Evidence regarding the value and utility of SMBG in insulin-naïve type 2 diabetes (T2DM) has been mixed. Failure to personally understand the value associated with SMBG results and/or share SMBG data with healthcare providers (HCPs) may contribute to poor treatment adherence. The Structured Testing Program (STeP) study, a prospective, cluster-randomized, multi-centered clinical trial, demonstrated that structured SMBG significantly improves glycemic control and quality of life in non-insulin-treated T2DM. In the study, 483 poorly-controlled (HbA1c ≥7.5%), insulin-naïve T2DM patients were randomized to structured testing (STG) or active control (ACG). All STG and ACG patients received free blood glucose meters and test strips. STG subjects also used the ACCU-CHEK® 360 View Blood Glucose Analysis System (”tool”) quarterly to collect/interpret 7-point glucose profiles over 3 consecutive days. STG patients then brought the tool to their HCPs. To evaluate STeP study patient perceptions regarding diabetes self-management and interactions with HCPs. A qualitative descriptive design; data were collected via phone interviews with 59 (20 ACG, 39 STG) STeP study participants. Data were analyzed using a content analysis approach. Sample characteristics included: 54% male; 56% White; mean age 57.1 years; 49% some college or more; mean duration of T2DM 7.4 years; and mean baseline HbA1c 8.9%. Although participants from both study arms perceived SMBG as having personal value, STG patients reported additional benefits of using the tool, including: more in-depth understanding of diabetes; increased confidence in daily decision-making; more meaningful discussions with HCPs; and shared decision-making regarding treatment. Our findings suggest that use of structured testing, as part of a comprehensive intervention where patients and HCPs collaborate to gather, interpret and utilize SMBG data, promotes a positive change in how patients view SMBG, improves patient comprehension of diabetes and diabetes self-management, and increases patient participation in their treatment regimens.

OBJECTIVE:To test whether a structured self-monitoring of blood glucose (SMBG) protocol reduces depressive symptoms and diabetes distress.RESEARCH DESIGN AND METHODS:A 12-month, cluster-randomised, clinical trial compared patients who received a collaborative, structured SMBG, physician/patient intervention with an active control. Studied were 483 insulin naïve type 2 diabetes patients (experimental = 256, control = 227) (≥ 7.5% HbA1c) from 34 primary care practices (experimental = 21, control = 13). Experimental patients used a paper tool to record a 7-point SMBG profile on each of three consecutive days prior to their quarterly physician visit. Patients and physicians interpreted SMBG results to make medication and lifestyle changes.CLINICAL TRIAL REGISTRATION:NIH Trial Registry Number: NCT00674986.MAIN OUTCOME MEASURES:Depressive symptoms (Patient Health Questionnaire: PHQ-8), diabetes-related distress (Diabetes Distress Scale: DDS). HbA1c and SMBG frequency were assessed quarterly; data were analysed using Linear Mixed Models (LMM) for intent-to-treat (ITT) and per protocol (PP) analyses.RESULTS:ITT analyses showed significant improvement in depression and disease-related distress among experimental and control patients from baseline to 12 months (p < 0.01 in both cases) with no between-group differences. Experimental patients displayed significantly greater reductions in distress related to regimen adherence than controls. Also, experimental patients with elevated diabetes distress or depressive symptoms at baseline showed significantly greater reductions in distress and depressive symptoms than control patients at 12 months. The greater improvement in mood in the experimental than control group was independent of improvements in glycaemic control and changes in SMBG frequency.CONCLUSIONS:Using well standardised measures, collaborative, structured SMBG leads to reductions, not increases, in depressive symptoms and diabetes distress over time, for the large number of moderately depressed or distressed type 2 patients in poor glycaemic control. Changes in affective status are independent of improvements in glycaemic control and changes in SMBG frequency for these patients.