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Device
Continuous Glucose Monitoring for Type 2 Diabetes
N/A
Recruiting
Led By Stephanie Kim, MD
Research Sponsored by Signos Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Medical diagnosis of Type 2 Diabetes; determined by review of subject-provided most recent Hg A1c
18 years and above
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during enrollment in the trial for a maximum of 5 years, including a 1 year follow up period, for a maximum of 6 years.
Awards & highlights
Study Summary
This trial will explore how CGM and mHealth platforms can help people with diabetes better control their weight and improve eating and exercise habits.
Who is the study for?
This trial is for adults with Type 2 Diabetes who are not using insulin. Participants must be willing to use a Continuous Glucose Monitor (CGM) device, engage with the Signos mHealth platform on their smartphone, and have medical clearance to make diet and lifestyle changes. They should not have severe hypoglycemia history, certain metabolic disorders, an eating disorder, or be taking specific medications like Clozapine.Check my eligibility
What is being tested?
The study tests if using a CGM device along with the Signos mobile health platform can help people with Type 2 Diabetes manage their weight better by promoting exercise and healthy eating habits. It's based on previous findings that suggest monitoring glucose levels can inspire beneficial behavioral changes.See study design
What are the potential side effects?
While this trial focuses on behavior change through technology rather than medication, potential side effects may include skin irritation from the CGM device adhesive or psychological impacts due to lifestyle adjustments.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with Type 2 Diabetes based on my latest Hg A1c test results.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ during enrollment in the trial for a maximum of 5 years, including a 1 year follow up period, for a maximum of 6 years.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during enrollment in the trial for a maximum of 5 years, including a 1 year follow up period, for a maximum of 6 years.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
App engagement
Change in weight in pounds
Glucose Metrics via Continuous Glucose Measurement (CGM)
Trial Design
1Treatment groups
Experimental Treatment
Group I: Signos digital health app and CGMExperimental Treatment1 Intervention
For all consented participants, the Signos app will use CGM data to provide recommendations customized to users for promoting general health and wellness.
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Who is running the clinical trial?
Signos IncLead Sponsor
2 Previous Clinical Trials
50,380 Total Patients Enrolled
Stephanie Kim, MDPrincipal InvestigatorSignos Inc
1 Previous Clinical Trials
380 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with Type 1 Diabetes.I have been diagnosed with an eating disorder like anorexia or bulimia.You have had a bad skin reaction to adhesive in the past.I follow a specific medical diet due to a condition like epilepsy.I have been diagnosed with Type 2 Diabetes based on my latest Hg A1c test results.I've had a severe low blood sugar episode needing help in the last 3 months.I am 18 years old or older.I have Type 2 Diabetes and am either using insulin or my last A1c was 10% or higher.I have had 10 or more skin infections like cellulitis.I own a smartphone and agree to use the Signos App for self-reporting my weight.I have a genetic disorder like PKU or MSUD.My doctor has approved me to make diet, exercise, and lifestyle changes.I am currently taking Clozapine, Hydroxyurea, or insulin.
Research Study Groups:
This trial has the following groups:- Group 1: Signos digital health app and CGM
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any opportunities for individuals to become involved in this research endeavor?
"Clinicaltrials.gov lists this trial as actively seeking participants, with the first post date being dated back to May 11th 2023 and most recent update having taken place on May 16th of the same year."
Answered by AI
How many participants are currently enrolled in this clinical trial?
"Affirmative. Clinicaltrials.gov reflects that this clinical trial is actively recruiting candidates since the initial post date of May 11th 2023, and its most current update on May 16th 2023. It requires approximately 20,000 patients to be recruited from one site."
Answered by AI
Who else is applying?
What state do they live in?
New York
What site did they apply to?
Signos
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
I was on with power and saw the trial. I would love help losing weight and also controlling my Diabete.
PatientReceived 2+ prior treatments
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