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. 2024 Dec;28(80):1–190. doi: 10.3310/JYPL3536

Hybrid closed-loop systems for managing blood glucose levels in type 1 diabetes: a systematic review and economic modelling.

Asra Asgharzadeh, Mubarak Patel, Martin Connock, Sara Damery, Iman Ghosh, Mary Jordan, Karoline Freeman, Anna Brown, Rachel Court, Sharin Baldwin, Fatai Ogunlayi, Chris Stinton, Ewen Cummins, Lena Al-Khudairy
PMCID: PMC11664472  PMID: 39673446

Abstract

BACKGROUND

Hybrid closed-loop systems are a new class of technology to manage type 1 diabetes mellitus. The system includes a combination of real-time continuous glucose monitoring from a continuous glucose monitoring device and a control algorithm to direct insulin delivery through an insulin pump. Evidence suggests that such technologies have the potential to improve the lives of people with type 1 diabetes mellitus and their families.

AIM

The aim of this appraisal was to assess the clinical effectiveness and cost-effectiveness of hybrid closed-loop systems for managing glucose in people who have type 1 diabetes mellitus and are having difficulty managing their condition despite prior use of at least one of the following technologies: continuous subcutaneous insulin infusion, real-time continuous glucose monitoring or flash glucose monitoring (intermittently scanned continuous glucose monitoring).

METHODS

A systematic review of clinical effectiveness and cost-effectiveness evidence following predefined inclusion criteria informed by the aim of this review. An independent economic assessment using iQVIA CDM to model cost-effectiveness.

RESULTS

The clinical evidence identified 12 randomised controlled trials that compared hybrid closed loop with continuous subcutaneous insulin infusion + continuous glucose monitoring. Hybrid closed-loop arm of randomised controlled trials achieved improvement in glycated haemoglobin per cent [hybrid closed loop decreased glycated haemoglobin per cent by 0.28 (95% confidence interval -0.34 to -0.21), increased per cent of time in range (between 3.9 and 10.0 mmol/l) with a MD of 8.6 (95% confidence interval 7.03 to 10.22), and significantly decreased time in range (per cent above 10.0 mmol/l) with a MD of -7.2 (95% confidence interval -8.89 to -5.51), but did not significantly affect per cent of  time below range (< 3.9 mmol/l)]. Comparator arms showed improvements, but these were smaller than in the hybrid closed-loop arm. Outcomes were superior in the hybrid closed-loop arm compared with the comparator arm. The cost-effectiveness search identified six studies that were included in the systematic review. Studies reported subjective cost-effectiveness that was influenced by the willingness-to-pay thresholds. Economic evaluation showed that the published model validation papers suggest that an earlier version of the iQVIA CDM tended to overestimate the incidences of the complications of diabetes, this being particularly important for severe visual loss and end-stage renal disease. Overall survival's medium-term modelling appeared good, but there was uncertainty about its longer-term modelling. Costs provided by the National Health Service Supply Chain suggest that hybrid closed loop is around an annual average of £1500 more expensive than continuous subcutaneous insulin infusion + continuous glucose monitoring, this being a pooled comparator of 90% continuous subcutaneous insulin infusion + intermittently scanned continuous glucose monitoring and 10% continuous subcutaneous insulin infusion + real-time continuous glucose monitoring due to clinical effectiveness estimates not being differentiated by continuous glucose monitoring type. This net cost may increase by around a further £500 for some systems. The Evidence Assessment Group base case applies the estimate of -0.29% glycated haemoglobin for hybrid closed loop relative to continuous subcutaneous insulin infusion + continuous glucose monitoring. There was no direct evidence of an effect on symptomatic or severe hypoglycaemia events, and therefore the Evidence Assessment Group does not include these in its base case. The change in glycated haemoglobin results in a gain in undiscounted life expectancy of 0.458 years and a gain of 0.160 quality-adjusted life-years. Net lifetime treatment costs are £31,185, with reduced complications leading to a net total cost of £28,628. The cost-effectiveness estimate is £179,000 per quality-adjusted life-year.

CONCLUSIONS

Randomised controlled trials of hybrid closed-loop interventions in comparison with continuous subcutaneous insulin infusion + continuous glucose monitoring achieved a statistically significant improvement in glycated haemoglobin per cent in time in range between 3.9 and 10 mmol/l, and in hyperglycaemic levels.

STUDY REGISTRATION

This study is registered as PROSPERO CRD42021248512.

FUNDING

This award was funded by the National Institute for Health and Care Research (NIHR) Evidence Synthesis programme (NIHR award ref: NIHR133547) and is published in full in Health Technology Assessment; Vol. 28, No. 80. See the NIHR Funding and Awards website for further award information.

Plain language summary

Type 1 diabetes mellitus is a lifelong condition whereby an individual’s pancreas significantly reduces or stops producing the hormone insulin that manages blood glucose levels. The individual must self-administer insulin and monitor their blood glucose levels. Hybrid closed-loop systems provide a control algorithm that reviews data and the impact of its past actions. Hybrid closed loop can reduce the burden on the patient by taking responsibility for handling the number of data and providing insulin when needed. The aim of this project is to review the clinical and financial benefits of hybrid closed-loop systems for managing glucose in people who have type 1 diabetes mellitus and are having trouble managing their condition. We looked at published studies following precise scientific approaches. We searched several online resources to find these studies. The National Institute for Health and Care Research provided additional studies that had not been published. The studies we found included the following information: people – with type 1 diabetes mellitus (any age group and including pregnant women) technology – people using a hybrid closed-loop system comparison – people using flash or intermittent glucose monitoring + pump therapy results – type 1 diabetes mellitus-related outcomes, such as glucose management, quality of life, heart disease, and complications related to the use of hybrid closed loop. Our online search found 12 randomised controlled trials that compared hybrid closed loop with continuous glucose monitoring + pump therapy. People in the hybrid closed-loop group had better glucose management (their glucose levels dropped by 0.28%). People in the hybrid closed-loop group had better glucose levels in the recommended range (between 3.9 and 10.0 mmol/l). People in the hybrid closed-loop group experienced less hyperglycaemic levels (above 10.0 mmol/l). The financial costs of hybrid closed loop suggest that it is more expensive (£1500) than continuous glucose monitoring + pump therapy. Studies that looked at hybrid closed loop in people with type 1 diabetes mellitus seem to suggest that it is better for diabetes management in terms of glucose levels, better time in range between 3.9 and 10 mmol/l, and less hyperglycaemic levels.

