Diabetes Technologies for Type 1 Diabetes
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores how new technologies can effectively manage type 1 diabetes (T1D) from the start. It focuses on using Continuous Glucose Monitoring (CGM) and Remote Patient Monitoring (RPM) to stabilize blood sugar levels and enhance overall well-being. The goal is to integrate these technologies into standard care for children with T1D. Those recently diagnosed with T1D who receive care at Stanford's Children's Diabetes Clinic, or those already using or wishing to start using a CGM, are suitable candidates for this trial. Participants must be willing to use a CGM that connects to a smart device for monitoring.
As a Phase 2 trial, this research measures the effectiveness of these technologies in an initial, smaller group, offering participants the opportunity to contribute to groundbreaking advancements in diabetes care.
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 focuses on using diabetes technology like CGMs (continuous glucose monitors) for managing type 1 diabetes.
What prior data suggests that these diabetes technologies are safe for type 1 diabetes patients?
Research shows that Continuous Glucose Monitoring (CGM) is generally easy to use. CGMs track blood sugar levels in real time with a small sensor attached to the body. Studies have found that using a CGM can help lower HbA1c levels, indicating better blood sugar control, which is crucial for effective diabetes management.
CGM is widely used and considered safe for people with both Type 1 and Type 2 diabetes. While minor issues like skin irritation from the sensor may occur, serious side effects are rare, suggesting the technology is safe for most people with diabetes.
Remote Patient Monitoring (RPM) helps track health data from a distance, allowing healthcare providers to monitor patients without frequent clinic visits. RPM is used for various health conditions and is generally safe, though specific safety data for diabetes management is less detailed.
In summary, both CGM and RPM are well-established technologies with a good safety record. Most people use them without problems, making them a safe choice for managing diabetes.12345Why are researchers excited about this trial?
Researchers are excited about using Continuous Glucose Monitoring (CGM) and Remote Patient Monitoring (RPM) for Type 1 Diabetes because these technologies offer a more proactive approach to managing the condition. Unlike traditional methods that rely on periodic blood sugar checks, CGM continuously tracks glucose levels, providing real-time data and alerts for immediate action. RPM enhances this by allowing healthcare providers to monitor patients' glucose data remotely, facilitating timely interventions. Together, they aim to stabilize blood sugar levels soon after diagnosis, potentially preventing the typical rise in HbA1c levels seen in the months following a Type 1 Diabetes diagnosis.
What evidence suggests that CGM and RPM are effective for type 1 diabetes?
Studies have shown that Continuous Glucose Monitoring (CGM) helps people with type 1 diabetes maintain stable blood sugar levels. This technology tracks glucose levels in real-time, leading to better management and reducing the risk of sudden spikes or drops. Research indicates that CGM can lower HbA1c levels, a measure of average blood sugar over several months. In this trial, participants will receive CGM combined with Remote Patient Monitoring (RPM) as part of the standard of care. This combination provides timely feedback and personalized care adjustments. Overall, these technologies have proven to make managing type 1 diabetes more effective and convenient.36789
Who Is on the Research Team?
David M Maahs, MD, PhD
Principal Investigator
Stanford University
Are You a Good Fit for This Trial?
The trial is for individuals up to 21 years old with Type 1 Diabetes seen at Stanford Children's Diabetes Clinic. Participants must agree to wear a CGM, use a smart device for data sharing in the RPM-care model, and plan to continue care at the clinic. The program aims for wide inclusivity and offers interpreter services.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Initial Treatment and Monitoring
Implementation of the 4T program as standard of care, including Continuous Glucose Monitoring (CGM) and Remote Patient Monitoring (RPM) within the first 30 days after T1D diagnosis
Ongoing Treatment and Adjustment
Continued use of CGM and RPM to manage and adjust treatment based on glucose data and patient needs, focusing on reducing HbA1c trajectory from 4 to 12 months post-diagnosis
Follow-up
Participants are monitored for safety and effectiveness after treatment, with a focus on psychosocial outcomes and diabetes distress
What Are the Treatments Tested in This Trial?
Interventions
- CGM and RPM
CGM and RPM is already approved in United States, European Union, Canada, Japan for the following indications:
- Type 1 diabetes management
- Type 2 diabetes management
- Type 1 diabetes management
- Type 2 diabetes management
- Type 1 diabetes management
- Type 2 diabetes management
- Type 1 diabetes management
- Type 2 diabetes management
Find a Clinic Near You
Who Is Running the Clinical Trial?
Stanford University
Lead Sponsor