Use of an insulin bolus advisor facilitates earlier and more frequent changes in insulin therapy parameters in suboptimally controlled patients with diabetes treated with multiple daily insulin injection therapy: results of the ABACUS trial.

BACKGROUND: We assessed the impact of using an automated bolus advisor integrated into a blood glucose meter on the timing and frequency of adjusting insulin therapy parameter settings and whether the availability of this technology would increase blood glucose test strip utilization in diabetes patients treated with multiple daily insulin injection (MDI) therapy. SUBJECTS AND METHODS: The Automated Bolus Advisor Control and Usability Study (ABACUS) trial, a 26-week, prospective, randomized, controlled, multinational study that enrolled 218 type 1 and type 2 diabetes patients, demonstrated that use of an automated insulin bolus advisor helps improve glycemic control in suboptimally controlled, MDI-treated patients. Patient data were assessed to determine when and how often changes in insulin parameter settings occurred during the study. Patient meters were downloaded to determine blood glucose monitoring frequency. RESULTS: One hundred ninety-three patients completed the study: 93 control arm (CNL) and 100 intervention (experimental) arm (EXP). Significantly more EXP (47.5%) than CNL (30.7%) patients received one or more changes in their insulin sensitivity factor (ISF) settings during the study (P=0.0191). Changes in ISF settings occurred earlier and more frequently in EXP than CNL patients throughout the study. A similar trend was seen in changes in insulin-to-carbohydrate ratios. There were no differences in daily self-monitoring of blood glucose frequency [mean (SD)] between CNL and EXP patients: 4.7 (1.5) versus 4.6 (1.3) (P=0.4085). CONCLUSIONS: Use of an automated bolus advisor was associated with earlier, more frequent changes in key insulin parameters, which may have contributed to subsequent improvements in glycemic control but without increased glucose test strip utilization.

Use of an insulin bolus advisor improves glycemic control in multiple daily insulin injection (MDI) therapy patients with suboptimal glycemic control: first results from the ABACUS trial.

OBJECTIVE: Use of automated bolus advisors is associated with improved glycemic control in patients treated with insulin pump therapy. We conducted a study to assess the impact of using an insulin bolus advisor embedded in a blood glucose (BG) meter on glycemic control and treatment satisfaction in patients treated with multiple daily insulin injection (MDI) therapy. The study goal was to achieve >0.5% A1C reduction in most patients. RESEARCH DESIGN AND METHODS: This was a 26-week, prospective, randomized, controlled, multinational study that enrolled 218 MDI-treated patients with poorly controlled diabetes (202 with type 1 diabetes, 16 with type 2 diabetes) who were 18 years of age or older. Participants had mean baseline A1C of 8.9% (SD, 1.2 [74 mmol/mol]), mean age of 42.4 years (SD, 14.0), mean BMI of 26.5 kg/m(2) (SD, 4.2), and mean diabetes duration of 17.7 years (SD, 11.1). Control group (CNL) patients used a standard BG meter and manual bolus calculation; intervention group (EXP) patients used the Accu-Chek Aviva Expert meter with an integrated bolus advisor to calculate insulin dosages. Glucose data were downloaded and used for therapy parameter adjustments in both groups. RESULTS: A total of 193 patients (CNL, n = 93; EXP, n = 100) completed the study. Significantly more EXP than CNL patients achieved >0.5% A1C reduction (56.0% vs. 34.4%; P < 0.01). Improvement in treatment satisfaction (Diabetes Treatment Satisfaction Questionnaire scale) was significantly greater in EXP patients (11.4 [SD, 6.0] vs. 9.0 [SD, 6.3]; P < 0.01). Percentage of BG values <50 mg/dL was <2% in both groups during the study. CONCLUSIONS: Use of an automated bolus advisor resulted in improved glycemic control and treatment satisfaction without increasing severe hypoglycemia.

Automated bolus advisor control and usability study (ABACUS): does use of an insulin bolus advisor improve glycaemic control in patients failing multiple daily insulin injection (MDI) therapy? [NCT01460446].

