Systemy FGM jako skuteczna metoda monitorowania glikemii u pacjentów z cukrzycą

Autorzy

Julia
Studenckie Koło Naukowe im. Zbigniewa Religii przy Katedrze Biofizyki w Zabrzu, Wydział Nauk Medycznych w Zabrzu, Śląski Uniwersytet Medyczny w Katowicach
Natalia Zaboklicka
Maria Stachura
Zuzanna Sito

Słowa kluczowe:

FGM, systemy monitorowania stężenia glukozy metodą skanowania, cukrzyca, SMBG

Streszczenie

Każdego roku liczba osób chorujących na cukrzycę dynamicznie się zwiększa. IDF podaje, że w 2021 roku wyniosła ona aż 537 milionów. Skuteczność leczenia cukrzycy jest zależna od regularnego monitorowania poziomu glukozy we krwi. Z tego względu w pracy scharakteryzowano różne sposoby pomiaru glikemii, stosowane przez pacjentów z cukrzycą. Rozdział ma na celu przedstawienie systemów FGM w świetle zwiększenia grupy chorych, których od stycznia 2023 obejmuje refundacja. Omówiony został zakres refundacji, jak również stanowisko Polskiego Towarzystwa Diabetologicznego na temat CGM/FGM. Dodatkowo przedstawiono efekty działania FGM na parametry glikemiczne, zestawienie FGM z samodzielnym pomiarem stężenia glukozy we krwi (SMBG), wpływ FGM na zdrowie psychiczne pacjentów, monitorowanie glikemii w ciąży, a także zastosowanie FGM w pandemii COVID-19. Wykazano przewagę systemów FGM nad SMBG zarówno, jeśli chodzi o skuteczność kontroli glikemii jak i komfort pacjentów. Z niniejszej pracy wynika, że pacjenci stosujący FGM mają mniejsze ryzyko depresji oraz powikłań cukrzycy niż Ci stosujący SMBG. Systemy FGM pozwalają na polepszenie jakości życia ciężarnych, a także pozwalają na obniżenie ryzyka związanego z hipo i hiperglikemią dla rozwijającego się płodu. Przegląd artykułów związanych z zastosowaniem telemedycyny w leczeniu cukrzycy w dobie pandemii COVID-19, nasuwa wniosek o konieczności poszerzenia jej zastosowania, ze szczególnym uwzględnieniem systemów FGM, w kontroli przebiegu tej choroby. Dane przedstawione w rozdziale potwierdzają, że FGM jest korzystnym systemem monitorowania glikemii, pozwalającym na polepszenie jakości życia pacjentów z cukrzycą.  

Bibliografia

International Diabetes Federation Diabetes Atlas. https://diabetesatlas.org (Dostęp: 10.03.2023)

Cukrzyca w liczbach. Serwis Ministerstwa Zdrowia i Narodowego Funduszu Zdrowia. https://pacjent.gov.pl (Dostęp: 10.03.2023)

Daneman D. Type 1 diabetes. Lancet. 2006;367(9513):847-858. doi:10.1016/S0140-6736(06)68341-4

Lee K, Gunasinghe S, Chapman A, et al. Real-World Outcomes of Glucose Sensor Use in Type 1 Diabetes-Findings from a Large UK Centre. Biosensors (Basel). 2021;11(11):457. Published 2021 Nov 15. doi:10.3390/bios11110457

Ismail L, Materwala H, Al Kaabi J. Association of risk factors with type 2 diabetes: A systematic review. Comput Struct Biotechnol J. 2021;19:1759-1785. doi:10.1016/j.csbj.2021.03.003

Zalecenia kliniczne dotyczące postępowania u chorych na cukrzycę 2022. Stanowisko Polskiego Towarzystwa Diabetologicznego. https://ptdiab.pl/zalecenia-ptd (Dostęp: 10.03.2023)

Babaya N, Noso S, Hiromine Y, et al. Flash glucose monitoring in type 1 diabetes: A comparison with self-monitoring blood glucose. J Diabetes Investig. 2020;11(5):1222-1229. doi:10.1111/jdi.13229

Wada E, Onoue T, Kobayashi T, et al. Flash glucose monitoring helps achieve better glycemic control than conventional self-monitoring of blood glucose in non-insulin-treated type 2 diabetes: a randomized controlled trial. BMJ Open Diabetes Res Care. 2020;8(1):e001115. doi:10.1136/bmjdrc-2019-001115

