simplera device
device OmniDash5 copy

Summary

The Simplera continuous glucose monitor (CGM) is Medtronic’s first disposable, all-in-one CGM. This sensor lasts for 7 days and sends real-time glucose readings to a compatible smartphone app or directly on an Apple Watch. No finger pricks or scanning is needed. 

FDA-approved for people with diabetes ages 2 years and older.

The first FDA-approved tubeless, waterproof pump that can be controlled entirely from a compatible Android smartphone. The system combines the Omnipod patch pump with the Dexcom continuous glucose monitor (CGM) to automatically adjust insulin delivery in response to glucose trends. It's easy to use and allows bolus dosing directly from a compatible smartphone.

Components

Simplera : Sensor

Simplera : Sensor

Sensor uses a thin, flexible filament inserted just under the skin to measure glucose levels every 5-minutes. Push-button applicator allows sensor to be placed on the body in one step.

Simplera : Receiver

Simplera : Receiver

Conveniently access glucose readings using a reader, smartphone, or directly on an Apple Watch. Phone app available for both iOS and Android devices.

Omnipod 5 : Pump

Omnipod 5 : Pump

Pods come with reservoirs and directions for application. They can be applied anywhere on the body that is comfortable.

Omnipod 5 : Sensor

Omnipod 5 : Sensor

Automatic applicator inserts sensor just under the surface of the skin and can be applied to many places on the body.

Omnipod 5 : Controller

Omnipod 5 : Controller

The Controller or a compatible smartphone allows the user to control the Pod using the Omnipod 5 App. Compatible smartphone can be used to view and administer boluses via the Omnipod 5 app.

Device Details

Overview

The Simplera is Medtronic's smallest continuous glucose monitor. It's disposable and has a flat, square shape.

This system includes a wearable, tubeless insulin Pod controlled by the Omnipod App on a compatible smartphone or a smartphone-like Insulet-provided Controller.

Affordability and Access

$$$$
No insurance coverage data. Provided by DME and/or Pharmacy. 

$$$$
Widely covered for insulin-dependent type 1 and 2. Supplies for Pump and Sensor provided by Pharmacy and/or DME suppliers. Projected price range; $5-$1260 to start and 0-$200/month.

Data Monitoring Options

Yes
Automatically and continuously sends data to the user’s Care Partner web-based cloud which is accessible by clinicians. 

Yes
Insulet Provided Glooko® is a data management platform that provides clear, actionable insights. Wireless data uploads directly into Glooko® to support both in-person and remote patient care.

Data View Options

Yes
Users must download the Simplera app to view and share data. Messages via the simplera app or text messages to notify care partners when glucose is high or low. 

Yes
Dexcom sensors permit remote monitoring. Wireless data uploads directly into Glooko® to support both in-person and remote patient care

Duration and Storage

7 Days
Sensors last 7 days. 

3-day pump 10-day sensor
Sensors last 10 days and transmitters last 90 and work at 50ºF – 108ºF. Under normal circumstances, your body temperature keeps the Pod within a range of 73°F and 98.6°F

Vision / Auditory / Dexterity

YES text to speech
YES vibration alerts
3 sound sources
SOME dexterity needed

NO text to speech
YES vibration alerts
SOME dexterity needed

Patient Considerations

Active Lifestyle

Waterproof when submerged in water and must be within range of the feet of the receiver or mobile device.

Activity. Target glucose is set to 150 mg/dl. Automated insulin delivery is decreased ~50%. The maximum insulin delivery is deceased. Activity mode can be run for 1-24 hours. Wear the Pod in the shower, in the pool, or in the ocean. The Controller is not waterproof and must be charged daily.

Avoiding Highs and Lows

Custom alerts can be set for highs, lows, and rapidly rising or falling glucose levels. Trend arrows show the direction glucose is heading, with the rate of change. 

Automated Mode uses insulin delivery history and sensor glucose value and trend to automatically increase, decrease, and pause insulin delivery based on current and predicted glucose values using a customizable glucose target.

Comfort

Smaller size. The sensor is small and flat, and no overtape is required. Simplera’s adhesive is made from an anti-lint material that prevents sweat and water from reaching the sensor.

Low profile & no tubing. Low profile sensor and Omnipod has no tubing but may require more adhesive on the body than other pumps.

Easy Insulin Dosing

Real-time data and alerts make dose adjustment easier. The device can be integrated with the Medtronic InPen, which offers a bolus calculator based on carb ratios, meal estimations, the amount of insulin on board, and fixed dosing regimens

Automatically adjusts dosing. Sensor trends feed into Pods' customizable dose adjustments and there are no interruptions in insulin delivery. You can set a target between 110 mg/dL – 150 mg/dL in 10 mg/dL increments. Basal and bolus in 0.05 increments. Extended bolus unavailable when using automated insulin delivery mode. 

Easy to Use

No scanning is required. Readings are sent directly to the mobile app every 5 minutes.

Smartphone Integration. Pod has fewer components to deal with than other pumps and can be fully controlled using a compatible smartphone. 

Fewer Fingersticks

Factory-calibrated sensor. Finger sticks needed for backup only.

Factory-calibrated sensor. Fingersticks needed for backup only.

Privacy

Discreet. Small, flat shape and ability to see sugar on a watch or phone.

Discreet. Sensor allows for checking blood glucose on phone/smartwatch. Most discreet pump option with no visible controller required if using an Android smartphone.