Tandem Announces FDA Clearance

t:slim X2 Insulin Pump Announces FDA Clearance

Tandem Diabetes Care Announces FDA Clearance of the t:slim X2 Insulin Pump with Control-IQ Advanced Hybrid Closed-Loop Technology

As a person living with type 1 diabetes for a little over 44 years, and a former and current pump user, this announcement is an exciting new development in managing diabetes. I am extremely confident that this will make our lives just a little bit easier. However, it goes without saying that we still must be vigilant with managing our diabetes.

Skills Include:
  • Understanding carb counting.
  • Being comfortable with diabetes self-care.
  • Questioning when ‘something’ doesn’t seem quite right.
  • And most important, listening to what your body is telling you.

On Dec. 13, 2019, Tandem announced the Food and Drug Administration clearance of the t:slim X2™ insulin pump with Control-IQ™ technology. The Control-IQ™ technology is an advanced hybrid-closed loop feature designed to help increase time in range (70-180 mg/dL). In order to take full advantage of this technology, the X2 pump must integrate with the Dexcom G6 continuous glucose monitor. It’s the first system cleared to deliver automatic correction boluses in addition to adjusting insulin to help prevent high and low blood sugar.

In a nutshell, a hybrid closed loop system automatically adjusts basal insulin delivery every five minutes based on sensor glucose readings. The intent is to maintain blood glucose levels as close to a specific target as possible. However, the hybrid piece is because one still needs to bolus for meals.

  • Predict and help prevent lows and highs.
  • Deliver automatic correction boluses.
  • Accommodate for differences in sleep and exercise activities.
  • Require no fingersticks for mealtime dosing or calibration with DexCom G6 CGM integration.
  • Easy to use.

Tandem expects the Control-IQ software update to be available for current t:slim X2 pump users by the end of January 2020. However, new pump orders will include the new software.

View the full release here: https://www.businesswire.com/news/home/20191213005424/en/

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