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References

  1. Holt RIG, DeVries JH, Hess-Fischl A, Hirsch IB, Kirkman MS, Klupa T, et al. The Management of Type 1 Diabetes in Adults. A consensus report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetes Care 2021;44:2589–625. https://doi.org/10.2337/dci21-0043 doi: 10.2337/dci21-0043. [DOI] [PubMed]
  2. National Institute for Health and Care Excellence. Type 1 Diabetes in Adults: Diagnosis and Management [NG17]. NICE; 2015. URL: www.nice.org.uk/guidance/ng17 (accessed 19 February 2021). [PubMed]
  3. Defining and Reporting Hypoglycemia in Diabetes. A report from the American Diabetes Association Workgroup on Hypoglycemia. Diabetes Care 2005;28:1245–9. https://doi.org/10.2337/diacare.28.5.1245 doi: 10.2337/diacare.28.5.1245. [DOI] [PubMed]
  4. National Institute for Health and Care Excellence. Integrated Sensor-augmented Pump Therapy Systems for Managing Blood Glucose Levels in Type 1 Diabetes (the MiniMed Paradigm Veo system and the Vibe and G4 PLATINUM CGM system). Diagnostics guidance [DG21]. NICE; 2016. URL: www.nice.org.uk/guidance/dg21 (accessed 18 February 2021).
  5. National Institute for Health and Care Excellence. Continuous Subcutaneous Insulin Infusion for the Treatment of Diabetes Mellitus. Technology appraisal guidance [TA151]. NICE; 2008. URL: www.nice.org.uk/guidance/ta151 (accessed 19 February 2021).
  6. National Institute for Health and Care Excellence. Guidance on the Use of Long‑acting Insulin Analogues for the Treatment of Diabetes – Insulin Glargine. Technology appraisal guidance [TA53]. London: NICE; 2002.
  7. Warren E, Weatherley-Jones E, Chilcott J, Beverley C. Systematic review and economic evaluation of a long-acting insulin analogue, insulin glargine. Health Technol Assess 2004;8(45). https://doi.org/10.3310/hta8450 doi: 10.3310/hta8450. [DOI] [PubMed]
  8. Waugh N, Cummins E, Royle P, Clar C, Marien M, Richter B, Philip S. Newer agents for blood glucose control in type 2 diabetes: systematic review and economic evaluation. Health Technol Assess 2010;14(46). https://doi.org/10.3310/hta14360 doi: 10.3310/hta14360. [DOI] [PubMed]
  9. Dolan P, Gudex C, Kind P, Williams A. A Social Tariff for EuroQoL: Results from a UK General Population Survey. University of York; 1995. URL: www.york.ac.uk/che/pdf/DP138.pdf (accessed 9 February 2021).
  10. Brazier J, Usherwood T, Harper R, Thomas K. Deriving a preference-based single index from the UK SF-36 health survey. J Clin Epidemiol 1998;51:1115–28. https://doi.org/10.1016/S0895-4356(98)00103-6 doi: 10.1016/s0895-4356(98)00103-6. [DOI] [PubMed]
  11. Brod M, Christensen T, Thomsen TL, Bushnell DM. The impact of non-severe hypoglycemic events on work productivity and diabetes management. Value Health 2011;14:665–71. https://doi.org/10.1016/j.jval.2011.02.001 doi: 10.1016/j.jval.2011.02.001. [DOI] [PubMed]
  12. Leckie AM, Graham MK, Grant JB, Ritchie PJ, Frier BM. Frequency, severity, and morbidity of hypoglycemia occurring in the workplace in people with insulin-treated diabetes. Diabetes Care 2005;28:1333–8. https://doi.org/10.2337/diacare.28.6.1333 doi: 10.2337/diacare.28.6.1333. [DOI] [PubMed]
  13. Frier BM, Jensen MM, Chubb BD. Hypoglycaemia in adults with insulin-treated diabetes in the UK: self-reported frequency and effects. Diabet Med 2016;33:1125–32. https://doi.org/10.1111/dme.12878 doi: 10.1111/dme.12878. [DOI] [PMC free article] [PubMed]
  14. Choudhary P, Shin J, Wang Y, Evans ML, Hammond PJ, Kerr D, et al. Insulin pump therapy with automated insulin suspension in response to hypoglycemia: reduction in nocturnal hypoglycemia in those at greatest risk. Diabetes Care 2011;34:2023–5. https://doi.org/10.2337/dc10-2411 doi: 10.2337/dc10-2411. [DOI] [PMC free article] [PubMed]
  15. Choudhary P. Insulin pump therapy with automated insulin suspension: toward freedom from nocturnal hypoglycemia. JAMA 2013;310:1235–6. https://doi.org/10.1001/jama.2013.278576 doi: 10.1001/jama.2013.278576. [DOI] [PubMed]
  16. Little SA, Leelarathna L, Walkinshaw E, Tan HK, Chapple O, Lubina-Solomon A, et al. Recovery of hypoglycemia awareness in long-standing type 1 diabetes: a multicenter 2 × 2 factorial randomized controlled trial comparing insulin pump with multiple daily injections and continuous with conventional glucose self-monitoring (HypoCOMPaSS). Diabetes Care 2014;37:2114–22. https://doi.org/10.2337/dc14-0030 doi: 10.2337/dc14-0030. [DOI] [PubMed]
  17. 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;11:83–95. https://doi.org/10.1007/s13300-019-00720-0 doi: 10.1007/s13300-019-00720-0. [DOI] [PMC free article] [PubMed]
  18. 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;23:2645–50. https://doi.org/10.1007/s11136-014-0712-x doi: 10.1007/s11136-014-0712-x. [DOI] [PubMed]
  19. Harris S, Mamdani M, Galbo-Jørgensen CB, Bøgelund M, Gundgaard J, Groleau D. The effect of hypoglycemia on health-related quality of life: Canadian results from a multinational time trade-off survey. Can J Diabetes 2014;38:45–52. https://doi.org/10.1016/j.jcjd.2013.09.001 doi: 10.1016/j.jcjd.2013.09.001. [DOI] [PubMed]
  20. Levy AR, Christensen TLU, Johnson JA. Utility values for symptomatic non-severe hypoglycaemia elicited from persons with and without diabetes in Canada and the United Kingdom. Health Qual Life Outcomes 2008;6:73. https://doi.org/10.1186/1477-7525-6-73 doi: 10.1186/1477-7525-6-73. [DOI] [PMC free article] [PubMed]
  21. Adler A, Jofre-Bonet M, Wilkinson G, Martin A, Mcguire A. Quantifying the loss of health-related quality of life from hypoglycemia. 2220-PO. Diabetes 2014;63:A564. https://doi.org/10.2337/db14-2207-2292
  22. 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;22:1523–34. https://doi.org/10.1185/030079906X115757 doi: 10.1185/030079906X115757. [DOI] [PubMed]
  23. Loveman E, Cave C, Green C, Royle P, Dunn N, Waugh N. The clinical and cost-effectiveness of patient education models for diabetes: a systematic review and economic evaluation. Health Technol Assess 2003;7. https://doi.org/10.3310/hta7220 doi: 10.3310/hta7220. [DOI] [PubMed]
  24. Iqbal A, Heller SR. The role of structured education in the management of hypoglycaemia. Diabetologia 2018;61:751–60. https://doi.org/10.1007/s00125-017-4334-z doi: 10.1007/s00125-017-4334-z. [DOI] [PMC free article] [PubMed]
  25. National Institute for Health and Care Excellence (NICE) NG17 Guideline Development Team. Type 1 Diabetes in Adults: Diagnosis and Management [B] Evidence Reviews for Continuous Glucose Monitoring in Adults with Type 1 Diabetes NICE Guideline NG17 Evidence Reviews Underpinning Recommendations 1.6.10 to 1.6.18 and Recommendations for Research in the NICE Guideline. NICE; 2022. URL: www.nice.org.uk/guidance/ng17/evidence/b-continuous-glucose-monitoring-in-adults-with-type-1-diabetes-pdf-11013435182 (accessed 20 September 2022).
