient to significantly raise risk of foot ulceration.

Management of Foot Ulceration and Associated Risk Factors

Foot Complication Surveillance

D - On the basis of findings from foot care surveillance, foot ulceration risk should be categorised into:

• Low current risk (normal sensation and palpable pulses)
• Increased risk (impaired sensory nerve function or absent pulses, or other risk factor)
• High risk (impaired sensory nerve function and absent pulses or deformity or skin changes, or previous ulcer)
• Ulcer present

Foot Care Management

B - For people found to be at increased risk or high risk of foot complications:

• Arrange specific assessment of other contributory risk factors including deformity, smoking, and level of blood glucose control.
• Arrange/reinforce specific foot care education, and review those at high risk as part of a formal foot ulcer prevention programme.
• Consider the provision of special footwear, including insoles and orthoses, if there is a deformity, callosities or previous ulcer.

B - For people with an ulcerated foot:

• Arrange referral to a specialist diabetes foot care team incorporating specifically trained foot care specialists (usually state-registered podiatrists) within one to two days if there is no overt infection of the ulcer or surrounding tissues, or as an emergency if such infection is present.
• Use antibiotics if there is any evidence of infection of the ulcer or surrounding tissues and continue these long term if infection is recurrent.
• Use foot dressings, taking account of cost according to local experience, ensuring arrangements are in place to monitor and change dressings frequently (often daily) accordingly to need.
• Remove dead tissue from diabetic foot ulcers.
• Consider the use of off-loading techniques (such as contact casting) for people with neuropathic foot ulcers.
• Do not use cultured human dermis (or equivalent), hyperbaric oxygen therapy, topical ketanserin, or growth factors in routine foot ulcer management.
• Consider ensuring complete and effective foot education through the use of graphic visualisations of the consequences of ill-managed foot ulceration in people with recurrent ulceration or previous amputation.
• Review progress in ulcer healing frequently (daily to monthly) according to need.
• If peripheral vascular disease is detected, refer for early assessment by a specialist vascular team.

Charcot Osteoarthropathy

D - Adults with suspected or diagnosed Charcot osteoarthropathy should be referred immediately to a multidisciplinary diabetes foot care team.

Management of Late Complications: Diabetes Nerve Damage

Diagnosis and Management of Erectile Dysfunction

D - Men should be asked annually whether erectile dysfunction is an issue.

A - A phosphodiesterase-5 (PDE5) inhibitor drug, if not contraindicated, should be offered where erectile dysfunction is a problem.

D - Referral to a service offering other medical and surgical management of erectile dysfunction should be discussed where phosphodiesterase-5 inhibitors are not successful.

Diagnosis and Management of Autonomic Neuropathy

D - In adults with Type 1 diabetes on insulin therapy who have erratic blood glucose control (or unexplained bloating or vomiting), the diagnosis of gastroparesis should be considered.

D - In adults with Type 1 diabetes who have altered perception of hypoglycaemia the possibility of sympathetic nervous system damage as a contributory factor should be considered.

D - In adults with Type 1 diabetes who have unexplained diarrhoea, particularly at night, the possibility of autonomic neuropathy affecting the gut should be considered.

D - Care should be taken when prescribing antihypertensive drugs not to expose people to the risks of orthostatic hypotension as a result of the combined effects of sympathetic autonomic neuropathy and blood pressure lowering drugs.

D - Adults with Type 1 diabetes who have bladder emptying problems should be investigated for the possibility of autonomic neuropathy affecting the bladder, unless other explanations are adequate.

D - The management of the symptoms of autonomic neuropathy should include standard interventions for the manifestations encountered (for example, for erectile dysfunction or abnormal sweating).

D - For adults with Type 1 diabetes with diagnosed or suspected gastroparesis a trial of prokinetic drugs is indicated (metoclopramide or domperidone, with cisapride* as third line if necessary).

*Note: Cisapride is not currently licensed in the United Kingdom (UK).

