Frequent use of an automated bolus advisor improves glycemic control in pediatric patients treated with insulin pump therapy: results of the Bolus Advisor Benefit Evaluation (BABE) study.

BACKGROUND: The relationship between frequency and sustained bolus advisor (BA) use and glycemic improvement has not been well characterized in pediatric populations. OBJECTIVE: The objective of this study is to assess the impact of frequent and persistent BA use on glycemic control among pediatric type 1 diabetes patients. METHODS: In this 6-month, single-center, retrospective cohort study, 104 children [61 girls, mean age: 12.7 yr, mean HbA1c 8.0 (1.6)% [64 (17.5) mmol/mol]], treated with the Accu-Chek Aviva Combo insulin pump, were observed. Frequency of BA use, HbA1c, hypoglycemia (<70 mg/dL), therapy changes, mean blood glucose, and glycemic variability (standard deviation) was assessed at baseline and month 6. Sub-analyses of the adolescent patient use (12 months) and longitudinal use (24 months) were also conducted. RESULTS: Seventy-one patients reported high frequency (HF) device use (≥50%); 33 reported low frequency (LF) use (<50%) during the study. HF users achieved lower mean (SE) HbA1c levels than LF users: 7.5 (0.1)% [59 (1.1) mmol/mol] vs. 8.0 (0.2)% [64 (2.2) mmol/mol], p = 0.0252. No between-group differences in the percentage of hypoglycemia values were seen at 6 months. HF users showed less glycemic variability (84.0 vs. 94.7, p = 0.0045) than LF users. More HF patients reached HbA1c target of <7.5 at 6 months 66.2% (+16.9) vs. 27.3% (-9.1), p = 0.0056. Similar HbA1c results were seen in adolescents and BA users at 24 months. CONCLUSION: Frequent use of the Accu-Chek Aviva Combo insulin pump BA feature was associated with improved and sustained glycemic control with no increase in hypoglycemia in this pediatric population.

Recommendations for Insulin Dose Calculator Risk Management.

Several studies have shown the usefulness of an automated insulin dose bolus advisor (BA) in achieving improved glycemic control for insulin-using diabetes patients. Although regulatory agencies have approved several BAs over the past decades, these devices are not standardized in their approach to dosage calculation and include many features that may introduce risk to patients. Moreover, there is no single standard of care for diabetes worldwide and no guidance documents for BAs, specifically. Given the emerging and more stringent regulations on software used in medical devices, the approval process is becoming more difficult for manufacturers to navigate, with some manufacturers opting to remove BAs from their products altogether. A comprehensive literature search was performed, including publications discussing: diabetes BA use and benefit, infusion pump safety and regulation, regulatory submissions, novel BAs, and recommendations for regulation and risk management of BAs. Also included were country-specific and international guidance documents for medical device, infusion pump, medical software, and mobile medical application risk management and regulation. No definitive worldwide guidance exists regarding risk management requirements for BAs, specifically. However, local and international guidance documents for medical devices, infusion pumps, and medical device software offer guidance that can be applied to this technology. In addition, risk management exercises that are algorithm-specific can help prepare manufacturers for regulatory submissions. This article discusses key issues relevant to BA use and safety, and recommends risk management activities incorporating current research and guidance.

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.