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An important question is whether improvements in technology can make better control accessible to patients who are not currently good candidates for insulin pumps.
The approval of new continuous glucose monitoring equipment, new insulin pumps, and the enabling software has created a lot of excitement in diabetes healthcare. Although a true artificial pancreas (closed loop self-contained insulin delivery device) has not yet been launched, several technological improvements have been made and some new more advanced devices are obtaining approval in the U.S. and other countries.
Improvements in the technology are most apparent in the software, which is advancing from making decisions on current glucose levels and the use of high and low thresholds to sophisticated algorithms for predicting future glucose levels from current trends. This allows for adjustment of insulin delivery before critical glucose levels are reached.
A predictive approach based on trends is much more physiologic and may prove to be more effective and safer than threshold based algorithms.
Integrated systems are gaining approvals and becoming more available to patients. In August the U.K.’s National Institute for Health and Care Excellence (NICE) issued a draft guidance recommending the MiniMed Paradigm Veo System from Medtronic for patients with Type 1 diabetes who experience frequent, severe hypoglycemia.
The system consists of an insulin pump, a continuous glucose sensor and a transmitter. The transmitter wirelessly sends glucose readings to the pump where the software makes adjustments to the amount of glucose being delivered.
NICE has cited a safety feature, “low-glucose-suspend,” as a key reason for its recommendation. The low-glucose-suspend feature is not available on the other devices considered by NICE. The safety feature automatically stops insulin delivery for two hours when a preset low glucose level is reached. The user can reprogram the device if they respond to an alarm alerting them to the low glucose level.
The MiniMed system has been available in the U.K. for several years and has recently been approved in Australia and other countries. The MiniMed 640G system is available in the U.S. and Medtronic is currently conducting a clinical trial of the predictive low glucose management system.
FDA recently approved the Dexcom G5 Mobile CGM System. This system is the first fully mobile glucose monitoring platform. The transmitter sends glucose readings directly to the patient’s iPhone or other iOS device. The information displayed to the patient (and to connected caregivers such as parents) includes glucose readings, trends and alerts. Confirmation by finger stick is still required before acting on the information.
These systems have been approved by regulators and in some cases by health technology assessment agencies (e.g., NICE) because of their performance in clinical trials and especially with regards to the potential for improving care overall, in particular limiting the number of serious hypoglycemic episodes. Limiting hypoglycemia is an important advance in improving care.
Other outcomes that should be of interest and that we need to know more about include impact on A1C in a broader population and impact on pre- and post-prandial blood sugar. This information should at some point be augmented by more complete data on actual outcomes such as age at onset of end-organ involvement including cardiovascular outcomes. Since this is a long term goal, the A1C and other measures will be of more importance in immediate decision making.
An important question is whether these improvements in technology can make better control accessible to patients who are not currently good candidates for insulin pumps.
Will safer and more automated systems allow for use by patients who are not technologically savvy or who have other reasons for not being on pumps now? Specifically will these new, smarter pumps be a good choice for patients with Type 1 diabetes who meet the American Association of Clinical Endocrinologists' suitability criteria, but are not on pumps for personal reasons?
The answer will depend on both the post-market safety records of these technologies and acceptance by the physicians who treat patients with diabetes.
The impact of these new technologies remains to be demonstrated in Type 2 diabetes. Since the opportunity to improve the lives of patients with Type 2 diabetes lies in early detection and treatment, technologies focused on insulin use have limited application.
Certainly some patients with Type 2 diabetes require multiple insulin injections and may benefit from pump use but this is not the majority of patients. More data is needed regarding the use of pumps in Type 2 diabetes, but technology by itself is unlikely to solve problems related to medication adherence, reluctance to use insulin and other personal issues related to diabetes treatment.
Research and development is moving ahead quickly. Clinicaltrials.gov currently lists more than 680 trials for monitoring in Type 1 diabetes, and 560 for monitoring in Type 2 diabetes.
FDA is considering a number of devices and integrated systems. These systems have the potential to improve patient safety and we also hope they will improve patient outcomes. Importantly, safer and easier to use systems may increase the number of patients who would be able to use and benefit from insulin pumps.