NCT05284071

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

Actiste® Diabetes Management as a Service (ADMS) - A Clinial Investigation With Insulin Treated Diabetes Patients in the UK

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Northern Care Alliance NHS Foundation Trust · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Diabetes type1
• Diabetes type2

Interventions

Type	Name	Description
DEVICE	Device: Actiste 1.0 and the Companion app with TBL Backend	Actiste automatically logs and shares real-life data on blood glucose values and actual injected insulin doses. With Actiste's built-in sensor, the exact injected dose is displayed and saved in the device memory together with a time stamp, which makes it easy for the user to know how much and when the insulin was injected, and spot missed doses. This simplifies the daily diabetes care for the user and thus may improve the quality of life for people with diabetes and may improve the patients' adherence to treatment plans. Actiste automatically logs and shares real-life data on blood glucose values and actual injected insulin doses. With Actiste's built-in sensor, the exact injected dose is displayed and saved in the device memory together with a time stamp, which makes it easy for the user to know how much and when the insulin was injected, and spot missed doses. This simplifies the daily diabetes care for the user and thus may improve the quality of life for people with diabetes.

Timeline

• Start date: 2022-03-14
• Primary completion: 2022-12-21
• Completion: 2022-12-21
• First posted: 2022-03-17
• Last updated: 2025-05-23

Locations

1 site across 1 country: United Kingdom