Continuous Glucose Monitoring for Type 2 Diabetes

Overseen By Trevor Sobol

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Kathleen Dungan

Must be taking: Insulin

Disqualifiers: Type 1 DM, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a device that continuously monitors blood sugar levels in hospitalized patients with type 2 diabetes who need insulin. The device sends data to the patient's smartphone and alerts them and their doctor if their blood sugar is too high or too low. This helps in better managing their diabetes after they leave the hospital. The device allows a person with diabetes to see their glucose levels continuously and to receive predictive alerts.

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 seems likely that you can continue your usual diabetes treatment, as the study involves monitoring glucose levels with a device.

Is the Dexcom G6 Continuous Glucose Monitoring System safe for humans?

The Dexcom G6 Continuous Glucose Monitoring System has been shown to be safe in various studies, including those involving pregnant women with diabetes and adults undergoing surgery. No device-related adverse events were reported, and any skin reactions were minor. ^{1 2 3 4 5}

How does continuous glucose monitoring differ from other treatments for type 2 diabetes?

Continuous glucose monitoring (CGM) like the Dexcom G6 system offers real-time tracking of blood sugar levels without the need for frequent finger pricks, unlike traditional self-monitoring methods. It provides alerts for high and low blood sugar levels, helping users manage their diabetes more effectively by making timely adjustments to their diet or medication. ^{5 6 7 8 9}

What data supports the effectiveness of the treatment Dexcom G6 CGM System for Type 2 Diabetes?

The Dexcom G6 CGM System has been shown to improve blood sugar control, as indicated by a significant reduction in hemoglobin A1c (a measure of average blood sugar levels over time) from 8.2% to 7.1% in people with Type 2 Diabetes using intensive insulin therapy. Additionally, users reported reduced diabetes-related stress and high satisfaction with the system. ^{4 5 7 8 10}

Who Is on the Research Team?

Kathleen Dungan, MD

Principal Investigator

OSU Medical Center

Are You a Good Fit for This Trial?

This trial is for adults over 18 with Type 2 Diabetes who use more than 10 units of basal insulin daily, have an A1c level above 8.0%, and own a smartphone compatible with the Clarity App. It's not for those in prison, unable to consent, discharged to nursing facilities, pregnant women, or individuals with Type 1 Diabetes.

Inclusion Criteria

I have Type 2 Diabetes.

Your hemoglobin A1c level is higher than 8.0%.

You have a smartphone that can use the Clarity App.

Exclusion Criteria

Prisoners

I am unable to give consent for medical procedures.

I am being discharged to a skilled nursing facility.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a Dexcom continuous glucose monitor (CGM) to wear post-hospital discharge for 12 weeks. CGM data is captured and analyzed, with personalized targets and alerts provided.

12 weeks

Initial setup visit, followed by remote monitoring

Extension

Continuation of CGM use for an additional 12 weeks to collect data on glucose control, without further reports to providers.

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Dexcom G6

Trial Overview The study tests how using the DexCom G6 continuous glucose monitor (CGM) after hospital discharge affects patients' blood sugar control over a period of 12 weeks. Participants will track their glucose levels via a smartphone app and receive personalized targets and alerts.

How Is the Trial Designed?

Group I: Dexcom CGM Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Kathleen Dungan

Lead Sponsor

Trials

6

Recruited

430+

DexCom, Inc.

Industry Sponsor

Trials

151

Recruited

35,700+

Kevin Sayer

DexCom, Inc.

Chief Executive Officer since 2015

Bachelor’s and Master’s degrees in Accounting and Information Systems from Brigham Young University

Dr. Shelly Lane

DexCom, Inc.

Chief Medical Officer since 2023

MD from University of California, San Diego

Published Research Related to This Trial

The enhanced algorithm for the Dexcom G6 Continuous Glucose Monitoring (CGM) System maintained high accuracy, with a 91.8% accuracy rate, while significantly reducing sensor errors.

The new algorithm led to a 59% decrease in total time spent in sensor error, improving data availability, which could enhance patient experience and integration with insulin delivery systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Modified CGM Algorithm Enhances Data Availability While Retaining iCGM Performance. Harvey Towers, RA., Zhang, X., Yousefi, R., et al.[2022]

The Dexcom G6 real-time continuous glucose monitoring (RT-CGM) system significantly improves glycemic control in adults with type 1 diabetes, showing a projected HbA1c reduction of 1.0% compared to 0.4% with standard blood glucose monitoring (SMBG).

Despite higher lifetime costs associated with RT-CGM (CAD 35,353 more than SMBG), it provides substantial quality of life benefits and is considered cost-effective, with an incremental cost-effectiveness ratio of CAD 16,931 per quality-adjusted life year (QALY) gained.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the Long-Term Cost-Effectiveness of the Dexcom G6 Continuous Glucose Monitor versus Self-Monitoring of Blood Glucose in People with Type 1 Diabetes in Canada. Roze, S., Isitt, JJ., Smith-Palmer, J., et al.[2022]

The Dexcom G6 continuous glucose monitoring (CGM) system demonstrated a mean absolute relative difference (MARD) of 7.7% in accuracy when compared to laboratory blood glucose measurements, indicating high reliability for monitoring glucose levels in children and adolescents with type 1 diabetes.

