So sánh Sử dụng MDI Tối ưu với Bơm có hoặc không có Cảm biến trong trường hợp Hạ Đường Huyết Nghiêm Trọng (thử nghiệm Hypo COMPaSS)

BMC Endocrine Disorders - 2012
Sally A. Little1, Thomas Chadwick2, Pratik Choudhary3, Cath Brennand2, Julia Stickland2, S. Barendse4, Tolulope Olateju5, Lalantha Leelarathna6, Emma Walkinshaw7, Horng Kai Tan8, Sally M. Marshall1, Raymond L. Thomas1, Simon Heller7, Mark L. Evans6, David Kerr5, Daniel Flanagan8, Jane Speight9, James Shaw1
1Institute of Cellular Medicine, The Medical School, Newcastle University, 4th Floor William Leech Building, Framlington Place, Newcastle upon Tyne, NE2 4HH, UK
2Institute of Health and Society, Newcastle University, Newcastle, UK
3Diabetes and Nutritional Sciences Division, Kings College London, London, UK
4AHP Research, Hornchurch, UK
5Bournemouth Diabetes Centre, Bournemouth, UK
6Institute of Metabolic Science, University of Cambridge, Cambridge, UK
7School of Medicine and Biomedical Sciences, Sheffield University, Sheffield, UK
8Peninsula College of Medicine and Dentistry, Plymouth, UK
9The Australian Centre for Behavioural Research in Diabetes, Diabetes Australia – Vic, Melbourne, Australia

Tóm tắt

Tóm tắt Nền tảng Hạ đường huyết nghiêm trọng (SH) là một trong những biến chứng được lo ngại nhất của bệnh tiểu đường tuýp 1 (T1DM) với tỷ lệ báo cáo gần 40%. Trong các thử nghiệm ngẫu nhiên về liệu pháp Tiêm nhiều lần mỗi ngày (MDI) và Bơm Insulin liên tục dưới da (CSII), có thể có lợi ích từ CSII trong việc giảm SH. Tuy nhiên, rất ít thử nghiệm đã sử dụng insulin analog cơ bản làm insulin nền trong nhóm MDI và những cá nhân có tình trạng SH đã được thiết lập thường bị loại trừ khỏi các nghiên cứu theo triển vọng. Trong các nghiên cứu đã công bố điều tra tác động của Giám sát Đường Glucose Liên tục Thực Thời (RT-CGM), lợi ích liên quan đến việc giảm SH vẫn chưa được chứng minh. Mục tiêu chính của nghiên cứu này là làm rõ xem liệu ở những người mắc T1DM bị phức tạp bởi việc nhận thức kém về hạ đường huyết (IAH), việc thực hiện các biện pháp dự phòng hạ đường huyết sinh hóa một cách nghiêm ngặt bằng cách sử dụng công nghệ tự quản lý đang có và hỗ trợ giáo dục có thể phục hồi nhận thức và giảm rủi ro tái phát SH hay không. Phương pháp/thiết kế Đây là một thử nghiệm ngẫu nhiên có đối chứng nhiều trung tâm so sánh việc tránh hạ đường huyết với MDI tối ưu và CSII có hoặc không có RT-CGM theo thiết kế nghiên cứu 2×2 ở những người mắc tiểu đường tuýp 1 có IAH. Biện pháp kết quả chính cho nghiên cứu này là sự khác biệt về IAH (Điểm Gold) sau 24 tuần. Các biện pháp kết quả thứ yếu bao gồm các chỉ số sinh học như HbA1c, tỷ lệ mắc SH, phân tích CGM mù, theo dõi glucose trong máu (SMBG) và phản ứng với hạ đường huyết trong các nghiên cứu chốt vàng chuẩn. Các chỉ số tâm lý xã hội bao gồm cảm giác hạnh phúc và chất lượng cuộc sống cũng sẽ được đánh giá bằng một loạt các biện pháp đã được xác thực và mới. Phân tích sẽ được thực hiện theo nguyên tắc dự định điều trị.

Từ khóa

#Hạ Đường Huyết Nghiêm Trọng #bệnh tiểu đường tuýp 1 #Giám sát Đường Glucose Liên tục Thực Thời #Tiêm Nhiều Lần Mỗi Ngày #Bơm Insulin

Tài liệu tham khảo

Forouhi NG, Merrick D, Goyder E, Ferguson BA, Abbas J, Lachowycz K: Diabetes prevalence in England, 2001-estimates from an epidemiological model. Diabet Med. 2006, 23 (2): 189-197. 10.1111/j.1464-5491.2005.01787.x. PubMed PMID: 16433718. Epub 2006/01/26. eng

The Diabetes Control and Complications Trial Research Group: The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. The Diabetes Control and Complications Trial Research Group. N Engl J Med. 1993, 329 (14): 977-986. PubMed PMID: 8366922. Epub 1993/09/30. eng

The Writing Team for the Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications Research Group: Sustained effect of intensive treatment of type 1 diabetes mellitus on development and progression of diabetic nephropathy: the Epidemiology of Diabetes Interventions and Complications (EDIC) study. JAMA. 2003, 290 (16): 2159-2167. PubMed PMID: 14570951. Pubmed Central PMCID: 2622725. Epub 2003/10/23. eng

