Diabetes Technologies for Type 1 Diabetes

FK
EP
Overseen ByErica Pang, BS
Age: < 65
Sex: Any
Trial Phase: Academic
Sponsor: Stanford University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 5 JurisdictionsThis treatment is already approved in other countries

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.12345

Why 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?

DM

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

Pediatric patients with existing T1D who wear a CGM or want to start a CGM and receive RPM
Dr. Maahs and Pediatric Endocrinology have philanthropic funds available to purchase compatible smart devices for participants who do not have a compatible smart device/phone
I or my guardian have a smartphone to use with the CGM for data sharing.
See 5 more

Exclusion Criteria

I have been diagnosed with diabetes, but it's not type 1.
Individuals with the intention of obtaining diabetes care at another clinic
Individuals who do not consent to CGM use, CGM data integration, remote monitoring
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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

4 weeks
Regular remote monitoring and in-person visits as needed

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

8 months
Monthly virtual and in-person visits

Follow-up

Participants are monitored for safety and effectiveness after treatment, with a focus on psychosocial outcomes and diabetes distress

4 weeks
2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • CGM and RPM
Trial Overview The '4T Sustainability Program' tests integrating teamwork, targets, technology (CGM), and tight glucose control into standard care for Type 1 Diabetes patients. It seeks to improve blood sugar levels, patient outcomes, and reduce disparities by using real-time monitoring.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Standard of Care - CGM and RPMExperimental Treatment1 Intervention

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

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Approved in United States as CGM and RPM for:
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Approved in European Union as CGM and RPM for:
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Approved in Canada as CGM and RPM for:
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Approved in Japan as CGM and RPM for:

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 116 individuals with type 1 diabetes, frequent use of continuous glucose monitoring (CGM) (≥10 scans/day) led to significant improvements in glycemic control, specifically in time in range (TIR) and time above range (TAR) at 6 and 12 months.
Predictors of better glycemic outcomes included having a baseline TIR of less than 50% and a higher frequency of scans, while being a woman and having a lower A1C at baseline were associated with more frequent scanning, indicating that certain demographic and clinical factors can influence CGM effectiveness.
Predictors of use and improvement in glycemic indices after initiating continuous glucose monitoring in real world: Data from Saudi Arabia.Alyusuf, EY., Alharthi, S., Alguwaihes, AM., et al.[2022]
Continuous glucose monitoring (CGM) and continuous subcutaneous insulin infusion (CSII) systems significantly improve A1C levels and reduce hypoglycemia compared to traditional self-monitoring of blood glucose (SMBG) and multiple daily injection (MDI) therapy.
The STAR 3 trial showed that patients with type 1 diabetes who switched to sensor-augmented pump therapy (SAPT) experienced rapid and sustained improvements in glucose control, with A1C levels remaining significantly lower than those using SMBG and MDI for up to one year.
Crossing the technology divide: practical strategies for transitioning patients from multiple daily insulin injections to sensor-augmented pump therapy.Rubin, RR., Borgman, SK., Sulik, BT.[2018]

Citations

Effectiveness of continuous glucose monitoring systems on ...We conducted a systematic review and meta-analysis to evaluate and investigate the impact of CGM systems on glycemic control in adults with type ...
Continuous Glucose Monitoring (CGM) use in patients with ...This study evaluates demographic and clinical variations between DM type 1 patients using CGM and non-CGM users; assessing healthcare utilization, glycemic ...
Diabetes Management Using Continuous Glucose ...The goal of this 52 week prospective study is to learn whether a Diabetes Care Management Program using a continuous glucose monitor (CGM) and remotely ...
Real-Time Continuous Glucose Monitoring in Pregnancies ...There is a paucity of data to understand the role of CGM in achieving higher glycemic goals compared with current monitoring standards using ...
Continuous Glucose Monitoring (CGM)Real-time continuous glucose monitoring has led to tremendous outcomes for people with diabetes who, without a CGM, may have experienced potentially life- ...
Continuous glucose monitoring system: Is it really accurate ...The continuous glucose monitoring system (CGM) has been used for constant checking of glucose level by measuring interstitial glucose concentrations.
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.
NCT02258373 | A Trial Comparing Continuous Glucose ...The primary objective of the study is to determine whether the routine use of Continuous Glucose Monitoring (CGM) without Blood Glucose Monitoring (BGM) ...
Intermittently Scanned Continuous Glucose Monitoring for ...In persons with type 1 diabetes and high glycated hemoglobin levels, the benefits of intermittently scanned continuous glucose monitoring ...
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