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Continuous Glucose Monitoring Device

Diabetic education and CGM monitoring for Type 2 Diabetes (DDT-CGM Trial)

N/A
Waitlist Available
Led By Thomas H Clark, MD
Research Sponsored by Intermountain Health Care, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from discharge to day 30
Awards & highlights

DDT-CGM Trial Summary

This trial will compare diabetic education and CGM use to reduce hospitalizations in type 1 diabetes. Intervention group will receive CGM, education & monitoring; control gets CGM after 30 days. Primary outcome is hospital visits in 30 days; time in range, hypo/hyperglycemia & patient satisfaction will also be evaluated.

Who is the study for?
This trial is for adults with Type 2 Diabetes who have high blood sugar levels (A1C ≥9), are newly diagnosed with A1C ≥8, take insulin or sulfonylureas, and are at high risk of post-hospital complications like heart failure or stroke. It's not for those with Type 1 Diabetes, in another trial recently, already using a CGM device, or unable to use one.Check my eligibility
What is being tested?
The study tests if using a Continuous Glucose Monitoring (CGM) device along with diabetes education can reduce hospital visits after discharge. Participants will get the CGM and training before leaving the hospital and will be monitored remotely by medical staff.See study design
What are the potential side effects?
While this study focuses on monitoring rather than medication side effects may include skin irritation from the CGM device adhesive or discomfort during placement. The remote nature of monitoring minimizes risks.

DDT-CGM Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from discharge to day 30
This trial's timeline: 3 weeks for screening, Varies for treatment, and from discharge to day 30 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Emergency room visit and rehospitalization
Secondary outcome measures
Emergency room visits
Patient satisfaction
Rehospitalizations
+5 more

DDT-CGM Trial Design

2Treatment groups
Active Control
Group I: Standard CareActive Control1 Intervention
A blinded CGM will be placed to review glucoses after discharge in the Standard Care arm.
Group II: Diabetic education and CGM monitoringActive Control1 Intervention
Treatment arm will get diabetic education, active CGM use with patient feedback for 14 days, active access to the PI for concerns relating to hospitalization. They will also receive a brief, 15 minute phone call from the PI on day 3-4, 6-7, 9-10 and day 14-15.

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Who is running the clinical trial?

Intermountain Health Care, Inc.Lead Sponsor
137 Previous Clinical Trials
1,962,990 Total Patients Enrolled
AbbottIndustry Sponsor
751 Previous Clinical Trials
478,055 Total Patients Enrolled
Thomas H Clark, MDPrincipal InvestigatorIntermountain Health Care, Inc.

Frequently Asked Questions

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Recent research and studies
clinicaltrials.govStudy
Diabetes Discharge Transitional CGM Study (DDT-CGM)
Christopher Jones 2021. "Diabetes Discharge Transitional CGM Study (DDT-CGM)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04729985.
All > Diabetes Type 2
~3 spots leftby Jul 2024
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