Remote CGM Monitoring for Type 1 Diabetes

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Disqualifiers: Non-T1D diabetes, Age > 21, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 1 year

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if frequent communication with patients through remote monitoring can improve the management of Type 1 Diabetes in the first year after diagnosis. Participants will wear a continuous glucose monitor (CGM), enabling the care team to track blood sugar levels remotely. This approach suits individuals diagnosed with Type 1 Diabetes within the last month who plan to continue care at the Stanford Children's Diabetes Clinic and agree to share their CGM data with their medical team. As an unphased trial, this study provides a unique opportunity to contribute to innovative diabetes care strategies.

Will I have to stop taking my current medications?

The trial information 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 remote CGM monitoring is safe for patients with Type 1 Diabetes?

Research has shown that using continuous glucose monitors (CGMs) with remote monitoring is safe. Studies have found that sharing CGM data in real-time can improve the quality of life and reduce stress for families managing type 1 diabetes. These studies have reported no major safety issues with CGMs.

This treatment involves wearing a small device on the body to continuously track blood sugar levels, effectively managing diabetes without serious side effects. Remote monitoring of this data enables healthcare teams to provide better support.

Overall, evidence suggests this method is well-tolerated and safe for people with type 1 diabetes. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about remote monitoring of continuous glucose monitor (CGM) data for managing Type 1 Diabetes because it offers a new layer of support and insight that isn't available through traditional self-monitoring methods. Unlike the standard approach, where patients manually check their blood sugar levels and make daily management decisions on their own, this method allows healthcare teams to remotely access CGM data in real-time. This means potential issues can be identified and addressed more quickly, improving the overall management of blood sugar levels. Additionally, this proactive approach can lead to more personalized and timely adjustments to treatment plans, enhancing patient outcomes and quality of life.

What evidence suggests that remote monitoring of CGM data is effective for Type 1 Diabetes?

Research has shown that remote monitoring of continuous glucose monitor (CGM) data, which participants in this trial will receive, can greatly benefit people with type 1 diabetes. Studies indicate that sharing real-time CGM data boosts confidence in managing low blood sugar for nearly 90% of patients and improves overall well-being for more than half of the users. One study found that using CGM led to better blood sugar control, with lower HbA1c levels, an important measure of diabetes management. In summary, remote CGM monitoring helps stabilize blood sugar levels, supporting better diabetes outcomes. ^{1 3 6 7 8}

Who Is on the Research Team?

Priya Prahalad, MD, PhD

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

This trial is for children and young adults up to 21 years old who have been newly diagnosed with Type 1 Diabetes within the last month. Participants must be seen at Stanford Children's Diabetes Clinic, agree to share their continuous glucose monitor (CGM) data for remote monitoring, and plan to continue their follow-up care at the same clinic.

Inclusion Criteria

People who have been diagnosed with type 1 diabetes at Stanford Children's Diabetes Clinic within the past month.

Individuals who agree to CGM data integration into the electronic medical record (EMR) for remote monitoring

You can't plan to get check-ups at the Stanford Children's Diabetes Clinic.

Exclusion Criteria

I have been diagnosed with a type of diabetes that is not Type 1.

I am over 21 years old.

I was diagnosed with diabetes more than a month ago.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants wear a continuous glucose monitor (CGM) and receive remote monitoring of the CGM data by the clinical care team

1 year

Remote monitoring with proactive contact

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Integration with Epic
• Remote Monitoring of CGM Data

Trial Overview The study aims to see if more contact between patients and healthcare providers through a system called GluVue can help manage diabetes better in the first year after diagnosis. This involves integrating CGM data into the patient's electronic medical record for closer monitoring.

How Is the Trial Designed?

Group I: Patients with Type 1 Diabetes Experimental Treatment 1 Intervention

Participants will wear a continuous glucose monitor (CGM) and receive remote monitoring of the CGM data by the clinical care team.

