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Review

Closed-loop insulin delivery systems in children and adolescents with type 1 diabetes

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Pages 157-166 | Received 23 Sep 2019, Accepted 07 Jan 2020, Published online: 20 Feb 2020

References

  • Patterson CC, Harjutsalo V, Rosenbauer J, et al. Trends and cyclical variation in the incidence of childhood type 1 diabetes in 26 European centres in the 25 year period 1989–2013: a multicentre prospective registration study. Diabetologia. 2019;62(3):408–417.
  • Atkinson MA, Eisenbarth GS, Michels AW. Type 1 diabetes. Lancet. 2014;383:69–82.
  • Lind M, Svensson A-M, Kosiborod M, et al. Glycemic control and excess mortality in type 1 diabetes. N Engl J Med. 2014;371:1972–1982.
  • Rawshani A, Sattar N, Franzén S, et al. Excess mortality and cardiovascular disease in young adults with type 1 diabetes in relation to age at onset: a nationwide, register-based cohort study. Lancet. 2018;392:477–486.
  • Nathan DM, Cleary PA, Backlund J-YC, et al. Intensive diabetes treatment and cardiovascular disease in patients with type 1 diabetes. N Engl J Med. 2005;353:2643–2653.
  • Dimeglio LA, Acerini CL, Codner E, et al. Glycemic control targets and glucose monitoring for children, adolescents, and young adults with diabetes 2018 ISPAD clinical practice consensus guidelines. Pediatr Diabetes. 2018 Oct;19 Suppl 27:105-114. doi: 10.1111/pedi.12737.
  • American Diabetes Association. 13. Children and adolescents: standards of medical care in diabetes—2019. Diabetes Care. 2019;42:S148–S164.
  • Battelino T, Danne T, Bergenstal RM, et al. Clinical targets for continuous glucose monitoring data interpretation: recommendations from the international consensus on time in range. Diabetes Care. 2019;42:1593–1603.
  • 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.
  • Dovc K, Boughton C, Tauschmann M, et al. Young children have higher variability of insulin requirements: observations during hybrid closed-loop insulin delivery. Diabetes Care. 2019;42:1344–1347.
  • Jabbour G, Henderson M, Mathieu ME. Barriers to active lifestyles in children with type 1 diabetes. Can J Diabetes. 2016;40:170–172.
  • Van Name MA, Hilliard ME, Boyle CT, et al. Nighttime is the worst time: parental fear of hypoglycemia in young children with type 1 diabetes. Pediatr Diabetes. 2018;19:114–120.
  • Frier BM. Hypoglycaemia in diabetes mellitus: epidemiology and clinical implications. Nat Rev Endocrinol. 2014;10:711–722.
  • Nimri R, Muller I, Atlas E, et al. MD-logic overnight control for 6 weeks of home use in patients with type 1 diabetes: randomized crossover trial. Diabetes Care. 2014;37:3025–3032.
  • Nimri R, Bratina N, Kordonouri O, et al. MD-Logic overnight type 1 diabetes control in home settings: A multicentre, multinational, single blind randomized trial. Diabetes Obes Metab. 2017;19:553–561.
  • Ly TT, Keenan DB, Roy A, 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.
  • Sharifi A, De Bock MI, Jayawardene D, et al. Glycemia, treatment satisfaction, cognition, and sleep quality in adults and adolescents with type 1 diabetes when using a closed-loop system overnight versus sensor-augmented pump with low-glucose suspend function: a randomized crossover study. Diabetes Technol Ther. 2016;18:772–783.
  • Ly TT, Roy A, Grosman B, et al. Day and night closed-loop control using the integrated medtronic hybrid closed-loop system in type 1 diabetes at diabetes camp. Diabetes Care. 2015;38:1205–1211.
  • Ly TT, Buckingham BA, De Salvo 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.
  • 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.
  • Tauschmann M, Allen JM, Wilinska ME, et al. 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;39:2019–2025.
  • Tauschmann M, Allen JM, Wilinska ME, 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;39:1168–1174.
  • Forlenza GP, Ekhlaspour L, Breton 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;21:159–169.