BACKGROUND: People with T1DM and insulin-treated T2DM often do not follow and/or adjust their insulin regimens as needed. Key contributors to treatment non-adherence are fear of hypoglycaemia, difficulty and lack of self-efficacy associated with insulin dose determination. Because manual calculation of insulin boluses is both complex and time consuming, people may rely on empirical estimates, which can result in persistent hypoglycaemia and/or hyperglycaemia. Use of automated bolus advisors (BA) has been shown to help insulin pump users to more accurately meet prandial insulin dosage requirements, improve postprandial glycaemic excursions, and achieve optimal glycaemic control with an increased time within optimal range. Use of a BA containing an early algorithm based on sliding scales for insulin dosing has also been shown to improve HbA1c levels in people treated with multiple daily insulin injections (MDI). We designed a study to determine if use of an automated BA can improve clinical and psychosocial outcomes in people treated with MDI. METHODS/DESIGN: The Automated Bolus Advisor Control and Usability Study (ABACUS) is a 6-month, prospective, randomised, multi-centre, multi-national trial to determine if automated BA use improves glycaemic control as measured by a change in HbA1c in people using MDI with elevated HbA1c levels (#62;7.5%). A total of 226 T1DM and T2DM participants will be recruited. Anticipated attrition of 20% will yield a sample size of 90 participants, which will provide #62;80% power to detect a mean difference of 0.5%, with SD of 0.9%, using a one-sided 5% t-test, with 5% significance level. Other measures of glycaemic control, self-care behaviours and psychosocial issues will also be assessed. DISCUSSION: It is critical that healthcare providers utilise available technologies that both facilitate effective glucose management and address concerns about safety and lifestyle. Automated BAs may help people using MDI to manage their diabetes more effectively and minimise the risk of long-term diabetes related complications. Findings from a recent study suggest that BA use positively addresses both safety and lifestyle concerns; however, randomised trials are needed to confirm these perceptions and determine whether bolus advisor use improves clinical outcomes. Our study is designed to make these assessments. TRIAL REGISTRATION: NCT01460446.

Influence of caffeine on frequency of hypoglycemia detected by continuous interstitial glucose monitoring system in patients with long-standing type 1 diabetes.

OBJECTIVE: The aim of this study was to investigate the effect of caffeine (in doses equivalent to normal daily ingestion) on rates and severity of hypoglycemia in patients with long-standing type 1 diabetes to determine the relationship between caffeine, autonomic function, and hypoglycemia. RESEARCH DESIGN AND METHODS: Using a double-blinded randomized study, we investigated the effect of caffeine versus placebo in 19 patients with long-standing type 1 diabetes using continuous glucose sensing technology and simultaneous assessment of autonomic function using Holter monitoring. RESULTS: Caffeine reduced the duration of nocturnal hypoglycemia with a mean duration of 49 minutes (range 0-235) versus 132 (0-468) minutes (P = 0.035). The reduction in duration of nighttime hypoglycemia was due to a decline in the number of episodes of moderate hypoglycemia at the expense of mild hypoglycemic episodes (P = 0.04). There was no overall correlation between reduced heart rate variability (a marker of autonomic dysfunction) and hypoglycemic events (r(s) = 0.12, P = 0.62). CONCLUSIONS: Our results suggest that caffeine is associated with a significant reduction in nocturnal hypoglycemia. The reduction in nocturnal hypoglycemia was not linked to the concomitant rise in parasympathetic activity associated with caffeine.

Influence of caffeine on heart rate variability in patients with long-standing type 1 diabetes.

OBJECTIVE: The effect of caffeine on cardiovascular health remains controversial. Patients with long-standing type 1 diabetes are at risk of autonomic failure and sudden cardiac death. We investigated the effects of caffeine on autonomic dysfunction (as assessed by heart rate variability [HRV]) in this high-risk group and in a control population. RESEARCH DESIGN AND METHODS: Using a randomized blinded, placebo-controlled, crossover design trial, we examined 2 weeks of caffeine consumption (250 mg twice daily) on HRV in 20 type 1 diabetic patients and 10 matched healthy volunteers. RESULTS: Baseline HRV was blunted in the diabetic patients (P < 0.0005 vs. control subjects) and markedly increased by caffeine in both groups (+103% in the group with diabetes [P = 0.009] and +38% in control subjects [P = 0.002]). The caffeine-associated increase in HRV was not statistically different between the control and the type 1 diabetes groups (P = 0.16). CONCLUSIONS: Modest amounts of caffeine improved autonomic function in diabetic patients and healthy volunteers. For individuals with abnormal HRV, regular caffeine use may have the potential to reduce the risk of cardiovascular events.