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Continuous Glucose Monitoring Education for Type 2 Diabetes (CUTDM Trial)

N/A

Waitlist Available

Research Sponsored by University of Washington

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be physically and cognitively able to use the home CGM monitoring device

Participants adults 18-60 years old

Must not have

Duration of diabetes >15 years

Type 1 diabetes or latent autoimmune diabetes

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 and 24 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial will test whether a diabetes self-management education and support intervention, when used with real-time continuous glucose monitoring, can help Latinx patients with type 2 diabetes better control their glycemic levels.

Who is the study for?

This trial is for Latinx adults aged 18-60 with Type 2 Diabetes, who have had the condition for less than 15 years and an A1C level of at least 8.0%. Participants must be able to attend virtual sessions, use a CGM device, and walk at least one city block. Those with serious health conditions or on prandial insulin are excluded.

What is being tested?

The study tests the effectiveness of the Compañeros en Salud diabetes education program combined with real-time continuous glucose monitoring (RT-CGM) in managing blood sugar levels in participants compared to just the education program alone.

What are the potential side effects?

While using RT-CGM like Dexcom G6 generally has minimal side effects, potential issues can include skin irritation where the sensor is placed, inaccurate readings leading to incorrect insulin dosing, and very rarely infection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can physically and mentally use a home glucose monitoring device.

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I am between 18 and 60 years old.

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I was diagnosed with type 2 diabetes in the last 15 years, with or without medication.

Exclusion Criteria

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

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I have had diabetes for more than 15 years.

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I have type 1 diabetes or latent autoimmune diabetes.

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I am currently using mealtime insulin.

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I have been diagnosed with cancer or another serious illness.

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I cannot walk at least 1 city block due to a health condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change at 12 and 24 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change at 12 and 24 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and change at 12 and 24 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

A1C

Secondary study objectives

BMI (kg/m2)

Blood pressure systolic and diastolic

CGM mean glucose

+12 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: CGM with DM educationActive Control1 Intervention

if you are in the intervention group you will received culturally tailored diabetes education and use a Real Time CGM device to see your glucose over 12 weeks. Both group will completed blinded CGM at the beginning of the study and at 24 weeks

Group II: Education onlyActive Control1 Intervention

If you are in the control group your will receive culturally tailored diabetes education and wear a blinded prior to education and after education sessions complete and 24 weeks

0 / 8Eligibility criteria met