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

5000 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of the 4T program is to implement proven methods and emerging diabetes technology into clinical practice to sustain tight glucose control from the onset of type 1 diabetes (T1D) and optimize patient-reported and psychosocial outcomes. The investigators will expand the 4T (Teamwork, Targets, Technology, and Tight Control) program to all patients seen at Stanford Pediatric Diabetes Endocrinology as the standard of care. Disseminating the 4T program as the standard of care will optimize the benefits of diabetes technology by lowering HbA1c, improving PROs, and reducing disparities.

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 data supports the effectiveness of the treatment CGM and RPM 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 an improved quality of life. ^{1 2 3 4 5}

Is continuous glucose monitoring (CGM) safe for humans?

Continuous glucose monitoring (CGM) systems have been shown to be generally safe for humans, with studies reporting no serious adverse events related to the device. Some minor issues like sensor site infections and skin irritation have been noted, but these are relatively rare. ^{6 7 8 9 10}

How is the treatment using CGM and RPM for type 1 diabetes different from other treatments?

This treatment is unique because it uses continuous glucose monitoring (CGM) to provide real-time data on blood sugar levels, helping to predict and prevent dangerous highs and lows. It also incorporates remote patient monitoring (RPM), allowing healthcare providers to track and manage diabetes more effectively from a distance, which can improve overall glucose control and quality of life. ^{11 12 13 14 15}

Research Team

David M Maahs, MD, PhD

Principal Investigator

Stanford University

Eligibility Criteria

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

I or my guardian have a smartphone to use with the CGM for data sharing.

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

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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) 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]

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]

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]

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 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]

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) 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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

A Prospective Multicenter Evaluation of the Accuracy of a Novel Implanted Continuous Glucose Sensor: PRECISE II. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Effect of Continuous Glucose Monitoring on Glycemic Control, Acute Admissions, and Quality of Life: A Real-World Study. [2022]

3. Netherlands 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. [2022]

4. England 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. [2022]

5. United States 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]

6. Israel pubmed.ncbi.nlm.nih.gov

Continuous Glucose Monitoring in Pediatrics: The Gap between Potential Benefits and the Reality of Utility. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

Accuracy of a Fourth-Generation Continuous Glucose Monitoring System in Children and Adolescents with Type 1 Diabetes. [2018]

8. England pubmed.ncbi.nlm.nih.gov

Diabetes: the role of continuous glucose monitoring. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Real-World Safety of an Implantable Continuous Glucose Sensor Over Multiple Cycles of Use: A Post-Market Registry Study. [2020]

10. United States pubmed.ncbi.nlm.nih.gov

Accuracy and reliability of continuous glucose monitoring in individuals with type 1 diabetes during recreational diving. [2009]

11. United States pubmed.ncbi.nlm.nih.gov

Continuous glucose monitoring: current use and future directions. [2022]

12. United States 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. [2023]

13. United States pubmed.ncbi.nlm.nih.gov

A comparative effectiveness analysis of three continuous glucose monitors. [2022]

14. United States pubmed.ncbi.nlm.nih.gov

Crossing the technology divide: practical strategies for transitioning patients from multiple daily insulin injections to sensor-augmented pump therapy. [2018]

15. Canada 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. [2023]