Aims: People with type 1 diabetes (T1D) can administer insulin by multiple daily injections (MDI) or continuous subcutaneous insulin infusion (CSII). Despite proven clinical benefits, the uptake of CSII is still low. Thus, this study investigates the change in treatment satisfaction and metabolic outcome of people with T1D switching from MDI to CSII therapy using an innovative modular micropump system. Methods: A total of 50 CSII-naive adults with T1D from Argentina were enrolled in a multi-center, prospective, single-armed study for the Accu-Chek® Solo micropump system (ACS). Change in diabetes treatment satisfaction after 13 weeks (mean 108, min 83, max 176 days) was assessed by the “Impact and Satisfaction” section of the Diabetes Technology Questionnaire (DTQ) as primary outcome. In addition, changes in the DTQ after 1 year and the HbA1c after 13 weeks and 1 year were measured. Results: The change score of the “Impact and satisfaction” part of the DTQ was 113.37 ± 16.74 (mean ± SD, p < 0.0001) after 13 weeks and 111.42 ± 14.42 (p < 0.0001) after 1 year (with 90 as non-change score). Based on predefined sub-categories, the following mean DTQ change scores were measured after 13 weeks / 1 year: 3.81 ± 0.61 / 3.79 ± 0.52 for “diabetes distress and burden”, 3.96 ± 0.68 / 3.98 ± 0.60 for “hypoglycemia fear, worry and behavior”, 3.56 ± 0.71 / 3.53 ± 0.52 for “device acceptance and satisfaction” (1 = much worse, 5 = much better). The mean HbA1c decreased from 8.20 % ± 1.34 to 7.92 % ± 1.18 (-0.28 %pt, p = 0.0341) after 13 weeks and 7.87 % ± 1.26 (-0.37 %pt, p = 0.0467) after 1 year. Thereby, one event of severe hypoglycemia and diabetic ketoacidosis (DKA) was reported during 17520 device days. Conclusion: The switch from MDI to CSII using the ACS led to a significant improvement of subjects’ treatment satisfaction and HbA1c. Effects were already measurable after 13 weeks and continued through 1 year indicating that using the ACS reduces disease burden among people with T1D. Disclosure A. Dain: None. S. Moceri: Employee; Roche Diabetes Care. N. Dagenbach: Employee; Roche Diabetes Care. C. Rees: Employee; Roche Diabetes Care. C. Vulcano: Employee; Roche Diabetes Care. G. Vogt: Employee; Roche Diabetes Care. T. J. Etter: None.

Background and aims: Intensified insulin therapy for type 1 diabetes (T1D) can be administered by multiple daily injection therapy (MDI) or continuous subcutaneous insulin infusion therapy (CSII) . Despite the clinical benefits of CSII, its therapeutic implementation rate remains low. Thus, this study aims to evaluate the change in treatment satisfaction and metabolic changes of people with T1D switching from MDI to CSII therapy using a novel modular patch pump system. Materials and Methods: A total of 50 adults from Argentina with T1D, naïve to CSII, were enrolled in a multi - center, prospective, single - armed study for the Accu-Chek® Solo micropump system (ACS) . Change in diabetes treatment satisfaction after 13 weeks (mean 106, min 83, max 176 days) was assessed by the “Impact and Satisfaction” section of the Diabetes Technology Questionnaire (DTQ) as the primary outcome. In addition, changes in the HbA1c were reported by the investigator as a secondary outcome. Results: The mean DTQ “now” score improved from 92.96 ± 14.98 to 103.15 ± 19.47 (p = 0.0166) and the “change” score, as the primary outcome, was 113.24 ± 17.50 (p < 0.0001) . Based on pre - defined sub - categories, the following mean DTQ scores were measured: 3.83 ± 0.62 for “diabetes distress and burden,” 3.98 ± 0.70 for “hypoglycemia fear, worry and behavior,” 3.59 ± 0.70 for “device acceptance and satisfaction,” 3.92 ± 0.61 for “other.” In addition, the mean HbA1c, as a secondary outcome, decreased from 8.19 % ± 1.36 to 7.83 % ± 1.23 (- 0.37 %pt, p = 0.0148) . Thereby, the HbA1c reduction was not associated with any reported incidents of hypoglycemia. Conclusion: The switch from MDI to the Accu-Chek® Solo micropump system led to a significant improvement of subjects’ treatment satisfaction after 13 weeks, which was linked to a significant reduction of the outcome HbA1c without any reported incidents of hypoglycemia. Disclosure A. Dain: Advisory Panel; Boehringer Ingelheim International GmbH, Novo Nordisk, Roche Diabetes Care, Speaker’s Bureau; Abbott Diabetes, AstraZeneca, Lilly Diabetes, Novo Nordisk. S. Moceri: Employee; Roche Diabetes Care. N. Dagenbach: Employee; Roche Diabetes Care. C. Rees: Employee; Roche Diabetes Care. C. Vulcano: Employee; Roche Diabetes Care. G. Vogt: Employee; Roche Diabetes Care. T. J. Etter: Employee; Roche Diabetes Care. Funding Roche Diabetes Care Gmbh, Mannheim, Germany

