Continuous Glucose Monitoring for Type 1 Diabetes

Enrolling by invitation at 1 trial location

Overseen By Idiana Vaquez, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Connecticut

Disqualifiers: Pregnancy, Lactation, Alcohol abuse, others

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

Approved in 5 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if continuous glucose monitoring (CGM) can help low-income adults with type 1 diabetes manage their condition more effectively. CGM tracks blood sugar levels in real-time, potentially reducing emergency visits and hospital stays. Participants will either use CGM or continue with regular blood sugar checks. Those with type 1 diabetes who receive care at certain health centers and find CGM challenging might be suitable candidates. The trial seeks to make CGM more accessible and effective for those who need it most. As an unphased trial, this study provides a unique opportunity for participants to contribute to this goal.

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

The trial protocol does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that continuous glucose monitoring is safe for low-income adults with type 1 diabetes?

Research shows that continuous glucose monitoring (CGM) is generally safe for people with type 1 diabetes. Studies have found that CGM users often achieve better blood sugar control, experiencing fewer dangerous episodes of high or low blood sugar.

One study found that people generally tolerate CGM well and express satisfaction with it. Many individuals with diabetes have used CGM for several years, seeing good results in managing their condition. The use of CGM is on the rise, with many users finding it enhances their overall diabetes management.

Overall, the safety data for CGM is positive, making it a promising option for improving diabetes care. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about continuous glucose monitoring (CGM) for Type 1 Diabetes because it offers a more dynamic and responsive way to manage blood sugar levels compared to traditional methods like self-monitoring of blood glucose (SMBG). Unlike SMBG, which involves finger-prick tests at set intervals, CGM provides real-time updates and trends, allowing users to see how their blood sugar is changing throughout the day. This constant feedback helps in making immediate adjustments to diet or insulin, potentially leading to better overall glucose control. Additionally, CGM can alert users to dangerous highs or lows, improving safety and peace of mind.

What evidence suggests that continuous glucose monitoring is effective for type 1 diabetes?

Research shows that Continuous Glucose Monitoring (CGM), which participants in the CGM Intervention Arm of this trial will receive, can greatly improve blood sugar control for people with type 1 diabetes. Studies have found that CGM helps lower HbA1c levels, an important measure for managing diabetes. CGM provides real-time information, offering 72 times more glucose data than traditional methods. This additional information helps people make better decisions and manage their diabetes more effectively. Research also indicates that people using CGM feel more satisfied with their diabetes care. Overall, CGM has proven more effective in managing type 1 diabetes than traditional blood sugar monitoring, which participants in the Self-Monitoring of Blood Glucose (SMBG) Arm will continue to use. ^{4 5 6 7 8}

Are You a Good Fit for This Trial?

This trial is for Hispanic adults over 24 with Type 1 Diabetes, who get care from a Federally Qualified Health Center. They must be willing to wear a CGM sensor and have an adult family member or friend participate in the study sessions. It's not specified who can't join.

Inclusion Criteria

I have been officially diagnosed with Type 1 Diabetes.

I am of Hispanic ethnicity.

My primary care provider is from a Federally Qualified Health Center.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive a 6-month, SEM-informed intervention to promote CGM uptake and maintenance, including 4-week personalized CGM sessions and virtual peer educator-led support groups.

6 months

4-week sessions with RN/CDCES, followed by virtual support groups

Control

Participants in the control arm receive the 6-month control condition focusing on self-monitoring of blood glucose (SMBG).

6 months

Follow-up

Participants are monitored for safety and effectiveness after the intervention, with assessments at baseline, 3 months, and 6 months.

6 months

What Are the Treatments Tested in This Trial?

Interventions

• CGM Intervention

Trial Overview The trial tests if a special program helps increase the use of Continuous Glucose Monitoring (CGM) technology among low-income Hispanic adults with T1D at health centers. Participants are randomly chosen to either try this new program or continue standard blood sugar testing.

How Is the Trial Designed?

Group I: Self-Monitoring of Blood Glucose (SMBG) Arm Experimental Treatment 1 Intervention

The SMBG control arm comprises participants receiving care from FQHC sites randomized to deliver the control condition. This arm will receive the 6-month control condition.

Group II: Continuous Glucose Monitoring (CGM) Intervention Arm Experimental Treatment 1 Intervention

The intervention arm comprises participants receiving care from FQHC sites randomized to deliver the intervention. This arm will receive the 6-month, SEM-informed intervention to promote CGM uptake and maintenance.

