PENDYFFRYN
MEDICAL GROUP DIABETIC CLINIC
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Protocol
Newly diagnosed
patients (Type 2)
Ensure that the diagnosis of type 2 diabetes
is correct. See criteria in Appendix.
Check the presenting symptoms and
blood sugar level. All patients should have full biochemical screening performed
at presentation, namely U&Es and creatinine, lipids (HDL and triglycerides),
LFTS.HbA1C should not be done at presentation as this is a monitoring test, and
an abnormal test is of no value.
The first thing to decide is whether
the patient should be given a prolonged trial of diet or whether a shorter period
of dietary modification is required:
OBESE
If BMI > 28, then 3- 6 months
trial of diet is in order, provided 1. Weight is coming down 2. HbA1C is not static
or rising during the 6 month period.
NON –
OBESE
HbA1C up to 8.4%. In these cases
only a short trial of diet is required (3 months). Review the HbA1C at 3 months.
If it is not <8.4% start metformin as per drug treatment protocol (40mg or
80mg).
DIET
Refer all patients to the dietician
at presentation. At this stage educational material regarding the importance of
diet should be given to the patient in the form of a ‘pack’. This
should contain all the necessary information to allow the patient to effectively
manage his own condition until such time as the dietician can see the patient.
The importance of fat and carbohydrate should be emphasized. The concept of the
‘healthy diet’ needs to be stressed.
EDUCATION
The educational background of the
patient and his attitude to the disease should be assessed prior to speaking to
the patient. Do not try to give the all the information in one sitting. The pack
will reinforce messages and any further concerns of the patient can be explored
at the next appointment. Areas to be covered (also in pack):
1. Weight: Give
the patient an idea of normal weight (BMI near to 25). Explain the importance
of attempting to keep normal body weight and the effect this will have on control
of the condition.
2. Exercise: Assess
the physical fitness of the patient. Ideally daily exercise lasting _ hour should
be advised. The level of exertion should be tailored to the patient’s fitness
and health status. However all patients should be aiming to exercise to increase
their heart rate during exercise.
3. Smoking: Advise
patients regarding ways of helping them to stop smoking. Arrange for a prescription
for niquitine patches. (See Appendix 3)
4. Alcohol: Advise
reduction and explain about the calorie content. Advise no more than 14 units
per week for women and 21 units per week for men.
5. General: During
the first session patients should be told that diabetes causes raised blood sugar,
and is due to lack or relative lack of insulin or its action. However it should
be made clear that it is a complex metabolic disease (without causing fear) and
that the aim to treatment is to address all areas where current evidence gives
us help as follows.
6. Blood pressure:
Reduce to 140/80. (See blood pressure protocol).
7. Lipids: All patients
to be issued with a prescription for simvastatin 40mg at their first appointment,
irrespective of their baseline cholesterol level. This should be put onto repeats
and the patient should be advised that this is lifelong treatment, which not only
reduces cholesterol, but has been should in trials to reduce patients’ risk
of cardiovascular disease.
8. If the initial
cholesterol level is above 5mmol/l, the patient should be advised that to have
a further blood test within 3 months. The aim in all diabetic patients is to lower
cholesterol to less than 5mmol/l; should follow-up levels exceed 5mmol/l, change
the treatment to atorvastatin 40mg. Please emphasize to patients that simvastatin
is safe, and has been shown in major trials to reduce mortality (1).
9. Monitoring: Most
of our patients are going to be TYPE 2 Diabetics. Blood monitoring
is not indicated. Explain that we will be basing their treatment
on their HbA1C levels. Urine testing sticks should be put on repeats. The limitation
of urine testing should be explained. Twice weekly monitoring is adequate. If
patients feel unwell, more frequent testing of urine is required, ideally daily.
Explain that persistent glycosuria, is a sign that control could be deteriorating,
and that they should request advice from the diabetic nurse. The relevance of
ketones in the urine should be explained. It should be made clear to patients
that it is persistent ketonuria that is of significance, occasional
ketones in the urine being of no relevance.
10. Understanding Complications:
Patients should be told about the possible sequelae of poor control. Retinopathy,
neuropathy, nephropathy and accelerated atherosclerosis associated with diabetes,
namely cerebrovascular disease and ischaemic heart disease should be briefly covered
(with further information in pack).Patients should understand that with regular
monitoring, many of the complications can be prevented, if detected early.
11. Driving: Patients
need to be told to inform their insurance company and if they are on tablets or
insulin to inform DVLA.
12. Retinal Screening:
Encourage patients to keep their appointments for digital retinal screening.
13. Foot Care: If
young and capable explain that they need to check their feet. If elderly, signs
of poor foot care, or if there is difficulty in caring for feet for any reason,
refer to the chiropodist.