Anaesthesia Autonomic Neuropathy

D - Anaesthetists should be aware of the possibility of parasympathetic autonomic neuropathy affecting the heart in adults with diabetes who are listed for procedures under general anaesthetic and who have evidence of somatic neuropathy or other manifestations of autonomic neuropathy.

Optimum Management of Painful Neuropathy

D - Use of simple analgesics (paracetamol, aspirin) and local measures (bed cradles) are recommended as a first step, but if trials of these measures are ineffective, they should be discontinued and other measures should be tried.

A - Where initial measures fail, a low to medium dose of a tricyclic drug* should be used, timed to be taken before the time of day the symptoms are troublesome; adults with Type 1 diabetes should be advised that this is a trial of therapy.

*Note: Tricyclic antidepressants and carbamazepine are not currently licensed in the UK for painful neuropathy associated with Type 1 diabetes.

A - Where an adequate trial of tricyclic drugs* fails, a trial of gabapentin should be started and not stopped unless ineffective at the maximum tolerated dose or at least 1,800 mg per day.

*Note: Tricyclic antidepressants and carbamazepine are not currently licensed in the UK for painful neuropathy associated with Type 1 diabetes.

D - If treatment with gabapentin is unsuccessful, carbamazepine* and phenytoin* should be considered.

*Note: Tricyclic antidepressants and carbamazepine are not currently licensed in the UK for painful neuropathy associated with Type 1 diabetes. Phenytoin is currently licensed in the UK for neuropathic pain under specialist supervision.

D - Where severe chronic pain persists despite trials of other measures, opiate analgesia may be considered. At this stage the assistance of the local chronic pain management service should be sought.

D - Professionals should be alert to the psychological consequences of chronic painful neuropathy and offer appropriate management where they are identified.

D - Where drug therapy is successful in alleviating symptoms, trials of reduced dosage and cessation of therapy should be considered after six months of treatment.

D - Where neuropathic symptoms cannot be adequately controlled it is useful, to help individuals cope, to explain:

• The reasons for the problem
• The likelihood of remission in the medium term
• The role of improved blood glucose control

Management of Special Situations

Adults who Are Newly Diagnosed

D - At the time of diagnosis (or if necessary after the management of critically decompensated metabolism) the professional team should develop with and explain to the person with Type 1 diabetes a plan for their early care. To agree such a plan will generally require:

• Medical assessment to:
  • Ensure security of diagnosis of type of diabetes
  • Ensure appropriate acute care is given when needed
  • Review and detect potentially confounding disease and drugs
  • Detect adverse vascular risk factors
• Environmental assessment to understand:
  • Social, home, work, and recreational circumstances of the individual and carers
  • Their preferences in nutrition and physical activity
  • Other relevant factors such as substance use
• Cultural and educational assessment to identify prior knowledge and to enable optimal advice and planning about:
  • Treatment modalities
  • Diabetes education programmes
• Assessment of emotional state to determine the appropriate pace of education

The results of the assessment should be used to agree a future care plan.

Some items of the initial diabetes assessment:

• Acute medical history
• Social, cultural, and educational history/lifestyle review
• Complications history/symptoms
• Long-term/recent diabetes history
• Other medical history/systems
• Family history of diabetes/arterial disease
• Drug history/current drugs
• Vascular risk factors
• Smoking
• General examination
• Weight/body mass index
• Foot/eye/vision examination
• Urine albumin excretion/urine protein/serum creatinine
• Psychological well-being
• Attitudes to medicine and self-care
• Immediate family and social relationships and availability of informal support

D - Elements of an individualised and culturally appropriate plan will include:

• Sites and timescales of diabetes education including nutritional advice (see sections above titled "Education Programmes for Adults with Type 1 Diabetes" and "Dietary Management")
• Initial treatment modalities (see sections above titled "Insulin Regimens" and "Insulin Delivery")
• Means of self-monitoring (see section above titled "Self-Monitoring of Blood Glucose")
• Means and frequency of communication with the professional team
• Follow-up consultations including surveillance at annual review (see individual late complications recommendations)
• Management of arterial risk factors (see section above titled "Arterial Risk Control")

D - After the initial plan is agreed, arrangements should be put in place to implement it without inappropriate delay and to provide for feedback and modification of the plan over the ensuing weeks.

