Diabetes Technologies for Type 1 Diabetes

Overseen By Erica Pang, BS

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Disqualifiers: Non-T1D diabetes, Other clinic, 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: 2

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. ^{1 2 3 4 5}

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. ^{3 6 7 8 9}

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

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.

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

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?

Group I: Standard of Care - CGM and RPM Experimental Treatment 1 Intervention

1\. Implement the 4T program as standard of care at Stanford Diabetes clinics, including Continuous Glucose Monitoring (CGM) and Remote Patient Monitoring (RPM) within the first 30 days after T1D diagnosis to reduce the rise in HbA1c trajectory observed 4-12 months post-diagnosis.

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

Approved in United States as CGM and RPM for:

• Type 1 diabetes management
• Type 2 diabetes management

Approved in European Union as CGM and RPM for:

• Type 1 diabetes management
• Type 2 diabetes management

Approved in Canada as CGM and RPM for:

• Type 1 diabetes management
• Type 2 diabetes management

Approved in Japan as CGM and RPM for:

• Type 1 diabetes management
• Type 2 diabetes management

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.

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 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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

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) 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]

Recent advancements in continuous glucose monitoring (CGM) and insulin delivery systems have significantly improved glucose control in individuals with type 1 diabetes mellitus (T1DM), as evidenced by increased time in range and decreased hypoglycemic events across multiple studies.

These technologies not only help lower HbA1c levels but also enhance quality of life and treatment satisfaction for both adults and children with T1DM, demonstrating their effectiveness without adding extra treatment burden.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The road from intermittently scanned continuous glucose monitoring to hybrid closed-loop systems. Part B: results from randomized controlled trials. De Ridder, F., den Brinker, M., De Block, C.[2023]

The Eversense continuous glucose monitoring (CGM) system demonstrated long-term safety with no related serious adverse events reported among 3023 patients over multiple sensor insertion-removal cycles, totaling 1260 patient-years of follow-up.

The most common minor adverse events included site infections and irritation, but these occurred at low rates, indicating that the Eversense CGM system is generally well-tolerated in real-world settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-World Safety of an Implantable Continuous Glucose Sensor Over Multiple Cycles of Use: A Post-Market Registry Study. Deiss, D., Irace, C., Carlson, G., et al.[2020]

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 involving six subjects with type 1 diabetes, the Navigator continuous glucose monitoring (CGM) device demonstrated the highest accuracy with a mean absolute relative difference (MARD) of 11.8%, compared to 16.5% for the Seven Plus and 20.3% for the Guardian.

The Navigator and Guardian devices showed nearly 100% data reporting reliability, while the Seven Plus had a lower reliability at 76%, highlighting significant differences in performance among the CGM devices tested.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparative effectiveness analysis of three continuous glucose monitors. Damiano, ER., El-Khatib, FH., Zheng, H., et al.[2022]

A survey of 310 participants with type 1 diabetes using advanced technologies showed that 80% were open to receiving mobile health (mHealth) support to improve glucose control, indicating a strong interest in digital health solutions.

Among those receptive to mHealth support, 98% were willing to share their continuous glucose monitoring (CGM) data, with a preference for communication through smartphone apps (71%) and SMS text messages (56%), highlighting the potential for personalized diabetes management through technology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accessibility and Openness to Diabetes Management Support With Mobile Phones: Survey Study of People With Type 1 Diabetes Using Advanced Diabetes Technologies. Lin, YK., Richardson, C., Dobrin, I., et al.[2023]

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]

The Guardian™ continuous glucose monitoring (CGM) system showed good accuracy in measuring glucose levels in children and adolescents with type 1 diabetes, with a mean absolute relative difference of about 10.9% for the Guardian Connect system and 11.1% for the Glucose Sensor Recorder.

The system was safe, with only one minor adverse event reported (contact dermatitis) and no serious device-related complications, supporting its use for diabetes management in pediatric patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accuracy of a Fourth-Generation Continuous Glucose Monitoring System in Children and Adolescents with Type 1 Diabetes. Slover, RH., Tryggestad, JB., DiMeglio, LA., et al.[2018]

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]

The Continuous Glucose Monitoring System (CGMS) proved to be accurate and reliable for monitoring glucose levels in individuals with type 1 diabetes during recreational scuba diving, with a mean absolute difference of 14.4% in readings.

The CGMS effectively detected hypoglycemia before and after dives, showing high specificity (94%) and negative predictive value (98%), indicating it is a useful tool for managing diabetes in challenging environments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accuracy and reliability of continuous glucose monitoring in individuals with type 1 diabetes during recreational diving. Adolfsson, P., Ornhagen, H., Jendle, J.[2009]

Continuous glucose monitoring (CGM) significantly reduced HbA(1c) levels by an average of 0.30% compared to self-monitoring of blood glucose, particularly benefiting patients with higher baseline HbA(1c) levels and more frequent sensor usage.

CGM also led to a 23% reduction in exposure to hypoglycemia, indicating it not only helps in better glucose control but also enhances safety by reducing the risk of low blood sugar episodes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Glycaemic control in type 1 diabetes during real time continuous glucose monitoring compared with self monitoring of blood glucose: meta-analysis of randomised controlled trials using individual patient data. Pickup, JC., Freeman, SC., Sutton, AJ.[2022]

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