Monitoring of Patients
14. Further follow up:
All the above messages will need to be reinforced. Arrange further appointments
for education and to discuss patient concerns. The frequency depends on the individual
patient. A 2 week follow- up either by telephone or in person is good practice.
All newly diagnosed should be reviewed within a month. Telephone follow-up is
in order at the discretion of the clinician.
14.1 Month follow up:
Check weight, blood pressure if previously raised, start Ramipril as per Pendyffryn
Medical Group Protocol: Address any patient concerns. Check home urine
testing results, and record blood sugar in surgery. In obese patients reinforce
the message about the importance of weight loss. If blood pressure previously
raised, check and adjust medication as per Pendyffryn Protocol
Further follow up:
15. HbA1C < 7.4.
6 monthly follow up
16. HbA1C > 7.4 3 monthly follow
up.
17. Diet controlled HbA1C < 6.8 ( at least 2 readings).
Annual follow up with advice to report persistent glycosuria
Protocol
for Drug Treatment of Type 2 Diabetes
All new patients should have an adequate
trial of diet (refer to dietician). Oral therapy should be commenced if raised
HbA1C (>7.0%) persists. In the obese ( BMI > 25), provided HbA1C is less
than 9%, then a trial of diet for up to six months is warranted. This policy should
be reassessed if ongoing weight loss during this monitoring period is not achieved.
Drug Treatment:
Metformin
This is the drug of choice for all
diabetics. Establish that there is no renal (creatinine > 150) or liver failure
and that there is no history of heart failure i.e. by asking patients and checking
records. Do not use metformin if patient is > 75 yrs of age. Start treatment
with, 500mg daily for 1 week and increase dosage at weekly intervals to 500mg
tds. Patients need counselling about GI side- effects. The maximum dosage is 1g
tds. If patients experience side effects, especially GI, then try reducing the
dosage. Remember that the drug should be taken after food.
Review the
patient every 3 months. If the HbA1C is elevated (>7.4%), increase the dose
of metformin to 850mg tds. IF the patient has side effects try
reducing the dose to 850mg bd, but then increasing back to 850mg tds after one
month. If this strategy fails, try to maintain the patient on the maximal tolerated
dose.
If compliance is thought to be a problem (this information may
not be volunteered, but is likely if the requested repeat medication does not
tally with the prescribed dosage) then twice daily metformin can be advised on
a regular basis. Again titrate the drug up to the maximum tolerated dose according
to HbA1C level.1G twice daily is the usual maximum tolerated dose.
IF
the patient is unable to tolerate metformin, proceed to use glicazide as below.
Glicazide
Start with 40mg daily (elderly >
75 or HbA1C 7.4 -8.4). Use 80mg if HbA1C >8.4%.
Check HbA1C in 3 months.
If HbA1C > 7.4% increase to 80mg bd. Review in 3 months, if HbA1C remains above
7.4%, increase to 160mg am, 80mg pm. In a further 3 months if HbA1C still >
7.4% increase glicazide to 160mg bd.
This drug can cause hypoglycaemia
and patients should be warned about this and instructed in how to correct low
blood sugar. Advise patients to report symptoms of hypoglycaemia, so that the
medication can be reduced or stopped. This is especially important in the elderly
where this complication can be more severe or life-threatening.
Use of rapid acting agents
viz repaglinide ( novonorm)
This drug has a limited role. Consider
it if the patient has a non-routine daily pattern. Start with 500 micrograms daily,
1mg if on glicazide previously. Can be increased 4mg stepwise, according to 3
monthly HbA1Cs.Because of the special circumstances of these patients, discuss
with the diabetic doctor or liaison nurse prior to commencing treatment.
HbA1C remains elevated
( >7.4%) despite monotherapy
Another agent should be added. Both
agents can be titrated up to the maximum dosage for that agent, so that the patient
is taking the maximal tolerated dose for the initial drug, with increasing dosage
of the second agent according to 3 monthly HBA1C levels.
Drug Treatment: Pioglitazone
This drug can be used provided the
patient has no liver or cardiac failure. Oedema is a side effect and patients
should be told of the possibility of some weight gain. Arrange for liver function
tests to be done prior to starting treatment, and if normal, issue a prescription
for 30mg daily. LFTs should be monitored every 2 months for 12 months.
It
can be used with metformin or Glicazide. Use this drug in patients whose renal
function is impaired (creatinine>150) and if metformin is not tolerated or
contraindicated. This drug should not be used first line. All patients should
have had an adequate trial of metformin or glicazide before its use is sanctioned.
The onset of action is slow. If HbA1C is still raised at 6 months, increase the
dose to 45mg.
Glimepiride
( Amaryl)
Only to be used where compliance
is a problem, as it is effective in once daily dosage. This agent should not be
used routinely. It is no more effective than sulphonylureas (NICE GUIDELINES).