  26. Harbour J, Dimitrova M, Colthart I, Stewart J, Herbert P. Closed Loop Systems and the Artificial Pancreas for the Management of Type 1 Diabetes [SHTG Recommendation]. Glasgow/Edinburgh: Healthcare Improvement Scotland, Scottish Health Technologies Group (SHTG); 2022. URL: https://shtg.scot/our-advice/closed-loop-systems-and-the-artificial-pancreas-for-type-i-diabetes-mellitus-t1dm/ (accessed 15 June 2022).
  27. Bergenstal RM, Nimri R, Beck RW, Criego A, Laffel L, Schatz D, et al.; FLAIR Study Group. A comparison of two hybrid closed-loop systems in adolescents and young adults with type 1 diabetes (FLAIR): a multicentre, randomised, crossover trial. Lancet 2021;397:208–19. https://doi.org/10.1016/S0140-6736(20)32514-9 doi: 10.1016/S0140-6736(20)32514-9. [DOI] [PMC free article] [PubMed]
  28. Nathan DM, Turgeon H, Regan S. Relationship between glycated haemoglobin levels and mean glucose levels over time. Diabetologia 2007;50:2239–44. https://doi.org/10.1007/s00125-007-0803-0 doi: 10.1007/s00125-007-0803-0. [DOI] [PMC free article] [PubMed]
  29. Lunati ME, Morpurgo PS, Rossi A, Gandolfi A, Cogliati I, Bolla AM, et al. Hybrid close-loop systems versus predictive low-glucose suspend and sensor-augmented pump therapy in patients with type 1 diabetes: a single-center cohort study. Front Endocrinol 2022;13:816599. https://doi.org/10.3389/fendo.2022.816599 doi: 10.3389/fendo.2022.816599. [DOI] [PMC free article] [PubMed]
  30. Messer LH, Berget C, Forlenza GP. A clinical guide to advanced diabetes devices and closed-loop systems using the CARES paradigm. Diabetes Technol Ther 2019;21:462–9. https://doi.org/10.1089/dia.2019.0105 doi: 10.1089/dia.2019.0105. [DOI] [PMC free article] [PubMed]
  31. Cochrane Collaboration. Handbook for Diagnostic Test Accuracy Reviews. 2021. URL: https://methods.cochrane.org/sdt/handbook-dta-reviews (accessed 18 February 2021).
  32. National Institute for Health and Care Excellence. Diagnostics Assessment Programme Manual. Manchester: NICE; 2011. URL: www.nice.org.uk/Media/Default/About/what-we-do/NICE-guidance/NICE-diagnostics-guidance/Diagnostics-assessment-programme-manual.pdf (accessed 21 February 2021). [PubMed]
  33. Lefebvre C, Glanville J, Briscoe S, Littlewood A, Marshall C, Metzendorf MI, et al. Chapter 4: Searching for and Selecting Studies. In Higgins J, Thomas J, Chandler J, Cumpston M, Li T, Page M, Welch V, editors. Cochrane Handbook for Systematic Reviews of Interventions. Version 6.2. London: Cochrane; 2021. URL: https://training.cochrane.org/handbook/current/chapter-04 (accessed 22 March 2021).
  34. Riemsma R, Corro Ramos I, Birnie R, Büyükkaramikli N, Armstrong N, Ryder S, et al. Integrated sensor-augmented pump therapy systems [the MiniMed® Paradigm™ Veo system and the Vibe™ and G4® PLATINUM CGM (continuous glucose monitoring) system] for managing blood glucose levels in type 1 diabetes: a systematic review and economic evaluation. Health Technol Assess 2016;20(17). https://doi.org/10.3310/hta20170 doi: 10.3310/hta20170. [DOI] [PMC free article] [PubMed]
  35. Tessier V. Périnatalité: Perinatality: Rappel favorisé sur la précision. Canadian Health Libraries Association – Association des bibliothèques de la santé du Canada; 2017. URL: https://extranet.santecom.qc.ca/wiki/!biblio3s/doku.php?id=concepts:perinatalite (accessed 29 June 2022).
  36. Kyrgiou M, Mitra A, Arbyn M, Paraskevaidi M, Athanasiou A, Martin-Hirsch PP, et al. Fertility and early pregnancy outcomes after conservative treatment for cervical intraepithelial neoplasia. Cochrane Database Syst Rev 2015;2016:CD008478. https://doi.org/10.1002/14651858.CD008478.pub2 doi: 10.1002/14651858.CD008478.pub2. [DOI] [PMC free article] [PubMed]
  37. Cochrane Pregnancy and Childbirth. Cochrane Pregnancy and Childbirth’s Trials Register: Detailed Search Methods Used to Maintain and Update the Specialised Register. 2018. URL: https://pregnancy.cochrane.org/sites/pregnancy.cochrane.org/files/public/uploads/cochrane_pregnancy_and_childbirth_search_methods_2018_1.docx (accessed 29 June 2022).
  38. Royal College of Nursing. Do It Yourself (DIY) Closed Loop for People Living with Type 1 Diabetes: Position Statement. 2020. URL: www.diabetes.org.uk/about-us/about-the-charity/our-strategy/position-statements/do-it-yourself-closed-loop (accessed 25 March 2021).
  39. National Institute for Health and Care Excellence. 6.1 Identifying and Selecting Relevant Evidence. In Developing NICE Guidelines: The Manual [PMG20]. London: NICE; 2014. URL: www.nice.org.uk/process/pmg20/ (accessed 22 March 2021).
  40. National Institute for Health and Care Excellence. Developing NICE Guidelines: The Manual [PMG20]. London: NICE; 2014. URL: www.nice.org.uk/process/pmg20/ (accessed 22 March 2021). [PubMed]
  41. Wade R, Sharif-Hurst S, Harden M, Walton M, Claxton L, Hodgson R, Eastwood A. Methods for selecting the best evidence to inform a NICE technology appraisal on selective internal radiation therapies for hepatocellular carcinoma. Syst Rev 2020;9:184. https://doi.org/10.1186/s13643-020-01447-x doi: 10.1186/s13643-020-01447-x. [DOI] [PMC free article] [PubMed]
  42. Sterne JAC, Savović J, Page MJ, Elbers RG, Blencowe NS, Boutron I, et al. RoB 2: a revised tool for assessing risk of bias in randomised trials. BMJ 2019;366:l4898. https://doi.org/10.1136/bmj.l4898 doi: 10.1136/bmj.l4898. [DOI] [PubMed]
  43. Sterne JA, Hernán MA, Reeves BC, Savović J, Berkman ND, Viswanathan M, et al. ROBINS-I: a tool for assessing risk of bias in non-randomised studies of interventions. BMJ 2016;355:i4919. https://doi.org/10.1136/bmj.i4919 doi: 10.1136/bmj.i4919. [DOI] [PMC free article] [PubMed]
  44. Cochrane Effective Practice and Organisation of Care (EPOC). EPOC Resources for Review Authors. 2021. URL: https://epoc.cochrane.org/resources/epoc-resources-review-authors (accessed 24 March 2021).
  45. Chaimani A, Caldwell DM, Li T, Higgins JP, Salanti G. Chapter 11: Undertaking Network Meta-analyses. In Higgins J, Thomas J, Chandler J, Cumpston M, Li T, Page M, Welch V, editors. Cochrane Handbook for Systematic Reviews of Interventions. Version 6.2. London: Cochrane; 2020. URL: https://training.cochrane.org/handbook/current/chapter-11 (accessed 19 February 2021).
  46. Benhamou PY, Lablanche S, Vambergue A, Pou S, Madrolle S, Romero-Ugalde H, et al. The beneficial effects of closed-loop insulin delivery in patients with highly unstable type 1 diabetes eligible for islet transplantation are maintained over 6 months: an extension study of the DBLHU-WP10 trial. Diabetes Obes Metab 2022;24:956–61. https://doi.org/10.1111/dom.14654 doi: 10.1111/dom.14654. [DOI] [PubMed]
  47. Boughton CK, Hovorka R. Advances in artificial pancreas systems. Sci Transl Med 2019;11. https://doi.org/10.1126/scitranslmed.aaw4949 doi: 10.1126/scitranslmed.aaw4949. [DOI] [PubMed]
  48. Collyns OJ, Meier RA, Betts ZL, Chan DSH, Frampton C, Frewen CM, 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;44:969–75. https://doi.org/10.2337/dc20-2250 doi: 10.2337/dc20-2250. [DOI] [PubMed]
