Tandem Diabetes Pump Durable Medical Equipment

Living with diabetes has never been this easy. The continuous glucose monitors, commonly known as CGMs, have changed the way people of managing diabetes. A small sensor typically inserted on the back of upper arm with the help of a micro needle that measure your glucose values from interstitial blood 24/7, and you can see these readings on either a handheld monitor or directly on your compatible smartphone. Then comes the automatic insulin delivery (AID) systems which help you get insulin boluses without the pain of injections and hassle of tubes (in tubeless pumps). These devices fall under the category of durable medical equipment, let’s take a dive into Tandem diabetes pump durable medical equipment.

How Do AID Systems Work?

Automated Insulin Delivery (AID) systems utilize continuous glucose monitors (CGMs), insulin pumps, and sophisticated algorithms to automatically adjust insulin delivery based on real-time glucose readings. The system predicts future glucose trends and makes insulin adjustments to prevent hyperglycemia (high blood sugar) and hypoglycemia (low blood sugar). Tandem Diabetes Pumps integrate with CGMs to form AID systems that provide users with better glucose control and flexibility.

Understanding Tandem Diabetes Pumps

Tandem Diabetes Pumps use advanced technology to deliver insulin accurately based on programmed settings or automated adjustments. Here’s how they function:

• Controller and Smartphone Compatibility: Tandem pumps can be operated via a dedicated controller or compatible smartphone app. The t:connect mobile app allows users to monitor insulin delivery, CGM trends, and pump status remotely.
• Automatic and Manual Boluses: Users can choose automatic insulin delivery based on CGM readings or manually administer boluses to cover meals or correct high blood sugar.
• Standalone Use Without a CGM Sensor: While Tandem pumps work best with a connected CGM, they can operate independently in manual mode. In standalone mode, the pump delivers insulin based on pre-set basal rates and user-initiated boluses without automatic adjustments.

Data Sharing Capabilities

Tandem Diabetes Pumps support secure data sharing through the t:connect platform. Users can share real-time data with healthcare providers, caregivers, or family members. The data can be accessed through the mobile app or web-based portal, enhancing collaborative diabetes management.

Tandem AID Systems

At the moment, there are two types of AID systems available in the US market by Tandem, t:slim X2 and Tandem Mobi insulin pump. Both of these pumps have the Control-IQ technology option available, which is not recommended for individuals who weigh less than 55 pounds or requires less than 10 insulin bolus units per day. You may turn off t:slim X2 Control IQ by tapping on Home screen > Options > My pump > Control IQ > Toggle on/off.

Turning on your Control IQ will require you to enter your weight and the amount of total basal insulin units you consume in a 24-hour time span (you may confirm this from your healthcare specialist). After you have entered both of these values, tab the check mark in the top right corner. Your control-IQ technology is now activated and you can see a gray diamond sign on the top left corner of your screen just below the batter sign.

1. t:slim X2 Insulin Pump:

• Works with Dexcom G6 sensor, Dexcom G7 sensor, and FreeStyle Libre 2 Plus.
• Primarily this system had Basal-IQ technology and was designed to minimize low blood sugar events.
• Now features Control-IQ technology for automated insulin delivery. Using the sensor values, this system can predict your blood sugar values 30 minutes ahead and insulin your insulin boluses accordingly.
• t:slim X2 insulin pump is Indicated to be used with NovoLog or Humalog U-100 insulin.
• Approved for individuals aged 6 and older living with diabetes.
• Requires a prescription and should only be used by a single patient only.

2. Tandem Mobi:

• Works with Dexcom G6 and Dexcom G7 sensors.
• Tandem Mobi is also equipped with the Control-IQ technology that predicts your glucose levels 30 mins ahead of time and adjust your insulin boluses accordingly (if turned on).Approved for individuals aged 6 and older living with diabetes.
• Requires a prescription and should be used by a single patient only.

FDA Approval Status

As per a pre-market approval shared by the FDA, Tandem Diabetes Care has received FDA approval for its t:slim X2 insulin pump. The pump can only be used for continuous insulin delivery and with Basal-IQ technology system. Tandem Mobi also received clearance for people with diabetes ages six and above.

Model-Wise Breakdown

Tandem Diabetes Pumps, classified as durable medical equipment, offer advanced insulin delivery solutions for individuals with diabetes. Their integration with CGMs, smartphone compatibility, and data-sharing capabilities make diabetes management more accessible and efficient. Get a free eligibility check now.

References:

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?ID=419643