Actiste® Diabetes Management as a Service (ADMS) Clinical Investigation

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

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.

Eligibility Criteria:
Inclusion Criteria:

1. Provision of informed consent
2. Adult males and females =18 years old
3. Diagnosed with diabetes I or II, since = 6 months prior to entering the investigation, according to investigator judgement
4. Currently using insulin as a component of the diabetes therapy, Sanofi Lantus insulin (glargine U100 insulin incartridge or disposable pen)± any form or manufacturer of oral antidiabetic drugs (OADs)/bolus insulin regimen/GLP-1RA
5. HbA1c 64-86mmol/mol in the last 30 days
6. Patients using Self-Monitoring of Blood Glucose (SMBG) = 1 month prior to entering the investigation
7. Able to use smartphone (iOS or Android)independently, according to investigator judgement
8. Currently using a system compatible smartphone (Android and iOS smartphones: iOS platform versions from 12.0 to 14.x and Android platform versions from 5.1 to 11.x
9. Able to use the device independently, according to investigator judgement

Exclusion Criteria:

1. Impaired vision affecting ability to use investigation device or smartphone, according to investigator judgement
2. Patients using a flash glucose monitor, continuous glucose monitor and/ or insulin pump
3. Pregnancy or lactation at time of study participation.
4. Physical or mental impairment affecting subjects' ability to use the device, per investigator judgement
5. Person not suitable for the investigation according to the investigator judgement.