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

NCT05284071 | Completed

• 1 other identifier: S21DIAB02-S
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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 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

Conditions

Diabetes type1; Diabetes type2

Keywords

Diabetes Management; HbA1c; Patient; Patient satisfaction

Outcome Measures

Primary Outcomes (1)

• Diabetes Treatment Satisfaction Questionnaire (change, DTSQc), at 3 months

  The Diabetes Treatment Satisfaction Questionnaire (Change, DTSQc) will be completed during the on-site visit at 3 months. The DTSQc is a modified version of the DTSQs designed to overcome ceiling effects and to detect changes in treatment satisfaction. Answers on a 7 graded scale from -3 to 3. In majority, higher score means better outcome.

  3 months

Secondary Outcomes (5)

• Percentage and absolute change in HbA1cat 3 and 6 months, compared to baseline

  6 months

• Percentage and absolute change in fasting blood glucose at 3 and 6 months, compared to baseline

  6 months

• Absolute and percentage change in DTSQ (Status) at 6 months, compared to baseline

  6 months

• Absolute and percentage change in EQ-5D-5L (each separate question and VAS) at 3 and 6 months, compared to baseline.

  6 months

• Summary of adherence in the population, from baseline to 3 months, from 3 months to end of investigation and from baseline to end of investigation.

  6 months

Study Arms (1)

Experimental: Single-Arm

EXPERIMENTAL

This is a prospective, single-arm, post-market study to verify clinical performance, treatment satisfaction and adherence, and safety of Actiste 1.0 (Actiste) and the Companion app with TBL Backend when used as intended by subjects diagnosed with T1DM or T2DM.

Device: Device: Actiste 1.0 and the Companion app with TBL Backend

Interventions

Device: Actiste 1.0 and the Companion app with TBL Backend DEVICE

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.

Experimental: Single-Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Northern Care Alliance NHS Foundation Trust: lead
• Brighter AB: collaborator

Study Sites (1)

Salford Royal Hospital Northern Care Alliance NHS Foundation Trust

Salford, Greater Manchester, M6 6HD, United Kingdom

Location

MeSH Terms

Conditions

Patient Satisfaction

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Adrian Heald, Dr

  Northern Care Alliance NHS Foundation Trust, Stott Lane, Salford, M6 8HD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2022
• First Posted: March 17, 2022
• Study Start: March 14, 2022
• Primary Completion: December 21, 2022
• Study Completion: December 21, 2022
• Last Updated: May 23, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)