Background: The benefit of Self-monitoring of Blood Glucose (SMBG) in people with non-insulin treated type 2\ndiabetes remains unclear with inconsistent evidence from randomised controlled trials fuelling the continued\ndebate. Lack of a consistent finding has been attributed to variations in study population and design, including the\nSMBG intervention. There is a growing consensus that structured SMBG, whereby the person with diabetes and\nhealth care provider are educated to detect patterns of glycaemic abnormality and take appropriate action\naccording to the blood glucose profiles, can prove beneficial in terms of lowering HbA1c and improving overall\nwell-being. Despite this, many national health agencies continue to issue guidelines restricting the use of SMBG in\nnon-insulin treated type 2 diabetes.\nMethods: The SMBG Study is a 12 month, multi-centre, randomised controlled trial in people with type 2 diabetes\nnot on insulin therapy who have poor glycaemic control (HbA1c �58 mmol/mol / 7.5%). The participants will be\nrandomised into three comparative groups: Group 1 will act as a control group and receive their usual diabetes care;\nGroup 2 will undertake structured SMBG with clinical review every 3 months; Group 3 will undertake structured SMBG\nwith additional monthly telecare support from a trained study nurse. A total of 450 participants will be recruited from\n16 primary and secondary care sites across Wales and England. The primary outcome measure will be HbA1c at\n12 months with secondary measures to include weight, BMI, total cholesterol and HbA1c levels at 3, 6, 9 and\n12 months. Participant well-being and attitude towards SMBG will be monitored throughout the course of the study.\nRecruitment began in December 2012 with the last participant visit due in September 2016.\nDiscussion: This study will attempt to answer the question of whether structured SMBG provides any benefits to\npeople with poorly controlled type 2 diabetes who are not being treated with insulin. The data will also clarify whether\nthe telecare support provides additional value. The overall acceptability of SMBG as a tool for self-management will be\nassessed.
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