Working Towards an Artificial Pancreas

By: Maryam Ahmed and Tyler Valente, PharmD Candidates c/o 2016

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Diabetes Mellitus is a condition in which the body cannot properly maintain its blood glucose. There are two types of Diabetes Mellitus (DM), Type 1 and Type 2, which vary greatly but each have at the crux an inability to transport glucose into the cells. Although commonly misconceived as a benign disease, complications of DM are extremely serious, including ketoacidosis, electrolyte imbalances, blindness, amputations, cardiovascular disease, and even death. DM currently affects more than 371 million people worldwide and is expected to affect 552 million by 2030.¹ DM is currently treated with medications that demonstrate various complex mechanisms, but researchers are presently working towards creating a revolutionary ‘artificial pancreas.’

The MiniMed^® 640G with Smartguard^™ technology is the most advanced insulin-pump delivery system of its kind. Manufactured by Medtronic Diabetes, the device has recently earned widespread attention in the media after it was first used on a four-year-old boy in Perth, Western Australia. It was mistakenly and prematurely dubbed ‘an artificial pancreas’ in headlines throughout the world. Although its technology is advanced, the MiniMed^® 640G is merely a “…critical step toward an artificial pancreas,” according to a Medtronic Diabetes press release.²

      Current insulin delivery systems contain a “threshold-suspend” technology, in which the “…device suspends insulin delivery [only] when glucose levels reach a preprogrammed low threshold and resumes delivery after 2 hours [regardless of levels]…”³ The MiniMed^® 640G with Smartguard^™ is innovative in that it utilizes “predictive low-glucose management,” which is advantageous because it can reliably predict, up to 30 minutes in advance, when one’s blood glucose will drop to a pre-programmed ‘low-limit.’ At this point, the device temporarily halts insulin delivery, preventing complications of hypoglycemia. Additionally, to ensure blood glucose levels do not rise too high, the MiniMed^® 640G resumes basal insulin delivery based on a sensor glucose value unique to each patient.⁴

Medtronic Diabetes has already released the MiniMed^® 640G in Australia and anticipates marketing in other countries in the next few months. In the United States, a clinical trial is currently in progress and scheduled to wrap up in April 2015.⁵ Over the past few months, two noteworthy surveys hoping to ascertain Type 1 Diabetics’ desire for an ‘artificial pancreas’ (AP) were launched in the US. The first, a pilot survey examining the attitudes of participants in an AP clinical trial, demonstrated a ‘high’ probability (86.1%) of future acceptance of an AP.⁶ The second survey was conducted online, advertised via social media, and received two hundred and sixty six responses over the course of one month. Over 90% of responders “indicated they were ‘highly likely’ to use a fully automated 24 [hour] AP.”⁷ Overall, both surveys suggested that there is a demand for a device that could potentially alleviate the burden of complicated self-care associated with DM.

Diabetes management with insulin therapy presently consists of frequent blood glucose tests and multiple injections. Insulin delivery systems currently on the market put one at risk for both hypo- and hyperglycemic crises. The MiniMed^® 640G with Smartguard^™ technology helps alleviate the burden of insulin therapy, while significantly lowering the risk of adverse events. Due to its ability to predict glucose levels, the MiniMed^® 640G with Smartguard^™ provides a breakthrough in technology towards the development of the highly sought-after AP.

SOURCES:

1. The scale of diabetes. Juvenile Diabetes Research Foundation. http://jdrf.org/about-jdrf/fact-sheets/general-diabetes-facts/.
2. New SmartGuard^(TM) technology helps people with diabetes manage the challenges of hypoglycemia. Medtronic. http://newsroom.medtronic.com/phoenix.zhtml?c=251324&p=irol-newsArticle&ID=2009123. Published on 01/21/15. Accessed on 03/01/15.
3. Tucker M. New insulin pump prompts ‘first artificial pancreas’ headlines. Medscape. http://www.medscape.com/viewarticle/838627. Published on 01/23/15. Accessed on 02/26/2015.
4. MiniMed^® 640G System. Medtronic. https://www.medtronic-diabetes.com.au/insulin-pumps/640g. Updated in 2015. Accessed on 02/25/15.
5. In clinic evaluation of the PLGM feature. Clinical Trials. https://www.clinicaltrials.gov/ct2/show/NCT02130284?term=NCT02130284&rank=1. Updated on 02/03/15. Accessed on 02/26/15.
6. Bevier WC, Fuller SM, Fuller RP, et al. Artificial pancreas (AP) clinical trial participants’ acceptance of future AP technology. Diabetes Technol Ther. 2014;16(9):590-5.
7. Barnard KD, Pinsker JE, Oliver N, Astle A, Dassau E, Kerr D. Future artificial pancreas technology for type 1 diabetes: what do users want? [published online ahead of print January 28 2015]. Diabetes Technol Ther. 2015.

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