Smart Insulin Pen/Smart Cap Bridge Technology Gap for MDI


People living with type 1 diabetes (T1D) have numerous advanced technologies to choose from to better manage their T1D: Continuous glucose monitors (CGMs), insulin pumps, and artificial pancreas systems, which combine the two.

These technologies can make managing T1D easier and help facilitate better outcomes: Fewer experiences of low blood sugar (called hypoglycemia) or high blood sugars (called hyperglycemia), better sleep, and more time-in-range.

There is no such thing as too many options to choose from for T1D management—what works for one person may not be the best fit for another.

Now, people living with T1D who prefer multiple daily injections (MDI) of insulin have two high-tech T1D management options: An insulin smart pen or an insulin smart pen cap.

What are Insulin Smart Pens/Smart Pen Caps? How Do They Work?

These are innovative devices used for MDI insulin administration.

Medtronic’s InPen™ (a Bluetooth-enabled insulin pen) was first cleared by the FDA in 2016, but received FDA clearance for all ages* in 2020. Bigfoot Biomedical’s Bigfoot Unity™ (a Bluetooth-enabled insulin pen cap) received regulatory clearance for ages 12 and up this past year.

Like conventional insulin pens, insulin smart pens can be used to administer certain long- or rapid-acting insulin as needed while basal insulin pen caps can track long-acting insulin.

Unlike conventional insulin pens and insulin pen caps, InPen and Bigfoot Unity do a lot more than physically deliver insulin into the body—they are part of an intuitive diabetes management system.

InPen and Bigfoot Unity pair with corresponding smartphone apps through which a person with diabetes can keep track of insulin doses, blood-glucose levels (via data from a compatible CGM or blood-glucose meter), as well as receive reminders, alerts, and reports.

More specifically, insulin smart pens/caps can:

  • Calculate insulin dosage based on current blood-glucose level, carbohydrate reading, meals, active insulin or insulin on board, and settings prescribed by a physician
  • Deliver correct half-unit doses that are ½ units**
  • Issue alerts to help prevent skipped or missed doses
  • Crunch the numbers when you’re trying to calculate how to dose for a meal or correct high blood glucose
  • Track the time and amount of every dose, and issue reminders for the next insulin dose   
  • Indicate whether insulin has expired or has been subjected to high temperatures so the cartridge can be replaced
  • Provide diabetes data to your health care team at any time
  • Sync with smart phones or watches, as well as popular diabetes data tracking platforms

Both InPen and Bigfoot Unity sync with CGMs that provide blood-glucose level data in real time; InPen with Medtronic’s Guardian™ Connect System or Dexcom and Bigfoot Unity with Abbott’s Freestyle Libre 2.  

Both can also be used by people using blood-glucose meters. Automatic transmission of blood glucose data may require the meter to meet technological requirements.  

This is crucial in that for the first time, people with T1D who do not wish to use any kind of wearable device, can finally reap some of the benefits of using more advanced T1D management technologies—and they have more than one choice. A huge step in bridging the T1D technology gap.

“One of JDRF’s goals is to make sure that everyone has the diabetes management tools that work best for them,” said Associate Director of Research at JDRF, Jonathan Rosen, Ph.D. “While we have driven forward the development of AP systems, which consist of a pump, CGM, and controller, and have demonstrated benefits in improving outcomes and reducing disease burden, we appreciate that not everyone wants to wear a pump and are thrilled to see the progress in smart pens like Medtronic’s InPen and Bigfoot Biomedical’s Unity. Smart pens can aid with many aspects of T1D care, including helping users determine when to take insulin and what the dose should be, which helps relieve the daily burden of T1D.”

“I am OBSESSED with My InPen”

Mattie Fisher is a wife and mother of two from Titusville, Florida. This marketing manager for a transportation firm is a plant-based lifestyle devotee who loves to spend time with her family outdoors—mostly engaging in water sports.

Diagnosed at age 12, Mattie has been living with T1D for 20 years. She can’t say enough good things about her InPen.

“I like to say I am OBSESSED—in a healthy way—with my InPen,” she said. 

When she was first diagnosed, Mattie used vials of long-lasting and rapid-acting insulin, along with syringes and lots of finger sticks. When she was ready to enter high school, she decided to try an insulin pump.

Turns out, it wasn’t the right fit for her.

“I did not like being connected to something all the time. Sleeping was uncomfortable, it would snag on different things,” she said.

She, her parents, and her heath care team decided to switch to insulin pens. 

“I have been on Humalog®1 pens and my long-lasting pens since age 16,” Mattie said. “The pens really seemed to suit my lifestyle better, but I did not get any of the perks that the insulin pump offered—having to manually do all the adding and subtracting for all meal boluses and corrections for any high blood sugars was not my strong suit.”

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She said this often led to her simply using a number she was comfortable with for meals or corrections.

“And that led to guessing, which is not a good idea,” she said.

Insta Attraction

All of that changed in March 2021.

“I came across another person on Instagram who is living with type 1 who was using the InPen,” Mattie said. “I had no clue what the InPen was and messaged her with a few questions. After a couple messages back and forth, I knew I had to find out more.”

She called Medtronic for more information and was immediately taken with InPen.

“I love that it does much of the work for me, as far as calculating how many units [of insulin] I need for the meal I am about to eat,” Mattie said. “I also enter my blood glucose and the amount of carbs into the InPen App—and BAM!—it does the rest. Lastly, it also calculates my correction dosage, if needed. And it automatically adjusts if I still have insulin on board [active in my body].”

Mattie uses the InPen with Medtronic’s Guardian Connect CGM. And while she raves about how much easier her T1D management is now, that is not the only big benefit.

“The InPen tells me how much insulin I have used and keeps track of how much insulin I still have in my system,” she said. “I am having fewer instances of low blood sugars now and my confidence in how I am managing my diabetes has improved greatly—almost immediately from using the InPen. I am happy with how my diabetes is being managed and I know my doctor is as well.”

Soon to Come: Even More Choices

Reportedly, other companies are working on products similar to InPen and Bigfoot Unity.

These will provide more people who choose MDI even more new technology choices to help ease the burden of managing their T1D, as well as potentially improve how they manage their T1D.

Mattie is living proof that finding the “just right” technology can make all the difference, and she’s far from the only person singing the praises of the InPen.

Editor’s note:

This educational content is made possible with support from Medtronic. JDRF produces this content to provide information to our supporters about their potential options for managing their T1D and not as an endorsement of products. Editorial control rests solely with JDRF.

*<7 requires adult supervision

**InPen only

  1. Humalog ® is a registered trademark of Eli Lilly and Company