Cost-utility of real-time continuous glucose monitoring versus self-monitoring of blood glucose and intermittently scanned continuous glucose monitoring in people with type 1 diabetes receiving multiple daily insulin injections in Denmark.
continuous glucose monitoring (CGM)
cost-effectiveness
health economics
hypoglycaemia
type 1 diabetes
Journal
Diabetes, obesity & metabolism
ISSN: 1463-1326
Titre abrégé: Diabetes Obes Metab
Pays: England
ID NLM: 100883645
Informations de publication
Date de publication:
09 2023
09 2023
Historique:
revised:
19
05
2023
received:
09
03
2023
accepted:
20
05
2023
medline:
3
8
2023
pubmed:
19
6
2023
entrez:
19
6
2023
Statut:
ppublish
Résumé
To determine the cost-effectiveness of the Dexcom G6 real-time continuous glucose monitoring (rt-CGM) system compared with both the self-monitoring of blood glucose (SMBG) and the Abbott FreeStyle Libre 1 and 2 intermittently scanned CGM (is-CGM) devices in people with type 1 diabetes receiving multiple daily insulin injections in Denmark. The analysis was performed using the IQVIA Core Diabetes Model, which associates rt-CGM use with glycated haemoglobin reductions of 0.6% and 0.36% based on data from the DIAMOND and ALERTT1 trials, respectively, compared with SMBG and is-CGM use. The analysis was performed from the payer perspective over a 50-year time horizon; future costs and clinical outcomes were discounted at 4% per annum. The use of rt-CGM was associated with an incremental gain of 1.37 quality-adjusted life years (QALYs) versus SMBG. Total mean lifetime costs were Danish Krone (DKK) 894 535 for rt-CGM and DKK 823 474 for SMBG, resulting in an incremental cost-utility ratio of DKK 51 918 per QALY gained versus SMBG. Compared with is-CGM, the use of rt-CGM led to a gain of 0.87 QALYs and higher mean lifetime costs resulting in an incremental cost-utility ratio of DKK 40 879 to DKK 34 367 per QALY gained. In Denmark, the rt-CGM was projected to be highly cost-effective versus both SMBG and is-CGM, based on a willingness-to-pay threshold of 1× per capita gross domestic product per QALY gained. These findings may help inform future policies to address regional disparities in access to rt-CGM.
Substances chimiques
Insulin
0
Blood Glucose
0
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
2704-2713Informations de copyright
© 2023 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd.
Références
Jørgensen ME, Kristensen JK, Reventlov Husted G, Cerqueira C, Rossing P. The Danish adult diabetes registry. Clin Epidemiol. 2016;8:429-434. doi:10.2147/CLEP.S99518
Carstensen B, Rønn PF, Jørgensen ME. Prevalence, incidence and mortality of type 1 and type 2 diabetes in Denmark 1996-2016. BMJ Open Diabetes Res Care. 2020;8(1):e001071. doi:10.1136/bmjdrc-2019-001071
Moalem S, Storey KB, Percy ME, Peros MC, Perl DP. The sweet thing about type 1 diabetes: a cryoprotective evolutionary adaptation. Med Hypotheses. 2005;65(1):8-16. doi:10.1016/j.mehy.2004.12.025
Nielsen HB, Ovesen LL, Mortensen LH, Lau CJ, Joensen LE. Type 1 diabetes, quality of life, occupational status and education level-a comparative population-based study. Diabetes Res Clin Pract. 2016;121:62-68. doi:10.1016/j.diabres.2016.08.021
Dansk Endokrinologisk Selskab. Continuous glucose monitoring national behandlings vejledninger. Published 2020. https://endocrinology.dk/nbv/diabetes-melitus/kontinuerlig-glukosemaaling-cgm-og-flash-glukosemaaling-fgm-til-boern-unge-og-voksne/ Accessed July 7, 2022.