With 96.2% of estimated glucose values falling within 20% of the reference values, the G6 system's accuracy supports its potential to enhance glycemic control and encourage consistent use among young patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Performance of a Factory-Calibrated, Real-Time Continuous Glucose Monitoring System in Pediatric Participants With Type 1 Diabetes. Welsh, JB., Zhang, X., Puhr, SA., et al.[2020]

In a study of 248 patients with type 1 or type 2 diabetes, initiating continuous glucose monitoring (CGM) with the Dexcom G6 System led to a significant reduction in HbA1c levels from 8.2% to 7.1% over 3-5 months, indicating improved glycemic control.

Participants also reported decreased diabetes distress and hypoglycemic concerns, with high satisfaction rates (93%) and ease of use (73%) for the CGM system, suggesting positive psychosocial impacts alongside clinical benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Change in Hemoglobin A1c and Quality of Life with Real-Time Continuous Glucose Monitoring Use by People with Insulin-Treated Diabetes in the Landmark Study. Gilbert, TR., Noar, A., Blalock, O., et al.[2022]

The G6 continuous glucose monitoring (CGM) system, which is factory-calibrated and designed for 10-day wear, demonstrated high accuracy with 92.3% of readings within ±20% of reference glucose values, making it a reliable tool for managing diabetes.

The system also features an 'Urgent Low Soon' alert that accurately predicts hypoglycemia 84% of the time, enhancing safety for users and addressing common barriers to CGM adoption.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accuracy of a Factory-Calibrated, Real-Time Continuous Glucose Monitoring System During 10 Days of Use in Youth and Adults with Diabetes. Wadwa, RP., Laffel, LM., Shah, VN., et al.[2019]

The Dexcom G6 continuous glucose monitoring system demonstrated acceptable accuracy during elective abdominal surgery, with a mean absolute relative difference of 12.7% between sensor readings and reference glucose values, based on 1207 data pairs from 20 adults.

No clinically significant adverse events were reported, indicating that the Dexcom G6 is a safe option for peri-operative glucose management in patients with (pre)diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Performance of a factory-calibrated, real-time continuous glucose monitoring system during elective abdominal surgery. Tripyla, A., Herzig, D., Joachim, D., et al.[2021]

In 2022, there were 281,963 reported adverse events related to continuous glucose monitors (CGMs), highlighting a significant safety concern for people with diabetes.

The analysis of adverse events for four CGM products revealed that common issues included inaccuracy and device malfunctions, indicating a need for improved monitoring and device reliability to enhance user experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse Event Causes From 2022 for Four Continuous Glucose Monitors. Krouwer, JS.[2023]

The Dexcom G6 continuous glucose monitoring system demonstrated high accuracy in pregnant women with diabetes, with 92.5% of CGM values falling within ±20% of reference blood glucose values, indicating reliable performance across different sensor wear sites.

The study found no significant device-related adverse events, and skin reactions at insertion sites were either absent or minor, highlighting the safety of the Dexcom G6 system for use in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Performance of the Dexcom G6 Continuous Glucose Monitoring System in Pregnant Women with Diabetes. Castorino, K., Polsky, S., O'Malley, G., et al.[2021]

The use of optional features in the G6 continuous glucose monitoring (CGM) system, such as alerts and remote data sharing, is associated with better glycemic outcomes, including increased time in range (TIR) for users.

Younger patients and those with type 1 diabetes are more likely to utilize certain features, indicating that demographics influence how effectively patients engage with CGM technology to manage their diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-World Evidence and Glycemic Improvement Using Dexcom G6 Features. Akturk, HK., Dowd, R., Shankar, K., et al.[2021]

The SEVEN PLUS System, a new continuous glucose monitoring device, demonstrated a median absolute relative difference of 13.0% compared to laboratory reference measurements, indicating good accuracy in glucose tracking for the 53 participants, mostly with type 1 diabetes.

The device showed improved sensor life, with 89% of sensors lasting the full 7 days, and no serious adverse events were reported, highlighting its safety and reliability for users.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New features and performance of a next-generation SEVEN-day continuous glucose monitoring system with short lag time. Bailey, T., Zisser, H., Chang, A.[2009]

Citations

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

A Modified CGM Algorithm Enhances Data Availability While Retaining iCGM Performance. [2022]

2. New Zealand pubmed.ncbi.nlm.nih.gov

Evaluation of the Long-Term Cost-Effectiveness of the Dexcom G6 Continuous Glucose Monitor versus Self-Monitoring of Blood Glucose in People with Type 1 Diabetes in Canada. [2022]

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

Performance of a Factory-Calibrated, Real-Time Continuous Glucose Monitoring System in Pediatric Participants With Type 1 Diabetes. [2020]

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

Change in Hemoglobin A1c and Quality of Life with Real-Time Continuous Glucose Monitoring Use by People with Insulin-Treated Diabetes in the Landmark Study. [2022]

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

Accuracy of a Factory-Calibrated, Real-Time Continuous Glucose Monitoring System During 10 Days of Use in Youth and Adults with Diabetes. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Performance of a factory-calibrated, real-time continuous glucose monitoring system during elective abdominal surgery. [2021]

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

Adverse Event Causes From 2022 for Four Continuous Glucose Monitors. [2023]

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

Performance of the Dexcom G6 Continuous Glucose Monitoring System in Pregnant Women with Diabetes. [2021]

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

Real-World Evidence and Glycemic Improvement Using Dexcom G6 Features. [2021]

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

New features and performance of a next-generation SEVEN-day continuous glucose monitoring system with short lag time. [2009]