Signos DM2 Empowerment Study (SIGNOS-CGM-EMPOWER-201-2022)
Weight Loss, Metabolic Syndrome, Diabetes Mellitus, Type 2
About this trial
This is an interventional treatment trial for Weight Loss focused on measuring health and wellness, excess adiposity
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.
Sites / Locations
- SignosRecruiting
Arms of the Study
Arm 1
Experimental
Signos digital health app and CGM
For all consented participants, the Signos app will use CGM data to provide recommendations customized to users for promoting general health and wellness.