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

Sponsor

Signos Inc (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05874635

Collaborator

(none)

20,000

Enrollment

Location

Arm

Anticipated Duration (Months)

277.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Weight Loss Metabolic Syndrome Diabetes Mellitus, Type 2 Central Obesity Insulin Resistance Glucose Intolerance Metabolic Glucose Disorders	Device: Continuous Glucose Monitor Device	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20000 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Open label single-arm studyOpen label single-arm study

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

May 11, 2023

Anticipated Primary Completion Date :

May 10, 2028

Anticipated Study Completion Date :

May 10, 2029

Arms and Interventions

Arm	Intervention/Treatment
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.	Device: Continuous Glucose Monitor Device 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. Other Names: CGM

Arm

Intervention/Treatment

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.

Device: Continuous Glucose Monitor Device

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.

Other Names:

CGM

Outcome Measures

Primary Outcome Measures

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
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.