Last updated: January 10, 2024
Sponsor: Signos Inc
Overall Status: Active - Recruiting
Phase
N/A
Condition
Diabetes Mellitus, Type 2
Hormone Deficiencies
Metabolic Syndrome
Treatment
Continuous Glucose Monitor Device
Clinical Study ID
NCT05874635
201-2022
Ages > 18 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Medical diagnosis of Type 2 Diabetes; determined by review of subject-provided mostrecent 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 lifestylechanges
- 18 years and above
- Own a smartphone and be willing to install the Signos App to personally receive textmessages 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
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 requiringassistance/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 formof insulin.
Study Design
Total Participants: 20000
Treatment Group(s): 1
Primary Treatment: Continuous Glucose Monitor Device
Phase:
Study Start date:
May 11, 2023
Estimated Completion Date:
May 10, 2029
Study Description
Connect with a study center
Signos
Palo Alto, California 94306
United StatesActive - Recruiting
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