Self-monitoring of Blood Glucose in Non-Insulin Treated Type 2 Diabetes (The SMBG Study): study protocol for a randomised controlled trial.

BACKGROUND: The benefit of Self-monitoring of Blood Glucose (SMBG) in people with non-insulin treated type 2 diabetes remains unclear with inconsistent evidence from randomised controlled trials fuelling the continued debate. Lack of a consistent finding has been attributed to variations in study population and design, including the SMBG intervention. There is a growing consensus that structured SMBG, whereby the person with diabetes and health care provider are educated to detect patterns of glycaemic abnormality and take appropriate action according to the blood glucose profiles, can prove beneficial in terms of lowering HbA1c and improving overall well-being. Despite this, many national health agencies continue to issue guidelines restricting the use of SMBG in non-insulin treated type 2 diabetes. METHODS: The SMBG Study is a 12 month, multi-centre, randomised controlled trial in people with type 2 diabetes not on insulin therapy who have poor glycaemic control (HbA1c ≥58 mmol/mol / 7.5%). The participants will be randomised into three comparative groups: Group 1 will act as a control group and receive their usual diabetes care; Group 2 will undertake structured SMBG with clinical review every 3 months; Group 3 will undertake structured SMBG with additional monthly telecare support from a trained study nurse. A total of 450 participants will be recruited from 16 primary and secondary care sites across Wales and England. The primary outcome measure will be HbA1c at 12 months with secondary measures to include weight, BMI, total cholesterol and HbA1c levels at 3, 6, 9 and 12 months. Participant well-being and attitude towards SMBG will be monitored throughout the course of the study. Recruitment began in December 2012 with the last participant visit due in September 2016. DISCUSSION: This study will attempt to answer the question of whether structured SMBG provides any benefits to people with poorly controlled type 2 diabetes who are not being treated with insulin. The data will also clarify whether the telecare support provides additional value. The overall acceptability of SMBG as a tool for self-management will be assessed. TRIAL REGISTRATION: UKCRN 12038 (Registered March 2012). ISRCTN21390608 (Retrospectively registered 15th May 2014).

Preventing the overdiagnosis of chest sepsis in children: A quality improvement project.

RATIONALE: Respiratory infections in children are one of the most common causes of hospital attendances and a common cause of sepsis. Most of these infections turn out to be viral in nature. However, the overuse of antibiotics is common and with increasing problems with antimicrobial resistance, changes to antibiotic prescribing practices need to be implemented urgently. AIMS AND OBJECTIVES: To test our hypothesis that a significant number of children and young people are diagnosed with and treated for 'chest sepsis' unnecessarily by evaluating adherence to British Thoracic Society and National Institute of Clinical Excellence sepsis guidelines, and to implement measures to prevent overdiagnosis. DESIGN: A baseline audit undertaken, stratified patient risk as per NICE sepsis guidelines. Data were analysed to assess adherence to these guidelines following presentation of possible lower respiratory tract infection. Questionnaires were sent to Paediatric doctors in local hospitals and focus groups were held to qualitatively evaluate the barriers and facilitators to preventing overdiagnosis. These informed implemented measures. RESULTS: The baseline audit showed 61% of children under two, who are more likely to have a viral chest infection were treated with intravenous antibiotics. Seventy-seven percent of children had blood tests and 88% had chest X-rays (CXRs) which are not routinely recommended. A total of 71% with a normal CXR had been treated with intravenous antibiotics. Barriers to preventing overdiagnosis included the over-sensitivity of the sepsis tool, anxiety and drug prescribing habits. Facilitators included visual cues and team work. Implemented changes including a revised sepsis pathway and raising awareness led to some positive changes. However, upon re-auditing there was no significant change in the number of children being overdiagnosed. CONCLUSIONS: Initial audit results supported our hypothesis that children were being overdiagnosed, over-investigated and over-treated. Despite multimodal interventions aimed at understanding the drivers underpinning these issues, the re-audit results mirrored the baseline audit despite a transient improvement following our campaign to raise awareness and further work to change physician behaviour is required.