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 @ 10:58 PM
Ignite Modification Date:
2025-12-24 @ 10:58 PM
NCT ID:
NCT04217369
Eligibility Criteria:
Inclusion Criteria:
* An individual with type I or type II diabetes treated with \> 1 insulin injections
* Currently using a smartphone compatible with the Diabits app
* Are willing to, or already wear a CGM which is compatible with the Diabits app
* Willing and able to provide informed consent, to have their data collected, and to complete questionnaires that are included as part of the protocol.
* HbA1c between 7.5 - 10 % ( 86 - 58 mmol/mol)
Exclusion Criteria:
* Patients who are pregnant or are planning to become pregnant during the duration of the study.
* Patients with major psychiatric illness or severe end-stage diabetes complications.
* Patients who use sensor-augmented pumps with automated features such as hybrid closed loop or predictive insulin suspension. This includes those who use non-commercial software such as DIY closed loop.
* Patients with prior use of the Diabits app
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT04217369
Study Brief:
Protocol Section:
NCT04217369