  49. Kariyawasam D, Morin C, Casteels K, Le Tallec C, Sfez A, Godot C, et al. Hybrid closed-loop insulin delivery versus sensor-augmented pump therapy in children aged 6–12 years: a randomised, controlled, cross-over, non-inferiority trial. Lancet Digit Health 2022;4:e158–68. https://doi.org/10.1016/S2589-7500(21)00271-5 doi: 10.1016/S2589-7500(21)00271-5. [DOI] [PubMed]
  50. McAuley SA, Trawley S, Vogrin S, Ward GM, Fourlanos S, Grills CA, et al. Closed-loop insulin delivery versus sensor-augmented pump therapy in older adults with type 1 diabetes (ORACL): a randomized, crossover trial. Diabetes Care 2022;45:381–90. https://doi.org/10.2337/dc21-1667 doi: 10.2337/dc21-1667. [DOI] [PubMed]
  51. Stewart ZA, Wilinska ME, Hartnell S, O’Neil LK, Rayman G, Scott EM, et al. Day-and-night closed-loop insulin delivery in a broad population of pregnant women with type 1 diabetes: a randomized controlled crossover trial. Diabetes Care 2018;41:1391–9. https://doi.org/10.2337/dc17-2534 doi: 10.2337/dc17-2534. [DOI] [PubMed]
  52. Tauschmann M, Thabit H, Bally L, Allen JM, Hartnell S, Wilinska ME, et al.; APCam11 Consortium. Closed-loop insulin delivery in suboptimally controlled type 1 diabetes: a multicentre, 12-week randomised trial. Lancet 2018;392:1321–9. https://doi.org/10.1016/S0140-6736(18)31947-0 doi: 10.1016/S0140-6736(18)31947-0. [DOI] [PMC free article] [PubMed]
  53. Thabit H, Tauschmann M, Allen JM, Leelarathna L, Hartnell S, Wilinska ME, et al. Home use of an artificial beta cell in type 1 diabetes. N Engl J Med 2015;373:2129–40. https://doi.org/10.1056/NEJMoa1509351 doi: 10.1056/NEJMoa1509351. [DOI] [PMC free article] [PubMed]
  54. von dem Berge T, Remus K, Biester S, Reschke F, Klusmeier B, Adolph K, et al. In-home use of a hybrid closed loop achieves time-in-range targets in preschoolers and school children: results from a randomized, controlled, crossover trial. Diabetes Obes Metab 2022;24:1319–27. https://doi.org/10.1111/dom.14706 doi: 10.1111/dom.14706. [DOI] [PubMed]
  55. Ware J, Allen JM, Boughton CK, Wilinska ME, Hartnell S, Thankamony A, et al.; KidsAP Consortium. Randomized trial of closed-loop control in very young children with type 1 diabetes. N Engl J Med 2022;386:209–19. https://doi.org/10.1056/NEJMoa2111673 doi: 10.1056/NEJMoa2111673. [DOI] [PubMed]
  56. Ware J, Boughton CK, Allen JM, Wilinska ME, Tauschmann M, Denvir L, et al.; DAN05 Consortium. Cambridge hybrid closed-loop algorithm in children and adolescents with type 1 diabetes: a multicentre 6-month randomised controlled trial. Lancet Digit Health 2022;4:e245–55. https://doi.org/10.1016/S2589-7500(22)00020-6 doi: 10.1016/S2589-7500(22)00020-6. [DOI] [PubMed]
  57. Weinzimer S, Bailey R, Bergenstal RM, Nimri R, Beck RW, Schatz D, et al. A Comparison of post-prandial glucose control in the Medtronic advanced hybrid closed-loop system vs 670G. Diabetes Technol Ther 2022;1:1. https://doi.org/10.1089/dia.2021.0568 doi: 10.1089/dia.2021.0568. [DOI] [PMC free article] [PubMed]
  58. Wheeler BJ, Collyns OJ, Meier RA, Betts ZL, Frampton C, Frewen CM, et al. Improved technology satisfaction and sleep quality with Medtronic MiniMed R advanced hybrid closed-loop delivery compared to predictive low glucose suspend in people with type 1 diabetes in a randomized crossover trial. Acta Diabetol 2022;59:31–7. https://doi.org/10.1007/s00592-021-01789-5 doi: 10.1007/s00592-021-01789-5. [DOI] [PubMed]
  59. Bassi M, Teliti M, Lezzi M, Iosca A, Strati MF, Carmisciano L, et al. A comparison of two hybrid closed-loop systems in Italian children and adults with type 1 diabetes. Front Endocrinol 2021;12:802419. https://doi.org/10.3389/fendo.2021.802419 doi: 10.3389/fendo.2021.802419. [DOI] [PMC free article] [PubMed]
  60. Beato-Vibora PI, Gallego-Gamero F, Ambrojo-Lopez A. Real-world outcomes with different technology modalities in type 1 diabetes. Nutr Metab Cardiovasc Dis 2021;31:1845–50. https://doi.org/10.1016/j.numecd.2021.02.028 doi: 10.1016/j.numecd.2021.02.028. [DOI] [PubMed]
  61. Beato-Vibora PI, Gallego-Gamero F, Ambrojo-Lopez A, Gil-Poch E, Martin-Romo I, Arroyo-Diez 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. https://doi.org/10.1016/j.diabres.2021.108986 doi: 10.1016/j.diabres.2021.108986. [DOI] [PubMed]
  62. Breton MD, Kovatchev BP. One year real-world use of the Control-IQ advanced hybrid closed-loop technology. Diabetes Technol Ther 2021;23:601–8. https://doi.org/10.1089/dia.2021.0097 doi: 10.1089/dia.2021.0097. [DOI] [PMC free article] [PubMed]
  63. Carlson AL, Sherr JL, Shulman DI, Garg SK, Pop-Busui R, Bode BW, 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;24:178–89. https://doi.org/10.1089/dia.2021.0319 doi: 10.1089/dia.2021.0319. [DOI] [PMC free article] [PubMed]
  64. Forlenza GP, Ekhlaspour L, DiMeglio LA, Fox LA, Rodriguez H, Shulman DI, et al. Glycemic outcomes of children 2–6 years of age with type 1 diabetes during the pediatric MiniMedTM 670G system trial. Pediatr Diabetes 2022;23:324–9. https://doi.org/10.1111/pedi.13312 doi: 10.1111/pedi.13312. [DOI] [PMC free article] [PubMed]
  65. Benhamou PY, Franc S, Reznik Y, Thivolet C, Schaepelynck P, Renard E, et al.; DIABELOOP WP7 Trial Investigators. Closed-loop insulin delivery in adults with type 1 diabetes in real-life conditions: a 12-week multicentre, open-label randomised controlled crossover trial. Lancet Digit Health 2019;1:e17–25. https://doi.org/10.1016/s2589-7500(19)30003-2 doi: 10.1016/S2589-7500(19)30003-2. [DOI] [PubMed]
  66. Hood KK, Laffel LM, Danne T, Nimri R, Weinzimer SA, Sibayan J, et al. Lived Experience of advanced hybrid closed-loop versus hybrid closed-loop: patient-reported outcomes and perspectives. Diabetes Technol Ther 2021;23:857–61. https://doi.org/10.1089/dia.2021.0153 doi: 10.1089/dia.2021.0153. [DOI] [PMC free article] [PubMed]
  67. NHS Digital. National Diabetes Audit, 2019–20, Type 1 Diabetes. NHS Digital; 2021. URL: https://digital.nhs.uk/data-and-information/publications/statistical/national-diabetes-audit/national-diabetes-audit-2019-20-type-1-diabetes (accessed 6 September 2022).
  68. Da Silva JD, Lepore G, Battelino T, Arrieta A, Castañeda J, Grossman B, et al. Real-world performance of the MiniMed™ 780G system: first report of outcomes from 4120 users. Diabetes Technol Ther 2022;24:113–9. https://doi.org/10.1089/dia.2021.0203 doi: 10.1089/dia.2021.0203. [DOI] [PMC free article] [PubMed]
  69. Vigersky RA, Bode BW, Brazg RL, Buckingham BA, Carlson AL, Kaiserman KB, et al. Glycemic control using recommended settings in youth and adults with type 1 diabetes (T1D) – Minimed 780G system with the calibration-free guardian 4 sensor results. Diabetes 2022;71:110-LB. https://doi.org/10.2337/db22-100-LB
  70. Arrieta A, Battelino T, Scaramuzza AE, Da Silva J, Castañeda J, Cordero TL, 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;24:1370–9. https://doi.org/10.1111/dom.14714 doi: 10.1111/dom.14714. [DOI] [PMC free article] [PubMed]
