CGM Use for Type 2 Diabetes

Overseen By Logan Franck, PharmD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Nebraska

Must be taking: Insulin, Diabetes medications

Disqualifiers: Insulin pump, Dialysis, Pregnant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

70 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Continuous glucose monitoring (CGM) has demonstrated improved outcomes in both type 1 and type 2 diabetes populations in comparison to traditional methods; however, these devices have not been well studied in underserved adult patients (e.g., low-income, uninsured) who may face additional barriers to monitoring. Furthermore, there is limited data exploring long-term (3- to 6- month) health care team-based management of these devices in the primary care setting. The purpose of this study is to further understand the benefits and barriers associated with CGM use in underserved populations with type 2 diabetes and improve their overall diabetes care.

Who Is on the Research Team?

Drew C Prescott, PharmD

Principal Investigator

University of Nebraska

Are You a Good Fit for This Trial?

This trial is for underserved patients with type 2 diabetes who have an A1c level over 9% and are using insulin or at least two diabetes medications. It's not open to those currently on dialysis, pregnant, using an insulin pump, with language barriers (non-English speakers), implanted medical devices, or cognitive/physical disabilities affecting CGM use.

Inclusion Criteria

A1c >9% at recruitment

I have type 2 diabetes.

I am taking insulin or two or more diabetes medications.

Exclusion Criteria

You have disabilities that may make it difficult for you to use the CGM device properly.

You are currently using an insulin pump.

Language difficulties (must understand and be able to read English)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are assigned to either a Continuous Glucose Monitoring (CGM) arm or a traditional glucometer arm for 6 months to track blood glucose levels.

6 months

Regular intervals for laboratory testing

Follow-up

Participants complete a final survey evaluating perceived/expected benefits or barriers to CGM use and willingness to continue CGM use.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Continuous glucose monitor
• Traditional glucometer

Trial Overview The study compares the effectiveness of a Continuous Glucose Monitor (CGM) versus a traditional glucometer in managing blood sugar levels in people with type 2 diabetes. The aim is to understand the benefits and challenges of CGM use in primary care for underserved populations.

How Is the Trial Designed?

Group I: Continuous Glucose Monitoring Experimental Treatment 1 Intervention

Participants will use a Freestyle Libre 2 monitoring device for 6 months to track blood glucose levels.

Group II: Traditional Glucometer Arm Active Control 1 Intervention

Participants will use a traditional glucose monitoring device (glucometer) to self-monitor their blood glucose for 6 months to track blood glucose levels.

Who Is Running the Clinical Trial?

University of Nebraska

Lead Sponsor

Trials

563

Recruited

1,147,000+

Great Plains IDeA-CTR

Collaborator

Trials

2

Recruited

90+