Effective Date

Date of Origin   

04-01-2025           

01-01-2022

iLet®

Infusion disposable pump supplies

The iLet Bionic Pancreas System is indicated for use by people with type 1 diabetes 6 years of age and older.

13

iLet Bionic Pancreas 

Infusion pump kit

The iLet Bionic Pancreas System is indicated for use by people with type 1 diabetes 6 years of age and older.

13

Omnipod® 5 G7

Infusion disposable pump supplies

For subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin.

11

Omnipod GO®

Infusion disposable pump kit

For the subcutaneous infusion of insulin at a preset basal rate in one 24-hour time period for 3 days (72 hours) in adults with type 2 diabetes.

12

Omnipod® 5 G6*

Infusion disposable pump supplies

For subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin.

*The Omnipod 5 System is designed to work with the Dexcom G6 Continuous Glucose Monitor (CGM)

11

Omnipod®

Infusion disposable pump kit

For subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin.

7

Omnipod DASH® System

Infusion disposable pump kit

For subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin.

8

twiist™

Infusion pump

For use by people with type 1 diabetes 6 years of age and older.

15

twiist™

Infusion pump supplies

For use by people with type 1 diabetes 6 years of age and older.

15

V-Go®

Infusion disposable pump kit

For continuous subcutaneous infusion of either 20 Units of insulin (0.83 U/hr), 30 Units of insulin (1.25 U/hr) or 40 Units of insulin (1.67 U/hr) in one 24-hour time period and on-demand bolus dosing in 2 Unit increments (up to 36 Units per one 24-hour time period) in adults requiring insulin. 

10

Diabetes

The American Diabetes Association recommends that most people with type 1 diabetes should be treated with multiple daily injections of prandial and basal insulin, or subcutaneous insulin infusion. In addition, many patients with type 2 diabetes eventually require insulin therapy for both prandial and basal blood glucose control.(4)

The purpose of insulin pumps is to mimic the pancreas’ normal release of insulin.(5) Since insulin pumps only use short-acting insulin, frequent blood glucose checks for safety are required. Most diabetes providers will require a patient to check their blood glucose at least four times daily before using an insulin pump. There are technical aspects to using a pump; using a pump can be more complicated than injections in some ways.(6) Insulin pump therapy is not recommended for people who are unable to perform at least four blood glucose checks per day, are unable to maintain contact with their healthcare provider, or are unable to use the system according to instructions.(1) 

Omnipod

The Omnipod is a small device that is filled with insulin by the patient and worn on the body. Up to 200 units of insulin can be injected into the Pod. Omnipod is designed for use with U-100 rapid-acting insulin. NovoRapid, Humalog, and Apidra are safe to use in the Omnipod, but only Humalog and Apidra are compatible for up to 72 hours. The Pod should be changed when either 200 Units of insulin has been delivered or 72 hours has elapsed. Once applied, the patient uses a Personal Diabetes Manager (PDM) wireless device to control the rate and amount of insulin delivered by the pod. Insulin can be delivered at a basal rate as well as a bolus (such as would be used at mealtime). The PDM also contains a FreeStyle blood glucose meter. Information from the PDM can be uploaded to data management software for review.(7)

The Omnipod DASH system uses the DASH PDM with a smart-phone like device with a touchscreen and connected to the Pod via Bluetooth. The Omnipod system and the Omnipod DASH system are not compatible; Pods from one system cannot be used with the other.(8)  The manufacturer warranties the PDM for a period of 4 years from initial purchase.(2) Omnipods are packaged in boxes of 10. Omnipod DASH pods are packaged in boxes of 5.(9)

The Omnipod 5 system is integrated with the Dexcom G6 Continuous Glucose Monitor. The Pod can be adjusted by using the Omnipod 5 App on a compatible smartphone, or with an included wireless controller.(11)

The Omnipod GO insulin delivery device is intended for the subcutaneous infusion of insulin at a preset basal rate in one 24-hour time period for 3 days (72 hours) in adults with type 2 diabetes. It comes in 7 different models: 10, 15, 20, 25, 30, 35, and 40 units per day. There is no ability to deliver a bolus dose of insulin using the Omnipod GO.(12)

V-Go System

The V-Go system is a device that is applied to the skin like a patch that delivers insulin to the patient. Three types of V-Go devices are available, delivering 20, 30, or 40 units of insulin over 24 hours. A U-100 fast acting insulin should be used with V-Go. Humalog, and NovoLog have been found to be safe for use in V-Go. The device delivers insulin at the basal rate over 24 hours specified by which device is selected. The device can also deliver a bolus of 2 units to the patient by clicking a button on the device. Up to 36 units (18 clicks) of insulin can be delivered via bolus per device. V-Go devices are packaged as a kit containing 30 V-Go devices and a filling accessory. They are to be dispensed as a full kit; kits are not to be broken apart.(10)

twiist AID System

The twiist system is intended for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin, ages 6 and above. The pump is able to reliably and securely communicate with compatible, digitally connected devices, including automated insulin dosing software, to receive, execute, and confirm commands from these devices. The twiist system is intended for single-patient home use and requires a prescription.(15) 

