Lipohypertrophy (LH), a common side effect of insulin therapy, is caused by repetitively injecting insulin into the same location.
When insulin is injected into LH lesions, the absorption of insulin may be erratic and unpredictable, which can lead to unexpected hyperglycemia and hypoglycemia and increased blood glucose variability.
To improve injection techniques and avoid LH, a new medical device, ROTO Track® which automatically guides the person with diabetes to rotate the abdominal insulin injections was tested.
The hypothesis is that the device can reduce the number of insulin injections in the same subcutaneous area as compared with non-aided standard insulin injection techniques in people with T1DM.
Methods: In this proof-of-concept cross-over study, baseline data about injection site in the abdominal region was collected blinded for one week with a non-guiding version of the device and compared to 12 weeks of device guidance in 35 people with T1DM. The device registered injection time and location on the abdomen. Based on this a "rotation score", the primary endpoint, was calculated. Secondary end points included number and size of LH, glycemic variability and HbA1c. LH sizes were documented by drawing on a wound care grid after palpation of the skin. Interstitial glucose was measured with a continuous glucose monitor and the coefficient of variation, CV was calculated.
Results: The rotation score improved significantly from a baseline mean of 40.2% to 49.9% after one week (CI: 2.2% - 17.2%, p=0.012) and improved further after 12 weeks to 52.2% (p<0.001).
After 12 weeks, LH was reduced both in mean size from 11.9 (+/- 9.5) cm2 to 8.2 (+/- 9.7) cm2 (p=0.041) and numbers (p=0.039) and the CV of interstitial glucose was reduced from 38.6 to 35.1 (p=0.009).
There were no changes in mean interstitial glucose, HbA1c or hypoglycemic events after 12 weeks.
Conclusion: This proof-of-concept study indicates that the device is safe, improves rotation, reduces LH and reduces glycemic variability.
C.K. Klarskov: None. Y.H. Hamid: None. R.T. Tjalk-Bøggild: Board Member; Self; ROTO Health ApS. Employee; Self; ROTO Health ApS. L. Tarnow: None. P.L. Kristensen: None.
Innovation Fund Denmark (8063-00049B); Nordic Healthcare Technology