Clinical Evaluation of a New, Lower Pain, One Touch Lancing Device for People With Diabetes: Virtually Pain-Free Testing and Improved Comfort Compared to Current Lancing Systems.

BACKGROUND: Patients worldwide use lancing devices to perform self-monitoring of blood glucose (SMBG). Continued innovation remains important to minimize pain associated with finger sticking to facilitate patient adherence to SMBG regimens. The original One Touch Delica lancer (OTD) reduced the pain of testing. This study investigated a completely re-engineered lancing system, called One Touch Delica Plus (OTDP), intended to further minimize pain while improving the patient experience. METHODS: One hundred and three subjects (type 1 or 2 diabetes) experienced finger sticks with both lancing systems. Device depth and blood volume (BV) generation were determined during visit 1. These parameters were used during pain assessments in visit 2. Patient feedback was also recorded using surveys. RESULTS: Finger-stick testing was less painful using OTDP compared to original OTD irrespective of whether 30 (-48.2 mm, -30.4 mm, P < 0.0001) or 33 gauge (-42.6 mm, 30.5 mm, P = 0.0004) lancets were used. All 103 subjects generated the required BV (≥0.4 µL) per protocol. At equivalent depth penetration, OTDP generated higher average BVs than OTD using 30 (1.58 µL, 1.10 µL) or 33 gauge lancets (1.39 µL, 0.98 µL). Subjects responded that testing with OTDP was virtually pain free (78%) and that testing with OTDP was less painful than using their current lancing systems (79%) or original OTD (67%). CONCLUSION: OTDP demonstrated lower pain than the original OTD lancing system and participants agreed that testing with OTDP was virtually pain free and less painful than using their current lancing systems.

Evaluating the OneTouch® Delica™: a low-pain lancing system for self-monitoring of blood glucose.

The pain associated with lancing can be a significant barrier to self-monitoring of blood glucose (SMBG). The OneTouch® Delica™ lancing device contains features to reduce lancing pain, including improved lancet control and stability, reduced vibration, and a thinner, 33-gauge lancet. This 2-visit, randomized controlled trial assessed perceived pain of lancing with the OneTouch® Delica™ compared with 4 other common lancing devices: OneTouch® Comfort™, ACCU-CHEK® Softclix, ACCU-CHEK® Multiclix, and Ascensia® Microlet™2. Two hundred patients with type 1 or type 2 diabetes mellitus were assigned to the OneTouch® Delica™ and also randomized to 1 of the 4 comparator devices (n=50 per device pair). At visit 1, we determined the minimum depth settings required to produce≥1 µL of fingertip blood for each patient with each device. At visit 2, patients lanced their fingertips with the devices at the predetermined depths and used a 150-mm visual analog scale (VAS) to rate lancing pain relative to their "usual pain" associated with SMBG. The VAS ranged from "much less painful" (0 mm) to "much more painful" (150 mm), with the midpoint (75 mm) labeled as "usual pain." Fingertip pain scores from patients using OneTouch® Delica™ were significantly lower than those obtained using OneTouch® Comfort™, ACCU-CHEK® Multiclix, and Ascensia® Microlet™2. Pain scores for OneTouch® Delica™ and ACCU-CHEK® Softclix were not significantly different. In conclusion, OneTouch® Delica™ was either less painful or no different than the comparator devices when used for fingertip lancing. Innovative lancing devices that cause less pain may improve compliance and persistence with prescribed SMBG.