CGM Intervention is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Continuous Glucose Monitoring for:

• Type 1 diabetes
• Type 2 diabetes

Approved in United States as Continuous Glucose Monitoring for:

• Type 1 diabetes
• Type 2 diabetes

Approved in Canada as Continuous Glucose Monitoring for:

• Type 1 diabetes
• Type 2 diabetes

Approved in Japan as Continuous Glucose Monitoring for:

• Type 1 diabetes
• Type 2 diabetes

Who Is Running the Clinical Trial?

University of Connecticut

Lead Sponsor

Trials

194

Recruited

162,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Published Research Related to This Trial

In 2022, there were 281,963 reported adverse events related to continuous glucose monitors (CGMs), highlighting a significant safety concern for people with diabetes.

The analysis of adverse events for four CGM products revealed that common issues included inaccuracy and device malfunctions, indicating a need for improved monitoring and device reliability to enhance user experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse Event Causes From 2022 for Four Continuous Glucose Monitors. Krouwer, JS.[2023]

Continuous Glucose Monitoring (CGM) devices are becoming essential for managing Type 1 diabetes, providing accurate glucose data every 5 minutes and helping users maintain tighter glycemic control without increasing hypoglycemia risk.

Despite their benefits, CGM use can lead to challenges that may negatively affect quality of life, particularly in children, highlighting the need for guidelines to support effective use of these devices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continuous Glucose Monitoring in Pediatrics: The Gap between Potential Benefits and the Reality of Utility. Taddeo, RL., Moser, JT., Minnock, PP.[2018]

In a study of 396 newly diagnosed type 1 diabetes patients, those who started continuous glucose monitoring (CGM) within the first year showed significantly better glycemic control over 2.5 years, with lower A1c levels compared to those who did not use CGM.

Early CGM users also experienced fewer diabetes-related emergency visits, indicating that CGM not only improves glucose management but also enhances safety by reducing severe hypoglycemic or hyperglycemic events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Glycemic Outcomes with Early Initiation of Continuous Glucose Monitoring System in Recently Diagnosed Patients with Type 1 Diabetes. Mulinacci, G., Alonso, GT., Snell-Bergeon, JK., et al.[2022]

Continuous glucose monitoring (CGM) can effectively lower A1C levels in individuals with type 1 diabetes, particularly in those with baseline A1C levels of 7.0% or higher, as shown in a 6-month follow-up study involving various age groups.

While CGM use led to a reduction in severe hypoglycemia events, the frequency of CGM usage decreased significantly over time, especially among children and adolescents, indicating challenges in maintaining consistent monitoring in younger populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of continuous glucose monitoring in a clinical care environment: evidence from the Juvenile Diabetes Research Foundation continuous glucose monitoring (JDRF-CGM) trial. [2022]

Initiating continuous glucose monitoring (CGM) within the first year of a type 1 diabetes diagnosis leads to significantly lower A1c levels over a 7-year period compared to those who did not use CGM, with A1c values consistently better in the CGM group (e.g., 7.3% vs. 8.1% at 6 months).

The study involved 396 patients and demonstrated that early CGM use is associated with long-term glycemic control, highlighting its efficacy in managing diabetes from the onset.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continuous Glucose Monitoring Initiation Within First Year of Type 1 Diabetes Diagnosis Is Associated With Improved Glycemic Outcomes: 7-Year Follow-Up Study. Champakanath, A., Akturk, HK., Alonso, GT., et al.[2022]

Continuous Glucose Monitoring (CGM) devices, including real-time (rtCGM) and intermittently scanned (isCGM), significantly improve glucose control and reduce hypoglycemia in insulin-treated individuals with diabetes, based on recent clinical evidence.

An updated algorithm was developed to help healthcare providers choose the most suitable CGM device for different clinical scenarios, such as type 1 and type 2 diabetes, pregnancy, and frailty, ensuring a personalized approach to diabetes management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An updated algorithm for an effective choice of continuous glucose monitoring for people with insulin-treated diabetes. Maiorino, MI., Buzzetti, R., Irace, C., et al.[2023]

The study demonstrated that a 7-day transcutaneous continuous glucose monitoring (CGM) system is safe and effective for individuals with insulin-requiring diabetes, with 97.2% of glucose readings falling within acceptable error zones.

After unblinding the CGM data, participants significantly reduced time spent in dangerously low and high glucose levels, while increasing time spent in the target glucose range, indicating improved glycemic control across both type 1 and type 2 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Relationship of fasting and hourly blood glucose levels to HbA1c values: safety, accuracy, and improvements in glucose profiles obtained using a 7-day continuous glucose sensor. Garg, S., Jovanovic, L.[2022]

Continuous glucose monitoring (CGM) significantly improves diabetes management for insulin-requiring patients, particularly in type 1 diabetes, by providing real-time insights into glycemic fluctuations and allowing for better lifestyle and medication adjustments.