  • Renard E, Tubiana-Rufi N, Bonnemaison-Gilbert E, et al. Closed-loop driven by control-to-range algorithm outperforms threshold-low-glucose-suspend insulin delivery on glucose control albeit not on nocturnal hypoglycaemia in prepubertal patients with type 1 diabetes in a supervised hotel setting. Diabetes Obes Metab. 2019;21:183–187.
  • Clemens AH, Chang PH, Myers RW. The development of biostator, a Glucose controlled insulin infusion system (GCIIS). Horm Metab Res. 1977;7:23–33 Suppl.
  • Kadish A. Automation control of blood sugar, i.a servomechanism for glucose monitoring and control. Am J Med Electron. 1963;3:82–86.
  • Battelino T, Phillip M. The first meeting of the loop club. J Pediatr Endocrinol Metab. 2004;17(3):375-376.
  • Kowalski AJ. Can we really close the loop and how soon? accelerating the availability of an artificial pancreas: a roadmap to better diabetes outcomes. Diabetes Technol Ther. 2009;11(Suppl 1):S113–9.
  • Kowalski A. Pathway to artificial pancreas systems revisited: moving downstream. Diabetes Care. 2015;38:1036–1043.
  • Bergenstal RM, Klonoff DC, Garg SK, et al. Threshold-based insulin-pump interruption for reduction of hypoglycemia. N Engl J Med. 2013;369:224–232.
  • Battelino T, Nimri R, Dovc K, et al. Prevention of hypoglycemia with predictive low glucose insulin suspension in children with type 1 diabetes: A randomized controlled trial. Diabetes Care. 2017;40:764–770.
  • Buckingham BA, Cameron F, Calhoun P, et al. Outpatient safety assessment of an in-home predictive low-glucose suspend system with type 1 diabetes subjects at elevated risk of nocturnal hypoglycemia. Diabetes Technol Ther. 2013;15:622–627.
  • Forlenza GP, Li Z, Buckingham BA, et al. Predictive low-glucose suspend reduces hypoglycemia in adults, adolescents, and children with type 1 diabetes in an at-home randomized crossover study: results of the PROLOG trial. Diabetes Care. 2018;41:2155–2161.
  • Biester T, Kordonouri O, Holder M, et al. “Let the algorithm do the work”: reduction of hypoglycemia using sensor-augmented pump therapy with predictive insulin suspension (smartguard) in pediatric type 1 diabetes patients. Diabetes Technol Ther. 2017;19:173–182.
  • Gaweł WB, Deja G, Kamińska H, et al. How does a predictive low glucose suspend (PLGS) system tackle pediatric lifespan challenges in diabetes treatment? Real world data analysis. Pediatr Diabetes. 2019 10.1111:pedi.12944.
  • Müller L, Habif S, Leas S, et al. Reducing hypoglycemia in the real world: a retrospective analysis of predictive low-glucose suspend technology in an ambulatory insulin-dependent cohort. Diabetes Technol Ther. 2019;21:478–484.
  • Pinsker JE, Lee JB, Dassau E, et al. Randomized crossover comparison of personalized MPC and PID control algorithms for the artificial pancreas. Diabetes Care. 2016;39:1135–1142.
  • Russell SJ, El-Khatib FH, Sinha M, et al. Outpatient glycemic control with a bionic pancreas in type 1 diabetes. N Engl J Med. 2014;371:313–325.
  • Haidar A, Smaoui MR, Legault L, et al. The role of glucagon in the artificial pancreas. Lancet Diabetes Endocrinol. 2016;4:476–479.
  • El-Khatib FH, Balliro C, Hillard MA, et al. Home use of a bihormonal bionic pancreas versus insulin pump therapy in adults with type 1 diabetes: a multicentre randomised crossover trial. Lancet. 2017;389:369–380.
  • Atlas E, Nimri R, Miller S, et al. MD-logic artificial pancreas system: A pilot study in adults with type 1 diabetes. Diabetes Care. 2010;33:1072–1076.
  • Nimri R, Phillip M. Artificial pancreas: fuzzy logic and control of glycemia. Curr Opin Endocrinol Diabetes Obes. 2014;21:251–256.
  • Biester T, Nir J, Remus K, et al. DREAM5: an open-label, randomized, cross-over study to evaluate the safety and efficacy of day and night closed-loop control by comparing the MD-logic automated insulin delivery system to sensor augmented pump therapy in patients with type 1 diabetes at h. Diabetes Obes Metab. 2019;21:822–828.
