Predictive hyperglycemia and hypoglycemia minimization: In-home double-blind randomized controlled evaluation in children and young adolescents

Pediatric Diabetes

Volumn 19, Issue 3, 2018, Pages 420-428

  Forlenza, Gregory P ^a   Raghinaru, Dan ^b   Cameron, Faye ^c   Wayne Bequette, B ^c   Peter Chase, H ^a   Paul Wadwa, R ^a   Maahs, David M ^a,d   Jost, Emily ^a   Ly, Trang T ^d   Wilson, Darrell M ^d   Norlander, Lisa ^d   Ekhlaspour, Laya ^d   Min, Hyojin ^d   Clinton, Paula ^d   Njeru, Nelly ^b   Lum, John W ^b   Kollman, Craig ^b   Beck, Roy W ^b   Buckingham, Bruce A ^d  

^a UNIVERSITY OF COLORADO   (United States)

^b JAEB CENTER FOR HEALTH RESEARCH   (United States)

^c RENSSELAER POLYTECHNIC INSTITUTE   (United States)

^d STANFORD UNIVERSITY   (United States)

Author keywords

automated insulin delivery; continuous glucose monitoring; type 1 diabetes

Indexed keywords

GLUCOSE; INSULIN;

ADOLESCENT; ARTICLE; BLOOD GLUCOSE MONITORING; CHILD; CLINICAL ARTICLE; CLINICAL EFFECTIVENESS; CONTROLLED STUDY; DISEASE DURATION; DOUBLE BLIND PROCEDURE; FAMILY STRESS; FEASIBILITY STUDY; FEMALE; GLYCEMIC CONTROL; HUMAN; HYPERGLYCEMIA; HYPOGLYCEMIA; INSULIN DEPENDENT DIABETES MELLITUS; INSULIN TREATMENT; INTERMETHOD COMPARISON; MALE; MULTICENTER STUDY; PATIENT SAFETY; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; TREATMENT DURATION; ALARM MONITOR; AMBULATORY MONITORING; BLOOD; DEVICES; GLUCOSE BLOOD LEVEL; INSULIN INFUSION;

ADOLESCENT; BLOOD GLUCOSE; CHILD; CLINICAL ALARMS; DIABETES MELLITUS, TYPE 1; DOUBLE-BLIND METHOD; FEASIBILITY STUDIES; FEMALE; HUMANS; HYPERGLYCEMIA; HYPOGLYCEMIA; INSULIN INFUSION SYSTEMS; MALE; MONITORING, AMBULATORY;

EID: 85034643556     PISSN: 1399543X     EISSN: 13995448     Source Type: Journal    
DOI: 10.1111/pedi.12603     Document Type: Article

References (47)

