Image

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

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

Non Recruiting
18 years and older
All
Phase N/A

Powered by AI

Overview

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.

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.

Eligibility

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 details
    Weight Loss
    Metabolic Syndrome
    Diabetes Mellitus
    Type 2
    Central Obesity
    Insulin Resistance
    Glucose Intolerance
    Metabolic Glucose Disorders

NCT05874635

Signos Inc

21 October 2025

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.