A variety of classes of medications are used to help people manage their diabetes, but the quest for alternative means of treating the condition doesn’t stop there. According to Juan Carlos Lopez-Talavera, MD, “Type 2 diabetes is not simply a disease of blood sugar, but a multi-organ pathology that leads to progressive pancreatic beta-cell failure, fundamentally caused by insulin resistance. We know that treatment alternatives to current drug therapy are desperately needed…”
Dr. Lopez-Talavera is the chief medical officer of a Massachusetts-based biotechnology company called Fractyl Health, which has recently announced that the U.S. Food and Drug Administration (FDA) has granted the company Breakthrough Device Designation for a new diabetes treatment that doesn’t rely on medication. The FDA launched the Breakthrough Device Program in order to give patients and healthcare providers access to new medical devices an treatments by accelerating the development and assessment of equipment that has the potential to generate more effective diagnosis and treatment of serious diseases.
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The new breakthrough therapy from Fractyl is called Revita DMR. DMR stands for duodenal mucosal resurfacing, a procedure based on Fractyl’s research into the role the gut plays in metabolic diseases (diseases that interfere with the body’s ability to process the nutrients in food). Duodenal mucosal resurfacing, which has already been tried on nearly 300 patients, is an outpatient endoscopic therapy that employs heat to resurface the lining of the upper intestine. The researchers at Fractyl believe Revita DMR has the potential to decrease insulin resistance, improve blood sugar control, lower weight, and decrease liver fat. As the company describes the therapy, it “directly addresses the intestinal hormonal impairment that contributes to insulin resistance and changes how the body absorbs and processes sugar.” Some patients, Fractyl believes, might be able to do without insulin. The company is also exploring the possible use of Revita DMR in metabolic disorders besides diabetes, such as nonalcoholic steatohepatitis (NASH) and polycystic ovarian syndrome (PCOS),
In 2015, Fractyl announced that the results of a small study (39 patients) done at a single site in Brazil indicated that the DMR system brought beneficial changes in blood sugar levels that were similar to those that follow weight-loss surgery. In order to further investigate the potential of Revita DMR, Fractyl is now enrolling patients who have insulin-treated type 2 diabetes in a much larger trial, which will enroll 300 type 2 patients at as many as 35 sites around the world. The results of that trial, if they are promising, will be submitted to the FDA for approval. To be eligible, participants must be between 21 and 70 years old, have been diagnosed with type 2 diabetes, and be currently taking long-acting insulin. Participation in the trial will be carried out in three stages. First comes a screening period of up to three months to determine if the study is suitable for the patient. That’s followed by a one-day visit to a study center where the procedure will be performed. Finally, a follow-up period will consist of six study visits either at the study center or the patient’s home, along with five phone calls.
Those interested can visit the study website or call 855-608-8751.
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