Cited by 115Diabetes Management and ResearchDiabetes Management and EducationDiabetes and associated disorders

Closed-Loop Insulin Therapy Improves Glycemic Control in Adolescents and Young Adults: Outcomes from the International Diabetes Closed-Loop Trial

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Isganaitis, Elvira, Raghinaru, Dan, Ambler-Osborn, Louise, Pinsker, Jordan E., Buckingham, Bruce A., Wadwa, R. Paul, Ekhlaspour, Laya, Kudva, Yogish C. +83 more·2021·Diabetes Technology & Therapeutics

Abstract

Objective: To assess the efficacy and safety of closed-loop control (CLC) insulin delivery system in adolescents and young adults with type 1 diabetes. Research Design and Methods: Prespecified subanalysis of outcomes in adolescents and young adults aged 14–24 years old with type 1 diabetes in a previously published 6-month multicenter randomized trial. Participants were randomly assigned 2:1 to CLC (Tandem Control-IQ) or sensor augmented pump (SAP, various pumps+Dexcom G6 CGM) and followed for 6 months. Results: Mean age of the 63 participants was 17 years, median type 1 diabetes duration was 7 years, and mean baseline HbA1c was 8.1%. All 63 completed the trial. Time in range (TIR) increased by 13% with CLC versus decreasing by 1% with SAP (adjusted treatment group difference = +13% [+3.1 h/day]; 95% confidence interval [CI] 9–16, P < 0.001), which largely reflected a reduction in time >180 mg/dL (adjusted difference −12% [−2.9 h/day], P < 0.001). Time <70 mg/dL decreased by 1.6% with CLC versus 0.3% with SAP (adjusted difference −0.7% [−10 min/day], 95% CI −1.0% to −0.2%, P = 0.002). CLC use averaged 89% of the time for 6 months. The mean adjusted difference in HbA1c after 6 months was 0.30% in CLC versus SAP (95% CI −0.67 to +0.08, P = 0.13). There was one diabetic ketoacidosis episode in the CLC group. Conclusions: CLC use for 6 months was substantial and associated with improved TIR and reduced hypoglycemia in adolescents and young adults with type 1 diabetes. Thus, CLC has the potential to improve glycemic outcomes in this challenging age group. The clinical trial was registered with ClinicalTrials.gov (NCT03563313).

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  • Both generation 1 low-glucose-suspend and generation 2 hybrid closed-loop systems improve glycated haemoglobin concentrations, time in target range, and time below target range in children, adolescents, and adults.

    “Both generation 1 low-glucose-suspend33 and generation 2 hybrid closed-loop systems improve glycated haemoglobin concentrations, the time in target range and the time below target range in children, adolescents34 and adults.35-37”

    From Blood glucose monitoring devices: current considerations (2023) · cites this paper as [34]

    The Results (page not provided) show that closed-loop therapy increased time in range and reduced time below 70 mg/dL in adolescents and young adults. HbA1c fell in the treatment group, but the between-group difference was not statistically significant; the Conclusions explicitly note this limitation. Citation 34 is attached to the adolescent claim, not the separate claims about generation 1 systems in children or outcomes in adults. (LLM, conf=0.90)

