A New Medical Device for Improved Rotation of Insulin Injections in Type 1 Diabetes Mellitus: A Proof-of-Concept Study.

Abstract

Lipohypertrophy (LH) is caused by repetitively injecting insulin into the same location. This can lead to unpredictable insulin absorption and increased glucose variability (GV). A new medical device, ROTO Track, automatically guides the user to rotate abdominal insulin injections to avoid LH lesions. This study aimed to test whether the medical device could reduce the number of insulin injections in the same subcutaneous area as compared with non-aided standard insulin injection techniques. In this proof-of-concept cross-over study, baseline data about injection site in the abdominal region were collected blinded for 1 week with a nonguiding version of the device and compared to 1 and 12 weeks of device guidance in 35 people with type 1 diabetes. The device registered time and location of abdominal injections. The primary endpoint was a "rotation score." Secondary endpoints included number and size of LH, GV, and hemoglobin A1c. The rotation score improved significantly from a baseline mean of 40.2% to 49.9% after 1 week (confidence interval: 2.2-17.2%, P = .012) and improved further after 12 weeks to 52.2% (P < .001). After 12 weeks, LH was reduced both in median size from 9.2 (range: [0.9-29.4]) cm2 to 5.4 (range: [0.0- 26.8]) cm2 (P = .041) and mean count from 1.4 (range: [1-2]) to 1.1 (range: [0-2], P = .039) and the coefficient of variation of interstitial glucose was reduced from 38.6 to 35.1 (P = .009). This proof-of-concept study indicates that the device improves rotation of insulin injections, and reduces LH and GV.