21 Sep 2017

New Innovations in Diabetes

Diabetes refers to a group of metabolic diseases with debilitating consequences in which the person has high blood glucose, either because the body’s insulin production is inadequate, or because the body’s cells do not respond properly to insulin, or both. Based on the cause for rise in blood glucose, there are three major types of Diabetes:

  • Type 1 Diabetes – Body does not produce enough insulin to control blood sugar
  • Type 2 Diabetes – The body produces insulin but cannot use it effectively
  • Gestational Diabetes – A temporary condition that occurs during pregnancy

The number of people with diabetes has risen from 108 million in 1980 to 422 million in 2014 according to a study done by World Health Organization (WHO).

WHO

Earlier methods to detect blood glucose level mostly involved testing blood and urine samples for glucose. Invasive methods like drawing blood several times a day can lead to both discomfort and infections. With the increase in the number of deaths related to diabetes and complex testing process, there is a need for early and continuous detection and monitoring of blood sugar level in patients when it rises above normalcy.

A team from the University of Maryland School of Medicine, US, came up with a potential solution to this problem in the form of a novel monosaccharide contact lens. To detect the tear glucose the team developed a new range of boronic acid containing fluorophores that can report the presence of glucose in tears. Glucose sensitive fluorophores are embedded into contact lenses. The team showed that their modified contact lenses were suitable for the continuous monitoring of tear glucose levels in the concentration range 50-500mM which tracks blood glucose levels that are 5-10 folds higher.

The image above captures the working principle of the technology. The photonic crystal sensing materials would be contained in the contact lens or ocular insert. The color diffracted changes with the tear glucose concentration. A simple mirrored compact-like device would illuminate the sensor material with white light. The color of the sensor would be determined by viewing the reflected (diffracted) light and comparing it with an exterior color wheel calibrated in terms of the blood glucose concentration.

In July 2014, Google announced its entry into the diabetes scene by announcing a partnership between Google X (now renamed X) and the European Pharma giant Novartis’ eye care unit Alcon. As part of the agreement, Alcon said it would look to create products from Google’s prototype smart contact lens, which uses miniature sensors and a radio antenna thinner than a human hair to track glucose levels.

To make the blood-glucose-monitoring contact lens, the researchers used technology that was initially developed for electronic products. They tinkered with a material called indium gallium zinc oxide (IGZO), whose electronic properties have recently helped boost the image quality in smartphone, tablet and flat-panel displays while also saving power and improving touch-screen sensitivity.

The researchers made contact lenses that included sheets of transistors made with IGZO. The transistors were coated with an enzyme called glucose oxidase, which breaks down sugar. This meant that when the contact lenses were exposed to glucose, a chemical reaction took place as the enzyme broke down the sugar. The transistors measured this reaction through changes in the electrical currents that flowed through the lenses. This indicated that glucose was present. Even very low concentrations of glucose could be detected by this method.

Since research first began in the field, a whole bunch of companies have started filing patents in the technology. This being a relatively new technology, most innovators in the field are pioneers paving way for a new industry. Since most diabetics also suffer from eye disorders, the lens will have to address more than one problem.
Since its inception, Google lens has come a long way. The lenses are now being developed with Alphabet’s life sciences unit Verily. Measuring blood sugar via the eye could allow diabetics to lead more normal lives without having to prick their fingers every time they have to test for blood glucose, while an autofocus contact lens would help people whose ability to focus is impaired when their eyes age. Many diabetics also suffer from Glaucoma and other eye related disorders that can also be detected using pressure sensors in the eye. Recent research is touching upon several of these disorders; however it is still unclear when the testing for these will begin.

Apart from advancements in detection and monitoring glucose level in diabetic patients, there is much advancement in systems where the diagnosis is coupled with therapy as well. The technique involves testing blood glucose levels using subcutaneous sensors. These systems are helpful in treating Type 1 Diabetes and feature an artificial pancreas (AP) – also called a closed loop system – which releases insulin when the glucose level in blood is higher than normal.

There are two major system-level approaches to achieving closed-loop control of blood glucose in diabetic individuals. The unihormonal approach uses insulin to reduce blood glucose and relies on complex safety mitigation algorithms to reduce the risk of hypoglycemia. The bihormonal approach, on the other hand uses insulin to lower blood glucose and glucagon to raise blood glucose, and also relies on complex algorithms to provide for safety of the user. The advent of modern smartphones has created the ability to use smartphone technology as the engineering centerpiece of an artificial pancreas.

Innovations in automated insulin delivery were also driven by families that had diabetic individuals at home. Fathers of children with diabetes and Associations for families with Type 1 diabetic individuals drove the awareness and research by using computer algorithms to record and display glucose levels. Several start ups were initiated to innovate and open source the findings in the field to make technology affordable to diabetic individuals.

In spite of the growing research driven by families of diabetic individuals, the closed loop Artificial Pancreas, was first developed in June 2014 by Massachusetts General Hospital and Boston University. The results obtained from the initial tests were presented at the American Diabetes Association. Since then several companies have upped the ante by racing to file patents in the technology domain. Analysts at Effectual observed high patent filings in artificial pancreas by Medtronic, Animas Corp., Halozyme, Johnson & Johnson, Nikkiso, University of California, Abbot, and Harvard University.

Companies investing in Artificial Pancreas Research are on the rise as evident from the below graph showing patent publications from 1998 to 2016 with each colored dot representing a year. Research in this area seems to be on the rise.

The map below represents the concentration of Artificial Pancreas patents filed in different parts of the world, based on the color gradient from purple to pink. USA denoted in dark red has the most number of filings.

On 28th September 2016, Food and Drug Administration (FDA) approved the use of the first hybrid closed loop system AF– Medtronic’s MiniMed 670G – to monitor and treat diabetes. A Public Benefit Corporation called Beta Bionics founded by Ed Damiano, the father of a juvenile with Type 1 Diabetes, says they will have an insulin only version of the closed loop Artificial Pancreas (iLet) approved in 2018. The development is funded by Eli Lilly.

Earlier in 2017, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) announced the funding of 4 pivotal researches towards artificial pancreas. Most of these projects are in their final phases of testing and development. A successful artificial pancreas would be a life-changing advance for many people with Type 1 diabetes. NIDDK is part of the National Institutes of Health (NIH), USA. “These studies aim to collect the data necessary to bring artificial pancreas technology to the people who need it,” said Dr. Guillermo Arreaza-Rubín, director of NIDDK’s Diabetes Technology Program.

“For many people with type 1 diabetes, the realization of a successful, fully automated artificial pancreas is a dearly held dream. It signifies a life freer from nightly wake-up calls to check blood glucose or deliver insulin, a life freer from dangerous swings of blood glucose,” said NIDDK Director Dr. Griffin P. Rodgers. “Nearly 100 years since the discovery of insulin, a successful artificial pancreas would mark another huge step toward better health for people with type 1 diabetes.”

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