Abstract
Background: Airborne Low Intensity Multi Frequency Ultrasound (ALIMFUS) is a novel add-on therapy mechanical therapy working on low intensity ultrasonography principle.
Materials and methods: This was an open label, self-controlled cross over, single centre, interventional, prospective clinical study, to study efficacy and safety of ALIMFUS in type II Diabetes using ambulatory glucose monitoring methods.
Results: After screening the subjects (n=48), 33 patients were included. There were 17 male (51.51%) and 16 female (48.48%) with mean age 52.39±9.39 years and duration of diabetes was 7.51±3.27 years. All the subjects were on 2/3 oral hypoglycemic agents with none being on insulin. 42.42% had dyslipidaemia and 33.33% had hypertension. There was an increase in time in range (65.96±19.72 to 66.73±19.92 mg/dL and time above range (26.40±22.51 to 27.21±21.01 mg/dL), there was reduction in time below range (7.64±11.66 to 6.06±12.33 mg/dL). There was significant reduction in Hba1C (8.07±0.90 % to 7.87±0.80 %, p 0.010), VLDL (31.07±18.13 to 28.54±14.52, p 0.001) and Total cholesterol: High density lipoprotein levels (3.64±0.75 to 3.45±0.67, p 0.010). Global assessment of overall efficacy by the investigator showed 68.74% had much improvement/no change. None had adverse events with good tolerability in all.
Conclusions: Airborne Low Intensity Multi Frequency Ultrasound showed significant HbA1C reduction and no significant change in ambulatory glucose monitoring parameters. ALIMFUS may be considered as an non-invasive, safe and well tolerated add-on novel technology in patients with uncontrolled glycemia.