Randomized trial of a dual-hormone artificial pancreas with dosing adjustment during exercise compared with no adjustment and sensor-augmented pump therapy

Diabetes, Obesity and Metabolism

Volumn 18, Issue 11, 2016, Pages 1110-1119

  Jacobs, P G ^a   El Youssef, J ^b   Reddy, R ^a   Resalat, N ^a   Branigan, D ^b   Condon, J ^a   Preiser, N ^a   Ramsey, K ^b   Jones, M ^b   Edwards, C ^b   Kuehl, K ^b   Leitschuh, J ^a   Rajhbeharrysingh, U ^a   Castle, J R ^b  

^a Oregon Health and Science University Department of Biomedical Engineering   (United States)

^b OREGON HEALTH AND SCIENCE UNIVERSITY   (United States)

Author keywords

artificial pancreas; continuous glucose monitoring (CGM); exercise; glucagon; hypoglycaemia; insulin delivery; type 1 diabetes

Indexed keywords

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

ADULT; ANALYTICAL PARAMETERS; ARTICLE; ARTIFICIAL PANCREAS; BLOOD GLUCOSE MONITORING; CARBOHYDRATE INTAKE; CHILL; CLINICAL ARTICLE; COMPARATIVE STUDY; CONTINUOUS GLUCOSE MONITORING; CONTROLLED STUDY; CROSSOVER PROCEDURE; DIZZINESS; DOSING ADJUSTMENT; DRUG DOSE REGIMEN; DUAL HORMONE ARTIFICIAL PANCREAS; EXERCISE; EXERCISE RELATED HYPOGLYCAEMIA; FEMALE; GLUCAGON SENSITIVITY; GLUCOSE SENSOR; GLYCEMIC CONTROL; HEART RATE; HUMAN; HYPOGLYCEMIA; INJECTION SITE EDEMA; INSULIN DEPENDENT DIABETES MELLITUS; INSULIN INFUSION RATE; INSULIN PUMP; INSULIN SENSITIVITY; MALE; MEDICAL PROCEDURES; NAUSEA; OUTCOME ASSESSMENT; PERCENTAGE OF TIME SPENT IN EUGLYCAEMIA; PERCENTAGE OF TIME SPENT IN HYPOGLYCAEMIA; PHYSICAL SENSITIVITY; RANDOMIZED CONTROLLED TRIAL; SENSOR AUGMENTED PUMP THERAPY; SOFTWARE; TREATMENT DURATION; TREATMENT OUTCOME; TREND STUDY; ADOLESCENT; ADVERSE DEVICE EFFECT; BLOOD; CHEMICALLY INDUCED; DEVICES; DIABETES MELLITUS, TYPE 1; DOSE RESPONSE; DRUG EFFECTS; GENETIC PROCEDURES; GLUCOSE BLOOD LEVEL; INSULIN INFUSION; METABOLISM; MIDDLE AGED; PHYSIOLOGY; PROCEDURES; YOUNG ADULT;

ADOLESCENT; ADULT; BIOSENSING TECHNIQUES; BLOOD GLUCOSE; CROSS-OVER STUDIES; DIABETES MELLITUS, TYPE 1; DOSE-RESPONSE RELATIONSHIP, DRUG; EXERCISE; FEMALE; GLUCAGON; HUMANS; HYPOGLYCEMIA; HYPOGLYCEMIC AGENTS; INSULIN; INSULIN INFUSION SYSTEMS; MALE; MIDDLE AGED; PANCREAS, ARTIFICIAL; YOUNG ADULT;

EID: 84981504995     PISSN: 14628902     EISSN: 14631326     Source Type: Journal    
DOI: 10.1111/dom.12707     Document Type: Article

References (24)

