Performance and safety of an integrated bihormonal artificial pancreas for fully automated glucose control at home

Diabetes, Obesity and Metabolism

Volumn 18, Issue 7, 2016, Pages 671-677

  Blauw, H ^a,b   van Bon, A C ^c   Koops, R ^b   DeVries, J H ^a  

^a UNIVERSITY OF AMSTERDAM   (Netherlands)

^b Inreda Diabetic BV   (Netherlands)

^c RIJNSTATE HOSPITAL   (Netherlands)

Author keywords

clinical trial; glucagon; glycaemic control; insulin therapy; type 1 diabetes

Indexed keywords

GLUCAGON; GLUCOSE; INSULIN; ANTIDIABETIC AGENT; GLUCOSE BLOOD LEVEL; INSULIN DERIVATIVE;

ADULT; ALGORITHM; ARTICLE; ARTIFICIAL PANCREAS; BLOOD GLUCOSE MONITORING; CLINICAL ARTICLE; CONTROLLED STUDY; CROSSOVER PROCEDURE; DEVICE SAFETY; FEMALE; GLUCOSE BLOOD LEVEL; GLUCOSE SENSOR; GLYCEMIC CONTROL; HOME CARE; HUMAN; HYPOGLYCEMIA; INSULIN DEPENDENT DIABETES MELLITUS; INSULIN PUMP; MALE; NAUSEA; OUTCOME ASSESSMENT; PILOT STUDY; RANDOMIZED CONTROLLED TRIAL; ADOLESCENT; AGED; BLOOD; CHEMICALLY INDUCED; DIABETES MELLITUS, TYPE 1; HYPERGLYCEMIA; INSULIN INFUSION; METABOLISM; MIDDLE AGED; TREATMENT OUTCOME; YOUNG ADULT;

ADOLESCENT; ADULT; AGED; BLOOD GLUCOSE; CROSS-OVER STUDIES; DIABETES MELLITUS, TYPE 1; FEMALE; GLUCAGON; HOME CARE SERVICES; HUMANS; HYPERGLYCEMIA; HYPOGLYCEMIC AGENTS; INSULIN INFUSION SYSTEMS; INSULINS; MALE; MIDDLE AGED; PANCREAS, ARTIFICIAL; PILOT PROJECTS; TREATMENT OUTCOME; YOUNG ADULT;

EID: 84964319821     PISSN: 14628902     EISSN: 14631326     Source Type: Journal    
DOI: 10.1111/dom.12663     Document Type: Article

References (18)

1. 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.
2. Kropff J, Del Favero S, Place J et al. 2 month evening and night closed-loop glucose control in patients with type 1 diabetes under free-living conditions: a randomised crossover trial. Lancet Diabetes Endocrinol 2015; 3: 939–947.
3. 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.
4. 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: 17–26.
5. Jacobs PG, El Youssef J, Castle J et al. Automated control of an adaptive bihormonal, dual-sensor artificial pancreas and evaluation during inpatient studies. IEEE Trans Biomed Eng 2014; 61: 2569–2581.
6. 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.
7. 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.
8. van Bon AC, Luijf YM, Koebrugge R, Koops R, Hoekstra JB, Devries JH. Feasibility of a portable bihormonal closed-loop system to control glucose excursions at home under free-living conditions for 48 hours. Diabetes Technol Ther 2014; 16: 131–136.
9. Gingras V, Rabasa-Lhoret R, Messier V, Ladouceur M, Legault L, Haidar A. Efficacy of dual-hormone artificial pancreas to alleviate the carbohydrate-counting burden of type 1 diabetes: a randomized crossover trial. Diabetes Metab 2016; 42: 47–54.
10. Thabit H, Lubina-Solomon A, Stadler M et al. Home use of closed-loop insulin delivery for overnight glucose control in adults with type 1 diabetes: a 4-week, multicentre, randomised crossover study. Lancet Diabetes Endocrinol 2014; 2: 701–709.
11. 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.
12. Gold AE, MacLeod KM, Frier BM. Frequency of severe hypoglycemia in patients with type I diabetes with impaired awareness of hypoglycemia. Diabetes Care 1994; 17: 697–703.
13. Clarke WL, Cox DJ, Gonder-Frederick LA, Julian D, Schlundt D, Polonsky W. Reduced awareness of hypoglycemia in adults with IDDM. A prospective study of hypoglycemic frequency and associated symptoms. Diabetes Care 1995; 18: 517–522.
14. Blauw H, Wendl I, DeVries JH, Heise T, Jax T, consortium P. Pharmacokinetics and pharmacodynamics of various glucagon dosages at different blood glucose levels. Diabetes Obes Metab 2016; 18: 34–39.
15. Clarke W, Kovatchev B. Statistical tools to analyze continuous glucose monitor data. Diabetes Technol Ther 2009; 11: S45–S54.
16. Carroll MF, Schade DS. The dawn phenomenon revisited: implications for diabetes therapy. Endocr Pract 2005; 11: 55–64.
17. Jackson MA, Caputo N, Castle JR, David LL, Roberts CT Jr, Ward WK. Stable liquid glucagon formulations for rescue treatment and bi-hormonal closed-loop pancreas. Curr Diab Rep 2012; 12: 705–710.
18. Heinemann L, DeVries JH. Reimbursement for continuous glucose monitoring. Diabetes Technol Ther 2016; 18: S248–S252.