Identify the study design A total of 453 patients were indiv

Identify the study design: A total of 453 patients were individually randomised to one of: (1) standardised usual care with 3-monthly HbA1c (control, n = 152); (2) blood glucose self-testing with patient training focused on clinician interpretation of results in addition to usual care (less intensive self-monitoring, n = 150); (3) SMBG with additional training of patients in interpretation and application of the results to enhance motivation and maintain adherence to a healthy lifestyle (more intensive self-monitoring, n = 151).

The primary outcome was HBA1c at 12 months, and an intention-to-treat analysis, including all patients, was undertaken. Blood pressure, lipids, episodes of hypoglycaemia and quality of life, measured with the EuroQol 5 dimensions (EQ-5D), were secondary measures. An economic analysis was also carried out, and questionnaires were used to measure well-being, beliefs about use of SMBG and self-reports of medication taking, dietary and physical activities, and health-care resource use.

Retrospective Cohort Study

Prospective Cohort Study

Cross Sectional Study

Case Control Study

Randomized Controlled Trial

None of the Above

Retrospective Cohort Study

Prospective Cohort Study

Cross Sectional Study

Case Control Study

Randomized Controlled Trial

None of the Above

Solution

In the study a randomized controlled trail is need to establish the anwers. Therefore, the study design is randomized controlled trail

Identify the study design: A total of 453 patients were individually randomised to one of: (1) standardised usual care with 3-monthly HbA1c (control, n = 152);

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