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Tandem's Control - IQ Cleared in United States 

15/01/2020

By Elad Goren

 

 

Tandem and the FDA have announced that Control - IQ is now cleared in the United States.

Control - IQ technology is an advanced hybrid closed loop system that uses an algorithm that detects your blood sugar and automatically delivers you insulin to help increase time in the American Diabetes Association's recommended target range. (70-180 mg/dl)

 

What makes Control- IQ technology unique?

Control - IQ technology helps increase time in the recommended blood sugar range by using Dexcom G6  continuous glucose monitoring values to predict blood glucose levels about 1/2 hour ahead and adjust the delivery of insulin accordingly.

This new technology also includes automatic correction boluses as needed.

 

According to the company's website, a clinical research that compared participants who used t:slim X2™ with Control - IQ's new technology to participants who used sensor - augmented pump therapy alone for 6 months, demonstrated significant "in range" differences .

Particpants who used the new algorithm spent an average of 71% "in range" time - per day, compared to 59% for sensor - augmented pump therapy users.

 

The trail followed 168 participants between ages 14-71 for 6 months.

The treatment effect was evident in the first month and consisted over 6 months.

Time in range improvement was observed at the end of the trail period after 6 months for a wide range of Hemoglobin A1C (HbA1C).

 

How does it work?

Control -IQ uses the TypeZero/ Dexcom hybrid closed loop algorithm which still requires calibration of data such as basal profile, insulin-to-carb ratio and insulin sensitivity factor.

Control - IQ aims to keep it's users in the recommended blood glucose rang as much as possible, employing numerous strategies when the predicted GCM value is;

 

  • >180 mg/dl it delivers a correction bolus 
  • >160 mg/dl it increases basal insulin delivery 
  • 112.5-160 mg/dl it maintains the user's profile setting.
  •  <112.5 mg/dl it decreases basal insulin delivery 
  • <70 mg/dl it stops  basal  insulin delivery at once.

 

The system aims to achieve a range of 112.5-160 mg/dl but during the night it is more rigorous as it targets a range of 112.5-120 mg/dl that should be achived before the person wakes up.

Control- IQ offers an exercise mode that increases the range to 140-160 mg/dL in effort to prevent an occurence of hypoglycemia during or after the work out session.

 

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