Diabetesforeningen. Diabekes.dk Ny opgørelse: Store regionale forskelle i diabetesudstyr. Published 2021. https://diabetes.dk/nyheder/2021/ny-opgorelse-store-regionale-forskelle-i-diabetesudstyr. Accessed July 7, 2022
Thabit H, Prabhu JN, Mubita W, et al. Use of factory-calibrated real-time continuous glucose monitoring improves time in target and HbA1c in a multiethnic cohort of adolescents and young adults with type 1 diabetes: the MILLENNIALS study. Diabetes Care. 2020;43(10):2537-2543. doi:10.2337/dc20-0736
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
Hásková A, Radovnická L, Petruželková L, et al. Real-time CGM is superior to flash glucose monitoring for glucose control in type 1 diabetes: the CORRIDA randomized controlled trial. Diabetes Care. 2020;43(11):2744-2750. doi:10.2337/dc20-0112
Visser MM, Charleer S, Fieuws S, et al. Comparing real-time and intermittently scanned continuous glucose monitoring in adults with type 1 diabetes (ALERTT1): a 6-month, prospective, multicentre, randomised controlled trial. Lancet. 2021;397(10291):2275-2283. doi:10.1016/S0140-6736(21)00789-3
Sortsø C, Green A, Jensen PB, Emneus M. Societal costs of diabetes mellitus in Denmark. Diabet Med. 2016;33(7):877-885. doi:10.1111/dme.12965
Palmer AJ, Roze S, Valentine WJ, et al. Validation of the CORE diabetes model against epidemiological and clinical studies. Curr Med Res Opin. 2004;20(Suppl 1):S27-S40. doi:10.1185/030079904X2006
Palmer AJ, Roze S, Valentine WJ, et al. The CORE diabetes model: projecting long-term clinical outcomes, costs and cost-effectiveness of interventions in diabetes mellitus (types 1 and 2) to support clinical and reimbursement decision-making. Curr Med Res Opin. 2004;20(Suppl 1):S5-S26. doi:10.1185/030079904X1980
McEwan P, Foos V, Palmer JL, Lamotte M, Lloyd A, Grant D. Validation of the IMS CORE diabetes model. Value Health. 2014;17(6):714-724. doi:10.1016/j.jval.2014.07.007
Ehlers LH, Lamotte M, Ramos MC, et al. The cost-effectiveness of oral semaglutide versus empagliflozin in type 2 diabetes in Denmark. J Comp Eff Res. 2022;11(1):29-37. doi:10.2217/cer-2021-0169
Statistics Denmark. Consumer price index. https://www.statbank.dk/PRIS111. Accessed July 13, 2022
Polonsky WH, Hessler D, Ruedy KJ, Beck RW, DIAMOND Study Group. The impact of continuous glucose monitoring on markers of quality of life in adults with type 1 diabetes: further findings from the DIAMOND randomized clinical trial. Diabetes Care. 2017;40(6):736-741. doi:10.2337/dc17-0133
Solli O, Stavem K, Kristiansen I. Health-related quality of life in diabetes: the associations of complications with EQ-5D scores. Health Qual Life Outcomes. 2010;8(1):18. doi:10.1186/1477-7525-8-18
Beaudet A, Clegg J, Thuresson PO, Lloyd A, McEwan P. Review of utility values for economic modeling in type 2 diabetes. Value Health. 2014;17(4):462-470. doi:10.1016/j.jval.2014.03.003
Evans M, Khunti K, Mamdani M, et al. Health-related quality of life associated with daytime and nocturnal hypoglycaemic events: a time trade-off survey in five countries. Health Qual Life Outcomes. 2013;11:90. doi:10.1186/1477-7525-11-90
Lauridsen JT, Lønborg J, Gundgaard J, Jensen HH. Diminishing marginal disutility of hypoglycaemic events: results from a time trade-off survey in five countries. Qual Life Res. 2014;23(9):2645-2650. doi:10.1007/s11136-014-0712-x
Currie CJ, Morgan CL, Poole CD, Sharplin P, Lammert M, McEwan P. Multivariate models of health-related utility and the fear of hypoglycaemia in people with diabetes. Curr Med Res Opin. 2006;22(8):1523-1534. doi:10.1185/030079906X115757
Matza LS, Stewart KD, Davies EW, Hellmund R, Polonsky WH, Kerr D. Health state utilities associated with glucose monitoring devices. Value Health. 2017;20(3):507-511. doi:10.1016/j.jval.2016.10.007
Laegemiddelstyrelsen. Vejledning om udarbejdelse af sundhedsøkonomiske analyser af laegemidler. VEJnr 9153 af 09/03/2018 (Danish Medicines Agency. Guidelines for the development of health-economic evaluation of medicines). https://www.retsinformation.dk/eli/retsinfo/2018/9153. Accessed July 13, 2022
Danish Ministry of Finance. Dokumentationsnotat-den samfundsøkonomiske diskonteringsrente. https://fm.dk/media/18371/dokumentationsnotat-for-den-samfundsoekonomiske-diskonteringsrente_7-januar-2021.pdf. Accessed August 23, 2022
Gross domestic product (GDP) per capita at current prices in Denmark from 2000 to 2021. https://www.statista.com/statistics/587297/gross-domestic-product-gdp-per-capita-in-denmark/. Accessed July 13, 2022
Kazibwe J, Gheorghe A, Wilson D, Ruiz F, Chalkidou K, Chi YL. The use of cost-effectiveness thresholds for evaluating health interventions in low- and middle-income countries from 2015 to 2020: a review. Value Health. 2022;25(3):385-389. doi:10.1016/j.jval.2021.08.014
The Sheffield Type 1 Diabetes Policy Model. https://www.sheffield.ac.uk/polopoly_fs/1.268462!/file/13.05.pdf. Accessed July 13, 2022.