The review highlights that CGM can lead to improved hemoglobin A1c (A1C) levels, reduced hypoglycemia, and enhanced quality of life, suggesting its potential benefits for broader patient populations with proper education and support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continuous glucose monitoring: A review of the technology and clinical use. Klonoff, DC., Ahn, D., Drincic, A.[2022]

The Eversense continuous glucose monitoring (CGM) system showed a mean absolute relative difference (MARD) of 8.8% compared to reference glucose measurements, significantly surpassing the accuracy goal of 20%, indicating its effectiveness in monitoring glucose levels in individuals with type 1 and type 2 diabetes.

The study, involving 90 participants over 90 days, reported a favorable safety profile with only one serious adverse event (1.1%) related to sensor removal, and 91% of sensors remained functional throughout the study period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Prospective Multicenter Evaluation of the Accuracy of a Novel Implanted Continuous Glucose Sensor: PRECISE II. Christiansen, MP., Klaff, LJ., Brazg, R., et al.[2019]

Continuous glucose monitoring (CGM) in adults with type 1 diabetes led to a significant reduction in A1C levels by an average of 0.4% over 12 months, indicating improved blood sugar control.

The use of CGM was associated with a decrease in severe hypoglycemia events, from 21.8 to 7.1 events per 100 person-years, demonstrating enhanced safety alongside its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sustained benefit of continuous glucose monitoring on A1C, glucose profiles, and hypoglycemia in adults with type 1 diabetes. Bode, B., Beck, RW., Xing, D., et al.[2022]

In a study of 203 older adults (average age 68) with type 1 diabetes, continuous glucose monitoring (CGM) significantly reduced the time spent with low glucose levels (<70 mg/dL) compared to standard blood glucose monitoring (BGM), showing a decrease from 5.1% to 2.7% in the CGM group.

CGM also led to a meaningful reduction in HbA1c levels (average decrease of 0.3%) compared to BGM, indicating better overall glucose control, while the safety profile showed fewer severe hypoglycemia events in the CGM group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Continuous Glucose Monitoring on Hypoglycemia in Older Adults With Type 1 Diabetes: A Randomized Clinical Trial. Pratley, RE., Kanapka, LG., Rickels, MR., et al.[2022]

Continuous glucose monitoring (CGM) technology allows for real-time tracking of glucose levels, helping users manage their blood sugar more effectively without increasing the risk of hypoglycemia.

Key challenges for CGM include ensuring sensor accuracy, reliability, and comfort, which are essential for advancing towards artificial pancreas systems that automate blood sugar management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continuous glucose monitoring: current use and future directions. DeSalvo, D., Buckingham, B.[2022]

The long-term implantable continuous glucose monitoring (LTI CGM) technology shows similar accuracy to existing continuous glucose monitoring devices, with low rates of adverse events, suggesting it is a safe option for patients.

Preliminary evidence indicates that LTI CGM may effectively lower hemoglobin A1c levels comparably to real-time continuous glucose monitoring (rtCGM), but further clinical trials are needed to fully assess its glycemic efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Review of the First Long-term Implantable Continuous Glucose Monitoring System Available in the United States. Cowart, K.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10460137/

The Effectiveness of Continuous Glucose Monitoring ... The results of our study demonstrated that the adoption of CGM device leads to significant improvements in glycemic control, as evidenced by a ...

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

Real-Time Continuous Glucose Monitoring in Pregnancies ... CGM provides 72 times more glucose data than conventional four times per day CBG monitoring. Patients can benefit from real-time CGM data and ...

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. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2598770

Effect of Continuous Glucose Monitoring on Glycemic ... This randomized clinical trial evaluated the effectiveness of continuous glucose monitoring vs usual care on hemoglobin A1c levels in adults with type 1.

5. nejm.org nejm.org/doi/full/10.1056/NEJMoa2205650

Intermittently Scanned Continuous Glucose Monitoring for ... Effectiveness of continuous glucose monitoring systems on glycemic control in adults with type 1 diabetes: A systematic review and meta ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10072139/

Use of Continuous Glucose Monitors to Manage Type 1 ... Long-term glycemic outcomes were also evaluated, and results showed that HbA1c levels were maintained up to 7 years after implementation of CGM ...

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

Efficacy and Safety of Continuous Glucose Monitoring and ... 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/sites/default/files/2025-06/CGM-Guidance-06-10-25.pdf

Guidance for the Use of Continuous Glucose Monitoring in ... By 2016, about 30% of people with type 1 diabetes used a CGM for their management, with that number rising to approximately 70-80% in. 2022.1,2 ...