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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

Tracking Information
First Submitted Date  ICMJE November 4, 2021
First Posted Date  ICMJE November 16, 2021
Last Update Posted Date May 18, 2023
Actual Study Start Date  ICMJE November 2, 2021
Estimated Primary Completion Date November 1, 2026   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 16, 2023)
  • 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
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: November 4, 2021)
  • Average fasting glucose [ Time Frame: During enrollment in the trial, minimum of 3 months, to maximum of 3 years, including a 2 year follow up period, for a maximum of 5 years. ]
    Daily fasting glucose, averaged periodically
  • Amount of weight lost for weight optimization [ Time Frame: During enrollment in the trial, minimum of 3 months, to maximum of 3 years, including a 2 year follow up period, for a maximum of 5 years. ]
    Number of pounds lost
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 16, 2023)
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: November 4, 2021)
  • Body composition [ Time Frame: During enrollment in the trial, minimum of 3 months, to maximum of 3 years, including a 2 year follow up period, for a maximum of 5 years. ]
    User input data including percentage of body fat or other measurements of body composition
  • Time in range [ Time Frame: During enrollment in the trial, minimum of 3 months, to maximum of 3 years, including a 2 year follow up period, for a maximum of 5 years. ]
    percentage of time spent "in range" glucose level less than 140 or as determined by other parameters
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Use of Continuous Glucose Monitoring in Non-Diabetic Population to Compliment Signos Mobile Health Platform
Official Title  ICMJE Use of Continuous Glucose Monitoring in Non-Diabetic Population to Compliment Signos Mobile Health Platform: Comprehensive Weight Optimization Program and Customized Lifestyle Modifications
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
Open label single arm study
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Weight Loss
  • Metabolic Syndrome
  • Pre-diabetes
  • Central Obesity
  • Glucose Intolerance
  • Metabolic Glucose Disorders
Intervention  ICMJE 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
Study Arms  ICMJE 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.
Intervention: Device: Continuous Glucose Monitor Device
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 16, 2023)
50000
Original Estimated Enrollment  ICMJE
 (submitted: November 4, 2021)
20000
Estimated Study Completion Date  ICMJE November 1, 2027
Estimated Primary Completion Date November 1, 2026   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Study Administration 6502634502 clinicaltrials@signos.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05121844
Other Study ID Numbers  ICMJE 195165
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Stephanie Kim, M.D., MPH, Signos Inc
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Signos Inc
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Signos Inc
Verification Date May 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP