In an innovative joint project at the University of North Carolina and at North Carolina State University, medical researchers are currently developing a “smart insulin patch” that can both measure blood glucose levels and then administer insulin to regulate it as needed for people with Type 1 diabetes. This is yet another approach at the core of much academic and commercial research and development at creating a “closed loop” system that senses and responds to changes in blood sugar.
Other ongoing research in this field is attempting to integrate continuous glucose sensors with insulin pumps, both of which are available on the market but not yet working together in a viable product with regulatory approval. Both of these approaches are efforts to create a biomedical system that can act as a fully functioning artificial pancreas for people with Type 1 diabetes.
The ongoing work on the smart insulin patch was covered in a fascinating article in the June 22, 2015 edition of The Washington Post entitled The ‘Smart’ Insulin Patch That Might One Day Replace Injections for Diabetic Patients by Brady Dennis. I will summarize, annotate and add a few questions of my own. (Two other recent Subway Fold posts on October 3, 2014 and June 16, 2015, clickable here and here, respectively, have covered one project to upload glucose monitoring data to the mobile devices of friends and relatives, and another by a medical device manufacturer using social media to reach out to people using insulin pumps.)
This new smart insulin patch is a square shape as small as a penny and is word on the skin. One side of it contains numerous tiny “microneedles” that the face the skin and contain “both insulin and a glucose-sensing enzyme”. Thus, when an increase in blood glucose is detected, the patch can release insulin into the patient’s system “quickly and painlessly”. As a result, the necessity for the delivering insulin by traditional means of a syringe or insulin pump is eliminated.
To date, the development team has only tested the patch on mice. Early test results, published here in The Proceedings of the National Academy of Science (subscription required), showed that the patch worked on the test animals starting within 30 minutes of its application and then lasting for up to nine hours.
Dr. John Buse, one of the co-authors and the director of the UNC Diabetes Center, finds this “exciting”, but he also believes it will take years to determine if this will work in humans. A very informative and detailed news release with photos of the patch and the microneedles, entitled Smart Insulin Patch Could Replace Painful Injections for Diabetes, has recently posted on the UNC Diabetes Center website.
Using current technology requires people with Type 1 diabetes to check their blood glucose levels a number of times each day and then corresponding regulate their insulin to balance the effects of these up and down readings. Other researchers have endeavored to “closed the loop” between insulin pumps and continuous glucose monitors, but these systems still require close attention and adjustments by the patient
The smart insulin patch, if proven safe and viable, could one day dramatically change protocols for the care of Type 1 diabetes. It is an attempt to more directly emulate the human body’s own insulin regulatory system. As well, the microneedles in the patch are designed to be far less invasive and nearly painless than today’s use of injections, pumps and sensors, all of which require larger needles to pierce the skin. It is designed to directly “tap into the blood flowing through the capillaries” in order to become activated.
The researcher team has also found that they could “fine tune the patch” to attain blood glucose levels within an acceptable range. As a result, they are hopeful that, in the future, the patch could be adjusted to each individual patient’s system (including, among other things, weight and insulin sensitivity), and the duration of the patch’s effectiveness could be extended to several days.
My questions are as follows:
- How exactly will the patch be personalized to meet the biological needs of each user? How will patients manage and regulate this from patch to patch? Is the goal to calibrate a single patch for the user or a series of patches as the user’s needs and environment changes?
- Can the patches be customized and fabricated using today’s commercial 3D printing technology?
- Will blood glucose levels still need to be checked regularly using current methods in order to assess and align the patch’s effectiveness and accuracy?
- Can the patch’s data on blood glucose levels and insulin dosages be uploaded onto mobile devices in order to be monitored by the patient’s health professionals and family members?
- Might the patch be used in conjunction with or even integrated into the Apple Watch as a medical app?
- Can other medications that a person with diabetes is taking also be administered, monitored and regulated with the patch, perhaps making it even “smarter”?