100 Participants Needed

Continuous Glucose Monitoring for Type 2 Diabetes

OK
TS
Overseen ByTrevor Sobol
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Kathleen Dungan
Must be taking: Insulin
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 3 JurisdictionsThis treatment is already approved in other countries

Trial Summary

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.

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.12345

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.12678

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.235910

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.

Research Team

KD

Kathleen Dungan, MD

Principal Investigator

OSU Medical Center

Eligibility Criteria

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.
See 1 more

Exclusion Criteria

Prisoners
I am unable to give consent for medical procedures.
I am being discharged to a skilled nursing facility.
See 2 more

Timeline

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

Treatment Details

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.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Dexcom CGMExperimental Treatment1 Intervention

Find a Clinic Near You

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 profile image

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 profile image

Dr. Shelly Lane

DexCom, Inc.

Chief Medical Officer since 2023

MD from University of California, San Diego

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.
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.
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.
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]

References

A Modified CGM Algorithm Enhances Data Availability While Retaining iCGM Performance. [2022]
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]
Performance of a Factory-Calibrated, Real-Time Continuous Glucose Monitoring System in Pediatric Participants With Type 1 Diabetes. [2020]
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]
Accuracy of a Factory-Calibrated, Real-Time Continuous Glucose Monitoring System During 10 Days of Use in Youth and Adults with Diabetes. [2019]
Performance of a factory-calibrated, real-time continuous glucose monitoring system during elective abdominal surgery. [2021]
Adverse Event Causes From 2022 for Four Continuous Glucose Monitors. [2023]
Performance of the Dexcom G6 Continuous Glucose Monitoring System in Pregnant Women with Diabetes. [2021]
Real-World Evidence and Glycemic Improvement Using Dexcom G6 Features. [2021]
10.United Statespubmed.ncbi.nlm.nih.gov
New features and performance of a next-generation SEVEN-day continuous glucose monitoring system with short lag time. [2009]
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