When the intervention phase of the UKPDS finished in 1997, all surviving UKPDS patients were entered into a ten-year, post-trial monitoring program. In 1998, following presentation of the trial’s primary results at the EASD meeting in Barcelona, patients and clinicians were advised of the need to lower both blood glucose and blood pressure levels as far as feasible. Patients returned to community or hospital-based diabetes care, according to their clinical needs, but with no attempt to maintain previously randomized therapies. They were seen annually until 2002 in UKPDS clinics with continued standardized collection of endpoint, biochemical and clinical data. Any patients unable to attend clinics were sent EQ-5D and health resource questionnaires, with additional questionnaires to their general practitioners to captured possible endpoints. These same questionnaires were used to follow all patients remotely from 2002 to 2007, as financial constraints meant UKPDS clinics could no longer be supported. The same endpoint ascertainment and adjudication process was used throughout to ensure analytic comparability.
The purpose of UKPDS post-trial monitoring was to:
- Observe the glycaemic and blood pressure control achieved as patients returned to their usual care physicians.
- Monitor the glucose and blood pressure lowering therapies prescribed.
- Look for possible “legacy effects” of earlier improved blood glucose and/or blood pressure control.
- Examine risk factor associations and the possible influence of randomised therapies on less frequent clinical and biochemical outcomes as more events were accrued.
UKPDS Office, Diabetes Trials Unit, OCDEM, Churchill Hospital, Old Road, Headington, Oxford, OX3 7LJ
Tel: +44 (0)1865 857255 Fax: +44 (0)1865 857254 Email: ukpds@dtu.ox.ac.uk
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