ACTIVE_NOT_RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-05-11
Study Completion:2029-05-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05874635

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Medical diagnosis of Type 2 Diabetes; determined by review of subject-provided most recent Hg A1c.
  2. * Subject is under current care of a primary care provider or specialist
  3. * Clearance by medical provider to participate in diet, physical activity, and lifestyle changes
  4. * 18 years and above
  5. * 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.
  6. * Willingness to complete quality of life questionnaires or other in-app surveys.
  7. * Willingness to use CGM device
  8. * Able to speak and read English
  9. * Be a Signos mHealth (mobile/web-based) user
  1. * Medical diagnosis of Type 1 Diabetes
  2. * Type 2 Diabetes currently using insulin or most recent A1c ≥10%
  3. * Severe hypoglycemia \<54 mg/dl resulting in seizure or unconsciousness, or requiring assistance/EMS/hospitalization - within 3 months prior to enrollment
  4. * Current medical diagnosis of an eating disorder (such as anorexia nervosa or bulimia)
  5. * Medical conditions (e.g., such as seizure disorder) requiring a specific medical diet.
  6. * Inborn error of metabolism such as phenylketonuria (PKU), glycogen storage disease, fructose intolerance, Maple Sugar Urine Disease (MSUD).
  7. * History of 10 or more soft tissue skin infections (such as cellulitis or abscesses)
  8. * Intolerable skin reaction from adhesive
  9. * Currently taking any of the following medications: Clozapine, Hydroxyurea, or any form of insulin.

Contacts and Locations

Principal Investigator

Stephanie Kim, MD
PRINCIPAL_INVESTIGATOR
Signos Inc

Study Locations (Sites)

Signos
Palo Alto, California, 94306
United States

Collaborators and Investigators

Sponsor: Signos Inc

  • Stephanie Kim, MD, PRINCIPAL_INVESTIGATOR, Signos Inc

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

Study Start Date2023-05-11
Study Completion Date2029-05-10

Study Record Updates

Study Start Date2023-05-11
Study Completion Date2029-05-10

Terms related to this study

Keywords Provided by Researchers

  • health and wellness
  • excess adiposity

Additional Relevant MeSH Terms

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