FAQs

Yes, Glooko works seamlessly with the Pivot Insulin Delivery System to synchronize your data. Instructions for signing up and logging into the Glooko Account are found in the Pivot User Guide.

Glooko is a comprehensive diabetes management platform that helps people with diabetes understand and control their blood glucose levels and well-being. Track your blood glucose, insulin, weight, exercise, food, and more, all in one place. Glooko helps you stay connected with your Care Team(s) between visits, identify trends, share reports with friends/family, and keep your diabetes data in one place.

My Glooko displays your Glooko account information. Deleting your Glooko account will permanently remove your stored activity data and you will no longer be able to use the Pivot™ Diabetes app.

You can temporarily detach your Pump from the Adhesive Pad and the Infusion Set during the three-day use period. Common reasons for detaching your Pivot™ System include the following:

Preparing for medical procedures such as MRIs, CT scans, X-rays, and/surgeries.

Participating in common daily activities, like swimming, bathing/showering, or contact sports.
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Yes. The Pivot system is MR (Magnetic Resonance) unsafe. The device presents a projectile hazard.

WARNING: The Pivot System cannot be used inside or in proximity to an MRI machine.

It is important to remove your Pivot System before using a sauna or jacuzzi, or while swimming, bathing, showering, or during contact sports. Your Pivot System is only protected against minor splashing (i.e., IP24 rating). Use of the Pivot System in these scenarios could lead to moderate hyperglycemia or Diabetic Ketoacidosis (DKA).

Choosing where you place your infusion site is important. The infusion site should be at least two inches away from your navel or previous infusion site and must be four inches away from a Continuous Glucose Monitor (CGM) sensor site.

The Patch must be launched into:

Fatty tissue on the abdomen

The upper thigh area

The back of the arm

CAUTIONS: Avoid areas with scarring, tattoos, moles, lipodystrophy, and areas that may get bumped or constricted such as the beltline or waistline. Placing your Pivot System incorrectly could lead to moderate hyperglycemia, or Diabetic Ketoacidosis (DKA). Always use a new infusion site that is at least 2 inches away from the previous infusion site. Using the same infusion site repeatedly may lead to infusion site infection, lipodystrophies, moderate hyperglycemia, or Diabetic Ketoacidosis (DKA). Contact your Healthcare Provider if you have symptoms of an infection at your infusion site.

1. Before setting up, wash your hands.

2. Choose the appropriate site location to attach your system.

3. Remove excess hair as required.

4. Clean the site with a 70% isopropyl alcohol wipe.

5. Allow the site to dry.

CAUTION: Do not place the device on broken skin. Before use, ensure your infusion site is clean. Failure to clean the site appropriately may lead to an infusion site infection or a delay in insulin therapy.

Using your fingers, create a wide pinch around your selected site and gently squeeze your skin for at least 5 seconds. When you are ready to insert the Patch, let go of the pinch and place the Inserter against your skin. Press the Launch Button firmly until a "click" is heard. Remove the Inserter from your skin.

WARNING: Every time you change your Cartridge, you must use a different infusion site and replace the Patch. Not doing so can lead to infection, moderate or severe hyperglycemia, or
Diabetic Ketoacidosis (DKA).

Your Pivot System does not require cleaning or maintenance.

If you would like to clean the outside of your Pump, ensure the Cartridge is fully attached and use a moistened cloth with water and a mild detergent to clean, then gently dry. Never submerge your Pump in any liquid or expose it to heat in an attempt to dry your Pump.

If you would like to clean the outside of your Inserter, use a moistened cloth with water and mild detergent to clean, then gently dry. Never submerge your Inserter in any liquid or expose it to heat in an attempt to dry your Inserter.

CAUTION: Only clean the Pump with water and a mild soap. Do not use alcohol, cleaners, solvents, or abrasive products to clean the Pump as this could lead to a toxic episode or cause cracks or discoloration to the Pump housing.

If this is your first time setting up your Pivot System, you must program your Basal Rate Schedule using the Pivot™ Diabetes App.

Set your Basal Rate Schedule in the Pivot Diabetes App by choosing the SINGLE RATE OPTION or a TWO-RATE OPTION.

The SINGLE RATE option will deliver insulin 24 hours per day at your chosen basal rate.

The TWO-RATE option will require two basal insulin delivery rates. You will choose the start time for both Day and Night. The time can be adjusted in 15-minute increments.

The Day rate will end when the Night rate is set to begin. For example, if you set your Nighttime rate to begin at 8:00 PM, your Daytime rate will automatically end at 8:00 PM, and the Nighttime rate will then begin.

