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 @ 12:11 PM
Ignite Modification Date:
2025-12-24 @ 12:11 PM
NCT ID:
NCT06848361
Eligibility Criteria:
Inclusion Criteria:
* Received outpatient care in the participating health system in the last 12 months
* Has a diagnosis of type 2 diabetes mellitus (ICD10 codes E08.xx, E09.xx, E11.xx, E13.xx,O24.1x , O24.3x, O24.8x, O24.9x)
* Last Hemoglobin A1c (HbA1c) value obtained in the last 6 months was ≥7.5%
* Currently prescribed at least one non-insulin diabetes medication
* Able to provide informed consent
* Able to interact with a simple smartphone application
* Owns or has access to a smartphone that is able to access an internet website
* Did not participate a prior study related to this protocol
Exclusion Criteria:
* Originally was diagnosed with type 2 diabetes before the age of 21 years
* Has a diagnosis of type 1 diabetes mellitus
* Has a diagnosis of gestational diabetes without any other diabetes diagnoses
* Is currently prescribed insulin
* Currently is using a CGM device
* Has a diagnosis (active or prior) of schizophrenia or other psychotic/delusional disorder
* Has a life-limiting severe illness (e.g., chronic obstructive pulmonary disease requiring oxygen)
* Is pregnant or planning to become pregnant within the next 6 months
* Has other concerns that may interfere significantly with their ability to participate in the intervention (ongoing health issues, personal events, etc.)
* Currently is enrolled in another diabetes management intervention study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
25 Years
Maximum Age:
75 Years
Study:
NCT06848361
Study Brief:
Protocol Section:
NCT06848361