Miller KM, Beck RW, Bergenstal RM, et al. Evidence of a strong association between frequency of self-monitoring of blood glucose and hemoglobin A1c levels in T1D exchange clinic registry participants. Diabetes Care. 2013;36(7):2009-2014. doi:10.2337/dc12-1770

Karter AJ, Ackerson LM, Darbinian JA, et al. Self-monitoring of blood glucose levels and glycemic control: the Northern California Kaiser Permanente Diabetes registry. Am J Med. 2001;111(1):1-9. doi:10.1016/s0002-9343(01)00742-2

Davidson MB, Castellanos M, Kain D, Duran P. The effect of self monitoring of blood glucose concentrations on glycated hemoglobin levels in diabetic patients not taking insulin: a blinded, randomized trial. Am J Med. 2005;118(4):422-425. doi:10.1016/j.amjmed.2004.12.006

Towfigh A, Romanova M, Weinreb JE, et al. Self-monitoring of blood glucose levels in patients with type 2 diabetes mellitus not taking insulin: a meta-analysis. Am J Manag Care. 2008;14(7):468-475.

McIntosh B, Yu C, Lal A, et al. Efficacy of self-monitoring of blood glucose in patients with type 2 diabetes mellitus managed without insulin: a systematic review and meta-analysis. Open Med. 2010;4(2):e102-e113.

Boland E, Monsod T, Delucia M, Brandt CA, Fernando S, Tamborlane WV. Limitations of conventional methods of self-monitoring of blood glucose: lessons learned from 3 days of continuous glucose sensing in pediatric patients with type 1 diabetes. Diabetes Care. 2001;24(11):1858-1862. doi:10.2337/diacare.24.11.1858

Vincze G, Barner JC, Lopez D. Factors associated with adherence to self-monitoring of blood glucose among persons with diabetes. Diabetes Educ. 2004;30(1):112-125. doi:10.1177/014572170403000119

Bakker JJ, Lameijer A, Flores Guerrero JL, Bilo HJG, van Dijk PR. Commencement of flash glucose monitoring is associated with a decreased rate of depressive disorders among persons with diabetes (FLARE-NL7). BMJ Open Diabetes Res Care. 2022;10(3):e002769. doi:10.1136/bmjdrc-2022-002769

Shah VN, Laffel LM, Wadwa RP, Garg SK. Performance of a Factory-Calibrated Real-Time Continuous Glucose Monitoring System Utilizing an Automated Sensor Applicator. Diabetes Technol Ther. 2018;20(6):428-433. doi:10.1089/dia.2018.0143

Wadwa RP, Laffel LM, Shah VN, Garg SK. Accuracy of a Factory-Calibrated, Real-Time Continuous Glucose Monitoring System During 10 Days of Use in Youth and Adults with Diabetes. Diabetes Technol Ther. 2018;20(6):395-402. doi:10.1089/dia.2018.0150

Leelarathna L, Wilmot EG. Flash forward: a review of flash glucose monitoring. Diabet Med. 2018;35(4):472-482. doi:10.1111/dme.13584

Young C, Grobelna A. Flash Glucose Monitoring Systems in Pediatric Populations With Diabetes. Ottawa (ON): Canadian Agency for Drugs and Technologies in Health; April 2021.

Pikee S, Khushbu K, Anupam P, Manju P, Sachin J. New Innovation: Use of Flash Glucose Monitoring for Evaluating Glycaemic Variability, Patient Satisfaction and Clinical Utility in Pregnant Women with Diabetes. J Obstet Gynaecol India. 2021;71(2):136-142. doi:10.1007/s13224-020-01391-9

Hansen KW. Effects of unrestricted access to flash glucose monitoring in type 1 diabetes. Endocrinol Diabetes Metab. 2020;3(3):e00125. Published 2020 Mar 19. doi:10.1002/edm2.125

Yan RN, Cai TT, Jiang LL, et al. Real-Time Flash Glucose Monitoring Had Better Effects on Daily Glycemic Control Compared With Retrospective Flash Glucose Monitoring in Patients With Type 2 Diabetes on Premix Insulin Therapy. Front Endocrinol (Lausanne). 2022;13:832102. Published 2022 Feb 10. doi:10.3389/fendo.2022.832102

Refundacja systemów ciągłego monitorowania glikemii (isCGM/FGM i rtCGM) szansą na poprawę opieki nad chorym na cukrzycę w Polsce. Stanowisko Polskiego Towarzystwa Diabetologicznego https://ptdiab.pl (Dostęp: 10.03.2023)

Rozporządzenie Ministra Zdrowia z dnia 27 października 2022 r. zmieniające rozporządzenie w sprawie wykazu wyrobów medycznych wydawanych na zlecenie (Dz. U. poz. 2319).

