Novel Bluetooth-Enabled Tubeless Insulin Pump: Innovating Pump Therapy for Patients in the Digital Age

Abstract

The Omnipod DASH™ Insulin Management System (Insulet Corp, Billerica, MA) is a discreet, tubeless, wearable insulin pump that holds up to 200 units of U-100 insulin and delivers therapy through customizable basal rates and bolus amounts. This recently FDA-cleared system consists of the insulin pump ("Pod"), which is worn on body and delivers insulin, and the Personal Diabetes Manager (PDM), which is a handheld device used to wirelessly control and monitor the Pod functionality. The PDM can also be paired with the CONTOUR^® NEXT ONE blood glucose (BG) meter (Ascensia Diabetes Care, Basel, Switzerland) to wirelessly receive BG readings. This review provides a detailed description of the Pod and PDM. Key features of the Pod are described, including the novel pump delivery mechanism, waterproof (IP28) housing design, and automated cannula insertion. The technology introduced in the new system, such as touchscreen PDM interface, Bluetooth^® wireless technology, and wireless internet connectivity, is also presented. Last, Omnipod^® Insulin Management System clinical data are reviewed, including early feasibility results for the Omnipod Horizon™ Automated Glucose Control hybrid closed-loop system.

Keywords: Omnipod; diabetes; insulin pump; patch pump; tubeless pump.

Figure 1.

Omnipod DASH™ Insulin Management System Personal Diabetes Manager (PDM) and Pod, with the interoperable CONTOUR^® NEXT ONE blood glucose meter.

Figure 2.

Schematic diagram showing the actuation mechanism of the Pod. Shape memory alloy (SMA) wire technology pulls the lever back and forth to deliver 0.05 units of insulin with each independent movement. Two wire segments are alternately heated (represented by red highlight on the wire, labeled A and B) to pivot the lever (indicated by yellow highlight). In diagram A, wire segment A is heated and contracts, causing the lever to pivot (indicated by red arrow) and push the gear wheel forward with the right arm (changing linear motion to rotational motion). In diagram B, wire segment A cools and elongates while wire segment B is heated and contracts, causing the lever to pivot in the other direction (indicated by red arrow) and push the gear wheel forward with the left arm.

Figure3.

Omnipod DASH™ Personal Diabetes Manager (PDM), Pod, and integrated data communication systems. The PDM communicates with the Pod and the CONTOUR^® NEXT ONE blood glucose meter through Bluetooth^® wireless technology. The PDM uploads data to the secure Insulet Cloud via Wi-Fi, which can then be viewed on a personal cell phone using the Omnipod VIEW™ mobile application. The PDM can also communicate through Bluetooth wireless technology to the Omnipod DISPLAY™ mobile application installed on a personal cell phone. The Omnipod DISPLAY mobile application can then automatically upload data to the Insulet Cloud using Wi-Fi or cellular data. Data uploaded to the Insulet Cloud will automatically merge with the Glooko^® data management system to allow integrated data management.

Figure 4.

Change in HbA1c at 3 months post–Omnipod treatment initiation in patients with type 1 diabetes. (A) Change from previous treatment with multiple daily injections (MDI). HbA1c change (mean ± SD) was –0.3% ± 1.3, –0.4% ± 1.4, –0.8% ± 1.3, and –0.6% ± 1.3 for pediatric, adolescent, adult, and total, respectively. *P = .002. **P < .001. (B) Change from previous treatment with continuous subcutaneous insulin infusion (CSII). HbA1c change (mean ± SD) was –0.3% ± 0.8, –1.1% ± 1.6, –0.4% ± 1.1, and –0.5% ± 1.1 for pediatric, adolescent, adult, and total, respectively. *P < .01. **P < .001. Reprinted with permission from Layne et al.

Figure 5.

Change in HbA1c level and total daily dose (TDD) of insulin from baseline on MDI therapy at 3 months post–patch pump treatment initiation in patients with type 2 diabetes. (A) Decrease in HbA1c level (mean ± SD) of 1.2% ± 1.4% (–13 ± 15 mmol/mol) from baseline on MDI therapy (pre–patch pump) versus postpatch pump at 3 months. (B) Decrease in TDD (mean ± SD) of 27.6 ± 30.9 units of insulin from baseline on MDI therapy (prepatch pump) versus post– patch pump at 3 months (n = 80). *P < .001. Reprinted with permission from Layne et al.