FAQs
Answers to Common Questions About Pivot™
The Modular Medical Pivot™ Insulin Delivery System is intended for the treatment of diabetes mellitus in persons requiring insulin.
Your Pivot™ System consists of an Inserter, Pump, Cartridge, Patch, and the Pivot™ Diabetes App. The Pivot™ Diabetes App operates on your smartphone device and connects to the Pump via Bluetooth® connection to support basal rate programming and viewing activity information.
The Pivot™ System can be filled with up to 3.0 mL (300 units) of Humalog® U-100 rapid-acting insulin and can be worn continuously for three days. Your Healthcare Provider will help you manage your insulin dosing regimen and prescribe insulin.
The Pivot™ System can be used by persons with diabetes to manage insulin therapy independently. The Pivot™ System is capable of delivering insulin at set and variable rates via a selectable basal rate between 0.5–4 units per hour (in 0.1-unit increments) and user-selected bolus doses between 2 and 20 units (in 2-unit increments).
The Modular Medical Pivot™ Insulin Delivery System is indicated for the subcutaneous delivery of insulin at set and variable rates, for the management of diabetes mellitus in persons requiring insulin, for individuals 18 years of age and greater.
The Pivot™ Insulin Delivery System is compatible with Humalog® U-100 rapid acting insulin only. Insulin Lispro U-100 (Generic Humalog®) may be used in place of Humalog® U-100 rapid acting insulin.
The Insulin Pump STARTER KIT contains: Pump (90-day use life), Inserter (2-year use life), Quick Start Guide, User Guide, Patient Medical Device card, 10 Cartridges and 10 patches in sealed trays, and 10 needles and syringes.
The supply kit contains the disposable components and accessories with a 3-day use life, this includes 5 cartridges, 5 Patches, and 5 syringes & needles.
The Pump has a single button to initiate priming, control insulin delivery, and check the Pivot™ System status. The Pivot™ System uses lights and tones to make users aware of the Pivot™ System status, delivery mode, and Alarms. The user can check the Pivot™ System status during use with a quick press of the Control Button.
The operating temperature for the pump is 41.0°F to 98.6°F (5°C to 37 °C). The Pump temperature equilibrates from 60.8°F to 98.6°F (16°C - 37°C) when worn on the body. If the system is being used outside of the temperature limits the system will deliver an Extreme Temperature Alarm.
The System should not be used outside of the altitude limits of -1,300ft - 10,000ft. (1060 hPa - 700hPa). If the system is being used outside of the altitude limits the system will deliver an Extreme Altitude Alarm
If you need to stop using your Pump for an extended period, please follow these guidelines on proper and safe storage of your Pump. Storage Condition of Pump and Inserter Temperature: -4°F to 140°F (-20°C to 60°C) Humidity: 15% to 90% RH non-condensing. Store your PUMP in a dry, clean location. Failure to store your Pump correctly can lead to moderate hypoglycemia, moderate hyperglycemia, Diabetic Ketoacidosis (DKA), or a delay in insulin therapy. CARTRIDGE and
PATCH must be kept in a dry location, avoiding direct sunlight. You must store your Cartridge and Patch according to the information found on their labeling. Failure to do so can lead to moderate hypoglycemia, moderate hyperglycemia, Diabetic Ketoacidosis (DKA), or a delay in insulin therapy. Store your INSERTER in a dry, clean location.
The Pivot™ System can be filled with up to 3.0mL (300 units) of Humalog® U-100 rapid acting insulin. NOTE: Do not fill past the Cartridge maximum capacity of 3.0mL (300 units) or below the minimum of 0.3 mL (30 units).
Pack your Pivot™ System supplies in your carry-on luggage. Do not pack your supplies in checked baggage, as they could get delayed or lost. Always carry an Emergency Kit while traveling. Check with your physician for information on the contents of your Emergency kit. Do not expose your Pivot™ System to X-ray screening used for carry-on and checked luggage. Newer full-body scanners used in airport security screening are also a form of X-ray screening and your Pivot™ System should not be exposed to them. Notify the Transportation Security Administration (TSA) Agent that your Pivot™ System cannot be exposed to X-ray machines and request an alternate means of screening. Visit TSA’s website at www.tsa.gov if you have any questions or concerns. You can contact TSA at TSA-ContactCenter@tsa.dhs.gov or call 1-866-289-9673.
Your Cartridge and Patch must be replaced at the end of the three-day use period, when you receive a Delivery Alarm, or if you detect an issue. You can detach your Pivot™ System using the following steps listed in the Pivot™ User Guide. CAUTION: Always dispose of the Cartridge and Patch safely and by your local disposal guidelines. The battery in the Cartridge poses the risk of injury due to fire if not disposed of properly.
CAUTIONS: Modular Medical contraindicates using the System if you have inadequate hearing due to the importance of the audible signals provided by the Pump. Ensure that you are able to detect audio and visual notifications. Being unable to hear an Alarm may prevent you from responding to a Pivot™ System event that requires your immediate attention and may lead to moderate hyperglycemia or Diabetic Ketoacidosis (DKA). If you are in a high-noise environment, keep an eye on your Pump, as the light signals will notify you of any issues.
The Pivot™ System is incompatible with certain common products that are used on the skin. These include bug sprays with or without DEET, perfumes, deodorant sprays, body lotions and sunscreens. Use of these products on the Pivot™ System itself or where the System is adhered to the skin can cause cracks in the plastic used to manufacture the Pivot™ components. DO NOT
allow these products to come in contact with the Pump, Cartridge or Inserter. ALWAYS remove your Pump before applying these products and ALWAYS wash your hands before handling your Pump, Cartridge or Inserter after using such products. ALWAYS change your Cartridge if it becomes exposed to such products and immediately clean your Pump. Failure to do so may result in damage to the Pump, Insulin Cartridge or Inserter and in some cases lead to moderate hyperglycemia,
moderate hypoglycemia, or Diabetic Ketoacidosis (DKA).
