Outcome measures for artificial pancreas clinical trials: A consensus report

Diabetes Care

Volumn 39, Issue 7, 2016, Pages 1175-1179

  Maahs, David M ^a   Buckingham, Bruce A ^b   Castle, Jessica R ^c   Cinar, Ali ^d   Damiano, Edward R ^e   Dassau, Eyal ^f,g   Hans De Vries, J ^h   Doyle, Francis J ^f,g   Griffen, Steven C ⁱ   Haidar, Ahmad ^j   Heinemann, Lutz ^k   Hovorka, Roman ^l   Jones, Timothy W ^m   Kollman, Craig ⁿ   Kovatchev, Boris ^o   Levy, Brian L ^p   Nimri, Revital ^q   O'Neal, David N ^r   Philip, Moshe ^q   Renard, Eric ^s   Russell, Steven J ^e,t   Weinzimer, Stuart A ^u   Zisser, Howard ^f   Lum, John W ⁿ   more..

^a UNIVERSITY OF COLORADO SCHOOL OF MEDICINE   (United States)

^b STANFORD UNIVERSITY   (United States)

^c OREGON HEALTH AND SCIENCE UNIVERSITY   (United States)

^d Illinois Institute of Technology   (United States)

^e Boston University   (United States)

^f University of California   (United States)

^g HARVARD UNIVERSITY   (United States)

^h UNIVERSITY OF AMSTERDAM   (Netherlands)

ⁱ JDRF   (United States)

^j MCGILL UNIVERSITY   (Canada)

^k Profil Institute for Metabolic Research   (Germany)

^l WELLCOME TRUST SANGER INSTITUTE   (United Kingdom)

^m UNIVERSITY OF WESTERN AUSTRALIA   (Australia)

ⁿ JAEB CENTER FOR HEALTH RESEARCH   (United States)

^o UNIVERSITY OF VIRGINIA   (United States)

^p Johnson and Johnson   (United States)

^q TEL AVIV UNIVERSITY   (Israel)

^r UNIVERSITY OF MELBOURNE   (Australia)

^s MONTPELLIER UNIVERSITY HOSPITAL   (France)

^t MASSACHUSETTS GENERAL HOSPITAL   (United States)

^u YALE UNIVERSITY SCHOOL OF MEDICINE   (United States)

more..

Author keywords

[No Author keywords available]

Indexed keywords

HEMOGLOBIN A1C; GLUCOSE BLOOD LEVEL; GLYCOSYLATED HEMOGLOBIN; HEMOGLOBIN A1C PROTEIN, HUMAN;

ANXIETY; ARTIFICIAL PANCREAS; BLOOD GLUCOSE MONITORING; CLINICAL TRIAL (TOPIC); CONFERENCE PAPER; DEPRESSION; DISEASE SEVERITY; EXERCISE; GLYCEMIC CONTROL; HEALTH CARE COST; HUMAN; INCIDENCE; INSULIN DEPENDENT DIABETES MELLITUS; MOTIVATION; PATIENT PREFERENCE; QUALITY OF LIFE; STRESS; TREATMENT OUTCOME; BLOOD; CONSENSUS; DIABETES MELLITUS, TYPE 1; GLUCOSE BLOOD LEVEL; METABOLISM; OUTCOME ASSESSMENT; PROCEDURES;

BLOOD GLUCOSE; CLINICAL TRIALS AS TOPIC; CONSENSUS; DIABETES MELLITUS, TYPE 1; HEMOGLOBIN A, GLYCOSYLATED; HUMANS; OUTCOME ASSESSMENT (HEALTH CARE); PANCREAS, ARTIFICIAL;

EID: 84975852962     PISSN: 01495992     EISSN: 19355548     Source Type: Journal    
DOI: 10.2337/dc15-2716     Document Type: Conference Paper

References (41)

