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Focused Ultrasound Therapy

Focused ultrasound is a noninvasive, therapeutic technology with the potential to improve the quality of life and decrease the cost of care for patients with diabetes. This novel technology focuses beams of ultrasound energy precisely and accurately on targets deep in the body without damaging surrounding normal tissue.

How it Works
Where the beams converge, focused ultrasound produces several therapeutic effects that are being evaluated. One mechanism is the precise ablation (thermal destruction of tissue) of the omentum, which has been used in preclinical studies for better control of blood sugar. A second mechanism is the focused ultrasound-enhanced delivery of drugs. A third mechanism is the use of focused ultrasound to perform targeted neuromodulation. While significant work has been accomplished, there is still much to be done before this technology will be widely available.

The primary options for treatment of diabetes include medication.

For certain patients, focused ultrasound could provide a noninvasive alternative to surgery with less risk of complications – such as surgical wound healing or infection – at a lower cost. Focused ultrasound can reach the desired target without damaging surrounding tissue, and it can be repeated, if necessary.

Clinical Trials

A clinical trial delivering pulsed focused ultrasound to the portal region of the liver and to the superior mesenteric plexus is recruiting patients in Connecticut.

An upcoming clinical trial using focused ultrasound to stimulate the vagus nerve and reduce glycemia is organizing in Arizona.

A clinical trial is using low intensity focused ultrasound to help with painful diabetic neuropathy in China.  

See a list of laboratory research sites >

Regulatory Approval and Reimbursement

Focused ultrasound treatment for diabetes is not yet approved by regulatory bodies or covered by medical insurance companies.

Notable Papers

Ashe J, Graf J, Madhavan R, Wallace K, Cotero V, Abate S, Pandey RK, Herzog R, Porindla SN, Shoudy D, Fan Y, Kao TJ, Puleo C. Investigation of liver-targeted peripheral focused ultrasound stimulation (pFUS) and its effect on glucose homeostasis and insulin resistance in type 2 diabetes mellitus: a proof of concept, phase 1 trial. QJM. 2023 Sep 12;116(8):667-685. doi: 10.1093/qjmed/hcad098. PMID: 37243693

Yi X, Luo Y, Zhou Q, Wang J, Yang Z. Visually controlled pulsatile release of insulin from chitosan poly-acrylic acid nanobubbles triggered by focused ultrasound. Int J Pharm. 2023 Jul 22;643:123266. doi: 10.1016/j.ijpharm.2023.123266. PMID: 37482226 

Cotero V, Graf J, Miwa H, Hirschstein Z, Qanud K, Huerta TS, Tai N, Ding Y, Jimenez-Cowell K, Tomaio JN, Song W, Devarajan A, Tsaava T, Madhavan R, Wallace K, Loghin E, Morton C, Fan Y, Kao TJ, Akhtar K, Damaraju M, Barenboim L, Maietta T, Ashe J, Tracey KJ, Coleman TR, Di Carlo D, Shin D, Zanos S, Chavan SS, Herzog RI, Puleo C. Stimulation of the hepatoportal nerve plexus with focused ultrasound restores glucose homoeostasis in diabetic mice, rats and swine. Nat Biomed Eng. 2022 Mar 31. doi: 10.1038/s41551-022-00870-w.

Razavi M, Ren T, Zheng F, Telichko A, Wang J, Dahl JJ, Demirci U, Thakor AS. Facilitating islet transplantation using a three-step approach with mesenchymal stem cells, encapsulation, and pulsed focused ultrasound. Stem Cell Res Ther. 2020 Sep 18;11(1):405. doi: 10.1186/s13287-020-01897-z.

Razavi M, Zheng F, Telichko A, Ullah M, Dahl J, Thakor AS. Effect of Pulsed Focused Ultrasound on the Native Pancreas. Ultrasound Med Biol. 2020 Mar;46(3):630-638. doi: 10.1016/j.ultrasmedbio.2019.11.016. Epub 2019 Dec 24.

Victoria Cotero, Ying Fan, Tea Tsaava, Adam M. Kressel, Ileana Hancu, Paul Fitzgerald, Kirk Wallace, Sireesha Kaanumalle, John Graf, Wayne Rigby, Tzu-Jen Kao, Jeanette Roberts, Chitresh Bhushan, Suresh Joel, Thomas R. Coleman, Stavros Zanos, Kevin J. Tracey, Jeffrey Ashe, Sangeeta S Chavan, Christopher Puleo. Noninvasive sub-organ ultrasound stimulation for targeted neuromodulation. Nature Communications. March 2019, volume 10, Article number: 952.

Winter PM, Lanier M, Partanen A, Dumoulin C. Initial investigation of a novel noninvasive weight loss therapy using MRI-Guided high intensity focused ultrasound (MR-HIFU) of visceral fat. Magn Reson Med. 2016 Jul;76(1):282-9. doi: 10.1002/mrm.25883. Epub 2015 Aug 18.

Di J1, Price J, Gu X, Jiang X, Jing Y, Gu Z. Ultrasound-Triggered Regulation of Blood Glucose Levels Using Injectable Nano-Network. Adv Healthc Mater. 2013 Nov 19. doi: 10.1002/adhm.201300490.

Saedi N, Kaminer M. New waves for fat reduction: high-intensity focused ultrasound. Semin Cutan Med Surg. 2013;32(1):26-30.

Jewell ML, Desilets C, Smoller BR. Evaluation of a novel high-intensity focused ultrasound device: preclinical studies in a porcine model. Aesthet Surg J. 2011;31(4):429-34.

Milleo FQ, Campos AC, Santoro S, Lacombe A, Santo MA, Vicari MR, Nogaroto V, Artoni RF. Metabolic effects of an entero-omentectomy in mildly obese type 2 diabetes mellitus patients after three years. Clinics (Sao Paolo). 2011;66(7):1227-33.

Fabbrini E, Tamboli RA, Magkos F, Marks-Shulman PA, Eckhauser AW, Richards WO, Klein S, Abumrad NN. Surgical removal of omental fat does not improve insulin sensitivity and cardiovascular risk factors in obese adults. Gastroenterology. 2010;139(2):448-55.

Click here for additional references from PubMed.

Clinical Trials