Lee J, Lee MH, Park J, et al. FGM-based remote intervention for adults with type 1 diabetes: The FRIEND randomized clinical trial. Front Endocrinol (Lausanne). 2022;13:1054697. Published 2022 Nov 25. doi:10.3389/fendo.2022.1054697

Bolinder J, Antuna R, Geelhoed-Duijvestijn P, Kröger J, Weitgasser R. Novel glucose-sensing technology and hypoglycaemia in type 1 diabetes: a multicentre, non-masked, randomised controlled trial. Lancet. 2016;388(10057):2254-2263. doi:10.1016/S0140-6736(16)31535-5

Haak T, Hanaire H, Ajjan R, Hermanns N, Riveline JP, Rayman G. Flash Glucose-Sensing Technology as a Replacement for Blood Glucose Monitoring for the Management of Insulin-Treated Type 2 Diabetes: a Multicenter, Open-Label Randomized Controlled Trial. Diabetes Ther. 2017;8(1):55-73. doi:10.1007/s13300-016-0223-6

Hohendorff J, Ucieklak D, Skupien J, et al. Risk factors of hypoglycaemia in type 1 diabetes individuals during intensive sport exercise-Data from the SPORTGIVECHANCE event. Int J Clin Pract. 2019;73(11):e13411. doi:10.1111/ijcp.13411

Lind M, Polonsky W, Hirsch IB, et al. Continuous Glucose Monitoring vs Conventional Therapy for Glycemic Control in Adults With Type 1 Diabetes Treated With Multiple Daily Insulin Injections: The GOLD Randomized Clinical Trial [published correction appears in JAMA. 2017 May 9;317(18):1912]. JAMA. 2017;317(4):379-387. doi:10.1001/jama.2016.19976

Beck RW, Riddlesworth T, Ruedy K, et al. Effect of Continuous Glucose Monitoring on Glycemic Control in Adults With Type 1 Diabetes Using Insulin Injections: The DIAMOND Randomized Clinical Trial. JAMA. 2017;317(4):371-378. doi:10.1001/jama.2016.19975

Tyndall V, Stimson RH, Zammitt NN, et al. Marked improvement in HbA1c following commencement of flash glucose monitoring in people with type 1 diabetes. Diabetologia. 2019;62(8):1349-1356. doi:10.1007/s00125-019-4894-1

Evans M, Welsh Z, Ells S, Seibold A. The Impact of Flash Glucose Monitoring on Glycaemic Control as Measured by HbA1c: A Meta-analysis of Clinical Trials and Real-World Observational Studies. Diabetes Ther. 2020;11(1):83-95. doi:10.1007/s13300-019-00720-0

Paris I, Henry C, Pirard F, Gérard AC, Colin IM. The new FreeStyle libre flash glucose monitoring system improves the glycaemic control in a cohort of people with type 1 diabetes followed in real-life conditions over a period of one year. Endocrinol Diabetes Metab. 2018;1(3):e00023. Published 2018 Jun 17. doi:10.1002/edm2.23

Nana M, Moore SL, Ang E, Lee ZX, Bondugulapati LNR. Flash glucose monitoring: Impact on markers of glycaemic control and patient-reported outcomes in individuals with type 1 diabetes mellitus in the real-world setting. Diabetes Res Clin Pract. 2019;157:107893. doi:10.1016/j.diabres.2019.107893

Oskarsson P, Antuna R, Geelhoed-Duijvestijn P, Krӧger J, Weitgasser R, Bolinder J. Impact of flash glucose monitoring on hypoglycaemia in adults with type 1 diabetes managed with multiple daily injection therapy: a pre-specified subgroup analysis of the IMPACT randomised controlled trial. Diabetologia. 2018;61(3):539-550. doi:10.1007/s00125-017-4527-5