Select “Confirm Treatment Settings” and provide user authentication such as Face ID or passcode.

(*) A flashing green light on your Pump indicates the request was received.

(*) Quickly press and release the Control Button to confirm your Basal Schedule.

(*) A flashing white light and three tones indicates that your schedule is set.

WARNING: It is not possible to change the configuration of the Pivot System while it is dispensing insulin. All changes to your Basal Rate Schedule must be done while your Pivot System is in Basal Suspend mode or is starting up after changing the Cartridge. This prevents the risk of accidental Basal Rate Schedule changes that could lead to moderate or severe hypoglycemia, moderate or severe hyperglycemia, or Diabetic Ketoacidosis (DKA).

Set your bolus increment level in 0.5, 1.0, 2.0, 3.0, and 4.0 unit increments. Each press of the Control Button on the Pump while setting up a bolus will deliver this amount of insulin.

Select “Next”. Then select "Confirm Treatment Settings" and provide user authentication such as Face ID or passcode. A flashing green light on your Pump indicates the request was received. Quickly press and release the Control Button to confirm your Treatment Settings. A flashing white light and three tones means that your schedule is set.

Basal Delivery Mode is the default mode of your System and delivers a continuous flow of basal insulin.
This mode automatically begins when your System has completed setup and priming.

Basal Delivery can be set at a rate of your choosing, between 0.5 - 4.0 units per hour, in 0.1 unit per hour increments. A single basal rate or two basal rates can be programmed in a 24-hour period.

While using your Pivot System, you can check the Pivot System status anytime with a quick press of the Control Button. A solid GREEN light and 3 consistent tones indicate Basal Delivery is active.

You will also see Basal Delivery status at the top of your Pivot™ Diabetes appDashboard. To view your current settings, scroll down to the Treatment Settings section.

Bolus Delivery Mode is used to deliver a specific quantity of bolus insulin during mealtimes or to correct high blood glucose levels.

Decide the number of insulin units you would like to deliver. Each press of the Control Button on the Pump equals the number of units you programmed in the app as the bolus increment.

Know your dose and find your presses in the table. Max dose is 20 units or 10 presses. Use the table to find the number of presses for your increment. Hold the control button until you see a blue light and hear a beep, then release. Once the blue light appears, quick press the button until you reach your dose. Each press adds one increment and gives one blue flash and beep to help you count.
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All values in units (U). The table ends at maximum presses or units for that increment.

Example:

(*) 1 press = 2 units

(*) 5 presses = 10 units

(*) 10 presses = 20 units (Maximum bolus is 20 units)

While using your Pivot System, you can check the Pivot System status anytime with a quick press of the Control Button.

A BLUE light on the Pump and 3 ascending tones indicates that you are currently in Bolus Delivery Mode.

You can verify bolus delivery on your Pivot™ Diabetes app in the status bar that says “Bolus Delivery Active” on your dashboard. You will also see “Bolus Delivery Started” when you scroll down to the Pump Activity section.

Check that you are currently in Bolus Delivery Mode by making a quick press on the Control Button. Look for a blue light on the Pump and listen for three ascending tones to indicate that you are currently in Bolus Delivery Mode.

Press and hold the Control Button until you see a green light and hear a single tone, then immediately release the button.

A solid green light and three tones indicate that the System has returned to Basal Delivery Mode.

Basal Suspend Mode is an additional mode available to temporarily pause the delivery of basal insulin.

You may pause your Basal insulin delivery for up to 2 hours. You can do so by entering Basal Suspend Mode.

Press and hold the Control Button until you see a WHITE light and hear a single tone , then immediately release the button.

You will observe a blue light and tone before it turns to white.

When you see a solid white light and hear three descending tones, that means your Pivot System has suspended insulin delivery.

Insulin delivery will automatically resume after the 2 hour suspend has ended.

CAUTION: Delivery remains suspended for 2 hours.

NOTE: Basal delivery may not be suspended while the Pump is in Bolus Delivery Mode. The user must first CANCEL the bolus, then they may suspend basal delivery.

To verify suspend, open the Pivot™ Diabetes App Dashboard and check for “InsulinDelivery Suspended” at the top and the recent Pump Activity log.

You can resume insulin delivery at any time by repeating the long press, or delivery willautomatically resume after 2 hours.

Press and hold the Control Button until you see a white light and hear a single tone, thenimmediately release the button.

When you see a solid green light and hear three consistent tones, that means your PivotSystem has resumed Basal Delivery.

While using your Pivot System, you can check the Pivot System status anytime with aquick press of the Control Button.

This check will show you the current Delivery Mode and also provide confirmation thatthe LED lights and sound signal tones are working correctly.

