What we do daily – from what we eat, how active we are, if we are ill or in pain, to the stress we experience – all impacts how our bodies react to insulin, affecting our blood sugar in completely different ways.
People with Type 1 diabetes, whose bodies no longer produce insulin, require insulin therapy to regulate blood sugar and must check blood sugar, or glucose, levels multiple times a day and adjust their insulin intake, including waking up during the night. Coping with both hypoglycemia (low blood sugar) and hyperglycemia (high blood sugar) is a way of life for diabetics.
New technology developed by Medtronic launched earlier this month in the first commercially available insulin pump system to automate the delivery of basal insulin – the “background” insulin that keeps blood sugar levels steady in the body throughout the day and night.
The MiniMed(TM) 670G system is a new type of insulin pump therapy that uses predictive algorithms to adjust insulin delivery. The individual wears an insulin pump as well as a continuous glucose monitor (CGM) and transmitter. The CGM features a small, flexible sensor that goes under the skin to detect blood sugar levels, which are then transmitted to the pump. The use of the algorithm automatically adjusts basal insulin delivery to the individual to keep blood sugar levels within a healthy range.
Using Medtronic’s SmartGuard HCL technology and Guardian Sensor 3, this type of system is called a hybrid closed-loop system because it automatically adjusts basal insulin. Users of the system still have to give insulin doses, or boluses, for meals.
“The response from the diabetes community has been tremendously positive,” said Alejandro Galindo, president of the Intensive Insulin Management division within the Diabetes Group at Medtronic. “We’ve essentially designed a smarter insulin pump that alleviates some of the burden associated with diabetes management, which can be unrelenting and exhausting.”
Medtronic’s MiniMed 670g is the only hybrid closed-loop insulin pump system approved by the Food and Drug Administration (FDA). The system is FDA-approved for people with Type 1 diabetes ages 14 years and older.
Through the predictive algorithm, the hybrid closed-loop system maintains the patient’s “time in range,” or the amount of time blood sugar levels stay within a healthy range. The goal for diabetics is to avoid blood sugar levels that are dangerously high or low and to stay within that healthy range as much as possible.
Jolene Mullinax, 37, grew up in La Vernia and has lived with diabetes since she was a 1-year-old. She has been using the new pump since the company introduced it to a small group of first-time users in March.
“This pump takes care of my insulin levels without any thought on my part,” Mullinax said. “The pump has an algorithm that learns your body’s blood sugar levels, detects any minute changes in your levels, and adjusts it by releasing small amounts of insulin as needed into your bloodstream.
“Before using this pump, I had to make these calculations for my hourly insulin dosing, even setting the alarm and waking up to check my levels when I’m sleeping.”
Mullinax has used insulin pump therapy since 2006.
“This is such an improvement over other pumps,” Mullinax said. “Circadian rhythms can impact your blood sugar levels, so this pump keeps my blood sugar levels constant even when I sleep.”
A danger for people with Type 1 diabetes is suffering severe hypoglycemia while sleeping and being unable to wake themselves up.
Medtronic has the only continuous glucose monitor approved by the FDA to power a hybrid closed-loop system in the insulin pump. The groundbreaking new technology is the first and only system that constantly self-adjusts to automatically keep a person’s blood sugar levels in range. While many Type 1 diabetics prick their fingers to check their blood sugar as many as a dozen times a day, Medtronic’s CGM is one of only a few on the market that requires as few as two finger pricks per day to calibrate.
“This technology is a significant breakthrough for the diabetes community, and as a practicing endocrinologist, I have been awaiting this moment on behalf of my patients for a very long time,” said Dr. Francine Kaufman, chief medical officer of the Diabetes Group at Medtronic. “I’m confident it will simplify diabetes care for both patients and clinicians alike.”
Training for patients started in March to accommodate the comprehensive training program customized for the MiniMed 670G system before its June launch. Medtronic, which has its Diabetes Therapy Management and Education Center in San Antonio, is processing new requests from those interested in receiving the new insulin pump after priority access orders are fulfilled for those patients in the trial group. Patients seeking information about the new system can visit here.
“This new system is way different than any other pump I’ve been on,” Mullinax said. “With a more typical pump there is a lot of trial and error.”
Medtronic’s long-term goal is to develop a fully automated closed-loop system for Type 1 diabetes users.