  71. Choudhary P, de Portu S, Arrieta A, Castañeda J, Campbell FM. Use of sensor-integrated pump therapy to reduce hypoglycaemia in people with type 1 diabetes: a real-world study in the UK. Diabet Med 2019;36:1100–8. https://doi.org/10.1111/dme.14043 doi: 10.1111/dme.14043. [DOI] [PubMed]
  72. Petrovski G, Al Khalaf F, Campbell J, Fisher H, Umer F, Hussain K. 10-day structured initiation protocol from multiple daily injection to hybrid closed-loop system in children and adolescents with type 1 diabetes. Acta Diabetol 2020;57:681–7. https://doi.org/10.1007/s00592-019-01472-w doi: 10.1007/s00592-019-01472-w. [DOI] [PMC free article] [PubMed]
  73. Farabi SS, Carley DW, Quinn L. Glucose variations and activity are strongly coupled in sleep and wake in young adults with type 1 diabetes. Biol Res Nurs 2017;19:249–57. https://doi.org/10.1177/1099800416685177 doi: 10.1177/1099800416685177. [DOI] [PMC free article] [PubMed]
  74. Pease A, Lo C, Earnest A, Kiriakova V, Liew D, Zoungas S. The efficacy of technology in type 1 diabetes: a systematic review, network meta-analysis, and narrative synthesis. Diabetes Technol Ther 2020;22:411–21. https://doi.org/10.1089/dia.2019.0417 doi: 10.1089/dia.2019.0417. [DOI] [PubMed]
  75. Breton MD, Kanapka LG, Beck RW, Ekhlaspour L, Forlenza GP, Cengiz E, et al.; iDCL Trial Research Group. A randomized trial of closed-loop control in children with type 1 diabetes. N Engl J Med 2020;383:836–45. https://doi.org/10.1056/NEJMoa2004736 doi: 10.1056/NEJMoa2004736. [DOI] [PMC free article] [PubMed]
  76. Boughton CK, Hartnell S, Thabit H, Mubita WM, Draxlbauer K, Poettler T, et al. Hybrid closed-loop glucose control compared with sensor augmented pump therapy in older adults with type 1 diabetes: an open-label multicentre, multinational, randomised, crossover study. Lancet Healthy Longev 2022;3:e135–42. https://doi.org/10.1016/s2666-7568(22)00005-8 doi: 10.1016/S2666-7568(22)00005-8. [DOI] [PMC free article] [PubMed]
  77. Brown SA, Kovatchev BP, Raghinaru D, Lum JW, Buckingham BA, Kudva YC, et al.; iDCL Trial Research Group. Six-month randomized, multicenter trial of closed-loop control in type 1 diabetes. N Engl J Med 2019;381:1707–17. https://doi.org/10.1056/NEJMoa1907863 doi: 10.1056/NEJMoa1907863. [DOI] [PMC free article] [PubMed]
  78. Ekhlaspour L, Forlenza GP, Chernavvsky D, Maahs DM, Wadwa RP, Deboer MD, et al. Closed loop control in adolescents and children during winter sports: use of the Tandem Control-IQ AP system. Pediatr Diabetes 2019;20:759–68. https://doi.org/10.1111/pedi.12867 doi: 10.1111/pedi.12867. [DOI] [PMC free article] [PubMed]
  79. Forlenza GP, Ekhlaspour L, Breton M, Maahs DM, Wadwa RP, DeBoer M, et al. Successful at-home use of the Tandem Control-IQ artificial pancreas system in young children during a randomized controlled trial. Diabetes Technol Ther 2019;21:159–69. https://doi.org/10.1089/dia.2019.0011 doi: 10.1089/dia.2019.0011. [DOI] [PMC free article] [PubMed]
  80. Kanapka LG, Wadwa RP, Breton MD, Ruedy KJ, Ekhlaspour L, Forlenza GP, et al.; iDCL Trial Research Group. Extended use of the Control-IQ closed-loop control system in children with type 1 diabetes. Diabetes Care 2021;44:473–8. https://doi.org/10.2337/dc20-1729 doi: 10.2337/dc20-1729. [DOI] [PMC free article] [PubMed]
  81. Bally L, Thabit H, Kojzar H, Mader JK, Qerimi-Hyseni J, Hartnell S, et al. Day-and-night glycaemic control with closed-loop insulin delivery versus conventional insulin pump therapy in free-living adults with well controlled type 1 diabetes: an open-label, randomised, crossover study. Lancet Diabetes Endocrinol 2017;5:261–70. https://doi.org/10.1016/s2213-8587(17)30001-3 doi: 10.1016/S2213-8587(17)30001-3. [DOI] [PMC free article] [PubMed]
  82. Leelarathna L, Dellweg S, Mader JK, Allen JM, Benesch C, Doll W, et al.; AP@home Consortium. Day and night home closed-loop insulin delivery in adults with type 1 diabetes: three-center randomized crossover study. Diabetes Care 2014;37:1931–7. https://doi.org/10.2337/dc13-2911 doi: 10.2337/dc13-2911. [DOI] [PubMed]
  83. Tauschmann M, Allen JM, Wilinska ME, Thabit H, Acerini CL, Dunger DB, Hovorka R. Home use of day-and-night hybrid closed-loop insulin delivery in suboptimally controlled adolescents with type 1 diabetes: a 3-week, free-living, randomized crossover trial. Diabetes Care 2016;39:2019–25. https://doi.org/10.2337/dc16-1094 doi: 10.2337/dc16-1094. [DOI] [PMC free article] [PubMed]
  84. Tauschmann M, Allen JM, Wilinska ME, Thabit H, Stewart Z, Cheng P, et al. Day-and-night hybrid closed-loop insulin delivery in adolescents with type 1 diabetes: a free-living, randomized clinical trial. Diabetes Care 2016;39:1168–74. https://doi.org/10.2337/ dc15-2078 doi: 10.2337/dc15-2078. [DOI] [PMC free article] [PubMed]
  85. Singh H, Mueller L, Alencar G, Habif S, Pinsker J. Real-world Evidence for Long-term Improvements in Glycemic Control Using Control-IQ Technology in a Large Cohort with Type 1 Diabetes from the United States. Paper presented at Australasian Diabetes Congress, Brisbane, QLD, Australia. URL: www.xcdsystem.com/adc/program/VY6jrda/index.cfm?pgid=2619&sid=21183&abid=116199 (accessed 16 September 2022).
  86. Forlenza GP, Carlson AL, Galindo RJ, Kruger DF, Levy CJ, McGill JB, et al. Real-World evidence supporting Tandem Control-IQ hybrid closed-loop success in the Medicare and Medicaid type 1 and type 2 diabetes populations. Diabetes Technol Ther 2022;24:814–23. https://doi.org/10.1089/dia.2022.0206 doi: 10.1089/dia.2022.0206. [DOI] [PMC free article] [PubMed]
  87. Bekiari E, Kitsios K, Thabit H, Tauschmann M, Athanasiadou E, Karagiannis T, et al. Artificial pancreas treatment for outpatients with type 1 diabetes: systematic review and meta-analysis. BMJ 2018; 361:k1310. https://doi.org/10.1136/bmj.k1310 doi: 10.1136/bmj.k1310. [DOI] [PMC free article] [PubMed]
  88. Boughton CK, Hovorka R. New closed-loop insulin systems. Diabetologia 2021;64:1007–15. https://doi.org/10.1007/s00125-021-05391-w doi: 10.1007/s00125-021-05391-w. [DOI] [PMC free article] [PubMed]
  89. Centre for Reviews and Dissemination. NHS EED MEDLINE Using OvidSP [Search Filter]. York: Centre for Reviews and Dissemination, University of York. URL: www.crd.york.ac.uk/crdweb/searchstrategies.asp#nhseedmedline (accessed 2 April 2022).
  90. National Institute for Health and Care Excellence. Type 1 Diabetes in Adults: Diagnosis and Management: Insulin Therapy [NICE guideline NG17]: Economic Model Report [Draft for Consulation]. NICE; 2021. URL: www.nice.org.uk/guidance/ng17/update/ng17-update-1/documents/economic-report (accessed 29 June 2022).
  91. National Institute for Health and Care Excellence. Diabetes Type 1: Insulin Therapies: Health Economics Search Strategies. NICE; 2021. URL: www.nice.org.uk/guidance/ng17/update/ng17-update-1/documents/search-strategies (accessed 29 June 2022).
