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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
Must not have
Medical diagnosis of Type 1 Diabetes
Current medical diagnosis of an eating disorder (such as anorexia nervosa or bulimia)
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
No Placebo-Only Group
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.
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.
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have been diagnosed with Type 1 Diabetes.
Select...
I have been diagnosed with an eating disorder like anorexia or bulimia.
Select...
I follow a specific medical diet due to a condition like epilepsy.
Select...
I've had a severe low blood sugar episode needing help in the last 3 months.
Select...
I have Type 2 Diabetes and am either using insulin or my last A1c was 10% or higher.
Select...
I have had 10 or more skin infections like cellulitis.
Select...
I have a genetic disorder like PKU or MSUD.
Select...
I am currently taking Clozapine, Hydroxyurea, or insulin.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
App engagement
Change in weight in pounds
Glucose Metrics via Continuous Glucose Measurement (CGM)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
100,380 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.