This is a prospective, single-arm, post-market clinical investigation to verify clinical performance, treatment satisfaction, adherence and safety of Actiste 1.0 and the Companion app with TBL Backend, referred to as Actiste diabetes management system (ADMS) when used as intended by subjects diagnosed with Diabetes Mellitus Type 1 or Type 2 (T1DM or T2DM). In total, 70 subjects diagnosed with T1DM or T2DM (35 subjects per type) using Glargine U100 basal insulin with or without oral antidiabetic drugs/bolus insulin regimen will be enrolled at 1 site in the UK. Each subject will be evaluated during a period of 6 months. Eight (8) visits are planned for each subject during the clinical investigation, including 3 visits to the study clinic and 5 visits conducted as telephone calls. During the visits, evaluations will be performed to assess blood glucose levels, adherence to the treatment plan, quality of life and treatment satisfaction. Data on blood glucose values, insulin injections and diabetesrelated data from the Companion app and TBL Backend will be shared by the subject.Each participant will be provided with the ADMS, including Actiste 1.0, and the Companion app for their smartphone with the TBL Backend. No comparator will be used.
The overall aim of the clinical investigation is to confirm clinical performance, treatment satisfaction, adherence and safety of Actiste 1.0 and the Companion~- Page 1 of 5 - app with TBL Backend when used by subjects with diabetes in need of insulin treatment.~Primary objective:~To assess diabetes treatment satisfaction in subjects with diabetes type 1 or type 2 in need of insulin treatment when using Actiste 1.0 and the Companion app with TBL Backend~Secondary objective:~To assess clinical performance and treatment adherence in subjects with diabetes type 1 or type 2 in need of insulin treatment when using Actiste 1.0 and the Companion app with TBL Backend