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Can’t Find the Remote Control? No Problem – New Insulin Pump from Calibra Goes the Distance Alone

San Francisco Bay Area-based Calibra Medical recently received clearance from the FDA for the Finesse, an “insulin patch-pen” for type 1 and type 2 diabetes. Of late, we have been seeing more and more technologically advanced pumps featuring remote controllers that are beginning to resemble full-on PDAs. The Finesse takes a completely different approach, eliminating the need for a controller or electronics – the device is mechanically controlled and insulin is dosed right from the patch-pen by simultaneously pressing two buttons. While it is similar in concept to the OmniPod (by Insulet) in the way the user wears the device, there is no handheld controller, displays, batteries, or memory. The Finesse is designed to deliver bolus doses of fast-acting insulin by a quick manual "click" of the pump by the user. A preset dose of 1 or 2 units of bolus insulin can be administered per click (if more insulin is needed than the base preset dose, the buttons are pushed repeatedly - as we understand it, 0.5 and 5 unit per click models will be added in the future). The device has a total reservoir capacity of 200 insulin units, meaning the patch-pen will last at least three days for the typical user.

In our view, the main advantages of the Finesse are its simplicity (once the user is familiar with the device, insulin can be easily bolused through clothing by clicking the buttons - dosing seems like it would be much quicker overall as well), its discretion (the company assured us the device can be worn under most clothing without being visible), and small size (Calibra reported the device to be in the ballpark of 2” long, 1” wide, and ¼” thick - very small compared to the other pumps currently on the market). Because the device is only intended to administer bolus insulin and not basal insulin, users still need to take their daily dose of Lantus or Levemir. And, it will not be an option at insulin initiation or for type 2 users only on basal therapy - but, it will be a technology that could dramatically help those who should be moving to basal-bolus but are avoiding it. To be sure, we believe this patch-pen could be a simpler alternative for patients transitioning from basal therapy to MDI or a more convenient way for patients already on MDI to administer mealtime and correction insulin. We also think patients who have avoided pumps to date due to size might very much like Calibra's look and feel. We look for payors to set reimbursement plans shortly, though we believe Calibra would do a great deal of good related to better adherence of insulin. As we understand it, Calibra is planning to launch the Finesse sometime in 2010. --JS

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