Innovative drug delivery systems are a technology sector receiving increased interest for a number of reasons. One area seeing enhanced design solutions is the diabetes management space. Delivering the required insulin while being mindful of a patient’s emotional state and concerns is a tricky design challenge. This article examines a variety of factors that all play a part in device development for this sector.
Diabetes has become a global pandemic with nearly 370 million people diagnosed worldwide.1 With more patients diagnosed every day, it’s important to understand the unique administration needs of diabetics to help them better manage their condition.
Advances in delivering insulin and other injectable therapeutics are focusing on user-centered drug delivery systems that help patients adhere to daily self-injection routines. Among patients, clinicians, and pharmaceutical manufacturers, there is increased interest in drug delivery systems that are safe, convenient, and help ease the administration process. Several recent innovations in drug delivery design that focus on patient needs are helping increase adherence to difficult daily treatment regimens.
The Diabetes Landscape
Nearly ten percent of the diabetic population is made up of those suffering from Type 1, or “insulin-dependent” diabetes, which is typically diagnosed in childhood.1 In this form, the pancreas produces very little or no insulin due to an auto-immune reaction that destroys beta cells. Type 1 patients need daily injections of insulin in order to control the levels of glucose in their blood.
Type 2 or “non-insulin dependent” diabetes makes up 90 percent of the cases worldwide.1 Typically, the pancreas produces some insulin, but the body does not produce enough to regulate blood glucose sufficiently. The form of diabetes, referred to as “adult-onset” is often associated with obesity.
Gestational diabetes occurs in two to ten percent of pregnancies in the United States and is a form of insulin resistance that occurs during pregnancy but may disappear after the patient gives birth. Women affected by gestational diabetes and their offspring are at increased risk of developing Type 2 diabetes later in life.
Spending on diabetes care topped $471 billion in 20112, and is expected to increase exponentially by 2030 as rates of diabetes and prediabetes are skyrocketing. It is estimated that 52 percent of the U.S. adult population could have diabetes or prediabetes by 2020, with certain ethnic groups at the highest risk.3 Gestational diabetes rates are also rising, and insulin is often the treatment of choice during pregnancy, since oral medications can cross the placental barrier and are not strong enough to provide effective treatment during pregnancy.
The diagnosis of diabetes can be frightening, and early on, adherence to the daily regimen for treatment may be difficult. As patients move from diagnosis to control of their condition, it is important to understand both emotional and physical needs when contemplating device design.
The Patient Journey
There are typically four stages that a patient moves through when diagnosed with a chronic condition such as diabetes. Initial diagnosis can result in denial and depression. Patients move from a healthy existence to one of daily monitoring and control. In the days and weeks following diagnosis, symptoms and emotions may impair the patient’s ability to interact with devices required for therapy. Ease of use and demonstrability, feedback that the dose has been administered properly, and minimal effort to administer should be part of the overall device design.
As patients gradually accept the condition, they are forced to take action to manage their diabetes. At this point, patients may experience frustration when initial efforts yield poor results. Maintaining a simple routine should be a priority, and devices should minimize steps and provide clear feedback and portability to help ensure adherence to treatment regimens.
Over time, patients may become more accustomed to the daily demands of their condition. They now have a basic working knowledge of the tools, including devices and drugs, and can use them in a formulaic, automatic manner. Through this stage, patients generally exert less effort to hide their diabetes in public, but might still try to protect loved ones from seeing the full extent of the management process. At this stage, convenience of use and the impact that the therapies have on lifestyle and quality of life may be more important than simplified steps. Devices that are quick and efficient, as well as those that are discrete, can slip into daily life without calling undue attention to the patient’s condition.
Finally, patients reach a point where they are in control of their illness, and through time, attention, and interest, have gained a deep understanding of diabetes management. They are expert users of their tools and enjoy a heightened degree of control, predicting, and planning appropriately for all circumstances. A well-designed system can become a platform to help monitor disease state progression, so devices designed with enabling technologies can help support the collection of information regarding physiologic measure, use patterns, adherence, and other relevant aspects of disease management.
The Device Landscape
A breadth of options exist for insulin delivery devices. Delivery and administration of insulin consists of three options: syringe, pen, and pump, with pens holding the largest segment in the insulin delivery device market with over 50 percent of the share.4 Patients rely heavily on the advice of their physician regarding recommendations for devices, but many are unaware of alternative devices or may lack device-specific training. Challenges for each segment are varied.
While syringe systems are the most affordable method for insulin delivery and offer a straight-forward approach to care, challenges include portability, increased pain from larger needles, and accidental needle sticks. Patients may also be embarrassed using a syringe because of its association with drug addicts.
Pen devices offer enhanced portability and convenience. Because the device is prefilled and easily assembled, it does not carry the same stigma as a syringe. However, many users may find the size of the injector inconvenient for multiple daily injections. In addition, since the cartridge is hidden, insulin visibility may be obstructed, and the pen cartridges carry less insulin than vials, causing supplies to be used more quickly.
Wearable pumps offer freedom, flexibility, and control through fewer injections and continuous insulin release. Pumps may reduce the steps involved in administering an insulin dose, thus mitigating the need to carry supplies. The device is also discrete because it is worn on the body under clothing. There are, however, misconceptions around pump use with patients often seeing the pump as a sign that the disease has progressed. Device malfunction and failure is also a concern, while others may not like the feel of being “attached” to the device.
Until a cure is available, trends in insulin delivery are streaming toward seamless integration into the patient’s life, simplicity, and convenience, as well as fewer painful injections. Newer options include closed-loop systems that combine blood glucose measurement with automatic dose adjustment; patch pumps with an integrated needle that eliminates a separate tubing and catheter set; programmable integration with existing lifestyle technology; and potential changes to administration, including possible oral medications. Such changes to delivery systems may improve adherence and allow patients to manage their condition better. While some therapies, such as GLP-1 drugs used as an adjunct to insulin therapy, can reduce the number of injections needed while improving control of the condition, designing devices that are automated, accommodating, affliction-free, and affordable will help to provide flexibility, reduce pain, and foster adherence until a cure is developed.
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1 World Health Organization, Diabetes Fact Sheet
2 IDF Diabetes Atlas 2012, 5th ed.
3 CDC 2011 National Diabetes Fact Sheet, UnitedHealth Group (UHG), GBI research report)
4 GBI Report, Diabetes Care Devices Market to 2018