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OneTouch 24/7 CGM System Clinical Trial Protocol-OneTouch 24/7 CGM System Pivotal Clinical Trial


We are excited to announce the opportunity to join the OneTouch 24/7 CGM System Clinical Trial Protocol conducted at Ocean Wellness Center and Help Shape the Future of Diabetes Management!

Are you ready to make a significant impact on diabetes care? We invite individuals with diabetes to participate in this groundbreaking clinical trial for the OneTouch 24/7 CGM System. This trial, conducted at Ocean Wellness Center, aims to evaluate the effectiveness, accuracy, and usability of this advanced Continuous Glucose Monitoring (CGM) system in transforming diabetes management.


What is the OneTouch 24/7 CGM System?

The OneTouch 24/7 CGM System is at the forefront of diabetes technology, providing real-time glucose monitoring that empowers individuals with diabetes. By continuously measuring glucose levels throughout the day and night, this system offers valuable insights into patterns, trends, and fluctuations, enabling personalized and proactive diabetes management.


Benefits of Participating in the Clinical Trial:

1️⃣ Access to Innovative Technology: Experience the latest advancements in diabetes management with the OneTouch 24/7 CGM System, offering real-time glucose data and customizable alerts.

2️⃣ Expert Medical Supervision: Benefit from the guidance and support of a team of experienced healthcare professionals and researchers at Ocean Wellness Center throughout the trial.

3️⃣ Contribute to Scientific Research: By participating, you play a vital role in advancing our understanding of the OneTouch 24/7 CGM System and its impact on diabetes management, potentially benefiting millions of individuals worldwide.


Inclusion Criteria:

To be eligible for participation, individuals should meet the following criteria:

1️⃣ Diagnosis of diabetes (Type 1 or Type 2)

2️⃣ Willingness to comply with the study protocol and complete all study procedures

3️⃣ Males and females aged 18 years or older

4️⃣ Known history of Type 1 Diabetes (T1D) or Type 2 Diabetes (T2D) with current, active use of insulin therapy

5️⃣ Agreement not to inject insulin or wear an insulin pump within 3 inches of the back of the upper arm or abdominal CGM device insertion site

6️⃣ Agreement not to apply the CGM device within 3 inches of a recent insulin pump infusion site

7️⃣ Willingness to wear CGM devices on both the abdominal area and back of the upper arm

8️⃣ Agreement not to use the CGM system glucose results for making insulin dosing or medication decisions while involved in the clinical study

9️⃣ Willingness to participate in the study for a period of 21 days and wear the CGM sensor 24 hours a day


Exclusion Criteria:

The following conditions exclude participation in the trial:

1️⃣ Acute illness with a recent hospital admission within 30 days

2️⃣ Cognitive disorder or other conditions rendering the subject unable to understand the nature, scope, and possible consequences of the study

3️⃣ Females who are pregnant or breastfeeding at the time of enrollment into the study, or who become pregnant during the study period

4️⃣ History of Diabetic Ketoacidosis (DKA) in the 12 months prior to the study session

5️⃣ History of severe migraines in the last 6 months, history of syncope in the last 6 months, history of epilepsy, history of adrenal disease

6️⃣ Hypoglycemia requiring clinical evaluation in the last 6 months, or history of severe hypoglycemia unawareness that presents a safety risk unmonitored, as defined by the Principal Investigator


How to Participate:

If you meet the inclusion criteria or want to learn more about this exciting clinical trial, contact our research team at 786-320-5233. Our dedicated team at Ocean Wellness Center will provide you with detailed information about the trial, eligibility requirements, and answer any questions you may have.


Don't miss this opportunity to be part of groundbreaking research conducted at Ocean Wellness Center and contribute to the advancement of diabetes management. Together, let's shape the future of diabetes care with the OneTouch 24/7 CGM System!


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