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  1. [1]1. Foster NC, Beck RW, Miller KM, et al. : State of type 1 diabetes management and outcomes from the T1D Exchange in 2016–2018. Diabetes Technol Ther 2019;21:66–72 [DOI] [PMC free article] [PubMed] [Google Scholar]
  2. [2]2. American Diabetes Association: 13. Children and adolescents: standards of medical care in diabetes-2020. Diabetes Care 2020;43:S163–S182 [DOI] [PubMed] [Google Scholar]
  3. [3]3. Hermann JM, Miller KM, Hofer SE, et al. : The transatlantic HbA1c gap; differences in glycaemic control across the lifespan between people included in the US T1D Exchange Registry and those included in the German/Austrian DPV registry. Diabet Med 2020;37:848–855 [DOI] [PubMed] [Google Scholar]
  4. [5]5. Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications Study Research Group: Mortality in type 1 diabetes in the DCCT/EDIC versus the general population. Diabetes Care 2016;39:1378–138327411699 [Google Scholar]
  5. [6]6. Diabetes Control and Complications Trial Research Group; Nathan DM, Genuth S, Lachin J, et al. : the effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med 1993;329:977–986 [DOI] [PubMed] [Google Scholar]
  6. [7]7. Ekhlaspour L, Forlenza GP, Chernavvsky D, et al. : Closed loop control in adolescents and children during winter sports: use of the Tandem Control-IQ AP system. Pediatr Diabetes 2019;20:759–768 [DOI] [PMC free article] [PubMed] [Google Scholar]
  7. [8]8. Ly TT, Buckingham BA, DeSalvo DJ, et al. : Day-and-night closed-loop control using the unified safety system in adolescents with type 1 diabetes at camp. Diabetes Care 2016;39:e106–e107 [DOI] [PMC free article] [PubMed] [Google Scholar]
  8. [9]9. Ly TT, Keenan DB, Roy A, Han J, et al. : Automated overnight closed-loop control using a proportional-integral-derivative algorithm with insulin feedback in children and adolescents with type 1 diabetes at diabetes camp. Diabetes Technol Ther 2016;18:377–384 [DOI] [PubMed] [Google Scholar]
  9. [10]10. Phillip M, Battelino T, Atlas E, et al. : nocturnal glucose control with an artificial pancreas at a diabetes camp. N Engl J Med 2013;368:824–833 [DOI] [PubMed] [Google Scholar]
  10. [11]11. Russell SJ, Hillard MA, Balliro C, et al. : Day and night glycaemic control with a bionic pancreas versus conventional insulin pump therapy in preadolescent children with type 1 diabetes: a randomised crossover trial. Lancet Diabetes Endocrinol 2016;4:233–243 [DOI] [PMC free article] [PubMed] [Google Scholar]
  11. [12]12. Duffus SH, Ta'ani ZA, Slaughter JC, et al. : Increased proportion of time in hybrid closed-loop “Auto Mode” is associated with improved glycaemic control for adolescent and young patients with adult type 1 diabetes using the MiniMed 670G insulin pump. Diabetes Obes Metab 2020;22:688–693 [DOI] [PMC free article] [PubMed] [Google Scholar]
  12. [13]13. Berget C, Messer LH, Vigers T, et al. : Six months of hybrid closed loop in the real-world: an evaluation of children and young adults using the 670G system. Pediatr Diabetes 2020;21:310–318 [DOI] [PMC free article] [PubMed] [Google Scholar]
  13. [14]14. Messer LH, Berget C, Vigers T, et al. : Real world hybrid closed-loop discontinuation: predictors and perceptions of youth discontinuing the 670G system in the first 6 months. Pediatr Diabetes 2020;21:319–327 [DOI] [PMC free article] [PubMed] [Google Scholar]
  14. [16]16. Chernavvsky DR, DeBoer MD, Keith-Hynes P, et al. : Use of an artificial pancreas among adolescents for a missed snack bolus and an underestimated meal bolus. Pediatr Diabetes 2016;17:28–35 [DOI] [PubMed] [Google Scholar]
  15. [17]17. Bangor A, Kortum P, Miller J: Determining what individual SUS scores mean: adding an adjective rating scale. J Usab Stud 2009;4:114–123 [Google Scholar]
  16. [19]19. Sherr JL: Closing the loop on managing youth with type 1 diabetes: children are not just small adults. Diabetes Care 2018;41:1572–1578 [DOI] [PMC free article] [PubMed] [Google Scholar]
  17. [22]22. Akturk HK, Giordano D, Champakanath A, et al. : 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;22:583–589 [DOI] [PubMed] [Google Scholar]
  18. [23]23. Messer LH, Forlenza GP, Sherr JL, et al. : Optimizing hybrid closed-loop therapy in adolescents and emerging adults using the MiniMed 670G System. Diabetes Care 2018;41:789–796 [DOI] [PMC free article] [PubMed] [Google Scholar] Associated Data This section collects any data citations, data availability statements, or supplementary materials included in this article.