Refer to BNF for dosage guidelines.
Acarbose
(Glucobay)
This agent, although effective, due
to high incidence of side effects, is only suitable where the patient is intolerant
of metformin or glicazide.It can be used alone or as an adjunct to metformin and/or
sulphonylureas.
The dose is 50mg daily, with advice to increase to 50mg
twice daily in the second week, and finally 50mg tds in the third week. Review
HbA1C at 3 months. If still> 7.4%, advise the patient to take 100mg tds.
Due to the high incidence of side effects, it is unlikely that we will be
using this drug to any extent. Only use acarbose in the following circumstances.
1. The patient is on maximum tolerated
doses of oral hypoglycaemics, i.e. metformin and glicazide, and HbA1C remains
> 7.4%.
2. The patient has reached a treatment plateau and further
increase of metformin or glicazide is not possible due to side effects or co-existent
morbidity, mainly heart failure, or renal impairment which makes use of metformin
a problem.
HbA1C REMAINS >7.4%
DESPITE ORAL THERAPY
Refer for insulin. A wait and watch
policy can be adopted in the 7.4% - 8.4% range. During this time you can assess
the patient’s compliance with therapy, advise regarding weight loss, and
give other lifestyle advice about exercise and diet. Generally speaking if the
HbA1C remains above 8.4% after 12 months, then referral for insulin should be
undertaken. During this time blood testing should be taught.
When
Wait and Watch is not appropriate
1. If the HbA1C is rising at the
3 monthly reviews.
2. The patient is experiencing
symptoms viz weight loss, polydipsia and polyuria.
3. Urine tests are showing persistent
ketonuria.
In the above cases prompt referral
is indicated.
Management of Hyperlipidaemia.
1. All patients should be on simvastatin
40mg. (Unless they are already taking an alternative lipid lowering agent). Start
treatment with 40mg simvastatin and advise patients that this is life-long treatment,
which not only reduces cholesterol but reduces their risk of a heart attack and
stroke. Give patients Pendyffryn Medical Group leaflet on use of simvastatin in
diabetics
IF TOTAL CHOLESTEROL IS
GREATER THAN 5mmol/l (i.e. despite an adequate trial of simvastatin
40mg, namely 3 months) .Be wary of non compliance in these patients. Change treatment
to atorvastatin 40mg and arrange a repeat fasting lipid profile in 6 weeks.
Pendyffryn
Medical Group Diabetic Annual Review
1.Weight – check and record.
2. Urine testing – check for
glucose and protein, If protein present send MSU to exclude a UTI.
3. Microalbuminuria. Give patients
a specimen bottle. See Appendix 2 for management of microalbuminuria.
4. Blood pressure. If elevated follow
Pendyffryn Protocol.
5. Smoking. Arrange prescription
for niquitine patches if patient agrees.
6. Alcohol. Advice regarding safe
limits.
7. Compliance. Check regime. Ensure
that tablets are being taken at the correct time in the correct dosage. If on
insulin, check that the patient understands the principles of altering insulin
dosage.
8. Patient concerns. Allow patient
to discuss any concerns. Identify any gaps in education that need addressing.
Supply patient with educational tools (pack) as required.
9. Eyes. Until retinal screening
with digital photography is established, instil tropicamide drops for the lead
diabetic clinicians to undertake fundoscopy. Advise patients regarding the importance
of seeing their optician annually.
10. Feet. Health Care Assistant:
Inspect for obvious diabetic problems. Check pulses, vibration sense and sensation
(use 10G monofilament). Refer to chiropodist if necessary. Question patients about
intermittent claudication as this information is often not volunteered.
11. If walking distance is compromised,
refer to GP for further management. All patients who have claudication should
be strongly advised to stop smoking. Check that these patients are on aspirin
75mg dispersible.
12. Review blood tests.HbA1C, U&Es.
LFTS, TFTs, lipids, HDL and total cholesterol.
13. Alter oral hypoglycaemics as
per Pendyffryn Protocol.
Ask patients about exertional chest
pain. Refer to GP any new cases of suspected angina. Check that patients with
IHD are taking aspirin 75mg dispersible daily. Enter as ‘Salicylate Phophylaxis’.
14. Record BP, weight, smoking, alcohol,
HBA1C and total cholesterol on computer using the appropriate read coding and
utilising the template for coding. Record the results of microalbuminuria using
read coding. (Vision template for new GP contract simplifies this).Record peripheral
pulses, vibration sense, sensation, using read coding.
Impaired Renal Function
STOP METFORMIN WHEN SERUM
CREATININE >150.
IF PATIENT TAKING GLICLAZIDE
AND METFORMIN PROCEED ALONG THESE LINES.
