Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2025-12-24 @ 5:08 PM
NCT ID:
NCT06478550
Eligibility Criteria:
Inclusion Criteria:
* Signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol).
* The decision to initiate treatment with commercially available semaglutide s.c. has been made by the patient and the Health Care Providers (HCP) and independently from the decision to include the patient in this study. Patients can be randomised up to 10 days after being prescribed semaglutide.
* Treatment with semaglutide s.c. is needed for intensification of glycaemic control and used according to label as judged by HCP.
* Male or female; aged 25-75 years (both inclusive) at the time of signing informed consent.
* Diagnosed with type 2 diabetes (T2D) at least 180 days prior to obtaining informed consent.
* Willing to comply with the protocol requirements which includes use of Patient Support Solution (PSS) app on own mobile device (iphone Operating System (iOS) 11 (or higher) and Android 4.1 (or higher) devices), using Mallya®, filling out questionnaires as judged by the HCP.
Exclusion Criteria:
* Previous participation in this study. Participation is defined as having given informed consent in this study.
* Treatment with any investigational drug within 30 days prior to enrolment into the study.
* Glucagon Like Peptide-1 Receptor Agonist (GLP-1 RA) use for 90 days prior to randomisation. However, one prescription of once-weekly semaglutide subcutaneously (s.c.) is allowed up to 10 days prior to randomisation.
* Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
* Use of pacemaker or body worn infusion pumps according to Mallya®'s instruction for use.
* Impaired eyesight prohibiting readability of PSS app provided on mobile device.
* Inability to independently self-manage anti-diabetic treatments received as judged by HCP.
* Inability to independently inject semaglutide s.c. treatment as judged by HCP.
* Inability to fulfil study requirement as judged by the HCP.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
25 Years
Maximum Age:
75 Years
Study:
NCT06478550
Study Brief:
Protocol Section:
NCT06478550