Diabetic Ketoacidosis (DKA)

D - Professionals managing DKA should be adequately trained including regular updating, and be familiar with all aspects of its management which are associated with mortality and morbidity. These topics should include:

• Fluid balance
• Acidosis
• Cerebral oedema
• Electrolyte imbalance
• Disturbed interpretation of familiar diagnostic tests (white cell count, body temperature, electrocardiography [ECG])
• Respiratory distress syndrome
• Cardiac abnormalities
• Precipitating causes
• Infection management including opportunistic infections
• Gastroparesis
• Use of high dependency and intensive care units
• And the recommendations below

Management of DKA should be in line with local clinical governance.

D - Primary fluid replacement in DKA should be with isotonic saline, not given too rapidly except in cases of circulatory collapse.

A - Bicarbonate should not generally be used in the management of DKA.

A - Intravenous insulin should be given by infusion in cases of DKA.

D - In the management of DKA, once plasma glucose concentration has fallen to 10 to 15 mmol/L, glucose-containing fluids should be given (not more than two litres in 24 hours) in combination with higher rates of insulin infusion than used in other situations (for example, 6 U/hour monitored for effect).

D - Potassium replacement should begin early in DKA, with frequent monitoring for the development of hypokalaemia.

A - Phosphate replacement should not generally be used in the management of DKA.

D - In patients whose conscious level is impaired, consideration should be given to insertion of a nasogastric tube, urinary catheterisation to monitor urine production, and heparinisation.

D - To reduce the risk of catastrophic outcomes in DKA, monitoring should be continuous and review should cover all aspects of clinical management at frequent intervals.

Inpatient Management

B - From the time of admission, the person with Type 1 diabetes and the team caring for him or her should receive, on a continuing basis, advice from a trained multidisciplinary team with expertise in diabetes.

D - Throughout the course of an inpatient admission, the personal expertise of adults with Type 1 diabetes (in managing their own diabetes) should be respected and routinely integrated into ward-based blood glucose monitoring and insulin delivery, using the person with Type 1 diabetes' own system. This should be incorporated into the nursing care plan.

D - Throughout the course of an inpatient admission, the personal knowledge and needs of adults with Type 1 diabetes regarding their dietary requirements should be a major determinant of the food choices offered to them (except when illness or medical or surgical intervention significantly disturbs those requirements).

D - Hospitals should ensure the existence and deployment of an approved protocol for inpatient procedures and surgical operations for adults with Type 1 diabetes. This should aim to ensure the maintenance of near-normoglycaemia without risk of acute decompensation, usually by the use of regular quality assured blood glucose testing driving the adjustment of intravenous insulin delivery.

D - Members of care teams managing adults with Type 1 diabetes in institutions, such as nursing homes, residential homes, and prisons, should follow the recommendations in this section.

Management During Acute Arterial Events

D - Optimal insulin therapy, which can be achieved by the use of intravenous insulin and glucose, should be provided to all adults with Type 1 diabetes with threatened or actual myocardial infarction or stroke. Critical care and emergency departments should have a protocol for such management.

Associated Disorders

DS - In adults with Type 1 diabetes who have a low body mass index or unexplained weight loss, markers of coeliac disease should be assessed.

D - Healthcare professionals should be alert to the possibility of the development of other autoimmune disease in adults with Type 1 diabetes (including Addison's disease, pernicious anaemia, and thyroid disorders).

Psychological Problems

B - Members of professional teams providing care or advice to adults with Type 1 diabetes should be alert to the development or presence of clinical or sub-clinical depression and/or anxiety, in particular where someone reports or appears to be having difficulties with self-management.

