Status:
COMPLETED
Actiste® Diabetes Management as a Service (ADMS) Clinical Investigation
Lead Sponsor:
Northern Care Alliance NHS Foundation Trust
Collaborating Sponsors:
Brighter AB
Conditions:
Diabetes type1
Diabetes type2
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 w...
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...
Eligibility Criteria
Inclusion
- Provision of informed consent
- Adult males and females =18 years old
- Diagnosed with diabetes I or II, since = 6 months prior to entering the investigation, according to investigator judgement
- 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
- HbA1c 64-86mmol/mol in the last 30 days
- Patients using Self-Monitoring of Blood Glucose (SMBG) = 1 month prior to entering the investigation
- Able to use smartphone (iOS or Android)independently, according to investigator judgement
- 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
- Able to use the device independently, according to investigator judgement
Exclusion
- Impaired vision affecting ability to use investigation device or smartphone, according to investigator judgement
- Patients using a flash glucose monitor, continuous glucose monitor and/ or insulin pump
- Pregnancy or lactation at time of study participation.
- Physical or mental impairment affecting subjects' ability to use the device, per investigator judgement
- Person not suitable for the investigation according to the investigator judgement.
Key Trial Info
Start Date :
March 14 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 21 2022
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT05284071
Start Date
March 14 2022
End Date
December 21 2022
Last Update
May 23 2025
Active Locations (1)
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1
Salford Royal Hospital Northern Care Alliance NHS Foundation Trust
Salford, Greater Manchester, United Kingdom, M6 6HD