1. Centers for Disease Control and Prevention. National Diabetes Fact Sheet: National Estimates and General Information on Diabetes and Prediabetes in the United States Atlanta, GA: U.S. Department of Health and Human Services Centers for Disease Control and Prevention; 2011.
2. 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.
3. 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.
4. 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;61:2569–2281.
5. Castle JR, Engle JM, El Youssef J, et al. Novel use of glucagon in a closed-loop system for prevention of hypoglycemia in type 1 diabetes. Diabetes Care. 2010;33:1282–1287.
6. Russell SJ, El-Khatib FH, Sinha M, et al. Outpatient glycemic control with a bionic pancreas in type 1 diabetes. New Engl J Med. 2014;371:313–325.
7. Tsintzas K, MacDonald IA. Type 1 Diabetes: Clinical Management of the Athlete London, Dordrecht, Heidelberg, New York: Springer; 2012.
8. Basu R, Johnson ML, Kudva YC, Basu A. Exercise, hypoglycemia, and type 1 diabetes. Diabetes Technol Ther. 2014;16:331–337.
9. Tansey MJ, Tsalikian E, Beck RW, et al. The effects of aerobic exercise on glucose and counterregulatory hormone concentrations in children with type 1 diabetes. Diabetes Care. 2006;29:20–25.
10. Diabetes Research in Children Network Study Group, Tsalikian E, Kollman C, et al. Prevention of hypoglycemia during exercise in children with type 1 diabetes by suspending basal insulin. Diabetes Care. 2006;29:2200–2204.
11. Schiavon M, Dalla Man C, Kudva YC, Basu A, Cobelli C. In silico optimization of basal insulin infusion rate during exercise: implication for artificial pancreas. J Diabetes Sci Technol. 2013;7:1461–1469.
12. 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;16:244–248.
13. Cryer PE. Mechanisms of hypoglycemia-associated autonomic failure in diabetes. New Engl J Med. 2013;369:362–372.
14. McMahon SK, Ferreira LD, Ratnam N, et al. Glucose requirements to maintain euglycemia after moderate-intensity afternoon exercise in adolescents with type 1 diabetes are increased in a biphasic manner. J Clin Endocrinol Metab. 2007;92:963–968.
15. Breton MD, Brown SA, Karvetski CH, et al. Adding heart rate signal to a control-to-range artificial pancreas system improves the protection against hypoglycemia during exercise in type 1 diabetes. Diabetes Technol Ther. 2014;16:506–511.
16. 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.
17. Sherr JL, Cengiz E, Palerm CC, et al. Reduced hypoglycemia and increased time in target using closed-loop insulin delivery during nights with or without antecedent afternoon exercise in type 1 diabetes. Diabetes Care. 2013;36:2909–2914.
18. Stenerson M, Cameron F, Payne SR, et al. The impact of accelerometer use in exercise-associated hypoglycemia prevention in type 1 diabetes. J Diabetes Sci Technol. 2015;9:80–85.
19. Turksoy K, Bayrak ES, Quinn L, Littlejohn E, Cinar A. Multivariable adaptive closed-loop control of an artificial pancreas without meal and activity announcement. Diabetes Technol Ther. 2013;15:386–400.
20. Pescatello LS. American College of Sports Medicine Guidelines for Exercise Testing and Prescription. 9th ed. Philadelphia, PA: Wolters Kluwer/Lippincott Williams & Wilkins Health; 2014.
21. Jacobs PG, Resalat N, El Youssef J, et al. Incorporating an exercise detection, grading, and hormone dosing algorithm into the artificial pancreas using accelerometry and heart rate. J Diabetes Sci Technol. 2015;9:1175–1184.
22. Davey RJ, Howe W, Paramalingam N, et al. The effect of midday moderate-intensity exercise on postexercise hypoglycemia risk in individuals with type 1 diabetes. J Clin Endocrinol Metab. 2013;98:2908–2914.
23. Turksoy K, Quinn LT, Littlejohn E, Cinar A. An integrated multivariable artificial pancreas control system. J Diabetes Sci Technol. 2014;8:498–507.
24. Yardley JE, Kenny GP, Perkins BA, et al. Resistance versus aerobic exercise: acute effects on glycemia in type 1 diabetes. Diabetes Care. 2013;36:537–542.