Isitt JJ, Roze S, Tilden D, et al. Long-term cost-effectiveness of Dexcom G6 real-time continuous glucose monitoring system in people with type 1 diabetes in Australia. Diabet Med. 2022;39(7):e14831. doi:10.1111/dme.14831
Reddy M, Jugnee N, Anantharaja S, Oliver N. Switching from flash glucose monitoring to continuous glucose monitoring on hypoglycemia in adults with type 1 diabetes at high hypoglycemia risk: the extension phase of the I HART CGM study. Diabetes Technol Ther. 2018;20(11):751-757. doi:10.1089/dia.2018.0252
Visser MM, Charleer S, Fieuws S, et al. Effect of switching from intermittently scanned to real-time continuous glucose monitoring in adults with type 1 diabetes: 24-month results from the randomised ALERTT1 trial. Lancet Diabetes Endocrinol. 2023;11(2):96-108. doi:10.1016/S2213-8587(22)00352-7
Gibb F, Stimson R, Wright R, Forbes S, Strachan M, Dover A. Conversion from FreeStyle Libre to Freestyle Libre 2 is associated with improvements in continuous glucose monitoring metrics. Diabetology. Vol 65. European Association for the Study of Diabetes; 2022:S52.
Puhr S, Derdzinski M, Welsh JB, Parker AS, Walker T, Price DA. Real-world hypoglycemia avoidance with a continuous glucose monitoring system's predictive low glucose alert. Diabetes Technol Ther. 2019;21(4):155-158. doi:10.1089/dia.2018.0359
Acciaroli G, van der Linden J, Chao C, Walker TC, Oliver N. Longitudinal analysis of users transitioning from the Dexcom G5 to the G6 RT-CGM system in Germany, Sweden and the United Kingdom (2018-2020). Diabet Med. 2023;40(2):e14946. doi:10.1111/dme.14946
Rilston S, Oliver N, Tanushi B, Hill N. The impact of CGM with a predictive hypoglycaemia alert function on hypoglycaemia in physical activity for people with type 1 diabetes: PACE study. Diabetologia. Vol 65. European Association for the Study of Diabetes; 2022:S72.
Ahola AJ, Saraheimo MT, Freese RI, Mäkimattila SM, Forsblom C, Groop PH. Fear of hypoglycaemia and self-management in type 1 diabetes. J Clin Transl Endocrinol. 2016;2016(4):13-18. doi:10.1016/j.jcte.2016.02.002
Chatwin H, Broadley M, Speight J, et al. The impact of hypoglycaemia on quality of life outcomes among adults with type 1 diabetes: a systematic review. Diabetes Res Clin Pract. 2021;174. https://eprints.whiterose.ac.uk/172828/. Accessed March 3, 2023
Martyn-Nemeth P, Quinn L, Penckofer S, Park C, Hofer V, Burke L. Fear of hypoglycemia: influence on glycemic variability and self-management behavior in young adults with type 1 diabetes. J Diabetes Complications. 2017;31(4):735-741. doi:10.1016/j.jdiacomp.2016.12.015
Brazeau AS, Rabasa-Lhoret R, Strychar I, Mircescu H. Barriers to physical activity among patients with type 1 diabetes. Diabetes Care. 2008;31(11):2108-2109. doi:10.2337/dc08-0720
Billings LK, Parkin CG, Price D. Baseline glycated hemoglobin values predict the magnitude of glycemic improvement in patients with type 1 and type 2 diabetes: subgroup analyses from the DIAMOND study program. Diabetes Technol Ther. 2018;20(8):561-565. doi:10.1089/dia.2018.0163
Martyn-Nemeth P, Duffecy J, Fritschi C, Quinn L. Challenges imposed by hypoglycemia in adults with type 1 diabetes. Clin Nurs Res. 2019;28(8):947-967. doi:10.1177/1054773818774702
Hansen UM, Skinner T, Olesen K, Willaing I. Diabetes distress, intentional hyperglycemia at work, and glycemic control among workers with type 1 diabetes. Diabetes Care. 2019;42(5):797-803. doi:10.2337/dc18-1426
Hansen UM, Olesen K, Willaing I. Diabetes stigma and its association with diabetes outcomes: a cross-sectional study of adults with type 1 diabetes. Scand J Public Health. 2020;48(8):855-861. doi:10.1177/1403494819862941
Dømgaard M, Bagger M, Rhee NA, Burton CM, Thorsteinsson B. Individual and societal consequences of hypoglycemia: a cross-sectional survey. Postgrad Med. 2015;127(5):438-445. doi:10.1080/00325481.2015.1045815
Champakanath A, Akturk HK, Alonso GT, Snell-Bergeon JK, Shah VN. Continuous glucose monitoring initiation within first year of type 1 diabetes diagnosis is associated with improved glycemic outcomes: 7-year follow-up study. Diabetes Care. 2022;45(3):750-753. doi:10.2337/dc21-2004
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
FDA. 510(k) substantial equivalence determination decision summary assay and instrument. https://www.accessdata.fda.gov/cdrh_docs/reviews/K193371.pdf. Accessed April 17, 2023