  • Cameron FM, Ly TT, Buckingham BA, et al. Closed-loop control without meal announcement in type 1 diabetes. Diabetes Technol Ther. 2017;19:527–532.
  • Forlenza GP, Cameron FM, Ly TT, et al. Fully closed-loop multiple model probabilistic predictive controller artificial pancreas performance in adolescents and adults in a supervised hotel setting. Diabetes Technol Ther. 2018;20:335–343.
  • Weinzimer SA, Steil GM, Swan KL, et al. Fully automated closed-loop insulin delivery versus semiautomated hybrid control in pediatric patients with type 1 diabetes using an artificial pancreas. Diabetes Care. 2008;31:934–939.
  • Turksoy K, Bayrak ES, Quinn L, et al. Multivariable adaptive closed-loop control of an artificial pancreas without meal and activity announcement. Diabetes Technol Ther. 2013;15:386–400.
  • Dovc K, Piona C, Yeşiltepe Mutlu G, et al.Faster compared to standard insulin aspart during day-and-night fully closed-loop insulin therapy in type 1 diabetes : a double-blind randomized crossover trial article faster compared to standard insulin aspart during day-and-night fully closed-loop ins. Diabetes Care. 2019;1–8.
  • Hovorka R, Allen JM, Elleri D, et al. Manual closed-loop insulin delivery in children and adolescents with type 1 diabetes: a phase 2 randomised crossover trial. Lancet. 2010;375:743–751.
  • Steil GM, Palerm CC, Kurtz N, et al. The effect of insulin feedback on closed loop glucose control. J Clin Endocrinol Metab. 2011;96:1402–1408.
  • Kovatchev B, Cobelli C, Renard E, et al. Multinational study of subcutaneous model-predictive closed-loop control in type 1 diabetes mellitus: summary of the results. J Diabetes Sci Technol. 2010;4:1374–1384.
  • 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.
  • Ly TT, Breton MD, Keith-Hynes P, et al. Overnight glucose control with an automated, unified safety system in children and adolescents with type 1 diabetes at diabetes camp. Diabetes Care. 2014;37:2310–2316.
  • Hovorka R, Elleri D, Thabit H, et al. Overnight closed-loop insulin delivery in young people with type 1 diabetes: A free-living, randomized clinical trial. Diabetes Care. 2014;37:1204–1211.
  • Thabit H, Tauschmann M, Allen JM, et al. Home use of an artificial beta cell in type 1 diabetes. N Engl J Med. 2015;373:2129–2140.
  • Spaic T, Driscoll M, Raghinaru D, et al. Predictive hyperglycemia and hypoglycemia minimization: in-home evaluation of safety, feasibility, and efficacy in overnight glucose control in type 1 diabetes. Diabetes Care. 2017;40:359–366.
  • Forlenza GP, Raghinaru D, Cameron F, et al. Predictive hyperglycemia and hypoglycemia minimization: in-home double-blind randomized controlled evaluation in children and young adolescents. Pediatr Diabetes. 2018;19:420–428.
  • De Bock MI, Roy A, Cooper MN, et al. Feasibility of outpatient 24-hour closed-loop insulin delivery. Diabetes Care. 2015;38:e186–e187.
  • Tauschmann M, Thabit H, Bally L, et al. Closed-loop insulin delivery in suboptimally controlled type 1 diabetes: a multicentre, 12-week randomised trial. Lancet. 2018;392:1321–1329.
  • Brown SA, Kovatchev BP, Raghinaru D, et al. Six-month randomized, multicenter trial of closed-loop control in type 1 diabetes. N Engl J Med. 2019;381(18):1707–1717.
  • Colberg SR, Sigal RJ, Yardley JE, et al. Physical activity/exercise and diabetes: a position statement of the american diabetes association. Diabetes Care. 2016;39:2065–2079.
  • Riddell MC, Gallen IW, Smart CE, et al. Exercise management in type 1 diabetes: a consensus statement. Lancet Diabetes Endocrinol. 2017;5:377–390.