  92. Arber M, Garcia S, Veale T, Edwards M, Shaw A, Glanville JM. Performance of Ovid MEDLINE search filters to identify health state utility studies. Int J Technol Assess Health Care 2017;33:472–80. https://doi.org/10.1017/s0266462317000897 doi: 10.1017/S0266462317000897. [DOI] [PubMed]
  93. Hypo-RESOLVE. Publications. 2022. URL: https://hypo-resolve.eu/publications (accessed 29 June 2022).
  94. Husereau D, Drummond M, Petrou S, Carswell C, Moher D, Greenberg D, et al. Consolidated Health Economic Evaluation Reporting Standards (CHEERS) statement. Eur J Health Econ 2013;14:367–72. https://doi.org/10.1007/s10198-013-0471-6 doi: 10.1007/s10198-013-0471-6. [DOI] [PubMed]
  95. Philips Z, Ginnelly L, Sculpher M, Claxton K, Golder S, Riemsma R, et al. Review of guidelines for good practice in decision-analytic modelling in health technology assessment. Health Technol Assess 2004;8(36). https://doi.org/10.3310/hta8360 doi: 10.3310/hta8360. [DOI] [PubMed]
  96. Herman WH, Braffett BH, Kuo S, Lee JM, Brandle M, Jacobson AM, et al. The 30-year cost-effectiveness of alternative strategies to achieve excellent glycemic control in type 1 diabetes: an economic simulation informed by the results of the diabetes control and complications trial/epidemiology of diabetes interventions and complications (DCCT/EDIC). J Diabetes Complications 2018;32:934–9. https://doi.org/10.1016/j.jdiacomp.2018.06.005 doi: 10.1016/j.jdiacomp.2018.06.005. [DOI] [PMC free article] [PubMed]
  97. Haahtela T. Real option approach for comparing lifetime costs of alternative diabetes type I treatment methods. Fuzzy Econ Rev 2016;21:71–91. https://doi.org/10.25102/fer.2016.02.04
  98. Pease A, Zomer E, Liew D, Earnest A, Soldatos G, Ademi Z, Zoungas S. Cost-effectiveness analysis of a hybrid closed-loop system versus multiple daily injections and capillary glucose testing for adults with type 1 diabetes. Diabetes Technol Ther 2020;22:812–21. https://doi.org/10.1089/dia.2020.0064 doi: 10.1089/dia.2020.0064. [DOI] [PubMed]
  99. Lambadiari V, Ozdemir Saltik AZ, de Portu S, Buompensiere MI, Kountouri A, Korakas E, et al. Cost-effectiveness analysis of an advanced hybrid closed loop insulin delivery system in people with type 1 diabetes in Greece. Diabetes Technol Ther 2021;28:28. https://doi.org/10.1089/dia.2021.0443 doi: 10.1089/dia.2021.0443. [DOI] [PubMed]
  100. Vallarino CR, Wong-Jacobson SH, Benneyworth BD, Meadows ES. Costs and outcomes comparison of diabetes technology usage among people with type 1 or 2 diabetes using rapid-acting insulin. J Diabetes Sci Technol 2021;17:439–48. https://doi.org/10.1177/19322968211052081 doi: 10.1177/19322968211052081. [DOI] [PMC free article] [PubMed]
  101. Pease A, Zomer E, Liew D, Lo C, Earnest A, Zoungas S. Cost-effectiveness of health technologies in adults with type 1 diabetes: a systematic review and narrative synthesis. Syst Rev 2020;9:171. https://doi.org/10.1186/s13643-020-01373-y doi: 10.1186/s13643-020-01373-y. [DOI] [PMC free article] [PubMed]
  102. Cohen O, Ledgaard Holm A, Buompensiere MI, Jendle J. Cost-effectiveness analysis of the MiniMed 780g system versus multiple daily injections with intermittently scanned continuous glucose monitoring in individuals with type 1 diabetes in Sweden. Diabetes Technol Ther 2021;23:A81. https://doi.org/10.1089/dia.2021.2525.abstracts
  103. Cohen O, Saltik AZO, Buompensiere MI, Walter E. Cost‐effectiveness analysis of the MiniMedTM 780g system versus multiple daily injections with intermittently scanned continuous glucose monitoring in individuals with type 1 diabetes in Austria. Diabetes Technol Ther 2021;23:A13–4. https://doi.org/10.1089/dia.2021.2525.abstracts
  104. Rai P, Zhang Y, Stover A, Iloabuchi C, Chiumente M, Kamal KM. Insulin Delivery Systems for Type 1 Diabetes Mellitus: A Comparison using a Decision Analysis Modeling Approach. Paper presented at International Society for Pharmaeconomics and Outcomes Research (ISPOR), Baltimore, MD, 19–23 May 2018. URL: www.researchgate.net/publication/326181840_Insulin_Delivery_Systems_for_Type_1_Diabetes_Mellitus_-_A_Comparison_Using_a_Decision_Analysis_Modeling_Approach
  105. Jendle J, de Portu S, Roze S. Cost Effectiveness Analysis of MiniMed 670G System versus Continuous Subcutaneous Insulin Infusion, in Individuals with Type 1 Diabetes. Paper presented at 12th International Conference on Advanced Technologies and Treatments for Diabetes, ATTD 2019, Berlin, Germany, 20–23 February 2019.
  106. Serne E, Roze S, Buompensiere MI, De Valk H. Cost-effectiveness analysis of the MiniMed 670g system versus multiple daily injections with intermittently scanned continuous glucose monitoring in individuals with type1 diabetes in the Netherlands. Diabetes Technol Ther 2021;23:A15–A6. https://doi.org/10.1089/dia.2021.2525.abstracts
  107. Roze S, Buompensiere I, Ozdemir Saltik Z, Cohen O. Cost effectiveness analysis of MiniMedTM 670g system versus continuous subcutaneous insulin infusion, in individuals with type1 diabetes in the United Kingdom. Diabetes Technol Ther 2020;22:A-83. https://doi.org/10.1089/dia.2020.2525.abstracts
  108. Young C, Hill S, Kim J, Cornelissen T, Herington E, Smith A, et al. Hybrid closed-loop insulin delivery systems for people with type 1 diabetes. Can J Health Technol 2021;1. https://doi.org/10.51731/cjht.2021.50
  109. Jendle J, Pohlmann J, de Portu S, Smith-Palmer J, Roze S. Cost-effectiveness analysis of the MiniMed 670G hybrid closed-loop system versus continuous subcutaneous insulin infusion for treatment of type 1 diabetes. Diabetes Technol Ther 2019;21:110–8. https://doi.org/10.1089/dia.2018.0328 doi: 10.1089/dia.2018.0328. [DOI] [PubMed]
  110. 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;12:2977–91. https://doi.org/10.1007/s13300-021-01157-0 doi: 10.1007/s13300-021-01157-0. [DOI] [PMC free article] [PubMed]
  111. Roze S, Buompensiere MI, Ozdemir Z, de Portu S, Cohen O. Cost-effectiveness of a novel hybrid closed-loop system compared with continuous subcutaneous insulin infusion in people with type 1 diabetes in the UK. J Med Econ 2021;24:883–90. https://doi.org/10.1080/13696998.2021.1939706 doi: 10.1080/13696998.2021.1939706. [DOI] [PubMed]
  112. Serne EH, Roze S, Buompensiere MI, Valentine WJ, De Portu S, de Valk HW. Cost-effectiveness of hybrid closed loop insulin pumps versus multiple daily injections plus intermittently scanned glucose monitoring in people with type 1 diabetes in the Netherlands. Adv Ther 2022;39:1844–56. https://doi.org/10.1007/s12325-022-02058-9 doi: 10.1007/s12325-022-02058-9. [DOI] [PubMed]
  113. Bergenstal RM, Garg S, Weinzimer SA, Buckingham BA, Bode BW, Tamborlane WV, Kaufman FR. Safety of a hybrid closed-loop insulin delivery system in patients with type 1 diabetes. JAMA 2016;316:1407–8. https://doi.org/10.1001/jama.2016.11708 doi: 10.1001/jama.2016.11708. [DOI] [PubMed]