Castellana M, Parisi C, Di Molfetta S, et al. Efficacy and safety of flash glucose monitoring in patients with type 1 and type 2 diabetes: a systematic review and meta-analysis. BMJ Open Diabetes Res Care. 2020;8(1):e001092. doi:10.1136/bmjdrc-2019-001092

Cowart K, Updike W, Bullers K. Systematic Review of Randomized Controlled Trials Evaluating Glycemic Efficacy and Patient Satisfaction of Intermittent-Scanned Continuous Glucose Monitoring in Patients with Diabetes. Diabetes Technol Ther. 2020;22(5):337-345. doi:10.1089/dia.2019.0345

Dover AR, Stimson RH, Zammitt NN, Gibb FW. Flash Glucose Monitoring Improves Outcomes in a Type 1 Diabetes Clinic. J Diabetes Sci Technol. 2017;11(2):442-443. doi:10.1177/1932296816661560

Kramer G, Michalak L, Müller UA, Kloos C, Werner C, Kuniss N. Association between Flash Glucose Monitoring and Metabolic Control as well as Treatment Satisfaction in Outpatients With Diabetes Type 1. Exp Clin Endocrinol Diabetes. 2021;129(4):303-308. doi:10.1055/a-0875-3988

Yaron M, Roitman E, Aharon-Hananel G, et al. Effect of Flash Glucose Monitoring Technology on Glycemic Control and Treatment Satisfaction in Patients With Type 2 Diabetes. Diabetes Care. 2019;42(7):1178-1184. doi:10.2337/dc18-0166

Ajjan RA, Jackson N, Thomson SA. Reduction in HbA1c using professional flash glucose monitoring in insulin-treated type 2 diabetes patients managed in primary and secondary care settings: A pilot, multicentre, randomised controlled trial. Diab Vasc Dis Res. 2019;16(4):385-395. doi:10.1177/1479164119827456

Pintus D, Ng SM. Freestyle libre flash glucose monitoring improves patient quality of life measures in children with Type 1 diabetes mellitus (T1DM) with appropriate provision of education and support by healthcare professionals. Diabetes Metab Syndr. 2019;13(5):2923-2926. doi:10.1016/j.dsx.2019.07.054

Boucher SE, Gray AR, Wiltshire EJ, et al. Effect of 6 Months of Flash Glucose Monitoring in Youth With Type 1 Diabetes and High-Risk Glycemic Control: A Randomized Controlled Trial. Diabetes Care. 2020;43(10):2388-2395. doi:10.2337/dc20-0613

Marsters BL, Boucher SE, Galland BC, et al. Cutaneous adverse events in a randomized controlled trial of flash glucose monitoring among youth with type 1 diabetes mellitus. Pediatr Diabetes. 2020;21(8):1516-1524. doi:10.1111/pedi.13121

Al Hayek AA, Robert AA, Al Dawish MA. Effectiveness of the Freestyle Libre Flash Glucose Monitoring System on Diabetes Distress Among Individuals with Type 1 Diabetes: A Prospective Study. Diabetes Ther. 2020;11(4):927-937. doi:10.1007/s13300-020-00793-2

Charleer S, Gillard P, Vandoorne E, Cammaerts K, Mathieu C, Casteels K. Intermittently scanned continuous glucose monitoring is associated with high satisfaction but increased HbA1c and weight in well-controlled youth with type 1 diabetes. Pediatr Diabetes. 2020;21(8):1465-1474. doi:10.1111/pedi.13128

Ali N, El Hamdaoui S, Nefs G, Tack CJ, De Galan BE. Improved glucometrics in people with type 1 diabetes 1 year into the COVID-19 pandemic. BMJ Open Diabetes Res Care. 2022;10(3):e002789. doi:10.1136/bmjdrc-2022-002789

Yu F, Lv L, Liang Z, et al. Continuous glucose monitoring effects on maternal glycemic control and pregnancy outcomes in patients with gestational diabetes mellitus: a prospective cohort study. J Clin Endocrinol Metab. 2014;99(12):4674-4682. doi:10.1210/jc.2013-4332

Alfadhli E, Osman E, Basri T. Use of a real time continuous glucose monitoring system as an educational tool for patients with gestational diabetes. Diabetol Metab Syndr. 2016;8:48. Published 2016 Jul 26. doi:10.1186/s13098-016-0161-5

