Signos DM2 Empowerment Study (SIGNOS-CGM-EMPOWER-201-2022)

Study Overview
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Brief Summary
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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
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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.

Official Title
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Use of Signos mHealth Platform in Participants With Non-Insulin Dependent Type 2 Diabetes: Weight and Blood Glucose

Conditions
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Weight Loss, Metabolic Syndrome, Diabetes Mellitus, Type 2, Central Obesity, Insulin Resistance, Glucose Intolerance, Metabolic Glucose Disorders

Intervention / Treatment
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* Device: Continuous Glucose Monitor Device


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Open label single-arm study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Signos digital health app and CGM<br>For all consented participants, the Signos app will use CGM data to provide recommendations customized to users for promoting general health and wellness. | Device: Continuous Glucose Monitor Device<br>* Continuous glucose monitoring automatically tracks blood glucose levels, also called blood sugar, throughout the day and night. You can see your glucose level anytime at a glance. You can also review how your glucose changes over a few hours or days to see trends. Seeing glucose levels in real time can help you make more informed decisions throughout the day about how to balance your food and physical activity.<br>* Other names: CGM;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucose Metrics via Continuous Glucose Measurement (CGM) | Glucose measured in mg/dl | 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 weight in pounds | Change in number of 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. | 
| App engagement | Meals logged, Exercises logged, Activities completed | During enrollment in the trial for a maximum of 5 years, including a 1 year follow up period, for a maximum of 6 years. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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health and wellness, excess adiposity