Studies have shown that collaborative parent-child relationships can positively influence both regimen adherence and glycemic control, and that regimen adherence is improved by parental involvement and monitoring of their child’s diabetes-related tasks. We hypothesized that immediate access to diabetes-related data and the ability to review these data retrospectively may increase feelings of confidence/safety in diabetes management and reduce hypoglycemia fear among parents of children/adolescents with type 1 diabetes (T1D). The Accu-Chek® Connect System (Roche Diabetes Care, Indianapolis, USA) consists of a blood glucose meter, smartphone application (app) and an online data management web portal. The meter connects wirelessly, via low-energy Bluetooth, to the user’s smartphone app, which provides multiple functions to facilitate diabetes management. The system allows users to share real-time glucose data and related information with others through a personal web portal and/or text message. In this 1-week, observational, mono-centric pilot study, we assessed perceptions of parents of children/adolescents (age 0-17 years) with type 1 diabetes and older children/adolescents (age 8-17 years) who used the system while attending the Friends for Life Conference, held July 6-12, 2015, at Disney’s Coronado Springs Resort, Florida. Participants received the system blood glucose meter, testing supplies, and a smartphone (if needed) and underwent a 15-minute training session on system use. Participants were asked to use the system for 3 or more days. Pre and post questionnaires were used to assess system use and impact on perceptions of confidence, safety, hypoglycemia fear, system utility and preference to current diabetes management method. A total of 91 parents of T1D children/adolescents and 79 T1D children/adolescents are included in this analysis. A large majority of parents and children/adolescents reported frequent use of the meter (83.5% and 96.2%, respectively) and smartphone app (65.9% and 87.3%, respectively). The majority of respondents “mostly agreed” that they felt more confident, safer and less worry about hypoglycemia when using the system (Figure 1). Comparison of continuous glucose monitoring (CGM) versus no CGM use showed notable differences in the percentage of parents who reported feelings of increased safety (68.4% vs 80.0%, P = .4437, respectively) and less fear of hypoglycemia (61.4% vs 83.3%, respectively, P = .0521). Most parent (73.6%) and children/adolescent (64.6%) respondents reported a preference for using the system over their prior diabetes management method. A notable difference was seen in preference for using the system over previous method between parents of multiple daily insulin injections (MDI)versus continuous subcutaneous insulin infusion (CSII)-treated children (84.0% vs 69.7%, respectively, P = .1941). Similar perceptions were reported by children/adolescent CGM versus no CGM users: increased safety (62.5% vs 82.1%, P = .0632, respectively) and less fear of hypoglycemia (60.4% vs 78.6%, respectively, P = .0745). Most parents (90.1%) and children/adolescents (93.7%) reported satisfaction with how the system helped them manage diabetes. Most respondents (86.8% parents, 650901 DSTXXX10.1177/1932296816650901Journal of Diabetes Science and TechnologyPrakasam et al letter2016

BackgroundThe relationship between frequency and sustained bolus advisor (BA) use and glycemic improvement has not been well characterized in pediatric populations.ObjectiveThe objective of this study is to assess the impact of frequent and persistent BA use on glycemic control among pediatric type 1 diabetes patients.MethodsIn 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.ResultsSeventy-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.ConclusionFrequent 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.

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.

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.