  • Zaharieva DP, Mcgaugh S, Pooni R, et al. Improved open-loop glucose control with basal insulin reduction 90 minutes before aerobic exercise in patients with type 1 diabetes on continuous subcutaneous insulin infusion. 2019;42(5):824–831.
  • Dovc K, Macedoni M, Bratina N, et al. Closed-loop glucose control in young people with type 1 diabetes during and after unannounced physical activity: a randomised controlled crossover trial. Diabetologia. 2017;60:2157–2167.
  • Patel NS, Van Name MA, Cengiz E, et al. Mitigating reductions in glucose during exercise on closed-loop insulin delivery: the ex-snacks study. Diabetes Technol Ther. 2016;18:794–799.
  • Breton MD, Cherñavvsky DR, Forlenza GP, et al. Closed-loop control during intense prolonged outdoor exercise in adolescents with type 1 diabetes: the artificial pancreas ski study. Diabetes Care. 2017;40:1644–1650.
  • 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.
  • Del Favero S, Boscari F, Messori M, et al. Randomized summer camp crossover trial in 5-to 9-year-old children: outpatient wearable artificial pancreas is feasible and safe. Diabetes Care. 2016;39:1180–1185.
  • Tauschmann M, Allen JM, Nagl K, et al. Home use of day and night hybrid closed loop insulin delivery in very young children: a multicenter 3-week, randomized trial. Diabetes Care. 2019;42:594–600.
  • Haidar A, Legault L, Matteau-Pelletier L, et al. Outpatient overnight glucose control with dual-hormone artificial pancreas, single-hormone artificial pancreas, or conventional insulin pump therapy in children and adolescents with type 1 diabetes: an open-label, randomised controlled trial. Lancet Diabetes Endocrinol. 2015;3:595–604.
  • Haidar A, Rabasa-Lhoret R, Legault L, et al. Single- and dual-hormone artificial pancreas for overnight glucose control in type 1 diabetes. J Clin Endocrinol Metab. 2016;101:214–223.
  • Huyett LM, Ly TT, Forlenza GP, et al. Outpatient closed-loop control with unannounced moderate exercise in adolescents using zone model predictive control. Diabetes Technol Ther. 2017;19(6):331–339.
  • Jacobs PG, El Youssef J, Reddy R, et al. Randomized trial of a dual-hormone artificial pancreas with dosing adjustment during exercise compared with no adjustment and sensor-augmented pump therapy. Diabetes Obes Metab. 2016;18:1110–1119.
  • Taleb N, Emami A, Suppere C, et al. Efficacy of single-hormone and dual-hormone artificial pancreas during continuous and interval exercise in adult patients with type 1 diabetes: randomised controlled crossover trial. Diabetologia. 2016;59:2561–2571.
  • Castle JR, El Youssef J, Wilson LM, et al. Randomized outpatient trial of single- and dual-hormone closed-loop systems that adapt to exercise using wearable sensors. Diabetes Care. 2018;41:1471–1477.
  • Lal RA, Basina M, Maahs DM, et al. One year clinical experience of the first commercial hybrid. Diabetes Care. 2019 Dec;42(12):2190–2196.
  • Barnard KD, Wysocki T, Ully V, et al. Closing the loop in adults, children and adolescents with suboptimally controlled type 1 diabetes under free living conditions: a psychosocial substudy. J Diabetes Sci Technol. 2017;11:1080–1088.
  • Barnard KD, Wysocki T, Allen JM, et al. Closing the loop overnight at home setting: psychosocial impact for adolescents with type 1 diabetes and their parents. BMJ Open Diabetes Res Care. 2014;2:e000025.
  • Tanenbaum ML, Hanes SJ, Miller KM, et al. Diabetes device use in adults with type 1 diabetes: barriers to uptake and potential intervention targets. Diabetes Care. 2017;40:181–187.
  • Iturralde E, Tanenbaum ML, Hanes SJ, et al. Expectations and attitudes of individuals with type 1 diabetes after using a hybrid closed loop system. Diabetes Educ. 2017;43:223–232.
  • Musolino G, Dovc K, Boughton CK, et al. Reduced burden of diabetes and improved quality of life: experiences from unrestricted day-and-night hybrid closed-loop use in very young children with type 1 diabetes. Pediatr Diabetes. 2019;20:794–799.
