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

Primary Purpose

Weight Loss, Metabolic Syndrome, Diabetes Mellitus, Type 2

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: 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.

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

Glucose Metrics via Continuous Glucose Measurement (CGM)
Glucose measured in mg/dl
Change in weight in pounds
Change in number of pounds
App engagement
Meals logged, Exercises logged, Activities completed

Secondary Outcome Measures

Full Information

First Posted
May 16, 2023
Last Updated
May 24, 2023
Sponsor
Signos Inc
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1. Study Identification

Unique Protocol Identification Number
NCT05874635
Brief Title
Signos DM2 Empowerment Study (SIGNOS-CGM-EMPOWER-201-2022)
Official Title
Use of Signos mHealth Platform in Participants With Non-Insulin Dependent Type 2 Diabetes: Weight and Blood Glucose
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 11, 2023 (Actual)
Primary Completion Date
May 10, 2028 (Anticipated)
Study Completion Date
May 10, 2029 (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
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weight Loss, Metabolic Syndrome, Diabetes Mellitus, Type 2, Central Obesity, Insulin Resistance, 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
20000 (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
Glucose Metrics via Continuous Glucose Measurement (CGM)
Description
Glucose measured in mg/dl
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 in pounds
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.
Title
App engagement
Description
Meals logged, Exercises logged, Activities completed
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: 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.
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
Citations:
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30040822
Citation
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Results Reference
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Citation
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11576521
Citation
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PubMed Identifier
34323335
Citation
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Citation
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Citation
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Citation
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Signos DM2 Empowerment Study (SIGNOS-CGM-EMPOWER-201-2022)

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