Continuous Glucose Monitoring for Type 2 Diabetes
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?
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
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
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.
Extension
Continuation of CGM use for an additional 12 weeks to collect data on glucose control, without further reports to providers.
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Dexcom G6
Find a Clinic Near You
Who Is Running the Clinical Trial?
Kathleen Dungan
Lead Sponsor
DexCom, Inc.
Industry Sponsor
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