Unlike its predecessor, the Control IQ is interoperable, meaning it’s designed to communicate with other compatible devices. People with type 1 diabetes won’t have to use products by Tandem Diabetes Care; they can build their own system using sensors and pumps that have the same FDA designation. “This is an important advancement because not every patient is the same and not every patient responds to devices in the same way,” says Betul Hatipoglu, MD, an endocrinologist at Cleveland Clinic Main Campus in Ohio, who is not associated with Tandem Diabetes Care. “This software allows people to have more options to select the sensors and pumps that fit their needs,” says Dr. Hatipoglu. The increased flexibility will likely lead to continuous improvements of the technology and more competitive costs, she adds. There are several more automated glucose control systems in the pipeline that are poised to go through the device authorization process soon, according to an article published in March 2019 in Diagnostics (BASEL). “In the future, we will likely see a system that requires no manual patient input and allows users to eat throughout the day without counting carbohydrates or entering in any blood sugars,” the authors wrote. The FDA has created a new regulatory classification for this type of device, which means future devices with the same intended use will be able to obtain approval by meeting those standards and demonstrating substantial equivalence to the Control-IQ Technology. RELATED: Your Top Type 1 Diabetes Questions, Answered
What Makes Tandem Diabetes Care Control-IQ Technology Different
In addition to being “interoperable,” there are several key features that set the new Control-IQ apart, according to a release by Tandem Diabetes Care. Those features include:
No Finger Sticks With Dexcom G6 CGM (continuous glucose monitoring) integration, there’s no need for finger sticks for mealtime dosing or calibration. The Control-IQ technology uses the CGM readings to predict glucose values 30 minutes ahead and can adjust the basal insulin delivery to keep the glucose in the desired range.A Basal Rate Module An increase in insulin delivery overnight ensures the person is at near-normal blood glucose levels (110–120 milligrams per deciliter, or mg/dL) by morning.Automatic Correction Boluses In the event that glucose levels are predicted to be over 180 mg/dL, the software calculates a correction bolus with a target of 110 mg/dL and delivers as needed.
According to Tandem’s release, the Control-IQ update, as well as the new pumps with the Control-IQ technology, will be available around January 2020. Current Tandem pump users will be offered a free software update — they won’t need to purchase a new device to have access to Control-IQ. As part of the approval process, a group using Control-IQ was compared with a control group that used a CGM combination that didn’t automatically adjust insulin. The six-month trial involved 168 people with type 1 diabetes who had been treated with an insulin pump or multiple daily injections for at least one year. All participants completed the trial. According to the results published in October 2019 in The New England Journal of Medicine, time spent in targeted glucose-level range for people using the Control-IQ increased from 61 percent at baseline to 71 percent. The control group remained unchanged at 59 percent. The mean difference between the two groups added up to 2.6 hours more per day spent in the targeted range. RELATED: FDA Approves First Implantable CGM for People With Diabetes
How the New Technology Benefits People With Type 1 Diabetes
Maintaining this level of blood sugar control means more than peace of mind — it can make a real difference in disease-related complications, says Hatipoglu. According to research published in August 2019 in Diabetes Care, which was cited in the recommendations from the Advanced Technologies and Treatments for Diabetes (ATTD) Congress, for each 10 percent reduction in time spent in the glucose target range, the risk of development or progression of retinopathy increases by 64 percent, and the risk of development of microalbuminuria increases by 40 percent. Both are potential complications of diabetes. “This technology is a miracle for both patients and doctors,” says Hatipoglu. “I’ve been practicing since 1997, and I never thought I would see an advancement like this for type 1 diabetes in my lifetime,” she says. “For the patient, it relieves them from thinking about what to do with their sugar every moment. For physicians, it relieves us from trying to micromanage the patient,” says Hatipoglu. The artificial intelligence that is fed all the information has the capacity to learn the individual patient’s patterns, and as a result can maximize the treatment so that they are close to normal, she adds. RELATED: Marathoner With Type 1 Diabetes Shares How a CGM System Keeps Her Blood Sugar Controlled The FDA has established criteria, called “special controls,” which outline regulatory requirements related to reliability, device interoperability, and cybersecurity for Control-IQ Technology and future devices that perform similar functions. There is a potential risk, in devices like this, for someone with bad intentions to hack into the system and create havoc, says Hatipoglu. “This possibility exists in many aspects of our lives these days — our phones, computers, even our medical records,” she says. In Hatipoglu’s opinion, this relatively small risk isn’t nearly enough to outweigh the improved glycemic control and freedom that Control-IQ and future devices bring to patients. “We are already seeing the benefits in clinical practice — it is really miraculous.”
