Use of diabetes data management software reports by health care providers, patients with diabetes, and caregivers improves accuracy and efficiency of data analysis and interpretation compared with traditional logbook data: first results of the Accu-Chek Connect Reports Utility and Efficiency Study (ACCRUES).

We assessed users' proficiency and efficiency in identifying and interpreting self-monitored blood glucose (SMBG), insulin, and carbohydrate intake data using data management software reports compared with standard logbooks. This prospective, self-controlled, randomized study enrolled insulin-treated patients with diabetes (PWDs) (continuous subcutaneous insulin infusion [CSII] and multiple daily insulin injection [MDI] therapy), patient caregivers [CGVs]) and health care providers (HCPs) who were naïve to diabetes data management computer software. Six paired clinical cases (3 CSII, 3 MDI) and associated multiple-choice questions/answers were reviewed by diabetes specialists and presented to participants via a web portal in both software report (SR) and traditional logbook (TL) formats. Participant response time and accuracy were documented and assessed. Participants completed a preference questionnaire at study completion. All participants (54 PWDs, 24 CGVs, 33 HCPs) completed the cases. Participants achieved greater accuracy (assessed by percentage of accurate answers) using the SR versus TL formats: PWDs, 80.3 (13.2)% versus 63.7 (15.0)%, P < .0001; CGVs, 84.6 (8.9)% versus 63.6 (14.4)%, P < .0001; HCPs, 89.5 (8.0)% versus 66.4 (12.3)%, P < .0001. Participants spent less time (minutes) with each case using the SR versus TL formats: PWDs, 8.6 (4.3) versus 19.9 (12.2), P < .0001; CGVs, 7.0 (3.5) versus 15.5 (11.8), P = .0005; HCPs, 6.7 (2.9) versus 16.0 (12.0), P < .0001. The majority of participants preferred using the software reports versus logbook data. Use of the Accu-Chek Connect Online software reports enabled PWDs, CGVs, and HCPs, naïve to diabetes data management software, to identify and utilize key diabetes information with significantly greater accuracy and efficiency compared with traditional logbook information. Use of SRs was preferred over logbooks.

Use of an automated decision support tool optimizes clinicians' ability to interpret and appropriately respond to structured self-monitoring of blood glucose data.

OBJECTIVE: We evaluated the impact of an automated decision support tool (DST) on clinicians' ability to identify glycemic abnormalities in structured self-monitoring of blood glucose (SMBG) data and then make appropriate therapeutic changes based on the glycemic patterns observed. RESEARCH DESIGN AND METHODS: In this prospective, randomized, controlled, multicenter study, 288 clinicians (39.6% family practice physicians, 37.9% general internal medicine physicians, and 22.6% nurse practitioners) were randomized to structured SMBG alone (STG; n = 72); structured SMBG with DST (DST; n = 72); structured SMBG with an educational DVD (DVD; n = 72); and structured SMBG with DST and the educational DVD (DST+DVD; n = 72). Clinicians analyzed 30 patient cases (type 2 diabetes), identified the primary abnormality, and selected the most appropriate therapy. RESULTS: A total of 222 clinicians completed all 30 patient cases with no major protocol deviations. Significantly more DST, DVD, and DST+DVD clinicians correctly identified the glycemic abnormality and selected the most appropriate therapeutic option compared with STG clinicians: 49, 51, and 55%, respectively, vs. 33% (all P < 0.0001) with no significant differences among DST, DVD, and DST+DVD clinicians. CONCLUSIONS: Use of structured SMBG, combined with the DST, the educational DVD, or both, enhances clinicians' ability to correctly identify significant glycemic patterns and make appropriate therapeutic decisions to address those patterns. Structured testing interventions using either the educational DVD or the DST are equally effective in improving data interpretation and utilization. The DST provides a viable alternative when comprehensive education is not feasible, and it may be integrated into medical practices with minimal training.

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].

BACKGROUND: 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. METHODS/DESIGN: The Structured Testing Program (STeP) study is a 12-month, cluster-randomised, multi-centre clinical trial to evaluate whether poorly controlled (HbA1c >or= 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. DISCUSSION: 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 >or= 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. TRIAL REGISTRATION: Current Controlled Trials NCT00674986.