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Active, Not Recruiting

NCT Number: NCT05874635

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Weight Loss Body Weight Body Weight Changes Central Obesity Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Intolerance Glucose Metabolism Disorders Hyperglycemia Hyperinsulinism Insulin Resistance Metabolic Diseases Metabolic Glucose Disorders Metabolic Syndrome Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity, Abdominal Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Signos

Palo Alto, California, 94306, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Continuous Glucose Monitor Device

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

Primary outcomes

  1. 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

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

Signos Inc

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2028
Study completion
2029
First posted
May 25, 2023
Registry last updated
Aug 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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