  • Lawton J, Blackburn M, Rankin D, et al. Participants’ experiences of, and views about, daytime use of a day-and-night hybrid closed-loop system in real life settings: longitudinal qualitative study. Diabetes Technol Ther. 2019;21:119–127.
  • Fullerton B, Jeitler K, Seitz M, et al. Intensive glucose control versus conventional glucose control for type 1 diabetes mellitus. In: Fullerton Beditor. Cochrane database syst. rev. Chichester, UK: John Wiley & Sons, Ltd; 2014. p. CD009122.
  • Beyond A1C Writing Group BAW. Need for regulatory change to incorporate beyond a1c glycemic metrics. Diabetes Care. 2018;41:e92–e94.
  • Foland-Ross LC, Reiss AL, Mazaika PK, et al. Longitudinal assessment of hippocampus structure in children with type 1 diabetes. Pediatr Diabetes. 2018;19:1116–1123.
  • Fox LA, Hershey T, Mauras N, et al. Persistence of abnormalities in white matter in children with type 1 diabetes. Diabetologia. 2018;61(7):1538-1547.
  • Lachin JM, Bebu I, Bergenstal RM, et al. Association of glycemic variability in type 1 diabetes with progression of microvascular outcomes in the diabetes control and complications trial. Diabetes Care. 2017;40:777–783.
  • Lovshin JA, Bjornstad P, Lovblom LE, et al. Atherosclerosis and microvascular complications: results from the canadian study of longevity in type 1 diabetes. Diabetes Care. 2018;41:2570–2578.
  • Tesovnik T, Kovac J, Hovnik T, et al. Association of glycemic control and cell stress with telomere attrition in type 1 diabetes. JAMA Pediatr. 2018;172:879.
  • Danne T, Nimri R, Battelino T, et al. International consensus on use of continuous glucose monitoring. Diabetes Care. 2017;40:1631–1640.
  • Agiostratidou G, Anhalt H, Ball D, et al. Standardizing clinically meaningful outcome measures beyond hba1c for type 1 diabetes: a consensus report of the american association of clinical endocrinologists, the american association of diabetes educators, the american diabetes association, the endo. Diabetes Care. 2017;40:1622–1630.
  • Beck RW, Bergenstal RM, Riddlesworth TD, et al. Validation of time in range as an outcome measure for diabetes clinical trials. Diabetes Care. 2019;42:400–405.
  • Weisman A, Bai J-W, Cardinez M, et al. Effect of artificial pancreas systems on glycaemic control in patients with type 1 diabetes: a systematic review and meta-analysis of outpatient randomised controlled trials. Lancet Diabetes Endocrinol. 2017;5:501–512.
  • Bekiari E, Kitsios K, Thabit H, et al. Artificial pancreas treatment for outpatients with type 1 diabetes: systematic review and meta-analysis. BMJ. 2018;361:k1310.
  • Garg SK, Weinzimer SA, Tamborlane WV, 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;19:155–163.
  • Forlenza GP, Pinhas-Hamiel O, Liljenquist DR, et al. Safety evaluation of the minimed 670g system in children 7–13 years of age with type 1 diabetes. Diabetes Technol Ther. 2019;21:11–19.
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). Four pivotal NIH-funded artificial pancreas research efforts begin. 2017. [cited 2019 April 12]. Available from: https://www.nih.gov/news-events/news-releases/four-pivotal-nih-funded-artificial-pancreas-research-efforts-begin.
  • Sherr J, Buckingham BA, Forlenza G, et al. Safety and performance of the omnipod hybrid closed-loop system in adults, adolescents, and children with type 1 diabetes over 5 days under free-living conditions. Diabetes Technol Ther. 2019 dia.2019.0286.
  • Braune K, O’Donnell S, Cleal B, et al. Real-world use of do-it-yourself artificial pancreas systems in children and adolescents: self-reported clinical outcomes (preprint). JMIR mHealth uHealth. 2019;7:1–9.
  • US Food and Drug Adminsitration. FDA warns against the use of unauthorized devices for diabetes management. 2019. [cited 2019 April 12]. Available from: https://www.fda.gov/news-events/press-announcements/fda-warns-against-use-unauthorized-devices-diabetes-management.
  • Jendle J, Pöhlmann J, De Portu S, et al. 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;21:110–118.

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