Shared care management of patients with type 2 diabetes across the primary and secondary healthcare sectors: study protocol for a randomised controlled trial

Table 1 Risk stratification model for patients with type 2 diabetes

	Level 1	Level 2	Level 3
HbA_1c (mmol/mol)	<53	53–75	>75
Blood pressure, systolic/diastolic (mm Hg)	<130/80	130/80–160/90	>160/90
Metabolic complications	No	Severe insulin resistance^a	Very fluctuating plasma glucose^b or severe hypoglycaemia
CVD^d	No	One previous MACE	>1 MACE, symptomatic CVD or NYHA II-IV
Diabetic foot disease	No	Peripheral neuropathy^c or artery disease^d	Previous or existing ulcer or Charcot foot
Retinopathy	No or simplex retinopathy	Progression of retinopathy	Macula oedema or proliferative retinopathy
Nephropathy	No	Micro-albuminuria^e	Macro-albuminuria^f

All parameters in level 1 have to be fulfilled to be allocated to risk stratification level 1. At risk stratification level 2, at least one parameter has to be fulfilled in level 2, and none in level 3. Patients at level 3 have to fulfil at least one of the parameters in level 3 [16].
HbA_1c haemoglobin A_1c, CVD cardiovascular disease, MACE major cardiovascular event, NYHA the New York Heart Association functional classification in patients with heart disease [36]
^aSevere insulin resistance: Insulin dose > 2.0 U/kg/day
^bVery fluctuating plasma glucose: Daily plasma glucose values of > 15 mmol/L or < 5 mmol/L
^cPeripheral neuropathy: Vibration perception threshold ≥ 25 mV evaluated by a biothesiometer
^dPeripheral artery disease: Ankle-brachial index < 0.9 with or without symptomatic claudication
^eMicro-albuminuria: > 1 occasion of urine albumin/creatinine ratio between 30 and 299 mg/g
^fMacro-albuminuria: Urine albumin/creatinine ratio ≥ 300 mg/g or an estimated glomerular filtration rate < 45 mL/min

ISSN: 1745-6215