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 @ 10:40 PM
Ignite Modification Date:
2025-12-24 @ 10:40 PM
NCT ID:
NCT05874635
Eligibility Criteria:
Inclusion Criteria:
* Medical diagnosis of Type 2 Diabetes; determined by review of subject-provided most recent Hg A1c.
* Subject is under current care of a primary care provider or specialist
* Clearance by medical provider to participate in diet, physical activity, and lifestyle changes
* 18 years and above
* Own a smartphone and be willing to install the Signos App to personally receive text messages or have access to a web-based survey to self-report their weight.
* Willingness to complete quality of life questionnaires or other in-app surveys.
* Willingness to use CGM device
* Able to speak and read English
* Be a Signos mHealth (mobile/web-based) user
Exclusion Criteria:
* Medical diagnosis of Type 1 Diabetes
* Type 2 Diabetes currently using insulin or most recent A1c ≥10%
* Severe hypoglycemia \<54 mg/dl resulting in seizure or unconsciousness, or requiring assistance/EMS/hospitalization - within 3 months prior to enrollment
* Current medical diagnosis of an eating disorder (such as anorexia nervosa or bulimia)
* Medical conditions (e.g., such as seizure disorder) requiring a specific medical diet.
* Inborn error of metabolism such as phenylketonuria (PKU), glycogen storage disease, fructose intolerance, Maple Sugar Urine Disease (MSUD).
* History of 10 or more soft tissue skin infections (such as cellulitis or abscesses)
* Intolerable skin reaction from adhesive
* Currently taking any of the following medications: Clozapine, Hydroxyurea, or any form of insulin.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05874635
Study Brief:
Protocol Section:
NCT05874635