The value of episodic, intensive blood glucose monitoring in non-insulin treated persons with type 2 diabetes: Design of the Structured Testing Program (STeP) Study, a cluster-randomised, clinical trial [NCT00674986]

<p>Abstract</p> <p>Background</p> <p>The value and utility of self-monitoring of blood glucose (SMBG) in non-insulin treated T2DM has yet to be clearly determined. Findings from studies in this population have been inconsistent, due mainly to design differences and limitations, including the prescribed frequency and timing of SMBG, role of the patient and physician in responding to SMBG results, inclusion criteria that may contribute to untoward floor effects, subject compliance, and cross-arm contamination. We have designed an SMBG intervention study that attempts to address these issues.</p> <p>Methods/design</p> <p>The Structured Testing Program (STeP) study is a 12-month, cluster-randomised, multi-centre clinical trial to evaluate whether poorly controlled (HbA1c ≥ 7.5%), non-insulin treated T2DM patients will benefit from a comprehensive, integrated physician/patient intervention using structured SMBG in US primary care practices. Thirty-four practices will be recruited and randomly assigned to an active control group (ACG) that receives enhanced usual care or to an enhanced usual care group plus structured SMBG (STG). A total of 504 patients will be enrolled; eligible patients at each site will be randomly selected using a defined protocol. Anticipated attrition of 20% will yield a sample size of at least 204 per arm, which will provide a 90% power to detect a difference of at least 0.5% in change from baseline in HbA1c values, assuming a common standard deviation of 1.5%. Differences in timing and degree of treatment intensification, cost effectiveness, and changes in patient self-management behaviours, mood, and quality of life (QOL) over time will also be assessed. Analysis of change in HbA1c and other dependent variables over time will be performed using both intent-to-treat and per protocol analyses. Trial results will be available in 2010.</p> <p>Discussion</p> <p>The intervention and trial design builds upon previous research by emphasizing appropriate and collaborative use of SMBG by both patients and physicians. Utilization of per protocol and intent-to-treat analyses facilitates a comprehensive assessment of the intervention. Use of practice site cluster-randomisation reduces the potential for intervention contamination, and inclusion criteria (HbA1c ≥ 7.5%) reduces the possibility of floor effects. Inclusion of multiple dependent variables allows us to assess the broader impact of the intervention, including changes in patient and physician attitudes and behaviours.</p> <p>Trial Registration</p> <p>Current Controlled Trials NCT00674986.</p

A qualitative study on healthcare professionals’ perceived barriers to insulin initiation in a multi-ethnic population

Background: Nationwide surveys have shown that the prevalence of diabetes rates in Malaysia have almost doubled in the past ten years; yet diabetes control remains poor and insulin therapy is underutilized. This study aimed to explore healthcare professionals’ views on barriers to starting insulin therapy in people with type 2 diabetes. Methods: Healthcare professionals consisting of general practitioners (n = 11), family medicine specialists (n = 10), medical officers (n = 8), government policy makers (n = 4), diabetes educators (n = 3) and endocrinologists (n = 2) were interviewed. A semi-structured topic guide was used to guide the interviews by trained facilitators. The interviews were transcribed verbatim and analysed using a thematic analysis approach. Results: Insulin initiation was found to be affected by patient, healthcare professional and system factors. Patients’ barriers include culture-specific barriers such as the religious purity of insulin, preferred use of complementary medication and perceived lethality of insulin therapy. Healthcare professionals’ barriers include negative attitudes towards insulin therapy and the ‘legacy effect’ of old insulin guidelines; whilst system barriers highlight the lack of resources, language and communication challenges. Conclusions: Tackling the issue of insulin initiation should not only happen during clinical consultations. It requires health education to emphasise the progressive nature of diabetes and the eventuality of insulin therapy at early stage of the illness. Healthcare professionals should be trained how to initiate insulin and communicate effectively with patients from various cultural and religious backgrounds

Self-monitoring of blood glucose in type 2 diabetes: an inter-country comparison.

Self-monitoring of blood glucose (SMBG) in type 2 diabetic patients was compared across 14 countries. There was an unexpectedly high SMBG-use in non-insulin-treated patients. Reimbursement polices differed by country, region, insurance status, and patient income. More rigorous and systematic data collection is needed to ensure evidence-based SMBG-use

Self-monitoring of blood glucose in type 2 diabetes: steps toward consensus

Those involved in type 2 diabetes care must be puzzled by the lack of consensus on self-monitoring of blood glucose (SMBG) (1,2,3), especially in non–insulin-treated patients. This is reflected by wide between-country variation in reimbursement for glucose meters and strips. Balanced evaluation of available data is required; however, further trials are needed to provide robust evidence as to how and in which groups SMBG use is justified.Fil: Davis, T. M. E.. University of Western Australia. Fremantle Hospital; AustraliaFil: Davis, W. A.. No especifíca;Fil: Farmer, A.. No especifíca;Fil: Gagliardino, Juan Jose. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - La Plata. Centro de Endocrinología Experimental y Aplicada. Universidad Nacional de La Plata. Facultad de Ciencias Médicas. Centro de Endocrinología Experimental y Aplicada; ArgentinaFil: Giorda,C.. No especifíca;Fil: Home, P.. No especifíca;Fil: Ji, L.. No especifíca;Fil: Johnson, J.. No especifíca;Fil: Karter, A. J.. No especifíca;Fil: Kolb, H.. No especifíca;Fil: Martin, S.. No especifíca;Fil: Mohan, V.. No especifíca;Fil: Nicolucci, A.. No especifíca;Fil: Porta, M.. No especifíca;Fil: Ramachandran, A.. No especifíca;Fil: Ramaiya, K. L.. No especifíca;Fil: Shah, J. H.. No especifíca;Fil: Shera, A.S.. No especifíca;Fil: Skei, S.. No especifíca;Fil: International SMBG Working Group. No especifíca