Xie W, Dai P, Qin Y, et al. Effectiveness of telemedicine for pregnant women with gestational diabetes mellitus: an updated meta-analysis of 32 randomized controlled trials with trial sequential analysis. BMC Pregnancy Childbirth 2020;20(198). doi.org/10.1186/s12884-020-02892-1

Grenard JL, Munjas BA, Adams JL, et al. Depression and medication adherence in the treatment of chronic diseases in the United States: a meta-analysis. J Gen Intern Med. 2011;26(10):1175-1182. doi:10.1007/s11606-011-1704-y

Aragona M, Rodia C, Bertolotto A, et al. Type 1 diabetes and COVID-19: The "lockdown effect". Diabetes Res Clin Pract. 2020;170:108468. doi:10.1016/j.diabres.2020.108468

Ceriello A, Standl E, Catrinoiu D, et al. Issues of Cardiovascular Risk Management in People With Diabetes in the COVID-19 Era. Diabetes Care. 2020;43(7):1427-1432. doi:10.2337/dc20-0941

Katulanda P, Dissanayake HA, Ranathunga I, et al. Prevention and management of COVID-19 among patients with diabetes: an appraisal of the literature. Diabetologia. 2020;63(8):1440-1452. doi:10.1007/s00125-020-05164-x

Cotovad-Bellas L, Tejera-Pérez C, Prieto-Tenreiro A, Sánchez-Bao A, Bellido-Guerrero D. The challenge of diabetes home control in COVID-19 times: Proof is in the pudding. Diabetes Res Clin Pract. 2020;168:108379. doi:10.1016/j.diabres.2020.108379

Bonora BM, Boscari F, Avogaro A, Bruttomesso D, Fadini GP. Glycaemic Control Among People with Type 1 Diabetes During Lockdown for the SARS-CoV-2 Outbreak in Italy. Diabetes Ther. 2020;11(6):1369-1379. doi:10.1007/s13300-020-00829-7

Dover AR, Ritchie SA, McKnight JA, et al. Assessment of the effect of the COVID-19 lockdown on glycaemic control in people with type 1 diabetes using flash glucose monitoring. Diabet Med. 2021;38(1):e14374. doi:10.1111/dme.14374

Ruissen MM, Regeer H, Landstra CP, et al. Increased stress, weight gain and less exercise in relation to glycemic control in people with type 1 and type 2 diabetes during the COVID-19 pandemic. BMJ Open Diabetes Res Care. 2021;9(1):e002035. doi:10.1136/bmjdrc-2020-002035

Prabhu Navis J, Leelarathna L, Mubita W, et al. Impact of COVID-19 lockdown on flash and real-time glucose sensor users with type 1 diabetes in England. Acta Diabetol. 2021;58(2):231-237. doi:10.1007/s00592-020-01614-5

Pla B, Arranz A, Knott C, et al. Impact of COVID-19 Lockdown on Glycemic Control in Adults with Type 1 Diabetes Mellitus, Journal of the Endocrine Society, 2020;4(12). doi.org/10.1210/jendso/bvaa149

Trief PM, Xing D, Foster NC, et al. Depression in adults in the T1D Exchange Clinic Registry. Diabetes Care. 2014;37(6):1563-1572. doi:10.2337/dc13-1867

Lustman PJ, Anderson RJ, Freedland KE, de Groot M, Carney RM, Clouse RE. Depression and poor glycemic control: a meta-analytic review of the literature. Diabetes Care. 2000;23(7):934-942. doi:10.2337/diacare.23.7.934

Deshmukh H, Wilmot EG, Gregory R, et al. Predictors of diabetes-related distress before and after FreeStyle Libre-1 use: Lessons from the Association of British Clinical Diabetologists nationwide study. Diabetes Obes Metab. 2021;23(10):2261-2268. doi:10.1111/dom.14467

Holt RI, de Groot M, Golden SH. Diabetes and depression. Curr Diab Rep. 2014;14(6):491. doi:10.1007/s11892-014-0491-3

Overend L, Simpson E, Grimwood T, Qualitative analysis of patient responses to the ABCD FreeStyle Libre audit questionnaire. Pract Diab, 2019;36(2):45-50. doi.org/10.1002/pdi.2213

Herman A, Aerts O, Baeck M, et al. Allergic contact dermatitis caused by isobornyl acrylate in Freestyle® Libre, a newly introduced glucose sensor. Contact Dermatitis. 2017;77(6):367-373. doi:10.1111/cod.12866

Opublikowane

9 czerwca 2023