Novel Diabetes Therapies

While diabetes management has not seen major breakthroughs in a while, the 2016 regulatory approval of the world’s first (albeit hybrid) artificial pancreas system by Medtronic has jump-started a diabetes management revolution that will dramatically change the current treatment paradigms.

Ask any diabetic about how he manages his condition, and you will hear a long list of challenges of living with the disease. It is definitely not a rant: managing the condition is indeed difficult. From daily finger pricks to monitor blood glucose levels to making the right calculations for insulin dosing, exercise regimens, or “carb counting” for food intake decisions, diabetics have to make several decisions every day—each of which can make or break their control over blood glucose levels. However, a host of new technological advances are becoming available and are likely to improve diabetics’ lives. While diabetes management has not seen major breakthroughs in a while, the 2016 regulatory approval of the world’s first (albeit hybrid) artificial pancreas system by Medtronic has jump-started a diabetes management revolution that will dramatically change the current treatment paradigms.

Diabetes: A Growing Health Care Concern

Diabetes is becoming a global health care challenge: the number of diabetics is expected to increase from 415 million in 2015 to 642 million in 2040, according to the International Diabetes Federation. This is worrisome because of the associated costs as well. The estimated cost of managing the diagnosed diabetic population in the United States alone was $245 billion in 2012, according to the Centers for Disease Control and Prevention. Some of these costs arise due to poor disease control and the resulting complications that become more expensive to manage. For example, diabetic retinopathy is a complication that results in blurred vision, dark areas and difficulty in perceiving colors or, in rare cases, even blindness. Naturally, quality of life declines significantly as complications of uncontrolled diabetes arise. We, therefore, need to find a solution to better manage diabetics so that they can lead better lives and the associated, preventable costs can be eliminated.

Challenges

The primary need for managing diagnosed diabetics is to ensure that their blood glucose levels remain within range, and that any fluctuations are immediately addressed. This is a two-part problem: monitoring glucose levels accurately enough and in real time; and taking immediate corrective action using medication (which could be pills or injections). Herein lies the challenges: how can diabetics’ glucose levels be monitored in real time when, until recently, the only available technology was the finger-prick method to test blood glucose levels on a glucometer? Even if high glucose levels are detected, can they immediately take medications? If yes, will the mode of delivery be easy (ingesting a pill) or will it be inconvenient and painful (injection, especially after a finger prick)? Will the medication be free of any side effects, such as nausea or dizziness? And how much (dosage) of the medication will be sufficient, or will it result in overdose (which will also compound side effects and could be fatal)?

The current solution approach is split into two parts: one for facilitating real-time monitoring and the other for enabling the appropriate amount of drug delivery.

Solution Part A: Real-Time Monitoring

Apart from invasive monitoring devices called continuous glucose monitors (Dexcom G5, for example), several semi-invasive and skin implant-based technologies are now commercially available, such as Abbott’s FreeStyle Libre and Senseonics’ EverSense. The “holy grail” of diabetes monitoring, however, is non-invasive glucose monitoring that can end the pricking of fingers for testing several times a day (which still tends to be a requirement for calibrating semi-invasive and implantable devices). Several non-invasive approaches are being developed; broadly, these can be categorized based on where monitoring occurs—eyes (teardrop), fingertip, earlobe or saliva. Big names and smaller start-ups are playing a role in making these products a reality. Approaches include the much-touted contact lenses (Google + Novartis), passing visible, infrared or other light through the skin to detect glucose (LighTouch Medical, OrSense, GlucoWise) and even salivary assessments (Quick LLC). While these are all exciting and can improve patient compliance by enabling real-time monitoring, none are yet close to commercialization. Diabetics, therefore, rely on continuous glucose monitors, which are invasive.

Solution Part B: Insulin Pumps + Artificial Pancreas

Not all diabetics are treated with insulin; in fact, a majority of Type 2 diabetics are managed on medication alone. However, the technology is available today to detect glucose levels in near- real time, and deliver insulin through the abdomen using an insulin pump (a body-worn reservoir) developed primarily for Type 1 diabetics who are dependent on insulin. This system is the crucial building block for a “true” artificial pancreas system. The important point to note here is that these are still being developed and perfected. They are also very expensive at the moment and used only by Type 1 diabetics and a small percentage of Type 2 diabetics who are in absolute medical need of an insulin pump.

The Alternative Solution: Microneedle Patches

Given the challenges with the monitoring and drug delivery approaches mentioned above, one promising approach is that of microneedle patches. The application of a patch the size of Band-Aid on the skin can facilitate transdermal drug delivery. This is currently applicable only for those diabetics who are not dependent on insulin and can be managed by medication alone.

Recent research advancements take this approach further, aiming to—in the proverbial sense—kill two birds with one stone. The concept employs microneedle patches for a dual role: monitoring glucose levels and responding in real time by releasing drugs to bring glucose levels under control sooner. It does this by integrating microneedle arrays with dual-mineralized particles that separately contain the drug and a chemical that detects glucose. When the microneedles detect glucose in the layers below the skin, they release the drug in response, in real time, with no manual intervention needed from the wearer. Another advantage of microneedle patches is their relatively pain-free application on the skin. Of course, glucose levels cannot be recorded using this approach, which poses another challenge for diabetics in managing their condition. Still, it probably works best for diabetics whose condition cannot be managed easily using traditional drugs alone.

The Road Ahead

Non-invasive monitoring, artificial pancreas, and microneedle technologies are all still being developed, and several challenges need to be overcome. They include improving the materials to withstand showering and sweating, and improving glucose detection sensitivity and accuracy to reduce false positives (for example, assessing how they work on skin types that vary because of race, local climate, or other  factors).

A diabetic of the future will definitely have access to better tools than those available today, making their lives much easier. Integration with other technologies, such as artificial intelligence and the Internet of Things, may enable a distant-future system that would counsel a patient based on history, genetic predisposition and the day’s diet and activity levels by actually saying something along the lines of: “If you have that particular dessert now, it will cause your glucose levels to shoot up, necessitating immediately performing activities like jogging to burn approximately 150 calories or an insulin injection of 0.5 units. Please select your choice: jogging or automatic insulin delivery.”

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