RECRUITING

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

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.

Conditions

Weight LossMetabolic SyndromeDiabetes Mellitus, Type 2Central ObesityInsulin ResistanceGlucose IntoleranceMetabolic Glucose Disorders
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Related Conditions:

Weight LossMetabolic SyndromeDiabetes Mellitus, Type 2Central ObesityInsulin ResistanceGlucose IntoleranceMetabolic Glucose Disorders

Study Overview

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Study Details

Study 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.

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

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

Condition
Weight Loss
Intervention / Treatment

-

Contacts and Locations

Palo Alto

Signos, Palo Alto, California, United States, 94306

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Signos Inc,

Stephanie Kim, MD, PRINCIPAL_INVESTIGATOR, Signos Inc

Study Record Dates

2029-05-10