Author(s): Bilous R., Prager R., Pieber T.R., Ramtoola S., Narendran P., Barnard K.D., Kohler K., Gelchsheimer U., Petersen B., Amstutz L., Schutz-Fuhrmann I.
Abstract: Background and aims: The Accu-Chek Insight diabetes therapy system combines a glucose meter with integrated bolus advice and extended data management capabilities with an insulin pump. The use of the new system was evaluated in a multicenter clinical trial conducted in Austria and the United Kingdom. Materials and methods: Individuals with type 1 (T1) or type 2 (T2) diabetes mellitus (DM) >18 years of age, and for >6 months on intensive insulin therapy were eligible for this 6-month study of the new system. All individuals received training on the use of the new system. HbA1c results were evaluated in a central laboratory. Pump signals were captured through data uploads using engineering software. User acceptance of the new system was assessed by means of a self-report questionnaire using an 11-point Likert Scale. Results: 90 individuals with T1DM were included in the intention-totreat analyses: age 41.8 (18-75) years, BMI 27.1 (19-41) kg/m<sup>2</sup>, HbA1c 7.8 (5.8 - 10.8) %, T1DM since 23 (1-49) years. 76 individuals had been previously on insulin pump therapy, and 14 on multiple daily injection (MDI) therapy. 81 individuals completed the study, 9 individuals discontinued the study or were withdrawn. Insulin pump experienced users maintained their mean baseline HbA<sub>1c</sub> levels (7.76+/-1.00%) at Month 3 (7.58+/-0.93%) and Month 6 (7.73+/-0.96) after switching from other insulin pump systems, most often the Accu-Chek Combo system, to the Accu-Chek Insight system.Mean HbA1c levels decreased in previous MDI users from 7.96+/-1.20% at baseline to 7.45+/-1.22% at Month 3 and 7.46+/-1.08% at Month 6. At month 6, the mean change from baseline was significantly different from 0: -0.50, 95% CI [-0.94; -0.06]. Two episodes each of severe hypoglycemia and diabetic ketoacidosis were reported. Most frequently recorded errors were electronic for the pump, and battery life time related for the meter. User acceptance of the new system was high, with highest ratings given for the ease of use of the insulin pump. Conclusion: In adults with type 1 diabetes, the new Accu-Chek Insight diabetes therapy system was effective and safe to use under routine practice conditions. Glycemic control improved when switching from MDI therapy, and was maintained in previous insulin pump users. User acceptance of the new system was high.
Publication Type: Journal: Conference Abstract