STOP METFORMIN, ADD
PIOGLITAZONE 30 MG AND PROCEED AS PER PROTOCOL.
Treatment
of Elevated Blood Pressure in Diabetic Patients
Target BP is 140/80 or less. Ideally
3 readings should be taken, on separate occasions, but in practice if 3 readings
taken on one sitting, when patient is relaxed and has been seated for 10 minutes
or so, are all above 140/ 80, then the patient should be treated along the lines
below. (See notes for patients regarding raised blood pressure in diabetics).
The first drug of choice is RAMIPRIL.
All screening tests, including renal function should be checked prior to initiation
of therapy. It is reasonable to accept renal tests in previous 3 months. If renal
function normal and the patient is not allergic to ACE group
of drugs, (It is safe to commence ACE inhibitors if the creatinine level is no
greater than 150 but discuss with GP if creatinine is abnormal) start treatment
with 2.5mg ramipril (1.25mg if patient > 75 yrs of age).
Arrange at this time for blood tests
for U&Es at 2 weeks after starting treatment. In the 5th week of treatment,
patients should be told to double their dose of RAMIPRIL (to 5mg, or 2.5mg if
elderly).After a further 4 weeks treatment doubling of dosage should be advised.
The target is 10mg for all patients.
If patients experience minor
side effects after a doubling of dose, they should be told to revert
to their previous dosage for 2 weeks and monitor their symptoms. Encourage patients
to attempt taking the original dosage after 2 weeks, but if the patient is certain
that they have had drug related side effects then continue on the lower dosage.
If persistent cough
is the only symptom, then monitor for 4 weeks. The patient should be changed to
telmisartan 40mg daily, if cough persists. Increase dose to 80mg
daily, if blood pressure does not reduce to <140/80. No further tests of renal
function are required other than those specified for ramipril ie creatinine level
at 2 weeks.
A slight rise in creatinine is acceptable
but discontinuation should be advised if creatinine exceeds 150.
Blood Pressure Remains
Elevated Despite above treatment
Some patients will require further
therapy to control their blood pressure.
Discuss each case with GP. As a
guide:
A blood pressure of< 140/80 is our target.
On Ramipril or
Telmisartan: Add bendrofluazide 2.5mg
If BP still not controlled:
add felodipine 2.5mg.
Microalbuminuria
- All patients must be screened for
microalbuminuria on an annual basis.
- Check urine for protein. If positive,
check an MSU. If negative screen for microalbuminuria.
- Management of Microalbuminuria.
- Arrange re-check in 6 months if
elevated. If BP is raised follow Pendyffryn Protocol for management of elevated
blood pressure in diabetics.
• If BP normal and micoalbuminuria
rising (on 6 month repeat) start Ramipril or Telmisartan as per protocol.
Appendix
1
Criteria for Diagnosing Diabetes
Methods
and criteria for diagnosing diabetes mellitus
1. Diabetes symptoms (i.e. polyuria,
polydipsia and unexplained weight loss)
plus
- A random venous plasma glucose concentration
>11.1 mmol/l or
- A fasting plasma glucose >7.0
mmol/l (Whole blood >6.1 mmol/l or
- 2 hour plasma glucose concentration
>11.1 mmol/l 2 hours after 75g oral glucose tolerance test (OGTT)
3. With no symptoms, diagnosis should
not be based on a single glucose determination but requires confirmatory plasma
venous determination. At least one additional glucose test result on another day
with a value in the diabetic range is essential, either fasting, from a random
sample, or from the two hour post glucose load. If the fasting or random values
are not diagnostic the 2-hour value should be used
4. The role of the oral glucose
tolerance test : our local laboratory at Glan Clwyd Hospital suggests this
test be performed if the results of the second test is not diagnostic.
Appendix
2
Impaired Fasting Glycaemia and Impaired
Glucose Tolerance
The
Oral Glucose Tolerance Test: WHO Criteria
Screening for Diabetes
Mellitus
All obese patients > 45yrs with BMI > 30 should
have a fasting blood sugar performed every 3 years. The those found to have impaired
glucose tolerance should be read coded and followed up by fasting blood sugar
or oral glucose tolerance test annually.
Appendix
3
Nicotine Patch Protocol
Smokes > 10/day:-
21 mg patch for 6 weeks
14 mg
patch for 2 weeks
7 mg patch for 2 weeks
Smokes < 10/day:-
14 mg daily for 6 weeks
7 mg
daily for 2 weeks
Side Effect
Switch to 14 mg patch for the remainder
of the initial 6 weeks before switching to the 7 mg patch.
REFERENCE
MRC/BHF Heart Protection Study of cholesterol lowering with simvastatin
in 20536 high-risk individuals: a randomized placebo-controlled trial.THE LANCET
6 July 2002 Vol 360 No. 9236 Pages 7-22
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