| Outcome Measures: |
Primary: Change in Averaged Mean Far Wall Common Carotid Artery Intima-media Thickness (cIMT), Progression of averaged mean far wall common carotid artery intima media thickness IMT (mean cIMT) measured using B mode ultrasonography with a 7.0 MHz or higher broadband linear array transducer and concurrent recording of 3-lead electrocardiogram (ECG). Longitudinal images of the common carotid artery will be obtained at anterior, lateral and posterior angles at baseline, 12, 24 and 36 months using Meijer's arc to standardize the transducer angle., 0, 12 months, 24 months, 36 months | Secondary: Change in HbA1c, Measured in accredited local laboratories participating in DCCT-aligned quality control programmes., Baseline, Year 3|Change in LDL Cholesterol, mmol/L Centrally assayed at the University of Glasgow, Baseline, Year 3|Change in Estimated Glomerular Filtration Rate, Number of participants developing new microalbuminuria; change in absolute concentration Calculated using the MDRD equation1 based on creatinine measured in accredited local laboratories, Baseline, Year 1, Year 2, Year 3|Number of Participants With Retinopathy and at Least a 2 Stage Progression in Retinopathy From Baseline to 36 Months, Two color 45° field retinal photographs (fields 1 and 2) from each eye at 0 and 36 months graded at the University of Wisconsin Ocular Epidemiology Reading Center (OERC) using the modified Airlie House classification scheme and the Early Treatment Diabetic Retinopathy Severity scale., Baseline, Year 3|Change in Weight, Measured at sites using calibrated weighing scales, Baseline, Year 1, Year 2, Year 3|Change in Insulin Dose, Units/ kg body weight Extracted by study nurses from the Study Diary and reported on the study CRF using dedicated fields, Baseline, Year 1, Year 2, Year 3|Change in Endothelial Function, In some centres (Arbitrary units) Reactive Hyperaemia Index using the ENDOPAT device (Itamar, Israel), Baseline, Year 1, Year 3
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| Locations: |
Royal Melbourne Hospital, Melbourne, Australia|St Vincent's Hospital, Melbourne, Australia|Royal Prince Albert Hospital, Sydney, Australia|St Joseph's Health Care, London, Ontario, Canada|Ottawa Hospital Riverside Campus, Ottawa, Canada|Steno Diabetes Centre, Gentofte, Denmark|Maastricht University Medical Centre, Maastricht, Netherlands|Aberdeen Royal Infirmary, Aberdeen, United Kingdom|Ayr Hospital, Ayr, KA6 6DX, United Kingdom|University Hospitals Bristol, Bristol, BS2 8HW, United Kingdom|Diabetes Support Unit, Ninewells Hospital and Medical School, Dundee, United Kingdom|University Hospital North Durham, Durham, United Kingdom|Edinburgh Royal Infirmary, Edinburgh, United Kingdom|Edinburgh Western Infirmary, Edinburgh, United Kingdom|Peninsula NIHR Clinical Research Facility, Royal Devon and Exeter NHS Foundation Trust, Exeter, United Kingdom|Stobhill Hospital, Diabetes Clinic, Glasgow, United Kingdom|Gloucestershire Royal Hospital, Gloucester, GL1 3NN, United Kingdom|Michael White Diabetes Centre, Hull Royal Infirmary, Hull, United Kingdom|Clinical Sciences Centre, University Hospital, Liverpool, United Kingdom|Clinical Investigation Unit, International Centre for Circulatory Health, Imperial College Healthcare NHS Trust, London, United Kingdom|Wellcome Trust Clinical Research Facility, Manchester Royal Infirmary, Manchester, United Kingdom|Newcastle NIHR Clinical Research Facility, Royal Victoria Hospital, Newcastle, United Kingdom|Diabetes Clinical Research Centre, Plymouth, Plymouth, United Kingdom|Salford Royal NHS Foundation Trust, Salford, United Kingdom
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