Signos DM2 Empowerment Study (SIGNOS-CGM-EMPOWER-201-2022)
- Conditions
- Central ObesityMetabolic Glucose DisordersWeight LossMetabolic SyndromeGlucose IntoleranceDiabetes Mellitus, Type 2Insulin Resistance
- Interventions
- Device: Continuous Glucose Monitor Device
- Registration Number
- NCT05874635
- Lead Sponsor
- Signos Inc
- Brief Summary
The use of continuous glucose monitoring (CGM) in earlier data has inspired behavioral changes leading to improved adherence to an exercise plan in individuals and eating habits in people with diabetes. Mobile health (mHealth) platforms provide satisfactory, easy-to-use tools to help participants in the pursuit of weight change goals. We hypothesize that the use of CGM data and the Signos mHealth platform will assist with weight control in a population of people with type 2 diabetes mellitus who are not using insulin.
- Detailed Description
The scope of this study is to enroll existing and new Signos non-insulin dependent type 2 diabetes mellitus users in a volunteer study that utilizes a continuous glucose monitor (CGM) and mobile health application \[Signos\] to optimize general wellness and body weight and composition. This is a no more than minimal risk study.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 20000
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Signos digital health app and CGM Continuous Glucose Monitor Device For all consented participants, the Signos app will use CGM data to provide recommendations customized to users for promoting general health and wellness.
- Primary Outcome Measures
Name Time Method App engagement During enrollment in the trial for a maximum of 5 years, including a 1 year follow up period, for a maximum of 6 years. Meals logged, Exercises logged, Activities completed
Glucose Metrics via Continuous Glucose Measurement (CGM) During enrollment in the trial for a maximum of 5 years, including a 1 year follow up period, for a maximum of 6 years. Glucose measured in mg/dl
Change in weight in pounds During enrollment in the trial for a maximum of 5 years, including a 1 year follow up period, for a maximum of 6 years. Change in number of pounds
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Signos
🇺🇸Palo Alto, California, United States