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Use of Continuous Glucose Monitoring in Non-Diabetic Population to Compliment Signos Mobile Health Platform

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ClinicalTrials.gov Identifier: NCT05121844
Recruitment Status : Recruiting
First Posted : November 16, 2021
Last Update Posted : May 18, 2023
Sponsor:
Information provided by (Responsible Party):
Stephanie Kim, M.D., MPH, Signos Inc

Study Description
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Brief Summary:
Metabolic syndrome and resulting downstream health effects remains a growing health concern. In published trials, the use of continuous glucose monitoring (CGM) assists behavioral changes efforts, leading to improved adherence and results from diet and exercise changes in individuals with obesity, pre-diabetes and diabetes. Mobile health (mHealth) platforms provide satisfactory, easy-to-use tools that help participants in the pursuit of weight change goals. We hypothesize that the use of CGM data and targeted coaching and nutrition education will assist with weight optimization goals in the general (non-diabetic) population using the Signos mHealth platform, with associated health benefits.

Condition or disease Intervention/treatment Phase
Weight Loss Metabolic Syndrome Pre-diabetes Central Obesity Glucose Intolerance Metabolic Glucose Disorders Device: Continuous Glucose Monitor Device Not Applicable

Detailed Description:
The scope of this study is to enroll existing and new Signos 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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50000 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Open label single arm study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Use of Continuous Glucose Monitoring in Non-Diabetic Population to Compliment Signos Mobile Health Platform: Comprehensive Weight Optimization Program and Customized Lifestyle Modifications
Actual Study Start Date : November 2, 2021
Estimated Primary Completion Date : November 1, 2026
Estimated Study Completion Date : November 1, 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight
Drug Information available for: Dextrose

Arms and Interventions
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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 Name: CGM


Outcome Measures
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Primary Outcome Measures :
  1. Average fasting glucose [ Time Frame: During enrollment in the trial for a maximum of 5 years, including a 1 year follow up period, for a maximum of 6 years. ]
    Daily fasting glucose, averaged periodically

  2. Change in weight [ Time Frame: 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 :
  1. Body composition [ Time Frame: During enrollment in the trial for a maximum of 5 years, including a 1 year follow up period, for a maximum of 6 years. ]
    User input data including percentage of body fat or other measurements of body composition

  2. Time in range [ Time Frame: During enrollment in the trial for a maximum of 5 years, including a 1 year follow up period, for a maximum of 6 years. ]
    percentage of time spent "in range" glucose level less than 140 or as determined by other parameters


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 18 years and above
  • Own a smartphone and be willing to install the Signos App to use the app, receive messages or notifications, and input weight and other data.
  • Willingness to complete questionaries or other surveys
  • Able to speak and read English

Exclusion Criteria:

  • Medical diagnosis of Type 1 Diabetes
  • Medical diagnosis of Type 2 Diabetes
  • Current medical diagnosis of an eating disorder (anorexia or bulimia) or previously struggled with disordered eating behaviors with current BMI less than 24
  • Medical conditions (e.g., such as seizure disorder) requiring a specific medical diet.
  • Inborn errors of metabolism such as phenylketonuria (PKU), glycogen storage disease, fructose intolerance, Maple Sugar Urine Disease (MSUD).
  • Chronic or severe disease (e.g, chronic obstructive pulmonary disease [COPD], coronary artery disease, cerebrovascular accident [CVA], or cardiac arrhythmia) that would preclude a subject from safely participating in dietary recommendations and/or physical activity
  • History of Gastric bypass or other bariatric surgery
  • 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: Hydroxyurea, insulin, sulfonylureas, or medications prescribed specifically for the treatment of diagnosed diabetes
  • Vulnerable populations such as minors, prisoners, or pregnant women will not be enrolled in this study. Women who become pregnant will be excluded at that time.
  • Inability or unwillingness of subject to give informed consent
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05121844


Contacts
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Contact: Study Administration 6502634502 clinicaltrials@signos.com

Locations
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United States, California
Signos Recruiting
Palo Alto, California, United States, 94306
Contact: Study Administrator    650-263-4502    clinicaltrials@signos.com   
Sponsors and Collaborators
Signos Inc
More Information
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Publications:

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Responsible Party: Stephanie Kim, M.D., MPH, Principal Investigator, Signos Inc
ClinicalTrials.gov Identifier: NCT05121844    
Other Study ID Numbers: 195165
First Posted: November 16, 2021    Key Record Dates
Last Update Posted: May 18, 2023
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Stephanie Kim, M.D., MPH, Signos Inc:
health and wellness
excess adiposity
Additional relevant MeSH terms:
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Metabolic Syndrome
Prediabetic State
Glucose Intolerance
Obesity, Abdominal
Glucose Metabolism Disorders
Weight Loss
Body Weight Changes
Body Weight
Insulin Resistance
 Hyperinsulinism
Metabolic Diseases
Diabetes Mellitus
Endocrine System Diseases
Hyperglycemia
Obesity
Overweight
Overnutrition
Nutrition Disorders