What is the STEP-1 Study?
The STEP-1 study is evaluating if an investigational medical device is safe and effective for reducing HbA1c and weight when used alongside lifestyle and dietary counseling in adults with type 2 diabetes who have not had success with other therapies. If you were diagnosed with type 2 diabetes less than 15 years ago and are not currently taking insulin, you may be able to participate.
What is the Investigational Device?
The investigational device is a thin, flexible sleeve called EndoBarrier®. It is designed to be a minimally-invasive alternative to insulin injections or surgery for people living with uncontrolled type 2 diabetes. The device is endoscopically placed by a physician in an outpatient procedure and can be left in place for up to 12 months.
The device is considered investigational in this study because it has not yet been approved for use. In previous studies, participants who received the device experienced a reduction in HbA1c and weight.
Why Participate?
Before a new medical device can become commercially available in the US, it must first be tested in a series of clinical trials. By choosing to volunteer for this study, you can help us learn more about how EndoBarrier® works. Your participation will contribute to research that may improve future treatment options for others living with uncontrolled type 2 diabetes.
Who Can Participate?
This study may be an option for people who are 30 to 65 years of age and meet the following requirements:
- Patients on a stable dose of at least 2 diabetes medications
- Diagnosed with type 2 diabetes less than 15 years ago
- HbA1c between 8 - 10% despite being on a stable dose of 2 diabetes medication(s) for at least 3 months
- Not currently taking insulin
- BMI between 30 - 50 kg/m2
There are other requirements to participate in this study. Answer a few questions to connect with a member of the study team, or visit ClinicalTrials.gov to learn more.
What To Expect
If you are eligible for this study and decide to participate, you will undergo an outpatient procedure under general anesthesia. During the procedure, the study doctor will place a thin tube with a small camera down your throat to view the inside of your upper gastrointestinal tract. If you have been assigned to receive the investigational device, the study doctor will implant it at the top of your small intestine. This is a "blinded" study, which means you will not initially know if you have received the investigational device. If it was placed, the study doctor will remove it after 12 months.
You will be enrolled in the study for about 24 months (2 years) and will need to attend at least 21 study visits and 2 follow-up phone calls during this time. These visits may include physical exams, blood draws, imaging, questionnaires, and counseling from a Registered Dietician. You will also need to track your weight, glucose level, and temperature every day in an electronic diary. The study team will show you how to use this.
Frequently Asked Questions
How is the investigational device placed?
The device is endoscopically implanted in the small intestine by a trained physician. During placement, the physician uses a thin tube guided by a camera to implant the device within the small intestine. Placement is performed as an outpatient procedure under general anesthesia and does not require incisions.
How does the investigational device work?
Once in place, the device conforms to the shape and movement of the intestine. It creates a physical barrier between receptors in the intestinal wall and food that has been shown to directly affect key hormone levels. Researchers believe these changes in gut hormones mimic those caused by Roux-en-Y gastric bypass, resulting in decreased HbA1c, BMI, and weight.
How is the investigational device removed?
The device is removed by a trained physician through a similar endoscopic outpatient procedure under general anesthesia.
What are the potential benefits of participating in the STEP-1 study?
Your health will be closely monitored throughout your time in the study, and you will receive all study-related procedures at no cost. Additionally, you have a 3 to 1 chance of receiving the investigational device, which may lower blood sugar levels, increase weight loss, and reduce cardiovascular risk. It is possible that you may not experience any benefit from participating in this study.
What are the potential risks?
All research studies and medical procedures come with some risks. The most commonly reported complications of the investigational device are gastrointestinal in nature and include nausea, vomiting, and upper abdominal pain. These are more likely in the early days and weeks following placement. The study team will discuss possible risks with you before you decide to participate.
What are the chances of receiving the investigational device?
Participants will be assigned to receive the device in a 3:1 ratio. This means you are 3 times more likely to receive it than not.
How long will I be in the study?
If you participate in this study, you will be enrolled for about 24 months (2 years).
What is required of me if I participate in this study?
You will need to attend regular visits throughout the study that may include blood tests, liver scans, and other assessments. You will also need to measure your blood sugars, temperature, and weight at home daily. Additionally, you will be asked to follow lifestyle guidance and recommendations from a registered dietician.
If I join the STEP-1 study, can I continue taking my medications?
You may remain on approved medications throughout the study. At your Screening Visit, you should tell the study team about all of the medications you take. If you are taking sulfonylureas, you will need to discontinue use 3 days before your implant procedure. The study team will let you know if this applies to you and will provide further instructions.
What if this study is not right for me?
Participating in this study is completely optional and up to you. You can choose to leave the study at any time, for any reason. Choosing to not participate in the STEP-1 study will not affect your future medical care in any way.
Does it cost anything to participate?
No. Additionally, you will receive compensation for study-related travel expenses.