Abstract
Background: Type 1 diabetes mellitus (T1D) is a chronic disease that requires exogenous insulin administration and intensive management to prevent any complications. Recent innovations in T1D management technologies include the Advanced Hybrid Closed-Loop delivery system (AHCL). The pioneer AHCL system provides automated basal and automated bolus corrections when needed.
Objective: This study aimed to compare the Advanced Hybrid Closed-Loop (AHCL) system and the Sensor-Augmented Pump (SAP) with Predictive Low Glucose Management (PLGM) system, in relation to glycaemic outcomes, general and diabetes-related Quality of Life (QoL), and diabetes distress.
Methods: General and diabetes-related QoL were assessed with the Diabetes Quality of Life Brief Clinical Inventory (DQOL-BCI) and the World Health Organization Quality of Life-BREF (WHOQOL-BREF), respectively. Diabetes distress was assessed with the Diabetes Distress Scale for Type 1 diabetes (T1-DDS).
Results: Eighty-nine T1D adults participated in the study, mostly females (65.2%), with a mean age of 39.8 (± 11.5 years). They had on average 23 years of diabetes (± 10.7) and they were on continuous subcutaneous insulin infusion therapy. Significant differences favoring the AHCL over the SAP + PLGM system were demonstrated by lower mean glucose levels, less time above range, lower scores on DQOL-BCI, T1-DDS, and higher scores on WHOQOL-BREF. Finally, the linear regression models revealed the association of time in range in most of the above aspects.
Conclusion: This study highlighted the advantages of the AHCL system over the SAP + PLGM system in the real-world setting in relation to general and diabetes-related QoL, diabetes distress, and glycaemic outcomes.
[1]
ElSayed NA, Aleppo G, Aroda VR, et al. 2. Classification and diagnosis of diabetes: Standards of care in diabetes—2023. Diabetes Care 2023; 46(S1): S19-40.
[http://dx.doi.org/10.2337/dc23-S002] [PMID: 36507649]
[http://dx.doi.org/10.2337/dc23-S002] [PMID: 36507649]
[2]
Sherr J, Cengiz E, Tamborlane WV. From pumps to prevention: Recent advances in the treatment of type 1 diabetes. Drug Discov Today 2009; 14(19-20): 973-81.
[http://dx.doi.org/10.1016/j.drudis.2009.06.011] [PMID: 19580883]
[http://dx.doi.org/10.1016/j.drudis.2009.06.011] [PMID: 19580883]
[3]
Ogle GD, James S, Dabelea D, et al. Global estimates of incidence of type 1 diabetes in children and adolescents: Results from the International Diabetes Federation Atlas, 10th Edition. Diabetes Res Clin Pract 2021; 183: 109083.
[4]
Dariya B, Chalikonda G, Srivani G, Alam A, Nagaraju GP. Pathophysiology, etiology, epidemiology of type 1 diabetes and computational approaches for immune targets and therapy. Crit Rev Immunol 2019; 39(4): 239-65.
[http://dx.doi.org/10.1615/CritRevImmunol.2019033126] [PMID: 32421967]
[http://dx.doi.org/10.1615/CritRevImmunol.2019033126] [PMID: 32421967]
[5]
Kulecki M, Uruska A, Naskret D, Zozulinska-Ziolkiewicz D. Arterial stiffness and type 1 diabetes: The current state of knowledge. Curr Diabetes Rev 2022; 18(3): e140621194054.
[http://dx.doi.org/10.2174/1573399817666210614113827] [PMID: 35546329]
[http://dx.doi.org/10.2174/1573399817666210614113827] [PMID: 35546329]
[6]
Jendle J, Buompensiere MI, Holm AL, de Portu S, Malkin SJP, Cohen O. The cost-effectiveness of an advanced hybrid closed-loop system in people with type 1 diabetes: A health economic analysis in Sweden. Diabetes Ther 2021; 12(11): 2977-91.
[http://dx.doi.org/10.1007/s13300-021-01157-0] [PMID: 34596879]
[http://dx.doi.org/10.1007/s13300-021-01157-0] [PMID: 34596879]
[7]
Renard E. Automated insulin delivery systems: From early research to routine care of type 1 diabetes. Acta Diabetol 2022; 60(2): 151-61.
[http://dx.doi.org/10.1007/s00592-022-01929-5] [PMID: 35994106]
[http://dx.doi.org/10.1007/s00592-022-01929-5] [PMID: 35994106]
[8]
Singh H, Venkatesan V. Safety and performance of continuous glucose monitoring: An overview. Curr Diabetes Rev 2022; 19(3): 49-60.
