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 @ 5:38 PM
Ignite Modification Date:
2025-12-24 @ 5:38 PM
NCT ID:
NCT03999268
Eligibility Criteria:
Inclusion Criteria:
* 18 years of age
* Able to read and follow study instructions in English (translations will not be provided)
* T2DM requiring the use of prandial and/or long-acting insulin
* Ability to self-administer insulin therapy
* Willing to download the study app on their smartphone
* Able and willing to provide a signed consent
* Able and willing to follow all study procedures
Exclusion Criteria:
* Pregnant (self-reported)
* Participants from the same household participating concurrently
* Use of a smartphone with iOS version 10.0 or lower
* Use of a smartphone with Android OS 5.0 "Lollipop" or lower
* Currently using a continuous subcutaneous insulin infusion device
* Participants with major depression
* Currently or planning to participate in a similar study that would affect the results of this study
* Currently or planning to participate in a clinical study that involves taking a drug, supplement, or use of an investigational drug
* Continued hospitalization or transfer to an assisted living facility
* Any condition the PI or designee deems to pose a risk to the participant in the study (includes anything that may prevent full participation in the study)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03999268
Study Brief:
Protocol Section:
NCT03999268