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.
Conditions:
🦠 Weight Loss 🦠 Metabolic Syndrome 🦠 Diabetes Mellitus, Type 2 🦠 Central Obesity 🦠 Insulin Resistance 🦠 Glucose Intolerance 🦠 Metabolic Glucose Disorders
🗓️ Study Start (Actual) 11 May 2023
🗓️ Primary Completion (Estimated) 10 May 2028
✅ Study Completion (Estimated) 10 May 2029
👥 Enrollment (Estimated) 20000
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Palo Alto, California, United States

📋 Eligibility Criteria

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.
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes

🗓️ 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 Registration Dates

  • First Submitted 16 May 2023
  • First Submitted that Met QC Criteria 16 May 2023
  • First Posted 25 May 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 10 January 2024
  • Last Update Posted 12 January 2024
  • Last Verified January 2024