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Published Research Related to This Trial

Continuous glucose monitoring (CGM) systems, including real-time (rtCGM) and intermittently scanned (isCGM), have been shown to significantly reduce HbA1C levels (by 0.3-0.6%) and improve time spent in the target glucose range (by 6.8-17.6%) in both type 1 and type 2 diabetes patients compared to traditional self-monitoring methods.

CGM use has also been associated with a decrease in hypoglycaemia rates, particularly severe hypoglycaemia in type 1 diabetes, and has improved treatment satisfaction among patients, highlighting its efficacy and safety in diabetes management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diabetes: the role of continuous glucose monitoring. Kluemper, JR., Smith, A., Wobeter, B.[2022]

In a study of 515 adults with type 1 diabetes using real-time continuous glucose monitoring (RT-CGM), there was a significant reduction in HbA1c levels from 7.7% to 7.4% over 12 months, indicating improved glycemic control.

The use of RT-CGM also led to a dramatic decrease in hospital admissions for severe hypoglycemia or ketoacidosis from 16% to 4%, along with reduced work absenteeism and improved quality of life, particularly in reducing fear of hypoglycemia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Continuous Glucose Monitoring on Glycemic Control, Acute Admissions, and Quality of Life: A Real-World Study. Charleer, S., Mathieu, C., Nobels, F., et al.[2022]

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]

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]

In a study of 104 adults with type 1 diabetes, those using intermittently scanned continuous glucose monitoring (isCGM) showed a significant reduction in HbA1c levels after 24 weeks compared to those using traditional blood glucose monitoring (BGM), with a difference of 0.3%.

The isCGM group also experienced a greater increase in time-in-range for blood glucose levels and a reduction in time spent in hyperglycemia, indicating improved glycaemic control overall.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of intermittently scanned continuous glucose monitoring in adult type 1 diabetes patients with suboptimal glycaemic control: A multi-centre randomized controlled trial. Yan, J., Zhou, Y., Zheng, X., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7906862/

Impact of Real-Time Continuous Glucose Monitoring Data ... Data sharing reportedly contributed to improved hypoglycemic confidence (for 89.4% of respondents), improved overall well-being (54.3%), and reduced diabetes ...

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

The Effectiveness of Continuous Glucose Monitoring ... CGM demonstrated improved outcomes in T1DM with lower HbA1c and reduced severe hypoglycemia, while in T2DM, CGM significantly lowered HbA1c ...

3. diabetesjournals.org diabetesjournals.org/diabetes/article/73/Supplement_1/1200-P/155576/1200-P-Effectiveness-of-Real-Time-Remote

1200-P: Effectiveness of Real-Time, Remote Continuous ... Following 3 months of RTM, A1c improved by 0.7% (p = 0.15). Alc increased after cessation of RTM. Time in range improved an average of 1.8% ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04540536

NCT04540536 | Feasibility and Effectiveness of Real-time, ... Primary outcome assessment will be the change in HbA1c after 3 months of real-time remote continuous glucose monitoring.

5. diabetes.jmir.org diabetes.jmir.org/2023/1/e43991/

Glycemic Outcomes and Feature Set Engagement Among ... Background: The benefits of real-time continuous glucose monitoring (RT-CGM) are well established for patients with type 1 diabetes (T1D) ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8875067/

Impact of Real-Time CGM Data Sharing on Quality of Life in ... To examine caregivers' experiences with real-time continuous glucose monitoring (RT-CGM) data sharing and its impact on quality of life (QoL) and health ...

7. diabetesjournals.org diabetesjournals.org/care/article/41/12/2641/36504/The-Use-of-Continuous-Glucose-Monitoring-With

The Use of Continuous Glucose Monitoring With Remote ... CGM with remote monitoring was found to improve multiple measures of quality of life, reduce family stress, and improve parental sleep.

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

Continuous Glucose Monitoring (CGM) CGMs continually monitor your blood glucose (blood sugar), giving you real-time updates through a device that is attached to your body.