[PMID: 35619270]
[PMID: 35619270]
[9]
Gagliardino JJ, Chantelot JM, Domenger C, et al. Impact of diabetes education and self-management on the quality of care for people with type 1 diabetes mellitus in the Middle East (the International Diabetes Mellitus Practices Study, IDMPS). Diabetes Res Clin Pract 2019; 147: 29-36.
[http://dx.doi.org/10.1016/j.diabres.2018.09.008] [PMID: 30218744]
[http://dx.doi.org/10.1016/j.diabres.2018.09.008] [PMID: 30218744]
[10]
Sanz-Nogués C, Mustafa M, Burke H, O’Brien T, Coleman C. Knowledge, perceptions and concerns of diabetes-associated complications among individuals living with type 1 and type 2 diabetes mellitus. Health Care 2020; 8(1): 25.
[http://dx.doi.org/10.3390/healthcare8010025] [PMID: 32019118]
[http://dx.doi.org/10.3390/healthcare8010025] [PMID: 32019118]
[11]
Arrieta A, Battelino T, Scaramuzza AE, et al. Comparison of MiniMed 780G system performance in users aged younger and older than 15 years: Evidence from 12 870 real‐world users. Diabetes Obes Metab 2022; 24(7): 1370-9.
[http://dx.doi.org/10.1111/dom.14714] [PMID: 35403792]
[http://dx.doi.org/10.1111/dom.14714] [PMID: 35403792]
[12]
Foerster V, Severn M. A hybrid closed-loop insulin delivery system for the treatment of type 1 diabetes. Diabetes Technol Ther 2017; 19(3): 155-63.
[13]
Tornese G, Buzzurro F, Carletti C, Faleschini E, Barbi E. Six-month effectiveness of advanced vs. standard hybrid closed-loop system in children and adolescents with type 1 diabetes mellitus. Front Endocrinol 2021; 12: 766314.
[http://dx.doi.org/10.3389/fendo.2021.766314] [PMID: 34858339]
[http://dx.doi.org/10.3389/fendo.2021.766314] [PMID: 34858339]
[14]
Beato-Víbora PI, Ambrojo-López A, Fernández-Bueso M, Gil-Poch E, Arroyo-Díez JF. Long-term outcomes of an advanced hybrid closed-loop system: A focus on different subpopulations. Diabetes Res Clin Pract 2022; 191: 110052.
[http://dx.doi.org/10.1016/j.diabres.2022.110052] [PMID: 36030902]
[http://dx.doi.org/10.1016/j.diabres.2022.110052] [PMID: 36030902]
[15]
ElSayed NA, Aleppo G, Aroda VR, et al. 7. Diabetes technology: Standards of care in diabetes — 2023. Diabetes Care 2023; 46(S1): S111-27.
[http://dx.doi.org/10.2337/dc23-S007] [PMID: 36507635]
[http://dx.doi.org/10.2337/dc23-S007] [PMID: 36507635]
[16]
American Diabetes Association. 7. Diabetes Technology: Standards of Medical Care in Diabetes-2019. Diabetes Care 2019; 42(S1): S71-80.
[PMID: 30559233]
[PMID: 30559233]
[17]
Benioudakis E, Karlafti E, Kalaitzaki A, Kaiafa G, Savopoulos C, Didangelos T. Technological developments and quality of life in type 1 diabetes mellitus patients: A review of the modern insulin analogues, continuous glucose monitoring and insulin pump therapy. Curr Diabetes Rev 2022; 18(7): e031121197657.
[http://dx.doi.org/10.2174/1573399818666211103163208] [PMID: 34732118]
[http://dx.doi.org/10.2174/1573399818666211103163208] [PMID: 34732118]
[18]
Thabit H, Hovorka R. Continuous subcutaneous insulin infusion therapy and multiple daily insulin injections in type 1 diabetes mellitus: A comparative overview and future horizons. Expert Opin Drug Deliv 2016; 13(3): 389-400.
[http://dx.doi.org/10.1517/17425247.2016.1115013] [PMID: 26618219]
[http://dx.doi.org/10.1517/17425247.2016.1115013] [PMID: 26618219]
[19]
Cherubini V, Gesuita R, Bonfanti R, et al. Health-related quality of life and treatment preferences in adolescents with type 1 diabetes. The VIPKIDS study. Acta Diabetol 2014; 51(1): 43-51.
