Continuous Glucose Monitoring for Diabetes

Overseen By Ayitevi Agbodji, MD,MPH&TM

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Tulane University

Must be taking: Insulin

Disqualifiers: Type 1 diabetes, Advanced renal disease, Pregnant, others

Compensation: Varies

Number of Visits: 1

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness of continuous glucose monitoring (CGM) in managing type 2 diabetes. It focuses on individuals who take at least one insulin shot daily and are either uninsured or have Medicaid. Participants will either use a CGM device or continue with regular self-monitoring methods. The researchers aim to determine if CGM can improve care in communities that often face healthcare challenges. Ideal candidates for this trial have type 2 diabetes, regularly take insulin, and encounter difficulties accessing regular healthcare. As an unphased trial, this study provides an opportunity to contribute to research that could enhance diabetes management for underserved communities.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, since the study involves participants who are already taking insulin, it seems likely that you will continue your insulin therapy.

What prior data suggests that continuous glucose monitoring is safe for diabetes management?

Research has shown that continuous glucose monitoring (CGM) is safe for people with diabetes. Studies indicate that CGM helps individuals maintain stable blood sugar levels and manage their diabetes more effectively. No major safety concerns have been reported, indicating that CGM is generally well-tolerated. Many people with diabetes already use CGM, further supporting its safety. Overall, CGM serves as a reliable tool in diabetes care. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Continuous Glucose Monitoring (CGM) for diabetes because it offers a real-time, dynamic picture of glucose levels, unlike traditional methods like fingerstick blood tests. CGM devices continuously track glucose levels throughout the day and night, providing insights into trends and patterns that standard self-monitoring can't capture. This can help people with diabetes make more informed decisions about diet, exercise, and medication, potentially leading to better blood sugar control and a reduced risk of complications. Additionally, the convenience of not having to perform multiple finger pricks daily is a significant improvement in quality of life for many patients.

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

Research has shown that Continuous Glucose Monitoring (CGM), which participants in this trial may receive, can help people with diabetes manage their condition more effectively. Studies have found that CGM slightly lowers HbA1c levels, an important measure of blood sugar control, by about 0.32%. Users of CGM often experience improvements in their "time in range," meaning the percentage of time their blood sugar stays within the target range. Specifically, one study noted an increase from 39.7% to 61.9%. Additionally, CGM users report greater satisfaction with their diabetes management. These findings suggest that CGM can significantly enhance blood sugar control and overall diabetes management. ^{4 5 6 7 8}

Who Is on the Research Team?

Shaveta Gupta, MD

Principal Investigator

Tulane University

Are You a Good Fit for This Trial?

This trial is for people with Type 2 Diabetes who are uninsured or on Medicaid and take insulin injections daily. It's aimed at helping those in underserved communities. The goal is to see if using Continuous Glucose Monitoring (CGM) can improve their health care.

Inclusion Criteria

HbA1C level ≥ 7.5%

Established with primary care clinic or endocrinology clinic or diabetes clinics in the New Orleans and surrounding areas

Patients with Medicaid or free care or uninsured

Exclusion Criteria

I have been diagnosed with type 1 diabetes.

Currently using continuous glucose monitoring (CGM) or insulin pump

Presence of serious co-morbidities that may hinder participation

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

1 visit (in-person)

Run-in

Participants undergo a two-week run-in period before randomization

2 weeks

Treatment

Participants are randomized to either continuous glucose monitoring or self-monitoring of blood glucose for 6 months

6 months

Monthly visits (in-person or virtual)

Follow-up

Participants are monitored for changes in HbA1c and other outcomes

6 months

Optional Follow-up

Participants in the self-monitoring group may opt to wear the CGM sensor for an additional 3 months

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Continuous Glucose Monitoring (CGM)

Trial Overview The study tests whether Continuous Glucose Monitoring (CGM) devices help manage diabetes better in an underserved population. Participants will be randomly chosen to either use CGM or continue their usual care, as a pilot before a larger study.

How Is the Trial Designed?

Group I: Continuous Glucose Monitoring (CGM) Active Control 1 Intervention

The study participants will be randomized to the continuous glucose monitoring group (intervention).

Group II: Self-Monitoring of Blood Glucose (SMBG) Placebo Group 1 Intervention

The study participants will be randomized to the self-monitoring group (control) after a period of two-week run-in and followed for 6 months. They will be given an opportunity to wear the CGM sensor for 3 months at the conclusion of the 6-month follow-up as an optional follow-up.

Who Is Running the Clinical Trial?

Tulane University

Lead Sponsor

Trials

129

Recruited

259,000+

Abbott

Industry Sponsor

Trials

760

Recruited

489,000+

Dr. Etahn Korngold

Abbott

Chief Medical Officer

MD, Harvard Medical School

Robert B. Ford

Abbott

Chief Executive Officer since 2020

Bachelor's degree from Boston College, MBA from UC Berkeley, Haas School of Business

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37987208/

Effectiveness of Continuous Glucose Monitoring on Metrics ... Moderate certainty of evidence indicated that use of CGM had a modest but statistically significant reduction in HbA1c levels of about 0.32%.

2. diabetesjournals.org diabetesjournals.org/care/article/48/9/1581/163057/Real-Time-Continuous-Glucose-Monitoring-in

Real-Time Continuous Glucose Monitoring in Pregnancies ... We demonstrated a significantly higher %TIR using real-time CGM compared with CBG glucose monitoring among pregnant people with GDM. Studies are ...

3. e-enm.org e-enm.org/journal/view.php?number=2600

Advances in Continuous Glucose Monitoring: Clinical ... Studies show that people with diabetes (PwD) using CGM achieve better glycemic outcomes and greater satisfaction with their diabetes management.

4. jmcp.org jmcp.org/doi/10.18553/jmcp.2024.30.10-b.s30

Using continuous glucose monitoring to measure and ... EFFICACY AND UTILITY OF CGM ... Other studies have demonstrated that CGM use significantly enhances users' understanding of their diabetes and ...

5. nature.com nature.com/articles/s41598-024-83548-4

Continuous glucose monitoring among adults with type 2 ... Patients showed improvements in time in range (39.7–61.9%, p < 0.0001), time > 180 mg/dL (60.1–37.9%, p < 0.001), time > 250 mg/dL (27.6–8.5%, p ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10931178/

Effects of CGM on Glycemic Control in Type 2 Diabetes The results of this study showed that intervention using CGM was effective in reducing HbA1c in type 2 diabetes.

7. diabetesjournals.org diabetesjournals.org/care/article/47/1/169/154009/Efficacy-and-Safety-of-Continuous-Glucose

Efficacy & Safety of CGM in Type 2 Diabetes: Review Both CGM and isCGM demonstrated a reduction in HbA 1c levels in individuals with T2D, and unlike CGM, isCGM use was associated with improved user satisfaction.

8. diabetes.org diabetes.org/advocacy/cgm-continuous-glucose-monitors

Continuous Glucose Monitoring (CGM) Real-time continuous glucose monitoring has led to tremendous outcomes for people with diabetes who, without a CGM, may have experienced potentially life- ...