1. Davis EA, Keating B, Byrne GC, Russell M, Jones TW. Hypoglycemia: incidence and clinical predictors in a large population-based sample of children and adolescents with IDDM. Diabetes Care. 1997;20(1):22–25.
2. The Diabetes Control and Complications Trial Research Group. Hypoglycemia in the Diabetes Control and Complications Trial. Diabetes. 1997;46(2):271–286.
3. Jones TW, Porter P, Sherwin RS, et al. Decreased epinephrine responses to hypoglycemia during sleep. N Engl J Med. 1998;338(23):1657–1662.
4. Ly TT, Jones TW, Griffiths A, et al. Hypoglycemia does not change the threshold for arousal from sleep in adolescents with type 1 diabetes. Diabetes Technol Ther. 2012;14(2):101–104.
5. Buckingham B, Wilson DM, Lecher T, Hanas R, Kaiserman K, Cameron F. Duration of nocturnal hypoglycemia before seizures. Diabetes Care. 2008;31(11):2110–2112.
6. Tanenberg RJ, Newton CA, Drake AJ. Confirmation of hypoglycemia in the “dead-in-bed” syndrome, as captured by a retrospective continuous glucose monitoring system. Endocr Pract. 2010;16(2):244–248.
7. Viaene AS, Van Daele T, Bleys D, Faust K, Massa GG. Fear of hypoglycemia, parenting stress, and metabolic control for children with type 1 diabetes and their parents. J Clin Psychol Med Settings. 2017;24(1):74–81.
8. Buckingham B, Block J, Burdick J, et al. Response to nocturnal alarms using a real-time glucose sensor. Diabetes Technol Ther. 2005;7(3):440–447.
9. 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–S119.
10. Kowalski A. Pathway to artificial pancreas systems revisited: moving downstream. Diabetes care. 2015;38(6):1036–1043.
11. Forlenza GP, Buckingham B, Maahs DM. Progress in diabetes technology: developments in insulin pumps, continuous glucose monitors, and progress towards the artificial pancreas. J Pediatr. 2016;169:13–20.
12. Hovorka R, Kumareswaran K, Harris J, et al. Overnight closed loop insulin delivery (artificial pancreas) in adults with type 1 diabetes: crossover randomised controlled studies. BMJ. 2011;d1855:342.
13. O'Grady MJ, Retterath AJ, Keenan DB, et al. The use of an automated, portable glucose control system for overnight glucose control in adolescents and young adults with type 1 diabetes. Diabetes Care. 2012;35(11):2182–2187.
14. Brown SA, Kovatchev BP, Breton MD, et al. Multinight “bedside” closed-loop control for patients with type 1 diabetes. Diabetes Technol Ther. 2015;17(3):203–209.
15. 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(9):824–833.
16. Kovatchev B, Cheng P, Anderson SM, et al. Feasibility of long-term closed-loop control: a multicenter 6-month trial of 24/7 automated insulin delivery. Diabetes Technol Ther. 2017;19(1):18–24.
17. 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.
18. 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(3):233–243.
19. Renard E, Farret A, Kropff J, et al. Day and night closed-loop glucose control in patients with type 1 diabetes under free-living conditions: results of a single-arm 1-month experience compared with a previously reported feasibility study of evening and night at home. Diabetes Care. 2016;39:1151–1160.
20. 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.
21. 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(7):1180–1185.
22. Bergenstal RM, Garg S, Weinzimer SA, et al. Safety of a hybrid closed-loop insulin delivery system in patients with type 1 diabetes. JAMA. 2016;316:1407–1408.
23. Anderson SM, Raghinaru D, Pinsker JE, et al. Multinational home use of closed-loop control is safe and effective. Diabetes Care. 2016;39:1143–1150.
24. 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(22):2129–2140.
25. Kovatchev BP, Renard E, Cobelli C, et al. Safety of outpatient closed-loop control: first randomized crossover trials of a wearable artificial pancreas. Diabetes Care. 2014;37(7):1789–1796.
26. 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(8):2310–2316.
27. Troncone A, Bonfanti R, Iafusco D, et al. Evaluating the experience of children with type 1 diabetes and their parents taking part in an artificial pancreas clinical trial over multiple days in a diabetes camp setting. Diabetes Care. 2016;39(12):2158–2164.
28. Weissberg-Benchell J, Hessler D, Polonsky WH, Fisher L. Psychosocial impact of the bionic pancreas during summer camp. J Diabetes Sci Technol. 2016;10(4):840–844.
29. Maahs DM, Calhoun P, Buckingham BA, et al. A randomized trial of a home system to reduce nocturnal hypoglycemia in type 1 diabetes. Diabetes Care. 2014;37(7):1885–1891.
30. Buckingham BA, Raghinaru D, Cameron F, et al. Predictive low-glucose insulin suspension reduces duration of nocturnal hypoglycemia in children without increasing ketosis. Diabetes Care. 2015;38(7):1197–1204.
31. 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(3):359–366.
32. 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(8):622–627.
33. Cameron F, Wilson DM, Buckingham BA, et al. Inpatient studies of a Kalman-filter-based predictive pump shutoff algorithm. J Diabetes Sci Technol. 2012;6(5):1142–1147.
34. The DCCT Research Group. The diabetes control and complications trial (DCCT). Design and methodologic considerations for the feasibility phase. Diabetes. 1986;35(5):530–545.
35. Standardization IOf ISO 15197:2013. : in vitro Diagnostic Test Systems—Requirements for Blood-Glucose Monitoring Systems for Self-Testing in Managing Diabetes Mellitus. Geneva, Switzerland: International Organization for Standardization; 2013.
36. Beck RW, Tamborlane WV, Bergenstal RM, Miller KM, DuBose SN, Hall CA. The T1D exchange clinic registry. J Clin Endocrinol Metab. 2012;97(12):4383–4389.
37. Miller KM, Foster NC, Beck RW, et al. Current state of type 1 diabetes treatment in the U.S.: updated data from the T1D exchange clinic registry. Diabetes Care. 2015;38(6):971–978.
38. Maahs DM, Hermann JM, DuBose SN, et al. Contrasting the clinical care and outcomes of 2622 children with type 1 diabetes less than 6 years of age in the United States T1D exchange and German/Austrian DPV registries. Diabetologia. 2014;57(8):1578–1585.
39. Hatton DL, Canam C, Thorne S, Hughes AM. Parents’ perceptions of caring for an infant or toddler with diabetes. J Adv Nurs. 1995;22(3):569–577.
40. Patton SR, Dolan LM, Smith LB, Thomas IH, Powers SW. Pediatric parenting stress and its relation to depressive symptoms and fear of hypoglycemia in parents of young children with type 1 diabetes mellitus. J Clin Psychol Med Settings. 2011;18(4):345–352.
41. 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(12):772–783.
42. 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 Ccare. 2014;2(1):e000025.
43. Haidar A, Legault L, Messier V, Mitre TM, Leroux C, Rabasa-Lhoret R. Comparison of dual-hormone artificial pancreas, single-hormone artificial pancreas, and conventional insulin pump therapy for glycaemic control in patients with type 1 diabetes: an open-label randomised controlled crossover trial. Lancet Diabetes Endocrinol. 2015;3(1):17–26.
44. 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(6):377–384.
45. 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(5):1204–1211.
46. Abraham MB, Nicholas JA, Ly TT, et al. Safety and efficacy of the predictive low glucose management system in the prevention of hypoglycaemia: protocol for randomised controlled home trial to evaluate the suspend before low function. BMJ Open. 2016;6(4):e011589.
47. Messer LH, Forlenza GP, Wadwa RP, et al. The dawn of automated insulin delivery: A new clinical framework to conceptualize insulin administration. Pediatr Diabetes. 2017; [epub ahead of print] https://doi.org/10.11/pedi.12535.