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

January 10, 2024 updated by: Stephanie Kim, M.D., MPH, Signos Inc

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

20000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
App engagement
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.
Meals logged, Exercises logged, Activities completed
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 Metrics via Continuous Glucose Measurement (CGM)
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.
Glucose measured in mg/dl
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 weight in 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.
Change in number of 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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Signos Inc

Investigators

  • Principal Investigator: Stephanie Kim, MD, Signos Inc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 11, 2023

Primary Completion (Estimated)

May 10, 2028

Study Completion (Estimated)

May 10, 2029

Study Registration Dates

First Submitted

May 16, 2023

First Submitted That Met QC Criteria

May 16, 2023

First Posted (Actual)

May 25, 2023

Study Record Updates

Last Update Posted (Actual)

January 12, 2024

Last Update Submitted That Met QC Criteria

January 10, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201-2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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