CGM and Education for Type 1 Diabetes (DDT-CGM Trial)

N/A

Waitlist Available

Led By Christopher Jones, 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

No Placebo-Only Group

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.

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.

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from discharge to day 30

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

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

Primary study objectives

Emergency room visit and rehospitalization

Secondary study objectives

Emergency room visits

Patient satisfaction

Rehospitalizations

+5 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: 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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