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

N/A

Recruiting

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 and 24 weeks

Awards & highlights

CUTDM Trial 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.Check my eligibility

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.See study design

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.

CUTDM Trial 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.

CUTDM Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

A1C

Secondary outcome measures

BMI (kg/m2)

Blood pressure systolic and diastolic

CGM mean glucose

+12 more

CUTDM 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 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of WashingtonLead Sponsor

1,740 Previous Clinical Trials

1,847,570 Total Patients Enrolled

9 Trials studying Diabetes

2,352 Patients Enrolled for Diabetes

American Diabetes AssociationOTHER

138 Previous Clinical Trials

99,426 Total Patients Enrolled

17 Trials studying Diabetes

1,867 Patients Enrolled for Diabetes

Washington State UniversityOTHER

101 Previous Clinical Trials

56,614 Total Patients Enrolled

3 Trials studying Diabetes

373 Patients Enrolled for Diabetes

Media Library

Diabetes Clinical Trial 2023: CGM with DM education Highlights & Side Effects. Trial Name: NCT05394844 — N/A

Diabetes Research Study Groups: CGM with DM education, Education only

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the cap on enrollment for this clinical experiment?

"Affirmative. Clinicaltrials.gov data indicates that this investigation, which was launched on November 11th 2022, is actively recruiting participants. Approximately 100 people need to be recruited from two different medical centres."

Answered by AI

Does the eligibility for this research trial extend to adults over 30 years old?

"This clinical trial has an upper age limit of 55, but is open to all individuals who have passed the age of majority."

Answered by AI

Does my profile meet the criteria for participation in this medical study?

"This clinical trial is recruiting 100 Latinx individuals with a diagnosis of type 2 diabetes mellitus within the last 5 years, aged 18-55. In addition to meeting these parameters, participants must have an A1C level at screening that exceeds 8%, as well as access to a personal device for remote educational attendance. Furthermore, they need to be physically and cognitively able to use home CGM monitoring devices and comply with any additional study procedures."

Answered by AI

Are there any open positions available for this research endeavor?

"Affirmative, the trial is currently enrolling patients. According to clinicaltrials.gov, it was initially advertised on November 11th 2022 and later adjusted on the same day. The study requires 100 individuals from 2 medical centres for participation."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Diabetes Education With Real-time Continuous Glucose Monitoring

Nicole Ehrhardt 2022. "Diabetes Education With Real-time Continuous Glucose Monitoring". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05394844.