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Authors
Isganaitis, E., Raghinaru, D., Ambler-Osborn, L., Pinsker, J. E., Buckingham, B. A., Wadwa, R. P., Ekhlaspour, L., Kudva, Y. C., Levy, C. J., Forlenza, G. P., Beck, R. W., Kollman, C., Lum, J. W., Brown, S. A., Laffel, L. M., for the iDCL Trial Research Group, Kovatchev, B., Anderson, S., Emory, E., Voelmle, M., Conshafter, K., Morris, K., Oliveri, M., Gondor-Fredrick, L., Mitchell, H., Calvo, K., Wakeman, C., Breton, M., Flint, E., Kim, K., Roethke, L., Church, M. M., Andre, C., Piper, M., Lam, D., O'Malley, G., Levister, C., Ogyaadu, S., Lovett, J., Simha, V., Dadlani, V., McCrady-Spitzer, S., Reid, C., Kumari, K., Forlenza, G., Alonso, G. T., Slover, R., Jost, E., Messer, L., Berget, C., Towers, L., Rossick-Solis, A., Jacobson, T., Town, M., Tabatabai, I., Keller, J., Salas, E., Doyle, F., Dassau, E., Passman, S., Campos, T., Murphy, C., Patibandla, N., Borgman, S., Arreaza-Rubín, G., Green, N., Kovatchev, B., Brown, S., Anderson, S., Breton, M., Laffel, L., Pinsker, J., Levy, C., Wadwa, R. P., Buckingham, B., Doyle, F., Renard, E., Cobelli, C., Reznik, Y., Arreaza-Rubín, G., Lum, J., Beck, R., Janicek, R., Gabrielson, D., Belle, S. H., Castle, J., Green, J., Legault, L., Willi, S. M., Wysham, C., & Eggerman, T.
Affiliations
  • Joslin Diabetes Center (US)
  • Jaeb Center for Health Research (US)
  • Sansum Diabetes Research Institute (US)
  • Pediatric Endocrinology and Diabetes, Stanford Children's Health, Stanford, California, USA.
  • Stanford Health Care (US)
  • Mayo Clinic (US)
  • Department of Medicine, Endocrinology, Diabetes and Bone Diseases, Mount Sinai Diabetes Center, New York, New York, USA.
  • Barbara Davis Center for Diabetes, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.
  • Jaeb Center for Health Research, Tampa, Florida, USA.
  • Endocrinology and Metabolism Division, Department of Medicine, Center for Diabetes Technology, University of Virginia, Charlottesville, Virginia, USA.
  • Research Division, Department of Pediatrics, Joslin Diabetes Center, Harvard Medical School, Boston, Massachusetts, USA.
Venue
Diabetes Technology & Therapeutics
Published
2021-04-20
Volume
23
Issue
5
Pages
342-349
ISSN
  • 1520-9156 (ISSN-L)
  • 1557-8593
OpenAlex
W3099316592
Cited by
115
References
5
Citations by year
2026: 13 · 2025: 22 · 2024: 25 · 2023: 23 · 2022: 19 · 2021: 13
FWCI
10.37
Type
journal article
Language
en
Open access
Locations
  • Diabetes Technology & Therapeutics (publishedVersion)
  • PubMed Central (publishedVersion)
  • PubMed (publishedVersion)
  • HAL (submittedVersion)
Funders
  • National Institute of Diabetes and Digestive and Kidney Diseases (P30DK057521, U24DK123768, UC4DK108483, P60DK020541, K23DK121942, P30DK036836, P30DK020541)
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (R21HD091974)
Topics
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Education
  • Life Sciences › Biochemistry, Genetics and Molecular Biology › Genetics › Diabetes and associated disorders
Keywords
artificial pancreas, type 1 diabetes, adolescents and young adults, glycemic control, time in range, sensor-augmented pump, continuous glucose monitoring, HbA1c, hypoglycemia, diabetic ketoacidosis
MeSH terms
Glycemic Control, Adolescent, Adult, Blood Glucose, Diabetes Mellitus, Type 1, Humans, Hypoglycemic Agents, Insulin, Insulin Infusion Systems, Young Adult

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