[http://dx.doi.org/10.1007/s00592-013-0466-x] [PMID: 23508374]
[http://dx.doi.org/10.1007/s00592-013-0466-x] [PMID: 23508374]
[20]
Nicolucci A, Maione A, Franciosi M, et al. Quality of life and treatment satisfaction in adults with Type 1 diabetes: A comparison between continuous subcutaneous insulin infusion and multiple daily injections. Diabet Med 2008; 25(2): 213-20.
[http://dx.doi.org/10.1111/j.1464-5491.2007.02346.x] [PMID: 18201210]
[http://dx.doi.org/10.1111/j.1464-5491.2007.02346.x] [PMID: 18201210]
[21]
Somali M, Paschou SA, Mouslech Z. Insulin pumps use in Greece: Efficacy and safety data from 140 patients with type 1 diabetes mellitus. Diabetes Res Clin Pract 2020; 160: 108026.
[http://dx.doi.org/10.1016/j.diabres.2020.108026] [PMID: 31954749]
[http://dx.doi.org/10.1016/j.diabres.2020.108026] [PMID: 31954749]
[22]
Burroughs TE, Desikan R, Waterman BM, Gilin D, McGill J. Development and validation of the diabetes quality of life brief clinical inventory. Diabetes Spectr 2004; 17(1): 41-9.
[http://dx.doi.org/10.2337/diaspect.17.1.41]
[http://dx.doi.org/10.2337/diaspect.17.1.41]
[23]
Rekleiti M, Souliotis K, Sarafis P, Kyriazis I, Tsironi M. Measuring the reliability and validity of the Greek edition of the Diabetes Quality of Life Brief Clinical Inventory. Diabetes Res Clin Pract 2018; 140: 61-71.
[24]
Fisher L, Polonsky WH, Hessler DM, et al. Understanding the sources of diabetes distress in adults with type 1 diabetes. J Diabetes Complications 2015; 29(4): 572-7.
[http://dx.doi.org/10.1016/j.jdiacomp.2015.01.012] [PMID: 25765489]
[http://dx.doi.org/10.1016/j.jdiacomp.2015.01.012] [PMID: 25765489]
[25]
Griva F, Thomakos P, Kepaptsoglou O, et al. Internal structure and psychometric properties of Diabetes Distress Scale for Type 1 Diabetes. Psychiatriki 2020; 31(4): 302-9.
[http://dx.doi.org/10.22365/jpsych.2020.314.302] [PMID: 33361060]
[http://dx.doi.org/10.22365/jpsych.2020.314.302] [PMID: 33361060]
[26]
THE WHOQOL GROUP. Development of the World Health Organization WHOQOL-BREF quality of life assessment. Psychol Med 1998; 28(3): 551-8.
[http://dx.doi.org/10.1017/S0033291798006667] [PMID: 9626712]
[http://dx.doi.org/10.1017/S0033291798006667] [PMID: 9626712]
[27]
Ginieri-Coccossis M, Triantafillou E, Tomaras V, Soldatos C, Mavreas V, Christodoulou G. Psychometric properties of WHOQOL-BREF in clinical and health Greek populations: Incorporating new culture-relevant items. Psychiatriki 2012; 23(2): 130-42.
[PMID: 22796911]
[PMID: 22796911]
[28]
Joshi M, Choudhary P. Multiple daily injections OR insulin pump therapy: Choosing the best option for your patient—an evidence-based approach. Curr Diab Rep 2015; 15(10): 81.
[http://dx.doi.org/10.1007/s11892-015-0644-z] [PMID: 26338287]
[http://dx.doi.org/10.1007/s11892-015-0644-z] [PMID: 26338287]
[29]
Pintaudi B, Gironi I, Nicosia R, et al. Minimed Medtronic 780G optimizes glucose control in patients with type 1 diabetes mellitus. Nutr Metab Cardiovasc Dis 2022; 32(7): 1719-24.
[http://dx.doi.org/10.1016/j.numecd.2022.03.031] [PMID: 35599092]
[http://dx.doi.org/10.1016/j.numecd.2022.03.031] [PMID: 35599092]
[30]
Hagger V, Hendrieckx C, Sturt J, Skinner TC, Speight J. Diabetes distress among adolescents with type 1 diabetes: A systematic review. Curr Diab Rep 2016; 16(1): 9.
[http://dx.doi.org/10.1007/s11892-015-0694-2] [PMID: 26748793]
[http://dx.doi.org/10.1007/s11892-015-0694-2] [PMID: 26748793]
[31]
World Health Organization. Programme on mental health: WHOQOL user manual, 2012 revision. World Health. Organization 1998.
