Actiste Diabetes Management as a Service (ADMS) Clinical Investigation
Research type
Research Study
Full title
Actiste® Diabetes Management as a Service (ADMS) – A Clinical Investigation with Insulin Treated Diabetes Patients in the UK
IRAS ID
299853
Contact name
Adrian Heald
Contact email
Sponsor organisation
Salford Royal NHS Foundation Trust
Duration of Study in the UK
0 years, 8 months, 2 days
Research summary
This is a prospective, single arm, post-market clinical investigation to verify clinical performance, treatment satisfaction and safety of Actiste 1.0 and the Companion app with The Benefit Loop (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 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, quality of life and treatment satisfaction. Treatment adherence will also be assessed. Data on blood glucose values, insulin injections and diabetes related data from the Companion app will be shared by the subject in PDF report and extracted from the app.
Each participant will be provided with the investigational product, Actiste 1.0 and the Companion app for their smart phone, which includes the TBL Backend. No comparator will be used.
REC name
West Midlands - Black Country Research Ethics Committee
REC reference
21/WM/0222
Date of REC Opinion
5 Nov 2021
REC opinion
Further Information Favourable Opinion