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

Signos

Status: Enrolling

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

Treatments: Device: Continuous Glucose Monitor Device

Study type: Interventional

Funder types: Industry

Identifiers

NCT05874635

201-2022

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20,000 participants in 1 patient group

Signos digital health app and CGM

Experimental group

Description:

For all consented participants, the Signos app will use CGM data to provide recommendations customized to users for promoting general health and wellness.

Treatment:

Device: Continuous Glucose Monitor Device