  114. Garg SK, Weinzimer SA, Tamborlane WV, Buckingham BA, Bode BW, Bailey TS, et al. Glucose outcomes with the in-home use of a hybrid closed-loop insulin delivery system in adolescents and adults with type 1 diabetes. Diabetes Technol Ther 2017;19:155–63. https://doi.org/10.1089/dia.2016.0421 doi: 10.1089/dia.2016.0421. [DOI] [PMC free article] [PubMed]
  115. Charleer S, De Block C, Van Huffel L, Broos B, Fieuws S, Nobels F, et al. Quality of life and glucose control after 1 year of nationwide reimbursement of intermittently scanned continuous glucose monitoring in adults living with type 1 diabetes (FUTURE): a prospective observational real-world cohort study. Diabetes Care 2020;43:389–97. https://doi.org/10.2337/dc19-1610 doi: 10.2337/dc19-1610. [DOI] [PubMed]
  116. Akturk HK, Giordano D, Champakanath A, Brackett S, Garg S, Snell-Bergeon J. Long-term real-life glycaemic outcomes with a hybrid closed-loop system compared with sensor-augmented pump therapy in patients with type 1 diabetes. Diabetes Obes Metab 2020;22:583–9. https://doi.org/10.1111/dom.13933 doi: 10.1111/dom.13933. [DOI] [PubMed]
  117. Palmer AJ, Roze S, Valentine WJ, Minshall ME, Foos V, Lurati FM, et al. Validation of the CORE diabetes model against epidemiological and clinical studies. Curr Med Res Opin 2004;20:S27–40. https://doi.org/10.1185/030079904X2006 doi: 10.1185/030079904X2006. [DOI] [PubMed]
  118. McEwan P, Foos V, Palmer JL, Lamotte M, Lloyd A, Grant D. Validation of the IMS CORE diabetes model. Value Health 2014;17:714–24. https://doi.org/10.1016/j.jval.2014.07.007 doi: 10.1016/j.jval.2014.07.007. [DOI] [PubMed]
  119. Thokala P, Kruger J, Brennan A, Basarir H, Duenas A, Pandor A, et al. The Sheffield Type 1 Diabetes Policy Model. HEDS Discussion Paper 13/05. Sheffield: School of Health and Related Research; 2013.
  120. Östenson CG, Geelhoed-Duijvestijn P, Lahtela J, Weitgasser R, Markert Jensen M, Pedersen-Bjergaard U. Self-reported non-severe hypoglycaemic events in Europe. Diabet Med 2014;31:92–101. https://doi.org/10.1111/dme.12261 doi: 10.1111/dme.12261. [DOI] [PMC free article] [PubMed]
  121. Heller SR, Frier BM, Hersløv ML, Gundgaard J, Gough SCL. Severe hypoglycaemia in adults with insulin-treated diabetes: impact on healthcare resources. Diabet Med 2016;33:471–7. https://doi.org/10.1111/dme.12844 doi: 10.1111/dme.12844. [DOI] [PMC free article] [PubMed]
  122. Donnelly LA, Morris AD, Frier BM, Ellis JD, Donnan PT, Durrant R, et al.; DARTS/MEMO Collaboration. Frequency and predictors of hypoglycaemia in type 1 and insulin-treated type 2 diabetes: a population-based study. Diabet Med 2005;22:749–55. https://doi.org/10.1111/j.1464-5491.2005.01501.x doi: 10.1111/j.1464-5491.2005.01501.x. [DOI] [PubMed]
  123. McAuley SA, Lee MH, Paldus B, Vogrin S, de Bock MI, Abraham MB, et al.; Australian JDRF Closed-Loop Research Group. Six months of hybrid closed-loop versus manual insulin delivery with fingerprick blood glucose monitoring in adults with type 1 diabetes: a randomized, controlled trial. Diabetes Care 2020;43:3024–33. https://doi.org/10.2337/dc20-1447 doi: 10.2337/dc20-1447. [DOI] [PubMed]
  124. Beck RW, Riddlesworth T, Ruedy K, Ahmann A, Bergenstal R, Haller S, et al.; DIAMOND Study Group. Effect of continuous glucose monitoring on glycemic control in adults with type 1 diabetes using insulin injections: the DIAMOND randomized clinical trial. JAMA 2017;317:371–8. https://doi.org/10.1001/jama.2016.19975 doi: 10.1001/jama.2016.19975. [DOI] [PubMed]
  125. 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;388:2254–63. https://doi.org/10.1016/s0140-6736(16)31535-5 doi: 10.1016/S0140-6736(16)31535-5. [DOI] [PubMed]
  126. Leese GP, Wang J, Broomhall J, Kelly P, Marsden A, Morrison W, et al.; DARTS/MEMO Collaboration. Frequency of severe hypoglycemia requiring emergency treatment in type 1 and type 2 diabetes: a population-based study of health service resource use. Diabetes Care 2003;26:1176–80. https://doi.org/10.2337/diacare.26.4.1176 doi: 10.2337/diacare.26.4.1176. [DOI] [PubMed]
  127. Kariyawasam D, Morin C, Casteels K, Le Tallec C, Godot C, Sfez A, et al. Diabeloop DBL4K hybrid closed-loop system improves time-in-range without increasing time-in-hypoglycemia in children aged 6-12 years. Diabetes 2021;70:98-LB. https://doi.org/10.2337/db21-98-LB
  128. Abraham MB, de Bock M, Smith GJ, Dart J, Fairchild JM, King BR, et al.; Australian Juvenile Diabetes Research Fund Closed-Loop Research group. Effect of a hybrid closed-loop system on glycemic and psychosocial outcomes in children and adolescents with type 1 diabetes: a randomized clinical trial. JAMA Pediatr 2021;175:1227–35. https://doi.org/10.1001/jamapediatrics.2021.3965 doi: 10.1001/jamapediatrics.2021.3965. [DOI] [PMC free article] [PubMed]
  129. Gordon J, Beresford-Hulme L, Bennett H, Tank A, Edmonds C, McEwan P. Relationship between hypoglycaemia, body mass index and quality of life among patients with type 1 diabetes: observations from the DEPICT clinical trial programme. Diabetes Obes Metab 2020;22:857–65. https://doi.org/10.1111/dom.13972 doi: 10.1111/dom.13972. [DOI] [PubMed]
  130. The Mount Hood 4 Modeling Group. Computer modeling of diabetes and its complications: a report on the Fourth Mount Hood Challenge Meeting. Diabetes Care 2007;30:1638–46. https://doi.org/10.2337/dc07-9919 doi: 10.2337/dc07-9919. [DOI] [PubMed]
  131. Nathan DM; DCCT/EDIC Research Group. The diabetes control and complications trial/epidemiology of diabetes interventions and complications study at 30 years: overview. Diabetes Care 2014;37:9–16. https://doi.org/10.2337/dc13-2112 doi: 10.2337/dc13-2112. [DOI] [PMC free article] [PubMed]
  132. Acharya SH, Philip S, Viswanath AK, Boroujerdi M, Waugh NR, Pearson DWM. Glycaemic control and body mass index in late-adolescents and young adults with type 1 diabetes mellitus: a population-based study. Diabet Med 2008;25:360–4. https://doi.org/10.1111/j.1464-5491.2007.02372.x doi: 10.1111/j.1464-5491.2007.02372.x. [DOI] [PubMed]
  133. Peasgood T, Brennan A, Mansell P, Elliott J, Basarir H, Kruger J. The impact of diabetes-related complications on preference-based measures of health-related quality of life in adults with type I diabetes. Med Decis Making 2016;36:1020–33. https://doi.org/10.1177/0272989x16658660 doi: 10.1177/0272989X16658660. [DOI] [PMC free article] [PubMed]
  134. Chatwin H, Broadley M, Speight J, Cantrell A, Sutton A, Heller S, et al.; Hypo-RESOLVE Consortium. The impact of hypoglycaemia on quality of life outcomes among adults with type 1 diabetes: a systematic review. Diabetes Res Clin Pract 2021;174:108752. https://doi.org/10.1016/j.diabres.2021.108752 doi: 10.1016/j.diabres.2021.108752. [DOI] [PubMed]
  135. Coolen M, Broadley M, Hendrieckx C, Chatwin H, Clowes M, Heller S, et al.; Hypo-RESOLVE Consortium. The impact of hypoglycemia on quality of life and related outcomes in children and adolescents with type 1 diabetes: a systematic review. PLOS ONE 2021;16:e0260896. https://doi.org/10.1371/journal.pone.0260896 doi: 10.1371/journal.pone.0260896. [DOI] [PMC free article] [PubMed]
