100 Participants Needed

Remote CGM Monitoring for Type 1 Diabetes

Age: < 65
Sex: Any
Trial Phase: Academic
Sponsor: Stanford University
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?

To determine if increased targeted contact between patients and the care team can improve diabetes outcomes in the 1st year after diagnosis. We will be using the GluVue platform to remotely view continuous glucose monitor (CGM) data.

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.

Is remote CGM monitoring safe for humans?

Continuous glucose monitoring (CGM) is generally safe for managing diabetes, with studies showing it helps reduce low blood sugar events and improve blood sugar control. However, some users, especially children, may experience challenges that affect their quality of life.12345

How is remote CGM monitoring different from other treatments for type 1 diabetes?

Remote CGM monitoring allows for continuous tracking of glucose levels in real-time, which can be shared with healthcare providers or caregivers, reducing the risk of prolonged low blood sugar levels, especially at night. This approach is unique because it leverages technology to provide ongoing, remote support and intervention, unlike traditional methods that rely on periodic blood sugar checks.16789

What data supports the effectiveness of this treatment for Remote CGM Monitoring for Type 1 Diabetes?

Research shows that using continuous glucose monitoring (CGM) helps people with type 1 diabetes better control their blood sugar levels, which can lead to fewer hospital visits and a better quality of life.1891011

Who Is on the Research Team?

PP

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.
See 1 more

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.
See 2 more

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?
1Treatment groups
Experimental Treatment
Group I: Patients with Type 1 DiabetesExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials
2,527
Recruited
17,430,000+

Published Research Related to This Trial

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

Citations

The effectiveness of Internet intervention on 926 patients with diabetes mellitus for up to 30 months. [2022]
Long-term effect of the Internet-based glucose monitoring system on HbA1c reduction and glucose stability: a 30-month follow-up study for diabetes management with a ubiquitous medical care system. [2022]
Remote glucose monitoring in camp setting reduces the risk of prolonged nocturnal hypoglycemia. [2023]
A Prospective Multicenter Evaluation of the Accuracy of a Novel Implanted Continuous Glucose Sensor: PRECISE II. [2019]
Effect of Continuous Glucose Monitoring on Glycemic Control, Acute Admissions, and Quality of Life: A Real-World Study. [2022]
Continuous Glucose Monitoring in Pediatrics: The Gap between Potential Benefits and the Reality of Utility. [2018]
Diabetes: the role of continuous glucose monitoring. [2022]
Glycemic Outcomes with Early Initiation of Continuous Glucose Monitoring System in Recently Diagnosed Patients with Type 1 Diabetes. [2022]
Use of Continuous Glucose Monitors to Manage Type 1 Diabetes Mellitus: Progress, Challenges, and Recommendations. [2023]
Effects of intermittently scanned continuous glucose monitoring in adult type 1 diabetes patients with suboptimal glycaemic control: A multi-centre randomized controlled trial. [2023]
11.United Statespubmed.ncbi.nlm.nih.gov
Analysis of "Accuracy of a 14-Day Factory Calibrated Continuous Glucose Monitoring System With Advanced Algorithm in Pediatric and Adult Population With Diabetes". [2022]
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