valuation of Airborne Low Intensity Multi Frequency Ultrasound, as an add-on Therapy in Type II Diabetic Patients: Self-controlled cross over study
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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.
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References
2. Shah VN, Mohan V. Diabetes in India: what is different? Curr Opin Endocrinol Diabetes Obes. 2015;22 (4):283-289. doi:10.1097/MED.0000000000000166
3. Pandey A, Tripathi P, Pandey R, Srivatava R, Goswami S. Alternative therapies useful in the management of diabetes: A systematic review. J Pharm Bioallied Sci. 2011;3 (4):504-512. doi:10.4103/0975-7406.90103
4. Vishnu N, Mini GK, Thankappan KR. Complementary and alternative medicine use by diabetes patients in Kerala, India. Glob Health Epidemiol Genom. 2017;2:e6. doi:10.1017/gheg.2017.6
5. Misra A, Gulati S, Luthra A. Alternative medicines for diabetes in India: maximum hype, minimum science. Lancet Diabetes Endocrinol. 2016;4 (4):302-303. doi:10.1016/S2213-8587 (15)00515-X
6. Milanese C, Cavedon V, Piscitelli F, Zancanaro C. Effect of low-intensity, low-frequency ultrasound treatment on anthropometry, subcutaneous adipose tissue, and body composition of young normal weight females. J Cosmet Dermatol. 2014;13 (3):202-207. doi:10.1111/jocd.12101
7. Suarez Castellanos I, Jeremic A, Cohen J, Zderic V. Ultrasound Stimulation of Insulin Release from Pancreatic Beta Cells as a Potential Novel Treatment for Type 2 Diabetes. Ultrasound Med Biol. 2017;43 (6):1210-1222. doi:10.1016/j.ultrasmedbio.2017.01.007
8. Yang C, Li Y, Du M, Chen Z. Recent advances in ultrasound-triggered therapy. J Drug Target. 2019;27 (1):33-50. doi:10.1080/1061186X.2018.1464012
9. Shivane V, Pathak H, Tamoli S, et al. Effect of Airborne Low Intensity Multi frequency ultrasound (ALIMFUS) on glycemic control, lipid profile and markers of inflammation in patients with uncontrolled type 2 diabetes: A multicentre proof of concept, randomized double blind Placebo controlled study. Diabetes Metab Syndr. 2022;16 (5):102483. doi:10.1016/j.dsx.2022.102483
10. American Diabetes Association Professional Practice Committee. 6. Glycemic Goals and Hypoglycemia: Standards of Care in Diabetes-2024. Diabetes Care. 2024;47 (Suppl 1):S111-S125. doi:10.2337/dc24-S006
11. American Diabetes Association Professional Practice Committee. 7. Diabetes Technology: Standards of Care in Diabetes-2024. Diabetes Care. 2024;47 (Suppl 1):S126-S144. doi:10.2337/dc24-S007
12. Brazg RL, Klaff LJ, Parkin CG. Performance variability of seven commonly used self-monitoring of blood glucose systems: clinical considerations for patients and providers. J Diabetes Sci Technol. 2013;7 (1):144-152. doi:10.1177/193229681300700117
13. 13. King F, Ahn D, Hsiao V, Porco T, Klonoff DC. A Review of Blood Glucose Monitor Accuracy. Diabetes Technol Ther. 2018;20 (12):843-856. doi:10.1089/dia.2018.0232
14. Nathan DM, Buse JB, Davidson MB, et al. Medical management of hyperglycemia in type 2 diabetes: a consensus algorithm for the initiation and adjustment of therapy: a consensus statement of the American Diabetes Association and the European Association for the Study of Diabetes. Diabetes Care. 2009;32 (1):193-203. doi:10.2337/dc08-9025
15. Bergenstal RM, Gal RL, Connor CG, et al. Racial Differences in the Relationship of Glucose Concentrations and Hemoglobin A1c Levels. Ann Intern Med. 2017;167 (2):95-102. doi:10.7326/M16-2596
16. Khosla L, Bhat S, Fullington LA, Horlyck-Romanovsky MF. HbA1c Performance in African Descent Populations in the United States With Normal Glucose Tolerance, Prediabetes, or Diabetes: A Scoping Review. Prev Chronic Dis. 2021;18:E22. doi:10.5888/pcd18.200365
17. Selvin E. Are There Clinical Implications of Racial Differences in HbA1c? A Difference, to Be a Difference, Must Make a Difference. Diabetes Care. 2016;39 (8):1462-1467. doi:10.2337/dc16-0042
18. ter Haar G. Therapeutic applications of ultrasound. Prog Biophys Mol Biol. 2007;93 (1-3):111-129. doi:10.1016/j.pbiomolbio.2006.07.005
19. Lavrinenko YeE. Low-Frequency Ultrasound Therapy in Combination Treatment of Patients with Type 2 Diabetes Mellitus. Mìžnarodnij endokrinologìčnij žurnal. 2013; (3.51):30-34. doi:10.22141/2224-0721.3.51.2013.84315
20. ElGendy MH, Mohamed AZ, Professor of Int. Medicine , Faculty of Medicine , Cairo University, Egypt., et al. Efficacy of ultrasonic lipolysis on blood cholesterol level in centrally obese women. IJPR. 2017;5 (4):2164-2170. doi:10.16965/ijpr.2017.163