The Bigfoot Unity Diabetes Management System is indicated for use for the following:

1. People living with type 1 or type 2 diabetes
2. Aged 12 years and older
3. People taking multiple daily injections of insulin; that includes long-acting insulin and rapid-acting mealtime insulin. 

The Bigfoot Unity System requires a prescription. Individual insurance coverage will vary. 

The Bigfoot Unity White Cap replaces the cap that came with your rapid-acting insulin pen. It is designed to help you remember the rapid-acting insulin doses that you take before eating (Mealtime Insulin) and to bring down a high glucose (Correction Insulin).

1. The White Cap shows how long it has been since you took your last dose of rapid-acting insulin from your pen.
2. You can scan your FreeStyle Libre 2 Sensor with your White Cap to view current glucose readings and trends.
3. The White Cap can receive glucose results from the connected blood glucose Meter (Bigfoot Meter).
4. The White Cap will record and send the past 8 hours of glucose information to the App.

See the Bigfoot Unity System User Guide for complete information on using the Caps with the System. You can download the User Guide within your Bigfoot Unity Mobile App, please select Help and Support from “My Settings.”

To use the Bigfoot Unity White Cap, you will begin by pairing the White Cap in the Bigfoot Unity App. You can follow the steps in the App - Set Up Devices - White Cap.

Once paired, the White Cap is designed to help you remember the rapid-acting insulin doses that you take before eating (mealtime insulin) and to bring down a high glucose (correction insulin).

1. Press the button on the White Cap once, to wake it up.
   • You can view the Time Since Last Dose and a reminder to Scan or Check BG.
   • Scan Sensor with the White Cap. Face the Cap to the Sensor. You will feel a vibration and hear a beep.
   • View your Sensor glucose value, trend arrow, and if you are prescribed correction insulin, the suggested correction insulin, if needed.
   • If using the Meter, perform a fingerstick with the Meter. Place the Meter within 12 inches of the White Cap. Turn on White Cap. Meter reading will display on the White Cap along with the suggested correction insulin, if needed.
2. Press the button on the Cap a second time, to view Meal dose options.
   • Meal dose options include: Small, Medium, and Large (based on meal size), Breakfast, Lunch and Dinner (based on meal time), and three specific carbohydrate amounts and amount of rapid-acting insulin.
3. Press the button on the Cap a third time, to view Meal + Correction dose suggestions.
4. Decide the dose. View your meal and what you plan to eat and decide how much insulin to take based on your meal (and the insulin suggested from Meal + Correction).
5. Take insulin
   • Remove the White Cap from the insulin pen.
   • Place an insulin pen needle on the insulin pen.
   • Dial up the dose on your insulin pen.
   • Inject insulin.
   • Remove the needle and dispose according to your local community guidelines for sharps disposal.
6. Place the White Cap back on the insulin pen to record the dose. You will see the timer on the White Cap return to 0 hr 0 min. 

Always check that the insulin name on the Cap matches the name on the insulin pen you intend to use before making a diabetes treatment decision. If you take a dose with the wrong insulin you could take too much or too little insulin, which may result in a severe low or high glucose.  If you suspect that you have taken the wrong insulin, closely monitor your blood glucose and immediately contact your healthcare professional for advice in managing your glucose.

If your last rapid-acting insulin dose logged using the White Cap was taken within the past 3 hours, the White Cap will display ‘Active Insulin’ and will not display a correction dose. This is because the last dose may be still working to bring down your glucose. Taking another insulin dose on top of the previous dose that is working may lead to hypoglycemia.

Keep your White Cap on your rapid-acting insulin pen, unless you are taking insulin.

Scan the Sensor with the White Cap at least every 8 hours to avoid any gaps in Sensor glucose data. You may scan as often as you like!

To charge the Bigfoot Unity White Cap, you will plug it into the charger that was provided in your Bigfoot Unity Training Pack. If your Cap is completely dead (no power), it will take up to 6-hours to fully charge the Cap.

