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

Primary Purpose

Weight Loss, Metabolic Syndrome, Pre-diabetes

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Continuous Glucose Monitor Device
Sponsored by
Signos Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Weight Loss focused on measuring health and wellness, excess adiposity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • SignosRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Signos digital health app and CGM

Arm Description

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

Outcomes

Primary Outcome Measures

Average fasting glucose
Daily fasting glucose, averaged periodically
Change in weight
Change in number of pounds

Secondary Outcome Measures

Body composition
User input data including percentage of body fat or other measurements of body composition
Time in range
percentage of time spent "in range" glucose level less than 140 or as determined by other parameters

Full Information

First Posted
November 4, 2021
Last Updated
May 16, 2023
Sponsor
Signos Inc
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1. Study Identification

Unique Protocol Identification Number
NCT05121844
Brief Title
Use of Continuous Glucose Monitoring in Non-Diabetic Population to Compliment Signos Mobile Health Platform
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 2, 2021 (Actual)
Primary Completion Date
November 1, 2026 (Anticipated)
Study Completion Date
November 1, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Signos Inc

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weight Loss, Metabolic Syndrome, Pre-diabetes, Central Obesity, Glucose Intolerance, Metabolic Glucose Disorders
Keywords
health and wellness, excess adiposity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Open label single arm study
Masking
None (Open Label)
Allocation
N/A
Enrollment
50000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Signos digital health app and CGM
Arm Type
Experimental
Arm Description
For all consented participants, the Signos app will use CGM data to provide recommendations customized to users for promoting general health and wellness.
Intervention Type
Device
Intervention Name(s)
Continuous Glucose Monitor Device
Other Intervention Name(s)
CGM
Intervention Description
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.
Primary Outcome Measure Information:
Title
Average fasting glucose
Description
Daily fasting glucose, averaged periodically
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.
Title
Change in weight
Description
Change in number of pounds
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.
Secondary Outcome Measure Information:
Title
Body composition
Description
User input data including percentage of body fat or other measurements of 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.
Title
Time in range
Description
percentage of time spent "in range" glucose level less than 140 or as determined by other parameters
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Study Administration
Phone
6502634502
Email
clinicaltrials@signos.com
Facility Information:
Facility Name
Signos
City
Palo Alto
State/Province
California
ZIP/Postal Code
94306
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Administrator
Phone
650-263-4502
Email
clinicaltrials@signos.com

12. IPD Sharing Statement

Plan to Share IPD
No
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Chandler-Laney PC, Morrison SA, Goree LL, Ellis AC, Casazza K, Desmond R, Gower BA. Return of hunger following a relatively high carbohydrate breakfast is associated with earlier recorded glucose peak and nadir. Appetite. 2014 Sep;80:236-41. doi: 10.1016/j.appet.2014.04.031. Epub 2014 May 10.
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Use of Continuous Glucose Monitoring in Non-Diabetic Population to Compliment Signos Mobile Health Platform

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