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 @ 10:17 PM
Ignite Modification Date:
2025-12-24 @ 10:17 PM
NCT ID:
NCT02749435
Eligibility Criteria:
Inclusion criteria:
For inclusion in the study participants must fulfill the following criteria:
* Provision of written informed consent prior to any study-specific procedures.
* Female or male aged ≥18 years at time of consent.
* Diagnosed with T2DM.
* Treatment with one or more non-insulin antihyperglycaemic medication(s) for at least 6 months prior to enrolment
* Own/have access to a smart phone with internet access and have access to the internet via a tablet or personal computer at least once a day. At the HCP's discretion, a patient may be without access to their smart phone service, data connection, and internet access for a period of time that should be ≤2 consecutive weeks
* HbA1c levels ≥8.0% and ≤11.0% within the last 6 months. If more than 1 value is available during the 6-month time period, all values must be within this range
* Body mass index (BMI) ≥25 and ≤55 kg/m2 within the last 3 months
* Ability to communicate in English
* Judged by their HCP to have suitable hearing, vision, manual dexterity, ability to understand instructions, and ability to use and understand smart phone and internet applications
* Negative pregnancy test (urine or serum) for female patients of childbearing potential
Exclusion criteria:
Participants cannot enter the study if any of the following exclusion criteria are fulfilled:
* Pregnancy
* Insulin use at baseline
* Current use of a smart phone- or web portal-based tool to help with management of T2DM
* History of type I diabetes or ketoacidosis
* Currently taking a weight loss medication
* Involvement in the planning and/or conduct of the study (applies to both AZ staff and/or staff and affiliates at the study site)
* Previous enrolment in the present study
* Participation in a clinical study with an investigational product or a disease state management program during the last 30 days
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02749435
Study Brief:
Protocol Section:
NCT02749435