See the Bigfoot Unity System User Guide for complete information on using the Caps with the System. You can download the User Guide within your Bigfoot Unity Mobile App, please select Help and Support from “My Settings.”

Both Caps should have enough battery power to begin using them when you first remove them from the packaging. If you see a “Charge Cap” message or a Low Battery symbol, you will need to charge the Caps.

Leave the insulin pen inside of the Caps when charging. You will not be able to use the Caps until you are done charging. It is suggested to charge your Caps while you are sleeping, or during a period of time when you won’t need to use the Cap for a few hours.

Use the Caps only with the Bigfoot USB charging cord and power adapter. If you need a replacement USB charging cord or power adapter, contact Bigfoot Customer Care at 551-244-3668 Monday - Friday, between the hours of 6am - 6pm Pacific Time (PT).

The White Cap is used with your rapid-acting insulin (often referred to as mealtime insulin). The White Cap replaces the insulin pen cap on your rapid-acting insulin pen. For a list of rapid-acting insulins that can be used with the Bigfoot Unity White Cap, click here.

Each White Cap is specifically designed to fit the insulin pen that your healthcare professional prescribed for you. If your rapid-acting insulin prescription changes, contact Bigfoot Customer Care at 551-244-3668 Monday - Friday, between the hours of 6am - 6pm Pacific Time (PT), as you may need a new White Cap.

The ‘Use Meter’ message will appear during the first 12 hours of a new Sensor. This message appears when it is recommended to check your blood glucose with your Bigfoot Meter and use that measurement to make treatment decisions. However, if at any time your White Cap displays this message, use the meter to check your blood glucose prior to making a treatment decision.

Do not place sharp objects inside the inner tubes of the Caps. Sharp objects can damage the inner lining of the Caps.

Yes, the Bigfoot Unity White Cap can be kept in the refrigerator. Follow the manufacturer’s recommendations on storing the insulin pen.

The Black Cap replaces the cap that came with your long-acting insulin pen. It is designed to help you remember the long-acting insulin dose that your health care professional recommends and to show how long it has been since you took your last dose of long-acting insulin from your pen.

To use the Bigfoot Unity Black Cap, you will begin by pairing the Cap to the App. You can follow the steps in the App - Set Up Devices - Black Cap. Once paired, the Black Cap is designed to help you remember the long-acting insulin dose that your health care professional has prescribed for you. 

Follow these steps when using the Black Cap:

1. Press the button on the Black Cap to wake it up. View the Time Since Last Dose.
2. Press the button a second time to view the recommended insulin dose as prescribed by your health care professional.
3. Remove the Cap from the insulin pen.
4. Take insulin
   • Remove the Black Cap from the insulin pen.
   • Place an insulin pen needle on the insulin pen.
   • Dial up the dose on your insulin pen.
   • Inject insulin.
   • Remove the needle and dispose according to your local community guidelines for sharps disposal.
5. Place the Black Cap back on the insulin pen to record the dose. You will see the timer on the Black Cap return to 0 hr 0 min
6. You cannot scan the Sensor with the Black Cap. Your Black Cap is not used to communicate with your Sensor or Meter.

Always check that the insulin name on the Cap matches the name on the insulin pen you intend to use before making a diabetes treatment decision. If you take a dose with the wrong insulin you could take too much or too little insulin, which may result in a severe low or high glucose. If you suspect that you have taken the wrong insulin, closely monitor your blood glucose and immediately contact your healthcare professional for advice in managing your glucose.

You should keep your Black Cap on your long-acting insulin pen, unless you are taking insulin.

To charge the Bigfoot Unity Black Cap, you will plug it into the charger that was provided in your Bigfoot Unity Training Pack. If your Cap is completely dead (no power), it will take up to 6-hours to fully charge the Cap.

See the Bigfoot Unity System User Guide for complete information on using the Caps with the System. You can download the User Guide within your Bigfoot Unity Mobile App, please select Help and Support from “My Settings.”

Both Caps should have enough battery power to begin using them when you first remove them from the packaging. If you see a “Charge Cap” message or a Low Battery symbol, you will need to charge the Caps.

