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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 below

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I have been diagnosed with Type 2 Diabetes based on my latest Hg A1c test results.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with Type 1 Diabetes.

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I have been diagnosed with an eating disorder like anorexia or bulimia.

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I follow a specific medical diet due to a condition like epilepsy.

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I've had a severe low blood sugar episode needing help in the last 3 months.

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I have Type 2 Diabetes and am either using insulin or my last A1c was 10% or higher.

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I have had 10 or more skin infections like cellulitis.

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I have a genetic disorder like PKU or MSUD.

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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.

This trial's timeline: 3 weeks for screening, Varies for treatment, and during enrollment in the trial for a maximum of 5 years, including a 1 year follow up period, for a maximum of 6 years. for reporting.

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.

0 / 10Eligibility criteria met