PARAMETER Name of the guideline

CONDITION Clinical condition making patients candidate for the event

EVENT Procedure or process

TARGET Targeted ratio of the number of events / patients with the condition

EVIDENCE Quotations with references to substantiate the target ratio

SPECIFIC GOAL The outcome aimed at by implementing the guideline

(1) Measurement of Fasting Blood Sugar

CONDITION All patients

EVENT Overnight plasma glucose estimation (12 hrs fasting)

TARGET At each regular visit in 100% of patients

SPECIFIC GOAL 80 - 120 mg/dL

Evidence 1

A meta-analysis of published randomized controlled trials comprising 529 patients from 16 trials, proved that long-term intensive glycemic control in type I diabetic patients significantly reduced the risks of diabetic retinopathy and nephropathy progression when compared with randomly assigned controls.

(Wang et al., 1993)

Evidence 2

Results of Diabetes Control & Complications Trial, which proved that strict diabetes control in Type I diabetics, through keeping the FBS between 70-120 mg/dL and HbA1c below 7.2% resulted in marked reduction in the risk of microvascular and neuropathic complications of diabetes up to 76%

(2) Measurement of HbA1c

CONDITION All diabetics

EVENT HbA1 or HbA1c

TARGET at least semiannually (100%) and preferably quarterly in insulin-treated patients and in non-insulin-treated patients with poor metabolic control

SPECIFIC GOAL 4 - 7.2%

HbA1c

• Integral measure of FBS & PPBS during the previous 2-3 months
• Does not need the patient to be fasting
• ? Predict micro & macrovascular complications

  ---

• Target (4 - 7 %)
• Accepted < 9%
• Poor Control 9 - 11%
• Very Poor Control >11%

  ---

Evidence 1

In a recent 5-year longitudinal cohort study among elderly diabetics it was found that the control of diabetes mellitus is the most important factor associated with prevention of progression of retinopathy. It was showed that, of the parameters examined only HbA1c was a significant risk factor for progression of retinopathy.

Evidence 2

One of the main laboratory goals of the DCCT was the maintain of the HbA1c within the normal range, in the studied group of patients with IDDM subjected to intensive insulin therapy. Such control of hyperglycemia results in effective reduction in the adjusted mean risk for the development of diabetic retinopathy, in the primary prevention cohort, by 76% as compared with the conventional therapy, and slowed the progression of retinopathy , in the secondary intervention cohort, by 54%, and reduced the development of proliferative or severe nonproliferative retinopathy by 47%.

(3) Measurement of Height and Weight

CONDITION All diabetics

EVENT Height (until maturity) and weight must be measured and body mass index to be calculated

TARGET At each regular visit (100%))

SPECIFIC GOAL Body Mass Index 20 - 26 kg/m2

Evidence

In the patients with type II diabetes, carbohydrate tolerance is reduced by obesity but frequently improves when reduced caloric intake results in attainment of normal weight.

(4) Blood Pressure Measurement

CONDITION All diabetics

EVENT B.P. must be measured using the mercury sphygmomanometer in both sitting and standing position.

TARGET At each regular visit (100%))

SPECIFIC GOAL 140 / 85 mmHg

Evidence 1

A meta-regression analysis of selected 100 controlled and uncontrolled studies proved that proteinuria in diabetics is decreased with the usage of antihypertensives and that was entirely explained by the changes in blood pressure.

Evidence 2

A meta-analysis of 21 studies of type I and II diabetics under therapy with ACE inhibitors was performed. Altogether 325 cases were analyzed, where a reduction in diastolic blood pressure (-25%) was associated with reduction of microalbuminuria/proteinuria by 33% under short-term treatment

( Bergemann et al., 1992)

Evidence 3

Hypertension was found to be 2.6 times higher for diabetic patients than for those with no diabetes.

Evidence 4

Hypertension contribute to the development and progression of chronic complications of diabetes. Hypertension should be treated aggressively to achieve and maintain blood pressure in the normal range.

(5) Measurement of Triglycerides , Cholesterol, LDL and HDL

CONDITION All adults and children with diabetes

EVENT Measurement fasting triglycerides, total cholesterol, HDL-cholesterol, and LDL-cholesterol.

TARGET Annually in 100% of all adults and every 2 yr.. in 100% of children

SPECIFIC GOAL

• Total Cholesterol <200 mg/dl
• Triglycerides <200 mg/dl
• LDL-Cholesterol <130 mg/dl
• HDL-Cholesterol >35(M) mg/dl >45(F) mg/dl

Evidence

The incidence of cardiovascular disease is four to five times greater in people with diabetes than in people without diabetes. Lipid disorders is one of the major risk factors for people with diabetes. All adults with diabetes should be screened for blood lipid levels including triglycerides, cholesterol, and high-density lipoprotein (HDL) cholesterol. The low-density lipoprotein (LDL) cholesterol should be measured more routinely in people with diabetes than suggested in the National Cholesterol Education Project (NCEP) guidelines.

