Diabetes type1 Clinical Trial
— ADMSUK01Official title:
Actiste® Diabetes Management as a Service (ADMS) - A Clinial Investigation With Insulin Treated Diabetes Patients in the UK
Verified date | March 2023 |
Source | Northern Care Alliance NHS Foundation Trust |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Completed |
Enrollment | 13 |
Est. completion date | December 21, 2022 |
Est. primary completion date | December 21, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Salford Royal Hospital Northern Care Alliance NHS Foundation Trust | Salford | Greater Manchester |
Lead Sponsor | Collaborator |
---|---|
Northern Care Alliance NHS Foundation Trust | Brighter AB |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Percentage and absolute change in HbA1cat 3 and 6 months, compared to baseline | During each on site visit, glycosylated haemoglobin(HbA1c) will be assessed. A blood sample will be taken by the site staff and HbA1c will be assessed per clinical routine at the site. | 6 months | |
Secondary | Percentage and absolute change in fasting blood glucose at 3 and 6 months, compared to baseline | Fasting glucose will be assessed per standard of care at the investigation site. Fasting glucose will be assessed using the Actiste device at least 4 times in the last 10 days (assessment period) before the investigation visit. The final data will be a mean of the measurements during the assessment period. The data will be extracted by the patient to a PDF file and provided to site 2 days before the visit. Site will ask what day and time the fasting blood glucose data was assessed. The data will also be summarised at the end of the investigation and the interim analysis with data from the Companion app and TBL Backend. | 6 months | |
Secondary | Absolute and percentage change in DTSQ (Status) at 6 months, compared to baseline | The Diabetes Treatment Satisfaction Questionnaire (Status, DTSQs) will be completed during the on-sitevisits at baseline and at 6 months.The DTSQs is recommended for measuring patient satisfaction with diabetes treatment. Answers on a 7 graded scale from 0 to 6. In majority, higher score means better outcome. | 6 months | |
Secondary | Absolute and percentage change in EQ-5D-5L (each separate question and VAS) at 3 and 6 months, compared to baseline. | The EQ5D5L questionnaire will be completed during the on-site visits at baseline and at 3 and 6 months. The EQ-5D-5L contains 5 questions, each with a 5 graded answer scale from "I am unable to..." to "I have no problems ...". The VAS scale is a scale from 0-100, where 100 means the best health you can imagine and 0 the worst health you can imagine | 6 months | |
Secondary | 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. | Adherence will be summarised at 3 and 6 months by assessing number and percentage of missed basal insulin injections per subject during the period between the visits, compared to the subject's treatment plan. For most subjects, a basal insulin injection is performed at 22.00 in the evening, per standard clinical routine. | 6 months |
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