Continuous Glucose Monitoring for Diabetes

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Must be taking: Insulin

Must not be taking: Acetaminophen, Hydroxyurea

Disqualifiers: Dementia, Suicidal ideations, Liver cirrhosis, End stage renal disease, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 10 days

100 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does exclude participants taking certain medications like acetaminophen in high doses and hydroxyurea. It also excludes those using a continuous glucose monitor (CGM) for insulin dosing or glucose checks.

What data supports the effectiveness of the treatment Dexcom G6 Continuous Glucose Monitoring System for diabetes?

Research shows that the Dexcom G6 system is accurate and reliable, with improvements in data availability and reduced sensor errors, which can enhance the user experience and integration with insulin delivery systems. Additionally, frequent use of this system is linked to better blood sugar control in people with diabetes. ^{1 2 3 4 5}

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

The Dexcom G6 Continuous Glucose Monitoring System is generally safe for use in humans, though some users have reported skin reactions to the adhesive used in the device. In a study with pregnant women with diabetes, the system was found to be accurate and safe, with no device-related adverse events and only minor or absent skin reactions at insertion sites. ^{6 7 8 9 10}

How is the Dexcom G6 PRO treatment different from other diabetes treatments?

The Dexcom G6 PRO is unique because it is a factory-calibrated continuous glucose monitoring (CGM) system that provides real-time glucose readings for up to 10 days without the need for manual calibrations, making it more convenient and user-friendly compared to traditional glucose monitoring methods. ^{3 4 5 6 11}

What is the purpose of this trial?

The purpose of this study is to measure differences in diabetes control with the use of continuous glucose monitor (CGM) and diabetes education compared with standard of care for glucose monitoring (glucometer checks) and diabetes education in participants with diabetes mellitus receiving therapy with insulin and being admitted to Mayo Clinic Advanced Care at Home Program (ACH).

Research Team

Adrian Dumitrascu, MD

Principal Investigator

Mayo Clinic

Eligibility Criteria

This trial is for adults with Type 1 or Type 2 diabetes using insulin and admitted to the Mayo Clinic's Advanced Care at Home Program. They must be able to consent, stay in the program for at least 72 hours, and handle a smartphone. It excludes pregnant/nursing individuals, those allergic to medical adhesives, with dementia or altered mental status, on dialysis, using other CGMs or certain medications.

Inclusion Criteria

I have been diagnosed with diabetes (type 1 or 2).

I use insulin injections or an insulin pump for my diabetes.

I am able to understand and sign the consent form.

Exclusion Criteria

I am currently taking hydroxyurea.

I am currently being treated for a severe diabetes complication.

I use a continuous glucose monitor for my diabetes management.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive continuous glucose monitoring or standard care for glucose monitoring for diabetes management

10 days

Home-based monitoring

Follow-up

Participants are monitored for continued use of continuous glucose monitor and diabetes control

40 days

Treatment Details

Interventions

• Dexcom G6 PRO

Trial Overview The study tests if a Continuous Glucose Monitor (Dexcom G6 PRO) combined with diabetes education improves blood sugar control compared to standard glucose meter checks and education in home care patients.

Participant Groups

Group I: Continuous Glucose Monitoring Experimental Treatment 1 Intervention

Subjects admitted to the Advanced Care at Home program (home hospital) will have the continuous glucose monitor sensor placed for up to 10 days to monitor and dose insulin.

Group II: Control Arm (Standard of Care) Active Control 1 Intervention

Subjects admitted to the Advanced Care at Home program (home hospital) will continue with standard of care glucose monitoring (capillary glucose levels checked via glucometer), insulin dosing, and DM treatment during the 10 day period.

Dexcom G6 PRO is already approved in United States, European Union for the following indications:

Approved in United States as Dexcom G6 for:

• Management of diabetes in persons aged 2 years and older

Approved in European Union as Dexcom G6 for:

• Continuous glucose monitoring in people with diabetes aged 2 years and older

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Findings from Research

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 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]

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]

In a study involving 11 patients with type 1 diabetes, the Dexcom G5 Mobile (DG5) continuous glucose monitor demonstrated significantly better accuracy than the Eversense (EVS) implantable sensor during controlled clinical conditions, particularly when blood glucose levels were decreasing.

While both devices showed similar accuracy during home monitoring, DG5 had a lower median absolute relative difference (ARD) of 7.91% compared to EVS's 11.4% during glucose excursions in a clinical setting, indicating it may be more reliable for detecting rapid changes in glucose levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparing the accuracy of transcutaneous sensor and 90-day implantable glucose sensor. Boscari, F., Vettoretti, M., Amato, AML., et al.[2021]

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 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]

In a study of five patients experiencing allergic contact dermatitis (ACD) from the Dexcom G6 glucose monitoring system, all were found to be sensitized to the new adhesive component 2,2'-methylenebis(6-tert-butyl-4-methylphenol) monoacrylate (MBPA), indicating it is a significant cause of skin reactions.

Testing revealed that isobornyl acrylate (IBOA) was not present in the adhesive and did not contribute to the skin issues, confirming that MBPA is the primary allergen responsible for the increased skin problems associated with the updated Dexcom G6 model.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Contact allergy to the Dexcom G6 glucose monitoring system-Role of 2,2'-methylenebis(6-tert-butyl-4-methylphenol) monoacrylate in the new adhesive. Oppel, E., Högg, C., Oschmann, A., et al.[2022]

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 analysis of adverse events for the Medtronic 670G insulin pump revealed that users experienced more hypoglycemic events when the auto mode was activated compared to when it was turned off.

For the Dexcom continuous glucose monitors, complaints about inaccuracies were most common when the readings fell within the acceptable range (B zone), indicating potential confusion among users regarding the reliability of the device.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Analysis of 2019 FDA Adverse Events for Two Insulin Pumps and Two Continuous Glucose Monitors. Krouwer, JS.[2022]

The FDA is considering a nonadjunctive label claim for the DEXCOM G5 Mobile continuous glucose monitoring (CGM) system, which would allow users to make insulin dosing decisions based solely on CGM data without needing confirmatory blood glucose tests.

If approved, this change could enhance diabetes management by providing real-time glucose readings every 5 minutes, along with alerts and trending information, potentially reducing the risk of hypoglycemia and improving overall patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Regulation Catches Up to Reality. Edelman, SV.[2019]

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]

References

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

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

2. 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]

3. 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]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Comparing the accuracy of transcutaneous sensor and 90-day implantable glucose sensor. [2021]

5. 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]

6. 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]

7. England pubmed.ncbi.nlm.nih.gov

Contact allergy to the Dexcom G6 glucose monitoring system-Role of 2,2'-methylenebis(6-tert-butyl-4-methylphenol) monoacrylate in the new adhesive. [2022]

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

An Analysis of 2019 FDA Adverse Events for Two Insulin Pumps and Two Continuous Glucose Monitors. [2022]

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

Regulation Catches Up to Reality. [2019]

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

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