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The First Automated Insulin Dosing Controller FDA Approved

Dec 20, 2019
 

Author: Steve Freed, R.PH., CDE


This approval is an example of artificial intelligence being used to improve the health of our patients with diabetes and will get us closer to a true artificial pancreas.

The Tandem t:slim X2 insulin pump will not only discontinue the delivery of insulin if blood sugars detected by a CGM record low blood sugars but will also calculate the amount of insulin needed and inject that insulin when needed for elevated blood sugars.

The approval was based on findings of a clinical trial for six months involving 168 patients with type 1 diabetes that showed those who used Control-IQ installed on a Tandem t:slim X2 insulin pump experienced 13 fewer minutes per day in hypoglycemia and 2.6 fewer hours in hyperglycemia, compared with those who used sensor-augmented insulin pump therapy. 

Control-IQ combines Tandem’s t:slim X2 This clearance was based on results from Tandem’s Control-IQ hybrid closed loop pivotal trial presented at the American Diabetes Association’s (ADA) 79th Scientific Sessions. Comparing the Control-IQ hybrid closed loop vs. the same pump and CGM without the Control-IQ algorithm:

  • Time-in-range (TIR) was a whopping 2.6 hours per day better with Control-IQ (70% vs. 59%), with most of the benefit from users spending 2.4 fewer hours per day above 180 mg/dl
  • A1C was 0.3% lower with Control-IQ (7.1% vs. 7.4%)
  • Average blood glucose was 14 mg/dl lower with Control-IQ (156 mg/dl vs. 170 mg/dl)
  • Time below 70 mg/dl was low (less than 2%) in both groups, though Control-IQ did slightly better at reducing time below 70 mg/dl by 13 minutes. That may not sound like so much to everyone, but it’s six and a half hours a month less time that participants were hypoglycemic!

With Control-IQ, the time-in-range benefits existed for every level of starting A1C – a positive sign that Control-IQ can help those already at a low A1C and those with higher A1C. Remarkably, all 168 participants completed the study, and Control-IQ users spent 92% of the six months with closed-loop active. In the study questionnaire, people scored Control-IQ:

  • 4.8/5 on the desire to continue using
  • 4.7/5 on ease of use
  • 4.6/5 on usefulness
  • 4.5/5 on trust

 

The pump, along with the Dexcom G6 CGM, and an algorithm built into the pump, adjusts basal insulin delivery and gives automatic correction boluses.  This technology can show real-time trends in hypoglycemia, hyperglycemia, and glucose variability, as well as quantify TIR and time in clinically significant hypo-and hyperglycemia. These data can reveal individual patterns of hypoglycemia, hyperglycemia, and glucose variability, enabling better tailoring of therapy to the patient.

Control-IQ uses the TypeZero/Dexcom hybrid closed-loop algorithm, which still requires all the normal pump settings (basal profile, insulin-to-carb ratio, insulin sensitivity factor). The system aims to keep users between 70-180 mg/dl as much as possible, using a combination of strategies. When the predicted CGM value in 30 minutes is:

  • Above 180 mg/dl, it gives a correction bolus
  • Above 160 mg/dl, it increases the basal insulin rate
  • Between 112.5-160 mg/dl, it maintains the default user settings
  • Below 112.5 mg/dl, it decreases basal insulin
  • Below 70 mg/dl, it turns off basal insulin

Users will still be expected to bolus for meals. The automated correction boluses occur when predicted CGM values in 30 minutes are above 180 mg/dl, a maximum of once per hour during the day; Control-IQ will give approximately 60% of a full correction bolus with a target of 110 mg/dl. These boluses occur on top of the automatic basal rate.

During the day, the system targets a range of 112.5-160 mg/dl. It is more aggressive at night – the goal is to arrive at 112.5-120 mg/dl by the time the user wakes up. Control-IQ also has an “exercise mode” that changes the target to be closer to 140-160 mg/dl to prevent any hypoglycemia.

Tandem aims to ship out new pumps with advanced hybrid closed loop algorithm Control-IQ “by the end of January 2020.” Control-IQ will also be offered as a free software update for current, in-warranty t:slim X2 pump users in the US. The download will be available through the Tandem Device Updater, which individuals access online from the convenience of their homes. A new prescription and completion of an online training module are required to receive the update. According to Tandem, current users of t:slim X2 should start receiving email notifications about Control-IQ shortly.

 Practice Pearls:

  • This approval opens the door for integrated CGM systems and alternate controller-enabled infusion pumps, or ACE insulin pumps, to be used with an interoperable automated glycemic controller as a complete automated insulin dosing system, also known as an artificial pancreas.
  • This is an example of how artificial intelligence can improve the health of those diagnosed with diabetes who need to use insulin to control their blood sugars.
  • This software and hardware will allow the patient to increase the time in range and improve A1c levels.

 

FDA Release Dec 2019Published in The New England Journal of Medicine in October.

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Steve Freed, R.Ph., Publisher www.Diabetesincontrol.com