The Tandem Mobi insulin pump is a sophisticated medical device designed for the subcutaneous delivery of insulin to manage diabetes mellitus in individuals requiring insulin. It offers advanced features for precise insulin dosing, including the ability to deliver various bolus types and integrate with continuous glucose monitoring (CGM) systems. The pump is intended for single-patient, home use and requires a prescription.
Function Description:
The primary function of the Tandem Mobi insulin pump is to deliver insulin at set and variable rates. It can calculate bolus amounts based on either CGM readings or manually entered glucose values, taking into account preset insulin-to-carb ratios and correction factors defined in Personal Profiles. This allows for highly personalized insulin delivery tailored to the user's needs.
A key feature of the Tandem Mobi system is its interoperable technology, enabling it to communicate securely with compatible, digitally connected devices, including automated insulin dosing software. This connectivity allows the pump to receive, execute, and confirm commands from these external devices, enhancing its functionality and ease of use.
The pump incorporates Control-IQ technology, which is designed to automatically increase, decrease, and suspend basal insulin delivery based on iCGM readings and predicted glucose values. This intelligent system can also deliver correction boluses when the glucose value is predicted to exceed a predefined threshold. Control-IQ technology is indicated for the management of Type 1 diabetes mellitus in persons 6 years of age and greater, for single patient use, and is compatible with NovoLog or Humalog U-100 insulin.
Usage Features:
The Tandem Mobi system is operated through a mobile app, providing a user-friendly interface for managing insulin delivery.
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Bolus Delivery:
- Initiating a Bolus: Users can tap "Bolus" from the navigation bar on the app's dashboard to begin the bolus process.
- Glucose Value Input: If Control-IQ technology is enabled, the current CGM reading may auto-populate. Users also have the option to manually enter or modify their glucose value.
- Correction Bolus: If the blood glucose (BG) is greater than the Target BG, the app will prompt the user to add a correction bolus. Users can choose "Yes" or "No" to proceed. Conversely, if the BG is less than the Target BG but greater than 70 mg/dL, the option to reduce the bolus amount will appear.
- Carbohydrate Entry: Users tap "0 grams" to enter the carbohydrate amount for their bolus. If the carb feature is turned off in the active Personal Profile, this area will read "units" instead.
- Desired Value Input: A numeric keypad appears for entering the desired carbohydrate value. After entering the value, users tap "Done" to continue.
- Review and Confirmation: The app displays a summary of the calculated bolus, including units, carbs, and glucose. Users tap "Next" to continue. If a calculated bolus exceeds the Max Bolus setting, it will be reduced, but users can override this by tapping on the calculated units.
- Final Delivery: Users verify the dose and tap "Confirm." To finalize delivery, they tap "Deliver Bolus" and use the smartphone's security feature (e.g., fingerprint, face ID, or passcode) to confirm. A "Bolus Confirmed" screen will then appear.
- Canceling a Bolus: A bolus in progress can be canceled by tapping the "X" icon on the app's Dashboard and confirming the cancellation.
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Extended Bolus Feature:
- This feature allows a portion of the bolus to be delivered immediately ("Deliver Now") and the remaining part to be delivered slowly over an extended period, up to eight hours. This is particularly useful for high-fat meals or for individuals with gastroparesis.
- Activation: From the "Confirm Bolus" screen, users tap the toggle next to "Extend Food Bolus" to activate it.
- Percentage Adjustment: Users can tap "50%" (or the displayed percentage) to adjust the proportion of the bolus delivered immediately. Any correction bolus amount will always be included in the "Deliver Now" portion. The percentage for "Deliver Later" is automatically calculated.
- Duration Selection: Users tap "2 hr" (or the displayed duration) to select the length of time for the extended delivery, up to eight hours (or two hours if Control-IQ technology is enabled, which is the default and maximum limit). After selecting, they tap "Done."
- Review and Confirmation: Users tap "Next" to review the extended bolus details, including "Now," "Later," and "Duration." They then verify the dose and tap "Confirm."
- Final Delivery: Similar to a standard bolus, users tap "Deliver Bolus" and use the smartphone's security feature to confirm delivery.
- Limitation: Only one extended bolus can be active at any given time. However, a standard bolus can be requested during the "Deliver Later" portion of an extended bolus.
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Quick Bolus Function:
- When enabled through the Settings menu of the Tandem Mobi mobile app, a standard bolus can be delivered directly from the pump by pressing the Pump button, without needing to access the app.
- Steps for Quick Bolus:
- Press and hold the Pump button.
- Listen for two beeps or feel for vibrations.
- Press the Pump button for each increment of desired delivery (e.g., three presses for three increments).
- Wait for the pump to beep/vibrate for each increment pressed.
- Press and hold the Pump button until the pump beeps/vibrates to confirm the bolus delivery.
Maintenance Features:
While the provided documentation does not explicitly detail maintenance features, the general operation of such a device implies certain aspects:
- User Guide Reference: The documentation consistently directs users to refer to the "user guide" for more detailed information on the operation of the Tandem Mobi system. This suggests that comprehensive instructions for routine care, troubleshooting, and potentially cleaning are provided in the full user guide.
- Personal Profiles: The ability to set and modify "Personal Profiles" for insulin-to-carb ratios and correction factors is a crucial aspect of maintaining the pump's effectiveness for individual users. Regular review and adjustment of these settings by the user, in consultation with their healthcare provider, are essential for optimal diabetes management.
- System Component Care: The safety information emphasizes that users must use the insulin pump, CGM, and all other system components in accordance with their respective instructions for use. This implies that each component has its own maintenance requirements.
- Device Removal for Medical Procedures: The Tandem pump and the CGM transmitter and sensor must be removed before MRI, CT, or diathermy treatment. This is a critical safety and maintenance instruction to prevent damage to the device and ensure patient safety during these procedures.
- Software Updates: As a digitally connected device, it is highly probable that the Tandem Mobi system will receive software updates. While not explicitly mentioned as a user-initiated maintenance task, keeping the app and pump software updated would be crucial for optimal performance, security, and access to new features.
The Tandem Mobi insulin pump is designed to be a reliable and secure tool for diabetes management, offering flexibility and advanced automation through its Control-IQ technology and user-friendly app interface.
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