1. The Diabetes Control and Complications Trial Research Group. The effect of intensive treatment of diabeteson the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med 1993;329:977-986
2. Bergenstal RM, Tamborlane WV, Ahmann A, et al.; STAR 3 Study Group. Effectiveness of sensor-augmented insulin-pump therapy in type 1 diabetes. N Engl J Med 2010;363:311-320
3. Hermanides J, Nørgaard K, Bruttomesso D, et al. Sensor-augmented pump therapy lowers HbA(1c) in suboptimally controlled Type 1 diabetes; a randomized controlled trial. Diabet Med 2011;28:1158-1167
4. Misso ML, Egberts KJ, Page M, O'Connor D, Shaw J. Continuous subcutaneous insulin infusion (CSII) versus multiple insulin injections for type 1 diabetes mellitus. Cochrane Database Syst Rev 2010;1:CD005103
5. Monami M, Lamanna C, Marchionni N, Mannucci E. Continuous subcutaneous insulin infusion versus multiple daily insulin injections in type 1 diabetes: a meta-analysis. Acta Diabe-tol 2010;47(Suppl. 1):77-81
6. O'Connell SM, Cooper MN, Bulsara MK, Davis EA, Jones TW. Reducing rates of severe hypogly-cemia in a population-based cohort of children and adolescents with type 1 diabetes over the decade 2000-2009. Diabetes Care 2011;34: 2379-2380
7. Miller KM, Foster NC, Beck RW, et al.; T1D Exchange Clinic Network. Current state of type 1 diabetes treatment in the U.S.: updated data from the T1D Exchange clinic registry. Diabetes Care 2015;38:971-978
8. Kowalski A. Pathway to artificial pancreas systems revisited: moving downstream. Diabetes Care 2015;38:1036-1043
9. U.S. Food and Drug Administration Center for Devices and Radiological Health. Guidance for Industry and Food and Drug Administration Staff: The Content of Investigational Device Exemption (IDE) and Premarket Approval (PMA) Applications for Artificial Pancreas Device Systems. Rockville, MD, U.S. Department of Health and Human Services, 2012
10. Bailey TS, Chang A, Christiansen M. Clinical accuracy of a continuous glucose monitoring system with an advanced algorithm. J Diabetes Sci Technol 2015;9:209-214
11. Damiano ER, McKeon K, El-Khatib FH, Zheng H, Nathan DM, Russell SJ. A comparative effectiveness analysis of three continuous glucose monitors: the Navigator, G4 Platinum, and Enlite. J Diabetes Sci Technol 2014;8: 699-708
12. Kropff J, Bruttomesso D, Doll W, et al. Accuracy of two continuous glucose monitoring systems: a head-to-head comparison under clinical research centre and daily life conditions. Diabetes Obes Metab 2015;17:343-349
13. Peyser TA, Nakamura K, Price D, Bohnett LC, Hirsch IB, Balo A. Hypoglycemic accuracy and improved low glucose alerts of the latest Dexcom G4 Platinum continuous glucose monitoring system. Diabetes Technol Ther 2015;17:548-554
14. Sharifi A, Varsavsky A, Ulloa J, et al. Redundancy in glucose sensing: enhanced accuracy and reliability of an electrochemical redundant sensor for continuous glucose monitoring. J Diabetes Sci Technol. 22 October 2015 [Epub ahead of print]
15. Thabit H, Leelarathna L, Wilinska ME, et al. Accuracy of continuous glucose monitoring during three closed-loop home studies under free-living conditions. Diabetes Technol Ther 2015; 17:801-807
16. Wentholt IM, Vollebregt MA, Hart AA, Hoekstra JB, DeVries JH. Comparison of a needle-type and a microdialysis continuous glucose monitor in type 1 diabetic patients. Diabetes Care 2005;28:2871-2876
17. Chiang JL, Kirkman MS, Laffel LM, Peters AL; Type 1 Diabetes Sourcebook Authors. Type 1 diabetes through the life span: a position statement of the American Diabetes Association. Diabetes Care 2014;37:2034-2054
18. Bergenstal RM, Ahmann AJ, Bailey T, et al. Recommendations for standardizing glucose reporting and analysis to optimizeclinical decision makingin diabetes: the ambulatoryglucosepro-file. J Diabetes Sci Technol 2013;7:562-578
19. Joubert M, Baillot-Rudoni S, Catargi B, et al.; Société Francophone du Diabète (SFD); Société Française d'Endocrinologie (SFE); EVAluation dans le Diabète des Implants ACtifs Group (EVADIAC). Indication, organization, practical implementation and interpretation guidelines for retrospective CGM recording: a French position statement. Diabetes Metab 2015;41:498-508
