Ralph Ziegler

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/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) 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.

Indications for insulin pump therapy in different age groups- : an analysis of 1567 children and adolescents

Aims  The German working group for pump therapy in paediatric patients has defined seven indications for continuous subcutaneous insulin infusion (CSII): dawn phenomenon, reduction of severe hypoglycaemia, improvement of hyperglycaemia, more flexibility, motivation, failure of injection therapy and pregnancy. In this study we analysed age‐specific differences for starting CSII in four age groups (group A: 0–4 years; group B: 5–9 years; group C: 10–14 years; group D: 15–19 years). We also investigated whether glycaemic goals could be reached.

Kaleidoscope model of diabetes care: time for a rethink?

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.

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]

BackgroundPeople 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/designThe 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.DiscussionIt 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 registrationNCT01460446

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

The relationship between frequency and sustained bolus advisor (BA) use and glycemic improvement has not been well characterized in pediatric populations.

Interferences and Limitations in Blood Glucose Self-Testing An Overview of the Current Knowledge

In general, patients with diabetes performing self-monitoring of blood glucose (SMBG) can strongly rely on the accuracy of measurement results. However, various factors such as application errors, extreme environmental conditions, extreme hematocrit values, or medication interferences may potentially falsify blood glucose readings. Incorrect blood glucose readings may lead to treatment errors, for example, incorrect insulin dosing. Therefore, the diabetes team as well as the patients should be well informed about limitations in blood glucose testing. The aim of this publication is to review the current knowledge on limitations and interferences in blood glucose testing with the perspective of their clinical relevance.

SPECTRUM A Training and Treatment Program for Continuous Glucose Monitoring for All Age Groups

Background: Optimal usage of continuous glucose monitoring (CGM) requires adequate training of the users. Providing patients with a CGM system without such a training usually doesn’t lead to the intended improvement in metabolic control. Methods: In Germany we developed a structured training program (“SPECTRUM”) to ensure a high quality standard for the use of CGM systems. Results: This program is suitably for patients of all age groups and is applicable to all CGM systems and all forms of insulin therapy. A curriculum was also developed so that training centers with less experience with CGM could become capable of offering comprehensive CGM training. Conclusions: We believe that usage of such a program can be an important step forward in achieving more widespread acceptance and use of CGM systems. Translations in other languages and evaluation with a controlled clinical trial are planned.

High Reported Treatment Satisfaction in People With Type 1 Diabetes Switching to Latest Generation Insulin Pump Regardless of Previous Therapy

Background: The effects of transition by individuals with type 1 diabetes (T1D) to more recently available continuous glucose monitoring (CGM)-enabled insulin pumps from either multiple daily insulin injections (MDI) or older insulin pumps on treatment satisfaction have not been well studied. We conducted a survey to assess treatment satisfaction among users of the Animas® Vibe™ insulin pump, a latest generation insulin pump (LGIP) system (CGM-enabled), after switching from MDI or earlier generation insulin pumps. Methods: Individuals with T1D from 141 centers in 5 countries and 4 language areas participated in the survey. Treatment satisfaction was assessed by the Insulin Treatment Satisfaction Questionnaire (ITSQ), which was included in a 50-item online questionnaire that also assessed preference for using the LGIP compared with previous treatment and satisfaction with key LGIP features. Results: A total of 356 individuals, ages 12-79 years, responded to the survey: mean (SD) age 38.4 (16.1) years; diabetes duration 19.1 (13.3) years; female 59%; previously treated with MDI 58%. Overall mean (SD) ITSQ scores were high among all respondents regardless of prior treatment: 95.1 (23.2) (scale: 0-132). No differences between previous-treatment groups were seen. Most (83%) of respondents rated the LGIP to be better than their previous insulin delivery system: “much better” (65%), “a bit better” (18%) regardless of age, and 95% would recommend using the LGIP to others. Conclusions: Use of the Animas Vibe was associated with high treatment satisfaction and perceived as a better method of insulin delivery regardless of previous insulin therapy or age.

Optimizing insulin pump therapy: the potential advantages of using a structured diabetes management program.

Abstract Use of continuous subcutaneous insulin infusion (CSII) therapy improves glycemic control, reduces hypoglycemia and increases treatment satisfaction in individuals with diabetes. As a number of patient- and clinician-related factors can hinder the effectiveness and optimal usage of CSII therapy, new approaches are needed to address these obstacles. Ceriello and colleagues recently proposed a model of care that incorporates the collaborative use of structured SMBG into a formal approach to personalized diabetes management within all diabetes populations. We adapted this model for use in CSII-treated patients in order to enable the implementation of a workflow structure that enhances patient–physician communication and supports patients’ diabetes self-management skills. We recognize that time constraints and current reimbursement policies pose significant challenges to healthcare providers integrating the Personalised Diabetes Management (PDM) process into clinical practice. We believe, however, that the time invested in modifying practice workflow and learning to apply the various steps of the PDM process will be offset by improved workflow and more effective patient consultations. This article describes how to implement PDM into clinical practice as a systematic, standardized process that can optimize CSII therapy.

Diagnosis, Therapy and Control of Diabetes Mellitus in Children and Adolescents

The following recommendations are directed to all professional and vocational groups which take care of and support children and adolescents with diabetes, as well as their families. It is also directed to higher level organisations, such as health insurers, which deal with diabetes. This guideline concentrates on the specifics for this age group which are not described in the DDG’s general guidelines for the therapy of type 1 diabetes, or are described there, but somewhat differently [1]. As stated in the specifications of the health ministries of Germany’s states and in keeping with the current practice of many clinics, this paediatric guideline applies to all diabetes patients who are not yet 18 years of age. In individual clinical cases this guideline can also be used for young adults.