Individuals with Type 2 diabetes are needed for a research study

Individuals with Type 2 diabetes are needed for a research study

Type 2 diabetes is a worldwide growing disease, common among adults. The current treatment consists of lifestyle changes and medications to keep the blood sugar at a healthy level. The ReCET Procedure is a non-surgical, investigational treatment designed to reduce blood sugar levels and improve glycemic control in adults with Type 2 diabetes.
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Disease information

Diabetes is a common condition, affecting approximately 10% of the adult population worldwide. Type 2 diabetes is the most prevalent type, accounting for 90% of all diabetic cases. When diagnosed with Type 2 diabetes, there is an impairment in processing sugar received in the diet, resulting in high blood sugar levels. The disease develops gradually, and risk factors include obesity, past family history, old age, and low physical activity. Several comorbidities are also related to diabetes and can include heart and blood vessel diseases, nerve damage, and kidney diseases.  

The current therapy for Type 2 diabetes includes lifestyle changes (diet and physical activity), medicines to increase insulin sensitivity, weight loss medication and insulin.  

Therapeutic background 

Managing diabetes can be challenging and does not only affect physical well-being but often the individual’s quality of life and mental health. This research study is therefore assessing a non-surgical, investigational treatment that aims to improve glucose regulation for individuals using non-insulin glucose lowering medications. The therapy is designed to induce a regeneration of healthy tissue in the intestine using a highly controlled electric energy. It is delivered through an endoscopic procedure. If you are interested and qualify for the study, you have the opportunity to participate in this research study. 

Who can participate? 

  • Males and females
  • Diagnosed with Type 2 diabetes
  • 22–70 years old
  • Using blood sugar control medications
  • Not using insulin

Site locations 

  • Camden, NJ
  • New Brunswick, NJ
  • Cleveland, OH
  • West Des Moines, IA
  • Chicago, IL
  • Dallas, TX
  • De Soto, TX
  • Cedar Park, TX
  • Round Rock, TX
  • Austin, TX
  • Bellaire, TX
  • Houston, TX
  • Sugar Land, TX
  • San Antonio, TX
  • Birmingham, AL
  • Orlando, FL
  • Ocoee, FL
  • West Palm Beach, FL
  • Hallandale Beach, FL
  • Miami Beach, FL
  • Miami, FL
  • Los Angeles, CA

Reimbursement 

If you are eligible and enrolled in the study you will be reimbursed for your time and expenses, such as travel. The study site staff will provide more information. The study procedure and tests required by the study are provided free of charge. 

Study description 

The research study will assess the safety and effectiveness of an investigational medical procedure for individuals with Type 2 diabetes. If you are interested and qualify to participate, staff at the study site will provide you with a detailed overview of the steps required to participate before you agree to take part. The staff will also take the time to review and discuss any questions you may have to ensure you are comfortable with participation. You have the right to withdraw from the trial with or without a reason at any time. This will not impact your future possibilities to receive health care. 

Screening and baseline visit 

Before you can be enrolled to the research study you will go through a pre-screening assessment over the phone to determine your eligibility. Your ability to participate in the study will be further assessed at the study site. At the study site, the study will be explained to you in detail, your questions will be answered, and you will be asked to sign the consent form. Your health status will be assessed, and additional tests, such as blood tests, will be conducted.  

The Procedure

The ReCET Procedure is a non-surgical, investigational treatment designed to reduce blood sugar levels and improve glycemic control in adults with Type 2 diabetes. During the procedure, a doctor introduces a small camera through the mouth to place a specialized device (catheter) in the duodenum (the first part of the small intestine). The catheter then delivers highly controlled electric energy to the lining of the duodenum. This energy triggers the body’s natural process to regenerate healthy cells that can help control blood sugar levels. The camera and catheter are then removed, and nothing is left inside the body. 
 
Following routine observation, the patient can return home the same day and resume normal activities shortly after. 

Post procedure follow-up

Your blood sugar control and health status will be monitored closely by the study site staff after the procedure.  You will also receive monthly lifestyle coaching sessions to help you develop a healthy lifestyle that are beneficial for your diabetes management. 

What does "investigational" mean in research?

Investigational means the ReCET™ System can only be used in clinical research studies. Use outside these studies is not approved by regulatory authorities like the U.S. Food and Drug Administration (FDA) or Therapeutic Goods Administration (TGA) in Australia. 

Timeframe

You will have 9 visits at the study site, with additional tests. Remote visits will occur in addition to the physical visits at the site. In the figure below you can see the maximum duration of the different periods of the research study.

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The goal of Health Panel is to improve health through research, but we need your help to do so. You can help by signing up for Health Panel and thereby possibly become a participant in research projects. We will only contact you if your health profile is consistent with a current research project. All research projects are pre-approved by the respective  Independent Ethics Committees (IEC) or Institutional Review Boards (IRB).

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