Leave the insulin pen inside of the Caps when charging. You will not be able to use the Caps until you are done charging. It is suggested to charge your Caps while you are sleeping, or during a period of time when you won’t need to use the Cap for a few hours.

Use the Caps only with the Bigfoot USB charging cord and power adapter. If you need a replacement USB charging cord or power adapter, contact Bigfoot Customer Care at 551-244-3668 Monday - Friday, between the hours of 6am - 6pm Pacific Time (PT).

The Bigfoot Unity Black Cap is for your long-acting insulin. It replaces the cap on your long-acting insulin pen. For a list of long-acting insulins that can be used with the Bigfoot Unity Black Cap, click here.

Each Black Cap is specifically designed to fit the insulin pen that your healthcare professional prescribed for you. If your long-acting insulin prescription changes, contact Bigfoot Customer Care at 551-244-3668 Monday - Friday, between the hours of 6am - 6pm Pacific Time (PT), as you may need a new Black Cap.

Do not place sharp objects inside the inner tubes of the Black Cap. Sharp objects can damage the inner lining of the Caps.

Yes, the Bigfoot Unity Black Cap can be kept in the refrigerator. Follow the manufacturer’s recommendations on storing the insulin pen.

Bigfoot Unity uses the Abbott FreeStyle Libre 2 Sensor for glucose monitoring. It is not integrated with the FreeStyle Libre 14-day or FreeStyle Libre 3 Sensor.

To find information on how to apply a Sensor, you can look at the following resources:

1. In the App:
   • Initial set up:
     1. Set Up Devices and Start Sensor.
     2. Select Step-by-Step Instructions for images and directions on how to apply the Sensor.
   • New Sensor:
     1. My Devices and Sensor
     2. Select Step-by-Step Instructions for images and directions on how to apply the Sensor.
2. Bigfoot Unity System User Guide, Chapter 7, Using the Sensor. You can download the User Guide within your Bigfoot Unity Mobile App, please select Help and Support from “My Settings.”
3. Abbott’s FreeStyle Libre Sensors Application Guide.

If you still have questions, contact Bigfoot Customer Care at 551-244-3668 between the hours of 6am - 6pm Pacific Time (PT).

You will need to actively scan your Sensor with the Bigfoot Unity White Cap to display your current glucose reading and trend information. You cannot scan the Sensor with the Bigfoot Unity Black Cap.

The FreeStyle Libre 2 Sensor lasts up to 14-days.

To start a new FreeStyle Libre 2 Sensor:

1. First, remove the old Sensor by pulling up the edge of the adhesive that keeps your Sensor attached to your skin.
   • Slowly peel away from your skin in one motion. Discard the used Sensor following directions from your healthcare professional.
2. Second, in the Bigfoot Unity App,
   • Tap on My Devices, then Sensor, Start New Sensor. Follow the steps in the App.
   • If you need support in applying a new Sensor, there are Step-by-Step Instructions in the App. Select Step-by-Step Instructions.

You must scan your Sensor with your Bigfoot Unity White Cap at least once every 8 hours to avoid gaps in data. You can scan your Sensor with your White Cap as often as you like to get glucose and trend information.

Tip: Scan your Sensor (at least) when you wake up, before meals, and before you go to bed.

You can only scan the Sensor with the White Cap to get glucose information. You will need to scan the Sensor with the phone to start a new Sensor, but after start-up you cannot scan the Sensor with your phone. You can only scan the Sensor with the White Cap.

Talk to your health care professional if you have questions about how you should use your Sensor glucose information to help manage your diabetes. 

If you receive a Sensor Unavailable Alert, look at the App. It will provide a short explanation on what you should do to fix the alert. Follow the instructions in the App to resolve the alert.

For additional support, call Bigfoot Customer Care at 551-244-3668 Monday - Friday, between the hours of 6am - 6pm Pacific Time (PT). 

Sensor glucose values, which are based on glucose levels in the interstitial fluid (fluid right below the skin), can be different from blood glucose values, measuring glucose from the capillaries in the blood (fingersticks). This can be especially true during times when your glucose is changing quickly (for example: after eating, after exercising or after taking a dose of insulin).