D - Diabetes professionals should ensure that they have appropriate skills in the detection and basic management of non-severe psychological disorders in people from different cultural backgrounds. They should be familiar with appropriate counselling techniques and appropriate drug therapy, while arranging prompt referral to specialists of those people in whom psychological difficulties continue to interfere significantly with well-being or diabetes self-management.

D - Special management techniques or treatment for non-severe psychological illness should not commonly be used, except where diabetes-related arterial complications give rise to special precautions over drug therapy.

Eating Disorders

C - Members of multidisciplinary professional teams should be alert to the possibility of bulimia nervosa, anorexia nervosa, and insulin dose manipulation in adults with Type 1 diabetes with:

• Over-concern with body shape and weight
• Low body mass index
• Poor overall blood glucose control

D - The risk of morbidity from the complications of poor metabolic control suggests that consideration should be given to early (and occasionally urgent) referral of adults with Type 1 diabetes to local eating disorder services.

D - Provision for high-quality professional team support at regular intervals with regard to counselling about lifestyle issues and particularly nutritional behaviour should be made for all adults with Type 1 diabetes from the time of diagnosis (see sections above titled "Education Programmes for Adults with Type 1 Diabetes" and "Dietary Management"). Refer to section 4 of the original guideline document for "Research recommendations."

Definitions:

Hierarchy of Evidence

Ia: Evidence obtained from meta-analysis of randomised controlled trials

Ib: Evidence obtained from at least one randomised controlled trial

IIa: Evidence obtained from at least one controlled study without randomisation

IIb: Evidence obtained from at least one other type of quasi experimental study

III: Evidence obtained from non-experimental descriptive studies, such as comparative studies, correlation studies, and case control studies

IV: Evidence from expert committee reports or opinions and/or clinical experience of respected authorities

DS: Evidence obtained from diagnostic studies

NICE: Evidence obtained from National Institute for Health and Clinical Excellence (NICE) guidelines or Health Technology Appraisal programme

Grading of Recommendations

A: Based on category I evidence

B: Based on category II evidence or extrapolated from category I

C: Based on category III evidence or extrapolated from category I or II

D: Directly based on category IV evidence or extrapolated from category I, II or III

DS: Evidence from diagnostic studies

NICE: Evidence obtained from National Institute for Health and Clinical Excellence (NICE) guidelines or Health Technology Appraisal programme

An algorithm is provided in the original guideline document for the key components of care of adults with Type 1 diabetes after diagnosis and at the annual and other regular reviews.

The type of supporting evidence is identified and graded for each recommendation (see "Major Recommendations").

• National Collaborating Centre for Chronic Conditions. Type 1 diabetes in adults. National clinical guideline for diagnosis and management in primary and secondary care. London (UK): Royal College of Physicians; 2004. 171 p. [382 references]

Not applicable: The guideline was not adapted from another source.

2004

National Collaborating Centre for Chronic Conditions - National Government Agency [Non-U.S.]

National Institute for Health and Clinical Excellence (NICE)

Guideline Development Group (GDG)
Consensus Reference Group (CRG)

Consensus Reference Group (CRG)

The names with an asterisk (*) against them were also members of the Guideline Development Group (GDG).

