Deborah Hinnen

Structured Self-Monitoring of Blood Glucose Significantly Reduces A1C Levels in Poorly Controlled, Noninsulin-Treated Type 2 Diabetes: Results from the Structured Testing Program study

OBJECTIVE To assess the effectiveness of structured blood glucose testing in poorly controlled, noninsulin-treated type 2 diabetes. RESEARCH DESIGN AND METHODS This 12-month, prospective, cluster-randomized, multicenter study recruited 483 poorly controlled (A1C ≥7.5%), insulin-naïve type 2 diabetic subjects from 34 primary care practices in the U.S. Practices were randomized to an active control group (ACG) with enhanced usual care or a structured testing group (STG) with enhanced usual care and at least quarterly use of structured self-monitoring of blood glucose (SMBG). STG patients and physicians were trained to use a paper tool to collect/interpret 7-point glucose profiles over 3 consecutive days. The primary end point was A1C level measured at 12 months. RESULTS The 12-month intent-to-treat analysis (ACG, n = 227; STG, n = 256) showed significantly greater reductions in mean (SE) A1C in the STG compared with the ACG: −1.2% (0.09) vs. −0.9% (0.10); Δ = −0.3%; P = 0.04. Per protocol analysis (ACG, n = 161; STG, n = 130) showed even greater mean (SE) A1C reductions in the STG compared with the ACG: −1.3% (0.11) vs. −0.8% (0.11); Δ = −0.5%; P < 0.003. Significantly more STG patients received a treatment change recommendation at the month 1 visit compared with ACG patients, regardless of the patient’s initial baseline A1C level: 179 (75.5%) vs. 61 (28.0%); <0.0001. Both STG and ACG patients displayed significant (P < 0.0001) improvements in general well-being (GWB). CONCLUSIONS Appropriate use of structured SMBG significantly improves glycemic control and facilitates more timely/aggressive treatment changes in noninsulin-treated type 2 diabetes without decreasing GWB.

Changes in Cortical Functioning With Acute Hypoglycemia and Hyperglycemia in Type I Diabetes

In this study, 18 type I (insulin-dependent) diabetic subjects aged 22–35 yr (mean age 29.3) and within 10 yr of diagnosis (mean 7.7) performed a battery of cognitive and psychomotor tasks under conditions of hypoglycemia (50 mg/dl), normoglycemia (100 mg/dl), and hyperglycemia (300 mg/dl). Blood glucose levels during testing were precisely maintained at the preselected level via a Biostator insulin/glucose-infusion system. The order of glycemic level was counterbalanced across subjects in a single-blinded design. Performance on tasks requiring visual tracking, visuomotor speed, concentration, and planning ability (pursuit rotor and trails B) were significantly impaired under conditions of hypoglycemia compared with normoglycemic levels. Visual reaction time was not significantly impaired under conditions of hypoglycemia or hyperglycemia.

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]

BackgroundThe 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/designThe 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.DiscussionThe 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.Trial RegistrationCurrent Controlled Trials NCT00674986.

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)

Background: 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. Method: 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. Results: 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. Conclusions: 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.

Effective use of paired testing in type 2 diabetes: practical applications in clinical practice.

Purpose The purpose of this article is to discuss practical approaches to the use of self-monitoring of blood glucose (SMBG) in clinical practice using paired glucose testing. A rationale for SMBG use and innovative tools for data collection and analysis are presented. Method Health care professionals from various medical specialties collaborated to review current evidence regarding the value and utility of SMBG and to formulate professional opinions regarding use of SMBG. The literature review included key SMBG studies from 2002 through 2009. Established guidelines, position papers, and other evidence were also reviewed for this report. Reference Manager Software was used to search ISI Web of Science, PubMed, and Z39.50 site databases. Results Although the utility of SMBG in non—insulin-treated type 2 diabetes remains controversial, a recent report from the International Diabetes Federation recommends SMBG use in this population if it is used to educate/ motivate individuals and/or monitor and adjust therapy. Health care providers must develop strategies to use SMBG in ways that address these criteria. Conclusions Paired SMBG (testing before/after specific events) promotes diabetes knowledge and self-management skills and facilitates assessment of the impact of behavioral changes, medical nutrition therapy, and pharmacologic interventions on glycemic levels. New tools have been developed to assist in using paired testing in clinical practice.