20. Matthaei S, Dealaiz Antuna R, Bosi E, Evans M, Geelhoed-Duijvestijn N, Joubert M. Consensus recommendations for the use of ambulatory glucose profile in clinical practice. Br J Diabetes Vasc Dis 2014;14:153-157
21. Wright E Jr, Manivannan S. Hot topics in primary care: ambulatory glucose profiling. J Fam Pract 2015;64(Suppl.):S44-S47
22. Doyle FJ 3rd, Huyett LM, Lee JB, Zisser HC, Dassau E. Closed-loop artificial pancreas systems: engineering the algorithms. Diabetes Care 2014;37:1191-1197
23. Clarke W, Kovatchev B. Statistical tools to analyze continuous glucose monitor data. Diabetes Technol Ther 2009;11(Suppl. 1):S45-S54
24. Brod M, Christensen T, Bushnell DM. The impact of non-severe hypoglycemic events on daytime function and diabetes management among adults with type 1 and type 2 diabetes. J Med Econ 2012;15:869-877
25. Brod M, Christensen T, Thomsen TL, Bushnell DM. The impact of non-severe hypo-glycemic events on work productivity and diabetes management. Value Health 2011;14: 665-671
26. Brod M, Pohlman B, Wolden M, Christensen T. Non-severe nocturnal hypoglycemic events: experience and impacts on patient functioning and well-being. Qual Life Res 2013;22:997-1004
27. Jensen MM, Pedersen-Bjergaard U. Self-reported frequency and impact of non-severe hypoglycemic events in insulin-treated diabetic patients in Denmark. Diabetes Management 2015;5:67-78
28. Amiel SA, Sherwin RS, Simonson DC, Tamborlane WV. Effect of intensive insulin therapy on glycemic thresholds for counterregula-tory hormone release. Diabetes 1988;37: 901-907
29. Cryer PE. Mechanisms of hypoglycemia-associated autonomic failure and its component syndromes in diabetes. Diabetes 2005;54:3592-3601
30. Kropff J, Del Favero S, Place J, et al.; AP@home Consortium. 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
31. Ly TT, Maahs DM, Rewers A, Dunger D, Oduwole A, Jones TW; International Society for Pediatric and Adolescent Diabetes. ISPAD clinical practice consensus guidelines 2014. Assessment and management of hypoglyce-mia in children and adolescents with diabetes. Pediatr Diabetes 2014;15(Suppl. 20): 180-192
32. Seaquist ER, Anderson J, Childs B, et al. Hypoglycemia and diabetes: a report of a workgroup of the American Diabetes Association and the Endocrine Society. Diabetes Care 2013;36: 1384-1395
33. Clarke WL, Renard E. Clinical requirements for closed-loop control systems. J Diabetes Sci Technol 2012;6:444-452
34. Del Favero S, Facchinetti A, Sparacino G, Cobelli C; AP@home Consortium. Retrofitting of continuous glucose monitoring traces allows more accurate assessment of glucose control in outpatientstudies. Diabetes Technol Ther 2015; 17:355-363
35. Hovorka R, Nodale M, Haidar A, Wilinska ME. Assessing performance of closed-loop insulin delivery systems by continuous glucose monitoring: drawbacks and way forward. Diabetes Technol Ther 2013;15:4-12
36. Kollman C, Calhoun P, Lum J, Sauer W, Beck RW. Evaluation of stochastic adjustment for glucose sensor bias during closed-loop insulin delivery. Diabetes Technol Ther 2014;16:186-192
37. Beck RW, Calhoun P, Kollman C. Challenges for outpatient closed loop studies: how to assess efficacy. Diabetes Technol Ther 2013;15: 1-3
38. Kovatchev BP, Patek SD, Ortiz EA, Breton MD. Assessing sensor accuracy for non-adjunct use of continuous glucose monitoring. Diabetes Technol Ther 2015;17:177-186
39. Barnard KD, Hood KK, Weissberg-Benchell J, Aldred C, Oliver N, Laffel L. Psychosocial assessment of artificial pancreas (AP): commentary and review of existing measures and their applicability in AP research. Diabetes Technol Ther 2015;17:295-300
40. U.S. Food and Drug Administration Center for Devices and Radiological Health. Patient Preference Information-Submission, Review in PMAs, HDE Applications, and De Novo Requests, and Inclusion in Device Labeling. Rockville, MD, U.S. Department of Health and Human Services, 2015
41. American Diabetes Association. Introduction. In Standards of Medical Care in Diabetes. Diabetes Care 2011;34(Suppl. 1):S1-S2