Members: Dr John Astbury, representing the Faculty of Public Health Medicine, Consultant in Health Protection, Health Protection Agency, Cumbria and Lancashire; Ms Clare Bailey, representing the Royal College of Ophthalmologists, Consultant Ophthalmologist, Bristol Eye Hospital; Mr Steven Barnes*, Health Services Research Fellow, National Collaborating Centre for Chronic Conditions; Mr Richard Broughton, representing the College of Optometrists, Community Optometrist, Surrey; Dr Vincent Connelly, representing the Royal College of Physicians of London*, Consultant Physician and Clinical Director, The James Cook University Hospital, Middlesbrough; Dr Melanie Davies, representing Diabetes UK, Consultant Physician in Diabetes and Endocrinology, University Hospitals of Leicester NHS Trust; Mr Richard Edlin*, Research Associate in Health Economics, Sheffield Health Economics Group, University of Sheffield, and Health Economist, National Collaborating Centre for Chronic Conditions; Dr Gary Frost, representing the British Dietetic Association*, Head of Therapy Services and Nutrition & Dietetic Research Group, Imperial College and Hammersmith Hospitals NHS Trust; Dr Roger Gadsby, representing the Royal College of General Practitioners*, GP in Nuneaton, Warwickshire, Senior Lecturer in Primary Care at the University of Warwick and Medical Adviser, Warwick Diabetes Care; Dr Marilyn Gallichan, representing the Royal College of Nursing, Diabetes Specialist Nurse, Royal Cornwall Hospitals Trust; Mr Rob Grant*, Project Manager, National Collaborating Centre for Chronic Conditions; Ms Irene Gummerson, Royal Pharmaceutical Society of Great Britain, Pharmacist, Yorkshire; Ms Debbie Hammond, patient and carer representative representing Diabetes UK*; Dr Simon Heller, Diabetes UK*, Reader in Medicine, University of Sheffield and Honorary Consultant Physician, Sheffield Teaching Hospitals NHS Trust; Professor Philip Home*, Professor of Diabetes Medicine, University of Newcastle upon Tyne, and Clinical Advisor, National Collaborating Centre for Chronic Conditions; Professor Des Johnston, Professor of Endocrinology and Metabolic Medicine, Imperial College and Hammersmith Hospitals NHS Trust, and CRG Chair, National Collaborating Centre for Chronic Conditions; Dr Colin Johnston, representing Diabetes UK, Consultant Physician and Endocrinologist, West Hertfordshire Hospitals NHS Trust; Dr George Kassianos, representing the Royal College of General Practitioners, General Practitioner, Berkshire; Dr Eric Kilpatrick, Association of Clinical Biochemists, Consultant in Chemical Pathology, Hull Royal Infirmary; Ms Suzanne Lucas, patient and carer representative, representing Diabetes UK*; Ms Emma Marcus, representing the British Dietetic Association, Clinical Specialist Diabetes Dietitian, Heart of Birmingham Teaching Primary Care Trust; Dr Alastair Mason*, GDG Lead, National Collaborating Centre for Chronic Conditions; Dr Greg McAnulty, representing the Royal College of Anaesthetists, Consultant in ITU and Anaesthesia, St George's Healthcare NHS Trust; Dr Colin McIntosh, representing Diabetes UK*, Consultant Physician in Diabetes and Endocrinology, Chelsea and Westminster Hospital NHS Trust and Honorary Senior Lecturer, Imperial College London; Ms Sarah O'Brien, Royal College of Nursing*, Nurse Consultant, St Helens and Knowsley Hospitals NHS Trust; Dr Vinod Patel, representing Diabetes UK, Consultant Diabetologist, George Eliot Hospital NHS Trust and Reader in Clinical Skills, University of Warwick Medical School; Ms Karen Reid*, Information Scientist, National Collaborating Centre for Chronic Conditions; Professor Ken Shaw, Royal College of General Practitioners, Consultant Physician and Director of Research & Development, Portsmouth Hospitals NHS Trust, and Association of British Clinical Diabetologists; Mr David Turner, patient and carer representative, representing Diabetes UK*; Ms Barbara Wall, Society of Chiropodists and Podiatrists, Senior Lecturer and Programme Leader for Podiatry, University of East London

All group members made a formal "declaration of interests" at the start of the guideline development and provided updates throughout. The National Collaborating Centre for Chronic Conditions (NCC-CC) and the Guideline Development Group (GDG) Chair monitored these.

This is the current release of the guideline.

This NGC summary was completed by ECRI on March 4, 2005. The information was verified by the guideline developer on September 29, 2006. This summary was updated by ECRI Institute on November 9, 2007, following the U.S. Food and Drug Administration advisory on Antidepressant drugs. This summary was updated by ECRI Institute on January 10, 2008, following the U.S. Food and Drug Administration advisory on Carbamazepine.

This summary is based on the original guideline, which is subject to the guideline developer's copyright restrictions.