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

Abstract

Introduction: 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. Methods: 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. Results: 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). Conclusion: This proof-of-concept study indicates that the device improves rotation of insulin injections, and reduces LH and GV.

Habits related to the use of insulin infusion set in patients with type 1 diabetes on pump therapy — the effect of the educational intervention

“…The evidence-based scheme presented in the Mayo Clinic recommendations involves the division of injection sites into quadrants (or halves when using the thighs or buttocks), the use of one quadrant per week, and the rotation from quadrant to quadrant in a consistent direction (e.g., clockwise) [10]. Recently, new medical devices have been invented to encourage and help patients treated with multiple insulin injections to rotate injection sites properly [31,32]. New applications in this field should be considered for patients using continuous subcutaneous insulin infusion [33].…”

Characteristics and morphology of lipohypertrophic lesions in adults with type 1 diabetes with ultrasound screening: an exploratory observational study

“…42 There are also some emerging electronic technologies that could support/reinforce injection behaviors such as rotation. 43 An additional and potentially clinically important observation in relation to the anatomical distribution of the observed nodules was that the depth of nodules, at the midpoint, correlated to the length of needle used for insulin injections. This suggests that altering needle length for periods of time could potentially increase the distribution of insulin across the available subcutaneous tissue, although the depth of an individual's subcutaneous tissue would be a limiting factor.…”

“… 42 There are also some emerging electronic technologies that could support/reinforce injection behaviors such as rotation. 43 …”

Lipohypertrophy and Insulin: An Update From the Diabetes Technology Society

“…47 It attaches directly to the insulin pen and activates when the pen is picked up and positioned at an anchor point in front of the navel. 47 Light from a light-emitting diode and vibration from a motor on the device show where to inject according to the PWD's injection plan. 47 The psychological challenges of injections also need to be considered regarding LH prevention and management.…”

“…47 Light from a light-emitting diode and vibration from a motor on the device show where to inject according to the PWD's injection plan. 47 The psychological challenges of injections also need to be considered regarding LH prevention and management.…”