Tidepool Loop enables the system to automatically adjust insulin delivery based on continuous glucose monitor (CGM) readings, your personalized settings, and predicted glucose levels. Designed for and by people living with diabetes, it provides a high degree of customization, including the widest target range of any AID system.  iiSure Technology directly measures the volume of insulin delivered and includes 4 checkpoints along the way to help ensure accurate delivery. This technology also allows the twiist system to alert you to blockages up to 9 times faster than other AID systems. twiist is the only AID system that allows you to bolus using the on-device bolus button, Apple iPhone, and through the Apple Watch. The insulin resevoir/cartridge holds 300 units of insulin and can be used up to 3 days.(15)

ilet Bionic Pancreas

The iLet Bionic Pancreas (BP) is a unique insulin delivery system, as it is only initialized using the person's body weight. The system automates insulin delivery without a warm-up period. Individuals do not count carbohydrates, but “announce” meals by determining if the meal they are about to have is “usual,” “more” or “less” than what they would typically eat for that meal type. The BP continually adapts to the person's insulin needs and autonomously determines basal, mealtime, and correction doses. Neither the user nor the medical team can modify the algorithm, which continuously adapts to an individual's insulin needs. All the insulin doses are determined entirely by the BP.(13,14) The insulin cartrigde and infusion sets are replace every 1 to 3 days depending on the cannula type (as noted in the table below). If needed the cartridge and infusion sets can be replaced independently of each other.(13)

The iLet ACE (alternate controller enabled) Pump and iLet Dosing Decision Software are designed to use rapid-acting U-100 insulin. According to the manufacturer, the cartridge within the pump holds 180 units of insulin. NovoLog, Humalog, and Fiasp are compatible with the system for use up to 72 hours (3 days).(13)

Safety

The Omnipod 5 System is NOT recommended for people who are:(1,2)

• Unable to monitor glucose as recommended by their healthcare provider are
• Unable to maintain contact with their healthcare provider are
• Unable to use the Omnipod 5 System according to instructions are
• Taking hydroxyurea as it could lead to falsely elevated CGM values and result in over-delivery of insulin that can lead to severe hypoglycemia
• Do NOT have adequate hearing and/or vision to allow recognition of all functions of the Omnipod 5 System, including alerts, alarms, and reminders
• Device components including the Pod, CGM transmitter, and CGM sensor must be removed before Magnetic Resonance Imaging (MRI), Computed Tomography (CT) scan, or diathermy treatment. In addition, the Controller and smartphone should be placed outside of the procedure room. Exposure to MRI, CT, or diathermy treatment can damage the components.

The twiist AID system with the Tidepool Loop is not intended for anyone unable or unwilling to:(15)

• Test blood glucose (BG) levels as recommended by their healthcare provider
• Maintain sufficient diabetes self-care skills See their healthcare provider regularly
• Demonstrate adequate carbohydrate-counting skills

The twiist AID system user must not:(15)

• Have difficulty seeing
• Have difficulty hearing
• Have deficient cognitive capabilities
• Have physical impairments that would make operating the device or iPhone difficult

Insulin pump therapy is NOT recommended for people who are:(1,2)

• Unable to perform at least four (4) blood glucose tests per day
• Unable to maintain contact with their healthcare provider
• Unable to use the any system according to instructions

1

Omnipod System User Guide. Insulet Corporation. 2018-2024. Available at: https://www.omnipod.com/safety.

2

Omnipod DASH System User Guide. Insulet Corporation. 2018-2024. Available at: https://www.omnipod.com/safety.

3

V-Go Health Care Provider website. Mankind Corporation. July 2023. Available at: https://www.go-vgo.com/hcp/.

4

American Diabetes Association Professional Practice Committee; 9. Pharmacologic Approaches to Glycemic Treatment: Standards of Care in Diabetes-2024. Diabetes Care 1 January 2024; 47 (Supplement_1): S158-S178. https://doi.org/10.2337/dc24-S009

5

Device Technology. American Diabetes Association. Available at: https://www.diabetes.org/diabetes/device-technology  

6

Who Should Use a Pump? American Diabetes Association. Available at: https://www.diabetes.org/diabetes/device-technology/who-should-use-a-pump.  

7

Podder’s Handbook Omnipod User’s Guide. Available at: https://www.myomnipod.com/en-gb/eros-user-guide. 

8

Omnipod Dash Insulin Management System Frequently Asked Questions. Available at: https://www.omnipod.com/what-is-omnipod/omnipod-dash

9

Diabetic Warehouse e-commerce site. Available at: https://www.diabeticwarehouse.org/pages/search-results-page?q=omnipod.  

10

V-Go Product Website. Available at: https://www.go-vgo.com/. 

11

Omnipod 5 information. Available at: https://www.omnipod.com/what-is-omnipod/omnipod-5.

12

Omnipod GO marketing approval letter and Form 3881 https://www.accessdata.fda.gov/cdrh_docs/pdf22/K223372.pdf.

13

iLet Bionic Pancreas pump user guide. Beta Bionics. 2024. Available at: https://www.betabionics.com/user-resources/

14

Weissberg-Benchell J, Vesco AT, Shapiro J, et al. Psychosocial Impact of the Insulin-Only iLet Bionic Pancreas for Adults, Youth, and Caregivers of Youth with Type 1 Diabetes. Diabetes Technol Ther. 2023;25(10):705-717. doi:10.1089/dia.2023.0238

15

twiist. Healthcare professionals - twiist. Twiist. Published June 28, 2024. https://twiist.com/healthcare-professionals/

Omnipod dash pods (gen 4)

*insulin infusion disposable pump reservoir*** ; *insulin infusion disposable pump supplies***

30

Pods

30

DAYS

08508200005;

Omnipod dash pods (gen 4)

*insulin infusion disposable pump reservoir*** ; *insulin infusion disposable pump supplies***

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Quantity limit for the Target Agent(s) will be approved when ONE of the following is met:

1. There is support for therapy with a higher quantity for the requested indication

Length of Approval:  up to 12 months