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Ziegler R.,Diabetes Clinic for Children and Adolescents | Rees C.,Roche Holding AG | Jacobs N.,Diabetes Clinic for Children and Adolescents | Parkin C.G.,CGParkin Communications Inc. | And 3 more authors.
Pediatric Diabetes | Year: 2016

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. © 2015 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd

Barnard K.D.,University of Southampton | Lloyd C.E.,Open University Milton Keynes | Dyson P.A.,University of Oxford | Davies M.J.,University of Leicester | And 5 more authors.
Diabetic Medicine | Year: 2014

National Audit Data highlight persistent sub-optimum control among increasing numbers of people living with diabetes, with severe consequences for the individual and the NHS. The aim of the present review was to introduce a new cohesive, holistic model of care, tailored to individual needs to support optimum diabetes outcomes. This model of diabetes is necessary in order to understand the driving forces behind behaviour and their impact on diabetes management. Feelings (an emotional state or reaction) and beliefs (an acceptance that something is true or real) are fundamental behavioural drivers and influence diabetes self-management choices. Individually, these explain some of the complexities of behaviour and, collectively, they impact on personal motivation (rationale/desire to act) to achieve a specific outcome. Inevitably, they independently affect diabetes self-management and the environment in which individuals live. A model of care that proposes the encompassing of environment, intrinsic thought and therapy regimens to provide tailored, personalized healthcare should support enhanced diabetes self-management and outcomes from diagnosis. The Kaleidoscope model of care could be deliverable in routine care, incorporating each of the influences on diabetes self-management, and should benefit both individuals with diabetes and healthcare professionals. © 2014 The Authors. Diabetic Medicine © 2014 Diabetes UK.

Ziegler R.,Diabetes Clinic for Children and Adolescents | Cavan D.A.,Bournemouth Diabetes and Endocrine Center | Cranston I.,Queen Alexandra Hospital | Barnard K.,University of Southampton | And 8 more authors.
Diabetes Care | Year: 2013

OBJECTIVE-Use of automated bolus advisors is associated with improved glycemic control in patients treatedwith 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. RESEARCHDESIGN 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/m2 (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) completedthe 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. © 2013 by the American Diabetes Association.

Pfutzner A.,Pfutzner Science and Health Institute | Weissmann J.,Roche Holding AG | Mougiakakou S.,University of Bern | Daskalaki E.,University of Bern | And 2 more authors.
Diabetes Technology and Therapeutics | Year: 2015

Introduction: The ProAct study has shown that a pump switch to the Accu-Chek® Combo system (Roche Diagnostics Deutschland GmbH, Mannheim, Germany) in type 1 diabetes patients results in stable glycemic control with significant improvements in glycated hemoglobin (HbA1c) in patients with unsatisfactory baseline HbA1c and shorter pump usage time. Patients and Methods: In this post hoc analysis of the ProAct database, we investigated the glycemic control and glycemic variability at baseline by determination of several established parameters and scores (HbA1c, hypoglycemia frequency, J-score, Hypoglycemia and Hyperglycemia Indexes, and Index of Glycemic Control) in participants with different daily bolus and blood glucose measurement frequencies (less than four day, four or five per day, and more than five per day, in both cases). The data were derived from up to 299 patients (172 females, 127 males; age [mean±SD], 39.4±15.2 years; pump treatment duration, 7.0±5.2 years). Results: Participants with frequent glucose readings had better glycemic control than those with few readings (more than five readings per day vs. less than four readings per day: HbA1c, 7.2±1.1% vs. 8.0±0.9%; mean daily blood glucose, 151±22? mg/dL vs. 176±30? mg/dL; percentage of readings per month >300? mg/dL, 10±4% vs. 14±5%; percentage of readings in target range [80-180? mg/dL], 59% vs. 48% [P<0.05 in all cases]) and had a lower glycemic variability (J-score, 49±13 vs. 71±25 [P<0.05]; Hyperglycemia Index, 0.9±0.5 vs. 1.9±1.2 [P<0.05]; Index of Glycemic Control, 1.9±0.8 vs. 3.1±1.6 [P<0.05]; Hypoglycemia Index, 0.9±0.8 vs. 1.2±1.3 [not significant]). Frequent self-monitoring of blood glucose was associated with a higher number of bolus applications (6.1±2.2 boluses/day vs. 4.5±2.0 boluses/day [P<0.05]). Therefore, a similar but less pronounced effect on glycemic variability in favor of more daily bolus applications was observed (more than five vs. less than four bolues per day: J-score, 57±17 vs. 63±25 [not significant]; Hypoglycemia Index, 1.0±1.0 vs. 1.5±1.4 [P<0.05]; Hyperglycemia Index, 1.3±0.6 vs. 1.6±1.1 [not significant]; Index of Glycemic Control, 2.3±1.1 vs. 3.1±1.7 [P<0.05]). Conclusions: Pump users who perform frequent daily glucose readings have a better glycemic control with lower glycemic variability. © 2015, Mary Ann Liebert, Inc.

Cavan D.A.,Bh Tec Inc. | Ziegler R.,Diabetes Clinic for Children and Adolescents | Cranston I.,Queen Alexandra Hospital | Barnard K.,University of Southampton | And 7 more authors.
BMC Family Practice | Year: 2012

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 (>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 >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. © 2012 Cavan et al.; licensee BioMed Central Ltd.

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