(6) Foot Examination

CONDITION All diabetics with manifestations of diabetic neuropathy

EVENT Documented foot examination (pulse, temperature, state of dryness, any ulceration, callus formation, abnormal gait, distended dorsal foot veins, small muscles wasting and for tinea pedis, evidence of sensory loss) and foot-care education.

TARGET In each regular visit in 100% of all diabetics with diabetic neuropathy

SPECIFIC GOAL Early detection and treatment of diabetic foot.

Evidence 1

A randomized clinical trial indicated that an intervention which included : (i) asking patients to remove their footwear (ii) performing foot examinations, and (iii) providing foot-care education at each regular visit

proved that patients receiving this intervention were less likely than control patients to have serious foot lesions & and other dermatologic abnormalities (p< 0.05)

Evidence 2

In USA foot problems are common in the 12 million diagnosed and undiagnosed diabetic subjects, and result in extensive hospitalization, disfiguring surgery, lifetime disability, and a diminished quality of life. Foot pathology has been reported as the most common complication of diabetes leading to hospitalization. Economic considerations extend beyond direct cost, where indirect cost estimates describing lost economic productivity because of related illness, disability, and premature death.

(7) Hypoglycemic Attacks

CONDITION Diabetics under insulin therapy, specially those with manifestations of diabetic neuropathy

EVENT Asked about the frequency, causes and severity of hypoglycaemic attacks.

TARGET In each regular visit in 100% of all diabetics fulfilling the condition.

SPECIFIC GOAL To minimize as much as possible the number of hypoglycaemic attacks while maintaining reasonable euglycemia, and to investigate and prevent completely severe attacks that may be life threatening.

Evidence 1

A meta-analysis of 16 published randomized controlled trials showed that The overall incidence of severe hypoglycemia increased by 9.1 episodes/100 person-years in the intensively treated type I diabetic patients.

Evidence 2

3-5% of deaths in patients with type I disease result from hypoglycaemia

(8) Eye Examination

CONDITION All patients aged 12-30 yr. with a diagnosis of diabetes of at least 5 yr. duration or over 30 yr. at the time of diagnosis or any patients with visual symptoms and/or abnormalities

EVENT Documented, comprehensive eye and visual examination or referral to ophthalmologist.

TARGET Annually in 100% of all diabetics fulfilling the condition.

SPECIFIC GOAL To diagnose as early as possible any diabetic retinopathic changes, and to start prompt therapy with photocoagulation at optimal time so as to preserve as much as you can the patient vision, and keep to the minimal the number of patients subjected to legal blindness.

Evidence 1

Diabetic retinopathy is the leading cause of acquired blindness among individuals of working age.

In USA a predicted annual savings of $101.0 million and 47,374 person-years-sight at the currently estimated 60% screening and treatment implementation level. If all patients received appropriate eye care, the predicted savings exceed 167.0 million and 79,236 person-years-sight.

Evidence 2

Diabetic retinopathy has a silent phase where no symptoms are evident, yet frequent screening is likely to elicit early sings. With awareness, regular examination, referral to a specialist, and timely treatment, vision can now be conserved in some patients with diabetes who, in earlier years, would have to become blind.

Blindness associated with more severe forms of diabetic retinopathy is thought to be 60% preventable.

Evidence 3

Of all adults with diagnosed diabetes in the United States, only 49% had a dilated eye examination in the past year. This included 57% of type I, 55% with insulin-treated type II, and 44% with type II not treated with insulin.

In diabetics with high risk of vision loss because of retinopathy or long duration of diabetes, the proportion with a dilated eye examination was only 61% and 57%, respectively.

(9) Measurement of Protein in Urine

CONDITION All diabetics after 5 years duration of diabetes

EVENT Test for total urinary protein excretion by RIA in a 24 hour urine sample or by microalbuminuria test strips.

TARGET Annually in 100% of all diabetics fulfilling the condition.

SPECIFIC GOAL Urinary albumin excretion must be lowered as much as possible (normal <30mg/dl) in normotensive diabetics, and if more the rate of it increase should be slowed or halted if possible.

Evidence

Microalbuminuric patients are about 20 times more likely to develop clinical proteinuria and renal failure over the subsequent 10 to 15 years than those with normal albumin excretion rates.

(10) Diabetes Education

CONDITION All diabetics

EVENT Some sort of diabetes education must be conducted plus assessment of knowledge of understanding of diabetes management skills (Plan for education consistent with the National Standards for Diabetes Patient Education). All newly diagnosed diabetics must be supplied with an education material.

TARGET At each regular visit in 100% of all diabetics

SPECIFIC GOAL To foster the role of patient in self-management of the disease, to keep the patient oriented with all aspects of the disease and its complications and to increase the patient compliance to the disease and therapy so as to minimize the patient role in misadjustement of the diabetic state.

Evidence

Two large meta-analysis researches (82, 73 studies) on the effects of diabetes patient education on patient outcome revelaed that patient education improved patient knowledge and self-management skills, weight loss, glycosylated hemoglobin levels, and psychological outcomes.