Closed-Loop Insulin Pump Brightens Future of Diabetes Management

DECEMBER 11, 2017
Matt Hoffman
This story is part of MD Magazine's Year-End Recap series.
Click here for Part 1, a look into the success of ketamine as a multifaceted therapy.
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For patients with type 1 diabetes (T1D), one of the biggest burdens of the condition is the need to manage it - more specifically, to manage their blood glucose levels.

With the September 2016 approval of the MiniMed 670G Insulin Pump System by the US Food and Drug Administration (FDA), produced by Medtronic, the patient’s ability to manage their glucose became much easier.

Normally, patients with T1D need to monitor their continuous glucose monitoring sensor and use the information the sensor provides them to predict and adjust the dose of insulin they set their pump to administer. While that open loop system is a major improvement from the previously used multiple daily injections, it still puts a burden on the patient, especially at night and for pediatric patients.

Medtronic’s device, however, is the first of its kind featuring a closed loop system that self-adjusts to the individual wearer. This allows for real-time alterations in insulin based on the needs at the time, and it is currently the only such device on the market that is able to control dosing automatically. Now, the system does the work for the patient.

“Our previous approach with the old pump systems, with set basal rates of insulin infusion that change every couple hours at most, was very naïve and inadequate,” Kevin Pantalone, DO, an endocrinologist at the Cleveland Clinic’s Twinsburg Family Health & Surgery Center, told MD Magazine. “They were set and largely remained the same on a daily basis, regardless of the fact that insulin requirements and patient physical activity levels in dietary habits were never constant.”

The plain and simple truth, as Pantalone says, is that maintaining glucose control is a “complex and dynamic process,” as evidenced by studies of this technology, in which different patients received vastly different insulin amounts at the same times each day. Despite this knowledge, the available delivery methods that could keep up were simply not available.

Comprised of 2 parts, Medtronic’s insulin pump system utilizes the MiniMed 670G pump and the Guardian Sensor 3 to monitor glucose levels. In October 2017, was named the Cleveland Clinic’s top medical innovation for 2018. In a statement, the clinic said it “enables direct communication between the continuous glucose monitoring device and insulin pump to stabilize blood glucose at an unprecedented level.” 
 
Kevin Pantalone, DOKevin Pantalone, DO
The device is also equipped with an AutoMode option, which automatically adjusts basal insulin delivery at 5-minute intervals, allowing the device to keep patients within their blood glucose target range at all times. Additionally, it features a Suspend Before Lows option, which grants the wearer the ability to set a low blood glucose limit, which the system then adjusts for by halting insulin administration up to 30 minutes prior to the patient hitting the limit, then automatically restarting once glucose levels recover - all without needing to alerting the patient.

"The FDA approval of the world's first hybrid closed-loop system is a culmination of many years of hard work and close collaboration with the clinical and patient communities to generate the body of evidence needed to advance this technology for those living with diabetes,” Francine Kaufman, MD, the chief medical officer of the Diabetes Group at Medtronic, said in a statement at the time of the device’s approval. "We appreciate the unprecedented speed by which the agency approved our PMA submission to help bring this advanced insulin pump therapy so quickly to US patients living with this challenging disease. We are committed to preparing for commercial launch as quickly as possible while ensuring we provide the most successful rollout of this novel therapy."

The biggest impact the device makes is the relief of patient burden, Pantalone said. Patients with T1D are somewhat forced to be constantly monitoring or thinking about what is happening with their blood sugar, or what is about to happen to it, based on how and when they eat, exercise, and go about their daily tasks.  

“What patients have told me they like most about this new technology is that it alleviates their mind from the constant burden of diabetes management, he said. “I don't think most people appreciate the burden that patients, particularly those with type 1 diabetes, face on a daily basis managing their disease. There are no vacations from controlling one’s blood sugar level. This new technology, while it may not afford them a true ‘vacation’, can at least help to alleviate the burden to some degree, and perhaps allow them to better focus their minds on other activities.”

Although the system is the first of its kind, it—somewhat surprisingly—hasn’t started a trend in the diabetes space yet, mostly due to the hurricane that ravaged Puerto Rico in recent months. Because of the island’s need for medical equipment, “[the] supply of the sensors that go with these pumps is inadequate right now so there is a delay in getting many patients on the new technology at the present time,” Pantalone said.

Despite that hiccup in getting the product at the moment, the device is projected to completely disrupt the market in 2018 due to the sheer demand anticipated, according to the Cleveland Clinic. As for the start of a trend, experts are expecting that a similar device achieving similar outcomes for the millions of patients with type 2 diabetes is just around the corner.

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