Continuous Glucose Monitoring for Type 1 Diabetes

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

30 Participants Needed

Trial Summary

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 data supports the idea that Continuous Glucose Monitoring for Type 1 Diabetes is an effective treatment?

The available research shows that Continuous Glucose Monitoring (CGM) is effective for people with Type 1 Diabetes. Studies indicate that using CGM helps improve blood sugar control over time. For example, one study found that people who started using CGM within a year of being diagnosed with Type 1 Diabetes had better long-term blood sugar levels. Another study showed that adults using CGM experienced fewer instances of low blood sugar. Overall, these findings suggest that CGM is a beneficial treatment for managing Type 1 Diabetes. ^{1 2 3 4 5}

What safety data is available for continuous glucose monitoring in Type 1 Diabetes?

Safety data for continuous glucose monitoring (CGM) includes information on adverse events, with 281,963 CGM-related adverse events reported in 2022. Studies have evaluated the safety and efficacy of CGM in various populations, including children, adolescents, and adults with Type 1 Diabetes. While CGM is generally considered safe and beneficial for managing diabetes, there are some negative aspects, particularly in pediatric use, that may affect quality of life and device utilization. Overall, CGM is an important tool for improving glycemic control, but patient education is crucial to minimize potential negative impacts. ^{3 6 7 8 9}

Is Continuous Glucose Monitoring (CGM) a promising treatment for Type 1 Diabetes?

Yes, Continuous Glucose Monitoring (CGM) is a promising treatment for Type 1 Diabetes. It helps people manage their blood sugar levels more effectively by providing real-time information. This can lead to better control of blood sugar and reduce the risk of low blood sugar episodes, especially in older adults. CGM also offers alerts for high or low blood sugar, helping users take action quickly. Overall, it improves blood sugar management without increasing the risk of low blood sugar. ^{1 10 11 12 13}

What is the purpose of this trial?

Hispanics adults with type 1 diabetes (T1D), despite their disproportionate burden of acute complications (hypoglycemia and diabetes ketoacidosis) and related emergency department visits, hospitalizations, and death, remain largely disenfranchised from continuous glucose monitoring (CGM), an efficacious technology to mitigate these inequities. To increase CGM uptake in low-income, Hispanic adults with T1D receiving diabetes management in federally qualified health centers (FQHCs), this pilot randomized control trial (RCT), will assess the feasibility of our study protocol, including our multi-level intervention informed by the Socio-Ecological Model.

Eligibility Criteria

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 am of Hispanic ethnicity.

I have been officially diagnosed with Type 1 Diabetes.

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

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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) 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 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]

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 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]

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]

References

1. United States 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]

2. United States pubmed.ncbi.nlm.nih.gov

Sustained benefit of continuous glucose monitoring on A1C, glucose profiles, and hypoglycemia in adults with type 1 diabetes. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Glycemic Outcomes with Early Initiation of Continuous Glucose Monitoring System in Recently Diagnosed Patients with Type 1 Diabetes. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

A Prospective Multicenter Evaluation of the Accuracy of a Novel Implanted Continuous Glucose Sensor: PRECISE II. [2019]

5. United States 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. [2022]

6. Ireland pubmed.ncbi.nlm.nih.gov

Continuous glucose monitoring: A review of the technology and clinical use. [2022]

7. United States 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. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

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

9. Israel pubmed.ncbi.nlm.nih.gov

Continuous Glucose Monitoring in Pediatrics: The Gap between Potential Benefits and the Reality of Utility. [2018]

10. United States pubmed.ncbi.nlm.nih.gov

Effect of Continuous Glucose Monitoring on Hypoglycemia in Older Adults With Type 1 Diabetes: A Randomized Clinical Trial. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Continuous glucose monitoring: current use and future directions. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

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

13. United States pubmed.ncbi.nlm.nih.gov

An updated algorithm for an effective choice of continuous glucose monitoring for people with insulin-treated diabetes. [2023]