[32]
Polonsky WH, Hood KK, Levy CJ, et al. How introduction of automated insulin delivery systems may influence psychosocial outcomes in adults with type 1 diabetes: Findings from the first investigation with the Omnipod® 5 System. Diabetes Res Clin Pract 2022; 190: 109998.
[http://dx.doi.org/10.1016/j.diabres.2022.109998] [PMID: 35853530]
[http://dx.doi.org/10.1016/j.diabres.2022.109998] [PMID: 35853530]
[33]
Speight J, Choudhary P, Wilmot EG, et al. Impact of glycaemic technologies on quality of life and related outcomes in adults with type 1 diabetes: A narrative review. Diabet Med 2023; 40(1): e14944.
[http://dx.doi.org/10.1111/dme.14944] [PMID: 36004676]
[http://dx.doi.org/10.1111/dme.14944] [PMID: 36004676]
[34]
ElSayed NA, Aleppo G, Aroda VR, et al. 6. Glycemic targets: Standards of care in diabetes—2023. Diabetes Care 2023; 46(S1): S97-S110.
[http://dx.doi.org/10.2337/dc23-S006] [PMID: 36507646]
[http://dx.doi.org/10.2337/dc23-S006] [PMID: 36507646]
[35]
Beato-Víbora PI, Gallego-Gamero F, Ambrojo-López A, Gil-Poch E, Martín-Romo I, Arroyo-Díez FJ. Amelioration of user experiences and glycaemic outcomes with an Advanced Hybrid Closed Loop System in a real-world clinical setting. Diabetes Res Clin Pract 2021; 178: 108986.
[http://dx.doi.org/10.1016/j.diabres.2021.108986] [PMID: 34329691]
[http://dx.doi.org/10.1016/j.diabres.2021.108986] [PMID: 34329691]
[36]
Collyns OJ, Meier RA, Betts ZL, et al. Improved glycemic outcomes with medtronic minimed advanced hybrid closed-loop delivery: Results from a randomized crossover trial comparing automated insulin delivery with predictive low glucose suspend in people with type 1 diabetes. Diabetes Care 2021; 44(4): 969-75.
[http://dx.doi.org/10.2337/dc20-2250] [PMID: 33579715]
[http://dx.doi.org/10.2337/dc20-2250] [PMID: 33579715]
[37]
Schiaffini R, Deodati A, Nicoletti MC, et al. Comparison of two advanced hybrid closed loop in a pediatric population with type 1 diabetes: A real-life observational study. Acta Diabetol 2022; 59(7): 959-64.
[http://dx.doi.org/10.1007/s00592-022-01886-z] [PMID: 35451679]
[http://dx.doi.org/10.1007/s00592-022-01886-z] [PMID: 35451679]
[38]
Carlson AL, Sherr JL, Shulman DI, et al. Safety and glycemic outcomes during the minimed™ advanced hybrid closed-loop system pivotal trial in adolescents and adults with type 1 diabetes. Diabetes Technol Ther 2022; 24(3): 178-89.
[http://dx.doi.org/10.1089/dia.2021.0319] [PMID: 34694909]
[http://dx.doi.org/10.1089/dia.2021.0319] [PMID: 34694909]
[39]
Lepore G, Rossini A, Bellante R, et al. Switching to the Minimed™ 780G system achieves clinical targets for CGM in adults with type 1 diabetes regardless of previous insulin strategy and baseline glucose control. Acta Diabetol 2022; 59(10): 1309-15.
[http://dx.doi.org/10.1007/s00592-022-01937-5] [PMID: 35857108]
[http://dx.doi.org/10.1007/s00592-022-01937-5] [PMID: 35857108]
[40]
Christiansen MP, Garg SK, Brazg R, et al. Accuracy of a fourth-generation subcutaneous continuous glucose sensor. Diabetes Technol Ther 2017; 19(8): 446-56.
[http://dx.doi.org/10.1089/dia.2017.0087] [PMID: 28700272]
[http://dx.doi.org/10.1089/dia.2017.0087] [PMID: 28700272]
[41]
Mian Z, Hermayer KL, Jenkins A. Continuous glucose monitoring: Review of an innovation in diabetes management. Am J Med Sci 2019; 358(5): 332-9.
[http://dx.doi.org/10.1016/j.amjms.2019.07.003] [PMID: 31402042]
[http://dx.doi.org/10.1016/j.amjms.2019.07.003] [PMID: 31402042]