DO NOT expose your Pump to within 6 inches of common products with magnets, including cell phone cases or wireless charging cases. Exposure to magnets or products with magnets may interfere with the Pump motor. Damage to the motor can lead to moderate or severe hypoglycemia, moderate hyperglycemia, or Diabetic Ketoacidosis (DKA).
The Pivot™ Diabetes App is only needed to program a new Pump, change the Basal Rate Schedule on a Pump in use. The Pivot™ Diabetes App operates on your smartphone device and connects to the Pump via Bluetooth® connection to support basal rate programming and viewing activity information. Your Basal Rate Schedule is programmed via the Pivot™ Diabetes App using rates determined by you and your Healthcare Provider.
The Pivot™ App is currently compatible with iOS version 26.0+. The Pivot™ App is currently
compatible with the following phone models:
• iPhone 12
• iPhone 12 Pro
• iPhone 12 Pro Max
• iPhone 13
• iPhone 13 Pro
• iPhone 13 Pro Max
• iPhone 14
• iPhone 14 Plus
• iPhone 14 Pro
• iPhone 14 Pro Max
• iPhone 15
• iPhone 15 Plus
• iPhone 15 Pro
• iPhone 15 Pro Max
• iPhone 16e
• iPhone 16
• iPhone 16 Plus
• iPhone 16 Pro
• iPhone 16 Pro Max
The Pivot™ App is available for download in the App Store. Download the Pivot™ App and follow the instructions to install the application. You will also need to sign up for a Glooko account if you do not already have one.
The Pivot App is only available in English.
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.
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.
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 naval or previous infusion site and must be four inches away from a Continuous Glucose Monitor (CGM) sensor site.
The Patch must be launched into the fatty tissue on the abdomen, upper thigh area, or 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.
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 “Apply New Schedule,” 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).
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.
Bolus Delivery Mode is used to deliver a specific quantity of bolus insulin during mealtimes or to
correct high blood glucose levels.
Bolus Increment: Each press equals 2 units of insulin.
Example: (*) 1 press = 2 units
(*) 5 presses = 10 units
(*) 10 presses = 20 units (Maximum allowable 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.
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 30 minutes. 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 (at least 7 seconds), 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 30-minute suspend has ended.
CAUTION: Delivery remains suspended for 30 minutes.
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.
While using your Pivot System, you can check the Pivot System status anytime with a quick press of the Control Button. Please refer to the Instructions for Use and the respective indicator lights that correspond to device status.
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.
The Delivery Alarm is a flashing red light and a REPEATING TONE indicating that your
Insulin Cartridge and Patch need to be replaced. An issue has been detected with the
disposable components of your System.
Your Pivot System will display information about each Alarm in the Pivot™ Diabetes App when the
Pump is connected to the App. If you select the More Information button for the Alarm, a pop-up
will appear to provide extra information about the specific alarm that occurred including the Alarm
Code, recommended next steps, and a phone number to call Modular Medical support if you need
help with your Pivot System.
Possible Cause for Delivery Alarm
Cartridge Expired Your Cartridge has reached 80 hours of use
Out of Insulin Insulin reservoir is empty
Occlusion Detected A blockage in the fluid path has been detected
Battery Empty Battery level is depleted
Cartridge Failure A critical error, malfunction, or failure of your Cartridge has been detected
Extreme Temperature System is being used outside of the temperature limits of 41.0°F - 98.6°F (5°C - 37°C)
Extreme Altitude System is being used outside of the altitude limits of -1,300ft 10,000ft (1060hPa - 700hPa)
The Technical Alarm is a flashing red light and a CONSTANT TONE indicating that you must replace your entire PIVOT System. An issue has been detected with your Pump.
A Technical Alarm indicates that your Pivot System has stopped insulin delivery.
Possible Cause for Technical Alarm
Pump Failure: A critical error, malfunction, or failure of your Pump has been detected.
Expired Pump: Your Pump has reached the end of its 90-day use
Your Pivot System will notify of problems using Alarms with a flashing red light and tone.
You may mute the audio feedback (tone) of an Alarm for 30 minutes by quickly pressing the Control Button.
If you receive an Alarm, this means that your Pivot System stopped delivering insulin.
If you receive an Alarm during a bolus delivery, you will not receive the full quantity
NOTES: To turn off the Alarm you must remove power to the Pump by removing the Cartridge
When fitted with an Insulin Cartridge, newly manufactured Pumps are water-resistant (Ingress Protection IP24).
Over time, the moisture protection capabilities of the Pump may be compromised by incidental bumps, drops, shock, exposure to incompatible chemicals or other unintentional events the Pump may be exposed to over time under normal use conditions.
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 installing a new cartridge (onto the pump), you will see a quick white light and single beep indicates power is on.
A flashing blue and green light will appear to indicate the Pump is ready to be connected with the Phone 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 yourPivot™ Supply Kit, however if you need a replacement card, one can beemailed to you. To obtain a replacement card, contact Customer Care at866-710-1200 or at CustomerCare@Modular-Medical.com
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. (Alarms at 80
hours of use)
Yes. The Pivot System is available through the pharmacy channel, but will be limited to specific geographies within the United States.
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.
You should always refer to your Quick Start Guide & Instructions for Use for help on the use of the Pivot System. Both are available as printed material in your Starter Kit.
If you have additional questions or need assistance with your Pivot System, you may contact Customer Care at 866-710-1200 or at CustomerCare@Modular-Medical.com.
Contact Support
Support You Can Feel, From People Who Get It
