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Continuous Glucose Monitoring Device
Continuous Glucose Monitoring for Diabetes
N/A
Waitlist Available
Led By Tresa McNeal, MD
Research Sponsored by Baylor Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 10 days
Awards & highlights
Study Summary
This trial will test whether or not systematic continuous glucose monitoring is an effective treatment option for patients with diabetes who are receiving care in a hospital setting.
Who is the study for?
This trial is for adults with diabetes who are hospitalized and expected to stay at least two more days. Participants must be willing to wear a CGM device and not use high doses of acetaminophen. It's not for pregnant or lactating women, those planning surgery within 48 hours, patients with certain skin conditions or allergies, active substance abusers, organ transplant recipients, or those with severe medical conditions.Check my eligibility
What is being tested?
The study tests the Dexcom Gen6 continuous glucose monitoring (CGM) device in hospitalized diabetic patients outside the ICU. The goal is to see if this newer CGM technology can improve blood sugar control and reduce hypoglycemic events compared to older devices.See study design
What are the potential side effects?
Potential side effects may include skin irritation or allergic reactions where the CGM device attaches due to adhesive or disinfectants used on the skin.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 10 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 10 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Hypoglycemia Events during hospitalization
Secondary outcome measures
Number of Hyperglycemia Events during hospitalization
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Treatment GroupExperimental Treatment1 Intervention
Treatment Group subjects will wear the CGM device during their hospitalization, up to 10 days, and glucose readings WILL be continuously monitored. Treatment Group subjects will have their glucose management guided by readings from the CGM device and standard of care finger sticks.
Group II: Control GroupActive Control1 Intervention
Control Group subjects will wear the CGM device during their hospitalization, up to 10 days, but glucose readings will NOT be continuously monitored. Control Group subjects will have their glucose management guided by routine standard of care finger sticks. The readings from the CGM device are recorded and reviewed retrospectively, but not used for glucose management during the hospital stay.
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Who is running the clinical trial?
Baylor Research InstituteLead Sponsor
200 Previous Clinical Trials
203,186 Total Patients Enrolled
1 Trials studying Diabetes
202 Patients Enrolled for Diabetes
Tresa McNeal, MDPrincipal InvestigatorBaylor Scott & White Medical Center - Temple
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You are 18 years old or older and have diabetes.You have taken more than 4 grams of Tylenol in a 24-hour period.You have skin conditions or injuries in areas where the device needs to be placed that could affect its accuracy.You have either Type 1 or Type 2 diabetes.You have had an organ transplant.You might need to receive insulin through a vein.People who are not expected to live much longer.You are currently very sick and need to stay in the intensive care unit or are expected to need intensive care soon.You are currently using drugs or alcohol excessively.You have serious medical conditions such as advanced kidney or liver disease, severe heart failure, or severe infection.
Research Study Groups:
This trial has the following groups:- Group 1: Control Group
- Group 2: Treatment Group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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