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Transforming Clinical Trials

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November 14, 2021

How Clinical Research Is Revolutionizing Diabetes Treatment

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      Aoife Delany

      Aoife Delany

      Lead Clinical Information Designer


    This World Diabetes Day, I am highlighting the importance of clinical trials for diabetic patients. According to the World Health Organization, the number of people with diabetes rose from 108 million in 1980, to 422 million in 2014, with prevalence increasing more quickly in low and middle income countries. The WHO also reports that one in two adults who have diabetes remain undiagnosed – that's 232 million people, with the majority having type 2 diabetes.

    Prior to 1921, diabetes was akin to a death sentence, until Banting and Best isolated insulin for injection. Originally extracted from cows and pigs, clinical researchers went on to develop synthetic insulin by modifying bacteria to mass-produce insulin in the lab during the 1980s. Clinical trials conducted during the 1950s gave us oral hypoglycemic agents for the treatment of type 2 diabetes.

    However, clinical trials have revolutionized treatments for diabetes and in recent years, there have been a number of exciting new developments in diabetes research, such as:

    • Glucose Monitoring Tattoos: Scientists at Harvard and MIT are exploring the possibility of using tattoos to detect changes in blood sugar, reducing the need for finger-prick tests. Traditional ink would be replaced by fluorescent biosensors that change color in response to high or low blood sugar.
    • Glucose Monitoring via your smartphone: A number of innovative technologies now enable you to monitor your blood sugar levels using your phone without the need for regular needle stick tests. These range from minimally invasive sensors beneath the skin to non-invasive peel-and-place patches that continuously monitor your blood sugar at regular intervals, wirelessly transmitting the data to your phone via Bluetooth.
    • Insulin Patches: In 2020, an insulin-delivery patch for the treatment of diabetes developed by American researchers, was accepted by the US Food and Drug Administration's Emerging Technology Program. Insulin would be delivered via a patch applied to the skin (like nicotine or contraceptive patches), removing the need to directly inject insulin. The next step is for the researchers to get approval to trial the technology in humans.
    • Light-Activated Insulin Producing Cells: In 2019, researchers at Tufts University transplanted engineered beta cells (insulin-producing cells of the pancreas) into diabetic mice. When exposed to light, these cells produced two to three times the normal amount of insulin, allowing glucose levels to be controlled without the need for drug intervention.
    • New Drug Targets: In January 2021, an insulin receptor was identified as a potential new drug target. In diabetic patients, the insulin- secreting β-cells in the pancreas become desensitized to insulin, so the body is unable to break down glucose properly. The newly discovered insulin receptor called "inceptor" acts as a blocker in the insulin production pathway to prevent overproduction. This receptor is abnormally activated in diabetic patients, which can block insulin and contribute to the desensitization of β-cells. Blocking the activity of inceptor through pharmaceuticals, offers a promising target for new treatments that could increase the sensitivity of the β-cells to insulin and protect against further β-cell damage, potentially leading to diabetes remission.
    • Curative Stem Cell Therapy: Promising early reports from clinical trials conducted by Vertex Pharmaceuticals show that VX-880, a stem cell-derived therapy, may have a curative effect for patients with type 1 diabetes. A diabetic patient was injected with a single infusion of synthetic insulin-producing cells. Ninety days later, the treatment had almost eliminated their need for insulin treatment entirely, offering hope that a cure may just be round the corner.

    As the exact cause of type 1 diabetes remains unknown, clinical research is vital. It will allow researchers to compare and contrast patient blood glucose levels, track metabolism, monitor organ functionality in relation to medications, shape the improvement of current treatments, bring new treatments to fruition, and perhaps one day, develop a cure.