  136. Jensen MV, Broadley M, Speight J, Scope A, Preston L, Heller S, et al.; Hypo-RESOLVE Consortium. The impact of hypoglycaemia on the quality of life of family members of adults with type 1 or type 2 diabetes: a qualitative systematic review. Diabet Med 2021;38:e14666. https://doi.org/10.1111/dme.14666 doi: 10.1111/dme.14666. [DOI] [PubMed]
  137. Matlock KA, Broadley M, Hendrieckx C, Clowes M, Sutton A, Heller SR, et al.; Hypo-RESOLVE consortium. Changes in quality of life following hypoglycaemia in adults with type 2 diabetes: a systematic review of longitudinal studies. Diabet Med 2022;39:e14706. https://doi.org/10.1111/dme.14706 doi: 10.1111/dme.14706. [DOI] [PMC free article] [PubMed]
  138. Foos V, McEwan P. Conversion of hypoglycemia utility decrements from categorical units reflecting event history into event specific disutility scores applicable to diabetes decision models. Paper presented at 23rd Annual Meeting of the International Society for Pharmacoeconomics and Outcomes Research, ISPOR 2018. Baltimore, MD United States. Value Health 2018;21:S223.
  139. Evans M, Khunti K, Mamdani M, Galbo-Jørgensen CB, Gundgaard J, Bøgelund M, Harris S. 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. https://doi.org/10.1186/1477-7525-11-90 doi: 10.1186/1477-7525-11-90. [DOI] [PMC free article] [PubMed]
  140. Yfantopoulos J, Chantzaras A. Health-related quality of life and health utilities in insulin-treated type 2 diabetes: the impact of related comorbidities/complications. Eur J Health Econ 2020;21:729–43. https://doi.org/10.1007/s10198-020-01167-y doi: 10.1007/s10198-020-01167-y. [DOI] [PubMed]
  141. Zhang Y, Wu J, Chen Y, Shi L. EQ-5D-3L Decrements by diabetes complications and comorbidities in China. Diabetes Ther 2020;11:939–50. https://doi.org/10.1007/s13300-020-00788-z doi: 10.1007/s13300-020-00788-z. [DOI] [PMC free article] [PubMed]
  142. Nauck MA, Buse JB, Mann JFE, Pocock S, Bosch-Traberg H, Frimer-Larsen H, et al.; LEADER Publication Committee for the LEADER Trial Investigators. Health-related quality of life in people with type 2 diabetes participating in the LEADER trial. Diabetes Obes Metab 2019;21:525–32. https://doi.org/10.1111/dom.13547 doi: 10.1111/dom.13547. [DOI] [PMC free article] [PubMed]
  143. Briggs AH, Bhatt DL, Scirica BM, Raz I, Johnston KM, Szabo SM, et al. Health-related quality-of-life implications of cardiovascular events in individuals with type 2 diabetes mellitus: a subanalysis from the Saxagliptin assessment of vascular outcomes recorded in patients with diabetes mellitus (SAVOR)-TIMI 53 trial. Diabetes Res Clin Pract 2017;130:24–33. https://doi.org/10.1016/j.diabres.2016.12.019 doi: 10.1016/j.diabres.2016.12.019. [DOI] [PubMed]
  144. Pratipanawatr T, Satirapoj B, Ongphiphadhanakul B, Suwanwalaikorn S, Nitiyanant W. Impact of hypoglycemia on health-related quality of life among type 2 diabetes: a cross-sectional study in Thailand. J Diabetes Res 2019;2019:5903820. https://doi.org/10.1155/2019/5903820 doi: 10.1155/2019/5903820. [DOI] [PMC free article] [PubMed]
  145. Christensen B, Ranjan AG, Rytter K, McCarthy OM, Schmidt S, Nørgaard K. Automated insulin delivery use in adults with type 1 diabetes (T1D) treated with insulin pump and continuous glucose monitoring (CGM) but not meeting glycemic targets: a randomized controlled trial [published online ahead of print 11 April 2024]. J Diabetes Sci Technol 2024. doi: 10.1177/19322968241242399. [DOI] [PMC free article] [PubMed]
  146. Lee TTM, Collett C, Bergford S, Hartnell S, Scott EM, Lindsay RS, et al.; AiDAPT Collaborative Group. Automated insulin delivery in women with pregnancy complicated by type 1 diabetes. N Engl J Med 2023;389:1566–78. https://doi.org/10.1056/NEJMoa230391 doi: 10.1056/NEJMoa2303911. [DOI] [PubMed]
  147. Beunen K, Van Wilder N, Ballaux D, Vanhaverbeke G, Taes Y, Aers XP, et al. Closed-loop insulin delivery in pregnant women with type 1 diabetes (CRISTAL): a multicentre randomized controlled trial–study protocol. BMC Pregnancy Childbirth 2023;23:180. doi: 10.1186/s12884-023-05481-0. [DOI] [PMC free article] [PubMed]
  148. Hásková A, Radovnická L, Petruželková L, Parkin CG, Grunberger G, Horová E, 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;43:2744–50. doi: 10.2337/dc20-0112. [DOI] [PMC free article] [PubMed]
  149. 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;20:751–7. doi: 10.1089/dia.2018.0252. [DOI] [PMC free article] [PubMed]
  150. Visser MM, Charleer S, Fieuws S, De Block C, Hilbrands R, Van Huffel L, 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;397:2275–83. doi: 10.1016/S0140-6736(21)00789-3. [DOI] [PubMed]
  151. Xu XM, Vestesson E, Paley L, Desikan A, Wonderling D, Hoffman A, et al. The economic burden of stroke care in England, Wales and Northern Ireland: using a national stroke register to estimate and report patient-level health economic outcomes in stroke. Eur Stroke J 2018;3:82–91. https://doi.org/10.1177/2396987317746516 doi: 10.1177/2396987317746516. [DOI] [PMC free article] [PubMed]
  152. Meands C, Hyde C. What is the cost of blindness? Br J Ophthalmol 2003;87:1201–4. doi: 10.1136/bjo.87.10.1201. [DOI] [PMC free article] [PubMed]
  153. Geelhoed-Duijvestijn PH, Pedersen-Bjergaard U, Weitgasser R, Lahtela J, Jensen MM, Östenson CG. Effects of patient-reported non-severe hypoglycemia on healthcare resource use, work-time loss, and wellbeing in insulin-treated patients with diabetes in seven European countries. J Med Econ 2013;16:1453–61. https://doi.org/10.3111/13696998.2013.852098 doi: 10.3111/13696998.2013.852098. [DOI] [PubMed]
  154. Orozco-Beltrán D, Mezquita-Raya P, Ramírez de Arellano A, Galán M. Self-reported frequency and impact of hypoglycemic events in Spain. Diabetes Ther 2014;5:155–68. https://doi.org/10.1007/s13300-014-0057-z doi: 10.1007/s13300-014-0057-z. [DOI] [PMC free article] [PubMed]
  155. Slover R, Pihoker C, Shulman D, Kaiserman K, Liljenquist D, Sherr J, et al. Safety and glycemic control during the Medtronic advanced hybrid closed-loop (Ahcl) pivotal trial in youth aged 7–17 years with type 1 diabetes (T1d). Diabetes Technol Ther 2022;24:A49. https://doi.org/10.1177/2164957X221096590
  156. Breton MD, Cherñavvsky DR, Forlenza GP, DeBoer MD, Robic J, Wadwa RP, et al. Closed-loop control during intense prolonged outdoor exercise in adolescents with type 1 diabetes: the artificial Pancreas Ski study. Diabetes Care 2017;40:1644–50. https://doi.org/10.2337/dc17-0883 doi: 10.2337/dc17-0883. [DOI] [PMC free article] [PubMed]
  157. Bergenstal RM, Beck RW, Close KL, Grunberger G, Sacks DB, Kowalski A, et al. Glucose management indicator (GMI): a new term for estimating A1C from continuous glucose monitoring. Diabetes Care 2018;41:2275–80. https://doi.org/10.2337/dc18-1581 doi: 10.2337/dc18-1581. [DOI] [PMC free article] [PubMed]

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