It’s the middle of the night, and once again, you can’t sleep. You try to convince yourself that your child is OK, but can you ever be completely sure? You have done everything you’re supposed to as the parent of a child with Type 1 Diabetes by maintaining a strict regimen of glucose tests, insulin injections, and a highly regulated diet. Yet, every night you relinquish all control to the unpredictable pancreas that resides within your child. While it is rare, 5% of T1D1 associated deaths occur without warning while sleeping, a statistic that distresses an exponential amount of patients, relatives, and caregivers all over the world.
There is now hope.
In late 2016, the FDA approved the first hybrid closed-loop insulin delivery system. This replaces the “open loop” concept in which there are essentially three separate systems at play: (1) the continuous glucose monitoring (“CGM”) device; (2) the insulin pump, and (3) the patient, who must use the information from the CGM to determine how much insulin to inject. This new technology enables direct communication between the CGM and insulin pump, and essentially removes the patient from the equation, save two to four pricks per day for calibration. It is being hailed as the world’s first artificial pancreas.
This approach has not just made T1D management easier than ever, it is also getting praise for stabilizing blood glucose at an unprecedented level. In one study, adolescent average levels of blood glucose (also referred to as “A1C levels”) dropped from 7.7% to 7.1%, and adult levels dropped from 7.3% to 6.8%. Sensor readings also showed participants raised their target blood glucose range by nearly 7 percentage points for the adolescents and 4 points for adults.
The remarkable results led to an FDA approval earlier than expected, and the market is projected to be officially disrupted in 2018 as more patients demand it and more insurers reimburse for the state-of-the-art system. Experts are also optimistic that the outcomes demonstrated in T1D patients will accelerate a similar product that can be offered to the millions of Type 2 diabetes patients in the near future.
Where Are They Now
Since the hybrid closed-loop insulin delivery system’s approval in 2016, the FDA has expanded its approval for use in more specific populations. Due to the system’s ease of operation and increased efficacy in blood glucose stabilization, the FDA is now supporting its use in younger type I diabetic patients. In September 2017, the system was approved for use in patients 14 years of age and older, and in June 2018, the approval was again expanded to include individuals aged 7 to 13. In August 2018, great strides were made toward closed-loop insulin delivery for type II diabetes patients. Novel study results highlighted better glycemic control with closed-loop delivery versus conventional insulin therapy in type II patients, supporting the technology’s use in this subset of the disease. The success of the first hybrid-closed loop system has led to a boom in research in the field as several other enterprises look to market similar devices.