Glucuretic effects and renal safety of dapagliflozin in patients with type 2 diabetes

Dapagliflozin is a selective sodium-glucose cotransporter 2 (SGLT2) inhibitor approved as a treatment for type 2 diabetes mellitus (T2DM) in the United States, the European Union and other countries. Dapagliflozin increases renal glucose excretion in an insulin-independent manner, and its mechanism of action is complementary to those of other antidiabetes medications. When used as monotherapy or in combination with other oral antidiabetes medications or insulin, dapagliflozin improves glycemic measures in patients with T2DM. Dapagliflozin treatment is also associated with weight reduction and a decrease in blood pressure, both of which may be beneficial in patients with T2DM. Because of its mechanism of action, dapagliflozin has a low intrinsic propensity to cause hypoglycemia. Overall, dapagliflozin is well tolerated, with the frequency of most adverse events similar to that seen with placebo. Cases of genital infections and, in some studies, urinary tract infections have been more frequent in dapagliflozin-treated groups compared with placebo groups. In the clinical development program, more cases of newly diagnosed bladder cancer were reported for patients treated with dapagliflozin (0.17%) compared with placebo or comparator (0.03%). Although there were not enough cases to determine causality, dapagliflozin should not be used in patients with bladder cancer and should be used with caution in patients with a history of bladder cancer. Dapagliflozin may decrease glomerular filtration rate (GFR), especially in elderly patients and patients with impaired renal function. Renal function should be monitored before initiation of dapagliflozin. Dapagliflozin should not be used in patients with an estimated GFR <60 ml/min/1.73 m2. No cardiovascular safety signals have been detected for dapagliflozin, and a long-term cardiovascular outcomes study is ongoing. Evidence from clinical trials suggests that dapagliflozin is a promising new treatment option for T2DM.

Effective Use of Structured Self-Management of Blood Glucose in Type 2 Diabetes: Lessons From the STeP Study

IN BRIEF The Structured Testing Program (STeP) study used structured self-monitoring of blood glucose (SMBG) as a component of a collaborative intervention. Study results showed significant clinical, behavioral, and quality-of-life benefits from the intervention. This article discusses some of the key lessons learned from the STeP study and presents a practical approach to incorporating and utilizing structured SMBG in primary care.

Safe and Efficacious Use of Automated Bolus Advisors in Individuals Treated With Multiple Daily Insulin Injection (MDI) Therapy Lessons Learned From the Automated Bolus Advisor Control and Usability Study (ABACUS)

Numerous studies have shown that use of integrated automated bolus advisors (BAs) provides significant benefits to individuals using insulin pump devices, including improved glycemic control and greater treatment satisfaction. Within the past few years, BA devices have been developed specifically for individuals treated with multiple daily insulin injection (MDI) therapy; however, many clinicians who treat these individuals may be unfamiliar with insulin pump therapy and, thus, BA use. Findings from the Automated Bolus Advisor Control and Usability Study (ABACUS) revealed that BA use can be efficacious and clinically meaningful in MDI therapy, and that most patients are willing and able to use this technology appropriately when adequate clinical support is provided. The purpose of this article is to review key learnings from ABACUS and provide practical advice for initiating BA use and monitoring therapy.

Short commentary on empagliflozin and its potential clinical impact

Sodium glucose cotransporter type 2 (SGLT2) inhibitors are a new class of drug developed to treat type 2 diabetes mellitus (T2DM). They target the kidney by reducing renal glucose reabsorption and promoting urinary glucose excretion, which reduces hyperglycemia in individuals with T2DM. The SGLT2 inhibitor empagliflozin has gained approval in the EU and in the USA for the treatment of adults with T2DM (there is no current indication in type 1 diabetes). Empagliflozin has shown a good efficacy and safety profile from clinical trials when given as monotherapy, and as an add-on therapy to other glucose-lowering agents. This short commentary reviews the key efficacy and safety data from empagliflozin phase III trials and examines the potential role this agent may have in the management of T2DM.

Clinical Implications of Canagliflozin Treatment in Patients With Type 2 Diabetes

IN BRIEF Sodium glucose cotransporter 2 (SGLT2) inhibitors are a new class of antihyperglycemic agents that lower blood glucose levels in patients with type 2 diabetes. SGLT2 inhibitors have an insulin-independent mechanism of action, acting to inhibit the reabsorption of glucose in the kidney, which leads to increases in urinary glucose excretion in individuals with elevated blood glucose levels. This article provides an overview of the role of the kidney in type 2 diabetes, describes the rationale for renal SGLT2 as a new target for glycemic control, and focuses on the clinical implications of incorporating the SGLT2 inhibitor canagliflozin into type 2 diabetes treatment regimens based on data from phase 3 studies.