CGM Use for Type 2 Diabetes

DP
LF
Overseen ByLogan Franck, PharmD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Nebraska
Must be taking: Insulin, Diabetes medications
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how continuous glucose monitors (CGMs) can assist people with type 2 diabetes, particularly those with limited access to healthcare. It seeks to understand the benefits and challenges of using CGMs compared to traditional glucose meters over six months. Participants will use either a Freestyle Libre 2 CGM or a traditional glucometer to monitor blood sugar levels. The trial seeks individuals with type 2 diabetes who have high blood sugar levels (A1c > 9%), are on insulin or multiple diabetes medications, and are not currently using an insulin pump. As an unphased trial, this study provides a unique opportunity to contribute to understanding how CGMs can enhance diabetes management for a broader population.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It seems likely that you can continue your current diabetes medications, as the study includes people who are on insulin or two or more diabetes medications.

What prior data suggests that continuous glucose monitoring is safe for underserved adults with type 2 diabetes?

Research has shown that continuous glucose monitors (CGMs), such as the Freestyle Libre 2, are safe for people with diabetes. Studies have found that these devices reduce the time spent with high blood sugar, demonstrating their effectiveness.

No major safety concerns have been reported for the Freestyle Libre system. However, users should take certain precautions. For instance, the sensor should not be used near MRI machines. Additionally, following instructions for sensor removal is important to prevent skin irritation.

Overall, CGMs are easy to use and have been linked to benefits like fewer hospital visits for heart-related issues in people with diabetes. This suggests they are not only effective but also safe for regular use.12345

Why are researchers excited about this trial?

Researchers are excited about continuous glucose monitoring (CGM) for Type 2 diabetes because it offers real-time blood sugar tracking, unlike traditional glucometers that require manual testing. CGMs, like the Freestyle Libre 2, provide continuous data, which can help in making timely adjustments to diet and medication. This proactive monitoring allows for better glucose control and potentially reduces the risk of complications associated with Type 2 diabetes.

What evidence suggests that continuous glucose monitoring is effective for type 2 diabetes?

Research has shown that continuous glucose monitors (CGMs), which participants in this trial may use, can help people with type 2 diabetes better control their blood sugar levels. One study found that people using CGMs spent 38% less time with low blood sugar compared to those using traditional methods. Other research indicates that CGMs allow people to track their blood sugar in real-time, simplifying daily diabetes management. These devices have also been linked to fewer hospital visits for heart-related issues in diabetes patients. Overall, CGMs provide a more effective way to manage diabetes than traditional blood sugar monitoring tools, which participants in the traditional glucometer arm of this trial will use.15678

Who Is on the Research Team?

DC

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)
See 3 more

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?
2Treatment groups
Experimental Treatment
Active Control
Group I: Continuous Glucose MonitoringExperimental Treatment1 Intervention
Group II: Traditional Glucometer ArmActive Control1 Intervention

Find a Clinic Near You

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+

Citations

Evaluation of the Effectiveness of Continuous Glucose ...Real-world evidence suggests CGMs provide improved clinical outcomes in patients with type 1 and type 2 diabetes including those with public ...
Impact of the FreeStyle Libre 2® System on Glycaemic ...Results: Eight weeks after using FSL2, compared with results from 3–4 weeks of use, there were no differences in the glucose management ...
Continuous Glucose Monitoring in Individuals With Type 2 ...The use of CGM in the population of people with type 2 diabetes has been shown to improve patients' ability to use real-time glycemic ...
Adult & Pediatric OutcomesFreeStyle Libre CGM systems make it easy to support better outcomes by enabling greater glucose control* · 38%12 less time in hypoglycemia vs. BGM (122 mins vs.
Abbott's Libre® Technology is First Continuous Glucose ...New data reveal a 78% reduction in cardiovascular disease-related hospitalizations for people living with Type 1 diabetes with prior severe low ...
Safety Information | The FreeStyle Libre SystemRead safety information regarding your FreeStyle Libre 14 day system, including MRI contraindications, insulin contraindications, and sensor removal ...
Diabetes and Heart Risk: Two Battles, One DeviceLibre technology is linked with reduced cardiovascular disease-related hospitalization for people with diabetes.
Effectiveness, safety and costs of the FreeStyle Libre glucose ...This study aimed to evaluate the effectiveness, safety and costs of FreeStyle Libre (FSL) glucose monitoring system for children and ...
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