Before using your Pivot System, ensure that you have been appropriately trained on its use by a certified Pivot System trainer.

Operating the Pivot System in the absence of training can lead to moderate or severe hypoglycemia, moderate hyperglycemia, or Diabetic Ketoacidosis (DKA).

When receiving your Pivot System there was a Training QR Code located inside the Pivot Supply Kit.

Refer to the QR Code to take you to the training website and schedule your training or you may contact Modular Medical Customer Care at 866-710-1200 or email them at Customercare@modular-medical.com

A Cartridge Alarm means an issue has been detected with your Cartridge. Check your Pivot™ Diabetes app for more information about the type of Alarm you have received and the recommended next steps.

If you receive an Alarm, this means that your Pivot System has stopped delivering insulin.

Possible Causes for Cartridge Alarm
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A Resumable Alarm occurs when the Pump detects it is outside of operating conditions.

If you receive an Alarm, this means that your Pivot System has stopped delivering insulin. Check your Pivot™ Diabetes app for more information about the type of Alarm you have received and the recommended next steps.

Possible Causes for a Resumable Cartridge Alarm

A Pump Alarm means an issue has been detected with your Pump. Check your Pivot™ Diabetes app for more information about the type of Alarm you have received and the recommended next steps.

If you receive an Alarm, this means that your Pivot System has stopped delivering insulin.

Possible Causes for Pump Alarm

Pump Failure Alarm
A critical error, malfunction, or failure of your Pump has been detected.

Pump Expired Alarm
Your Pump has reached the end of its 90-day use life.

Your Pivot System will notify you of problems using Alarms with a flashing red light and tone.

If you receive an Alarm, this means that your Pivot System has stopped delivering insulin. Check your Pivot™ Diabetes app immediately for more information about the type of Alarm you have received and the recommended next steps.

You may mute the audio feedback tone of an Alarm for 30 minutes by quickly pressing the Control Button.

If you receive an Alarm during a bolus delivery, you will not receive the full quantity. This may lead to moderate hyperglycemia.

Alarms must be addressed promptly. Failure to respond to alarms may result in premature battery drain, which can stop insulin delivery and increase the risk of moderate hyperglycemia or Diabetic Ketoacidosis (DKA).

When fitted with an Insulin Cartridge, newly manufactured Pumps are water-resistant (Ingress Protection IP24).

Your Pivot System is only protected against minor splashing. Do not submerge your Pump or allow water to get inside the Pump. Always inspect your Pump for damage. If there are signs of fluid entry, discontinue the use of the Pump.

CAUTIONS: It is important to remove your Pivot System before using a sauna or jacuzzi, or while swimming, bathing, showering, or during contact sports. Your Pivot System is only protected against minor splashing (i.e., IP24 rating). Use of the Pivot System in these scenarios could lead to moderate hyperglycemia or Diabetic Ketoacidosis (DKA).

If air bubbles are present, angle the Cartridge as shown below to move the air bubble to the Fill Port. Reinsert the needle into the Fill Port & draw back the plunger to remove the air bubble.

CAUTION: Do not pierce the Fill Port more than 4 times as this could cause insulin to leak and could lead to moderate hyper glycemia, Diabetic Ketoacidosis (DKA), or a delay in insulin therapy.

When the Pump and Cartridge are connected successfully, you will see a white light and hear a single tone.

A flashing blue and green light indicates the Pump needs to be programmed with the Pivot™ Diabetes app.

To obtain additional supplies, you should speak with your provider, physician or call Modular Medical Customer Care @ 866-710-1200 / CustomerCare@Modular-Medical.com

The patient medical device card is shipped in your Pivot Supply Kit, however if you need a replacement card, one can be emailed to you. To obtain a replacement card, contact Customer Care at 866-710-1200 or at CustomerCare@Modular-Medical.com

Your Pivot System, including all components and accessories, should be disposed of in accordance with your local regulations.

Always dispose of the Cartridge and Patch safely and in accordance with your local disposal guidelines. The battery in the Cartridge poses the risk of injury due to fire if not disposed of properly.

No maintenance is required for the Pivot System. Every Cartridge contains a battery that is designed to last for up to three days of use.

NOTE: Do not attempt to replace your Cartridge battery. Doing so could lead to a delay in insulin therapy.

Every Cartridge contains a battery that is designed to last for up to three days of use.

Yes. The Pivot System is available through the pharmacy channel.

The Pivot System is currently only available in the United States.

We are working on making the Pivot System available in additional markets, but no further information is available at this time.

The cost of the Pivot system depends on your individual coverage and is determined through your insurance plan.