If your glucose readings and alerts from Bigfoot Unity do not match your symptoms or expectations, perform a fingerstick with your Meter to make diabetes treatment decisions.

Talk to your health care professional if you have questions about how you should use your Sensor glucose information to help manage your diabetes.

No, if using Bigfoot Unity, you can only link to the Bigfoot Unity App and use the White Cap to scan the Sensor.

To communicate the Bigfoot Meter blood glucose reading to the Bigfoot Unity System, you must have your Bigfoot Meter and Bigfoot Unity White Cap within 12 inches of each other.

1. Perform a fingerstick with the Bigfoot Meter.
2. Once the blood glucose value is shown on the Meter, turn on the White Cap by pressing the button one time to display the Time Since Last Dose screen.
3. The blood glucose value will display on the White Cap and in the App.

Tip: Wake up the Bigfoot Meter and the White Cap at the same time for the glucose information to be displayed.

If it has been greater than 10 minutes since performing a fingerstick with the Meter, it will not display the information to the White Cap. You will need to retest your fingerstick with the Meter. 

In order to share your blood glucose values with the Bigfoot Unity System, you must use the Bigfoot Meter that came with the System to have communication across devices and in the Bigfoot Unity App.

There are four alerts on the Bigfoot Unity Diabetes Management System. Alerts will display, sound and vibrate on your App/phone.

1. Very Low Glucose Alert: You will receive this alert when your glucose is less than 55 mg/dL. This is a mandatory alert, you cannot turn it off.
2. Low Glucose Alert: You will receive this alert when your glucose is less than 70 mg/dL.
3. Sensor Unavailable Alert: You will receive this alert when your Sensor is unable to obtain and send a glucose reading or Alert to your App.
4. Long-Acting Dose Alert: You will receive this alert when Bigfoot Unity thinks you may have missed a long-acting insulin dose from your Bigfoot Unity Black Cap.
   1. The pre-set duration time for this alert is 25 hours. You have the option to select the duration time from 24 - 48 hours.
   2. Important Note: Prior to taking your long-acting insulin, check the Time Since Last Dose on your Bigfoot Unity Black Cap to verify if a long-acting dose is needed. You may have received this Alert in error, if your App and Bigfoot Unity Black Cap have not communicated recently. (Remember: Cap before App)

With proper setting, Alerts will display in the App, AND provide a sound AND vibrate on your phone.

There is no high glucose alert on the Bigfoot Unity System.

If you do not tap OK to acknowledge an Alert, it will repeat every 5 minutes for the Very Low Glucose, Low Glucose and Sensor Unavailable Alert, and every 15 minutes for the Long-Acting Dose Alert.

You cannot make changes to My History or the Bigfoot Unity Report in the Bigfoot Unity App.

Yes, in the Bigfoot Unity App, you can download and share your Bigfoot Unity Report.

How to download and share the Bigfoot Unity Report.

1. Open the Bigfoot Unity App on your phone. You will see the option for My Settings.
   1. Tap My Settings
   2. Tap My Data
   3. You will see Retrieving Your Data on the screen.
   4. The Bigfoot Unity Report will display and include your most recent 14-days of data. It is formatted as a PDF document.
2. Print, send or save.
   1. Once downloaded and in a PDF, at the bottom of the screen on your phone, you will see the share icon ().
   2. Tap the share icon ().
   3. Options for sharing the Report:
      1. Print: Send the Report to a printer (wireless)
      2. Save: Save the Report as a PDF file
      3. Send: Attach the Report to an email or text message

Talk with your diabetes care team to understand how to best share your Bigfoot Unity Report with them. You can print and bring it to a clinic visit or email it. Or you can save the report and share it through your electronic medical record if you have a patient portal.

Before making any changes to your insulin therapy, speak with your health care team.

For additional support, call Bigfoot Customer Care at 551-244-3668 Monday - Friday, between the hours of 6am - 6pm Pacific Time (PT).