Cryer PE: Hypoglycaemia: the limiting factor in the glycaemic management of Type I and Type II diabetes. Diabetologia. 2002, 45 (7): 937-948. 10.1007/s00125-002-0822-9. PubMed PMID: 12136392. Epub 2002/07/24. eng

Pedersen-Bjergaard U, Pramming S, Heller SR, Wallace TM, Rasmussen AK, Jorgensen HV: Severe hypoglycaemia in 1076 adult patients with type 1 diabetes: influence of risk markers and selection. Diabetes Metab Res Rev. 2004, 20 (6): 479-486. 10.1002/dmrr.482. PubMed PMID: 15386817. Epub 2004/09/24. eng

Tattersall RB, Gill GV: Unexplained Deaths of Type-1 Diabetic-Patients. Diabet Med. 1991, 8 (1): 49-58. 10.1111/j.1464-5491.1991.tb01516.x. PubMed PMID: ISI:A1991ET26600010. English

Cryer PE, Davis SN, Shamoon H: Hypoglycemia in diabetes. Diabetes Care. 2003, 26 (6): 1902-1912. 10.2337/diacare.26.6.1902. PubMed PMID: 12766131. Epub 2003/05/27. eng

DCCT: Epidemiology of severe hypoglycemia in the diabetes control and complications trial. The DCCT Research Group. Am J Med. 1991, 90 (4): 450-459. PubMed PMID: 2012085. Epub 1991/04/01. eng

Geddes J, Wright RJ, Zammitt NN, Deary IJ, Frier BM: Diabetes Care. 2007, 30 (7): 1868-1870. 10.2337/dc06-2556. PubMed PMID: 17416785. Epub 2007/04/10. eng

Geddes J, Schopman JE, Zammitt NN, Frier BM: Prevalence of impaired awareness of hypoglycaemia in adults with Type 1 diabetes. Diabet Med. 2008, 25 (4): 501-504. 10.1111/j.1464-5491.2008.02413.x.

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 (7): 697-703. 10.2337/diacare.17.7.697. PubMed PMID: 7924780. Epub 1994/07/01. eng

Veneman T, Mitrakou A, Mokan M, Cryer P, Gerich J: Induction of hypoglycemia unawareness by asymptomatic nocturnal hypoglycemia. Diabetes. 1993, 42 (9): 1233-1237. 10.2337/diabetes.42.9.1233. PubMed PMID: 8349033. Epub 1993/09/01. eng

Mitrakou A, Fanelli C, Veneman T, Perriello G, Calderone S, Platanisiotis D: Reversibility of unawareness of hypoglycemia in patients with insulinomas. N Engl J Med. 1993, 329 (12): 834-839. 10.1056/NEJM199309163291203. PubMed PMID: 8355741. Epub 1993/09/16. eng

Fanelli CG, Epifano L, Rambotti AM, Pampanelli S, Di Vincenzo A, Modarelli F: Meticulous prevention of hypoglycemia normalizes the glycemic thresholds and magnitude of most of neuroendocrine responses to, symptoms of, and cognitive function during hypoglycemia in intensively treated patients with short-term IDDM. Diabetes. 1993, 42 (11): 1683-1689. 10.2337/diabetes.42.11.1683. PubMed PMID: 8405713. Epub 1993/11/01. eng

Cranston I, Lomas J, Maran A, Macdonald I, Amiel SA: Restoration of hypoglycaemia awareness in patients with long-duration insulin-dependent diabetes. Lancet. 1994, 344 (8918): 283-287. 10.1016/S0140-6736(94)91336-6. PubMed PMID: 7914259. Epub 1994/07/30. eng

Gale EA: A randomized, controlled trial comparing insulin lispro with human soluble insulin in patients with Type 1 diabetes on intensified insulin therapy. The UK Trial Group. Diabet Med. 2000, 17 (3): 209-214. 10.1046/j.1464-5491.2000.00258.x. PubMed PMID: 10784225. Epub 2000/04/28. eng

Heller SR, Amiel SA, Mansell P: Effect of the fast-acting insulin analog lispro on the risk of nocturnal hypoglycemia during intensified insulin therapy. U.K. Lispro Study Group. Diabetes Care. 1999, 22 (10): 1607-1611. 10.2337/diacare.22.10.1607. PubMed PMID: 10526722. Epub 1999/10/20. eng

Holleman F, Schmitt H, Rottiers R, Rees A, Symanowski S, Anderson JH: Reduced frequency of severe hypoglycemia and coma in well-controlled IDDM patients treated with insulin lispro. The Benelux-UK Insulin Lispro Study Group. Diabetes Care. 1997, 20 (12): 1827-1832. 10.2337/diacare.20.12.1827. PubMed PMID: 9405901. Epub 1997/12/24. eng

Ratner RE, Hirsch IB, Neifing JL, Garg SK, Mecca TE, Wilson CA: Less hypoglycemia with insulin glargine in intensive insulin therapy for type 1 diabetes. U.S. Study Group of Insulin Glargine in Type 1 Diabetes. Diabetes Care. 2000, 23 (5): 639-643. 10.2337/diacare.23.5.639. PubMed PMID: 10834423. Epub 2000/06/02. eng

Pieber TR, Eugene-Jolchine I, Derobert E: Efficacy and safety of HOE 901 versus NPH insulin in patients with type 1 diabetes. The European Study Group of HOE 901 in type 1 diabetes. Diabetes Care. 2000, 23 (2): 157-162. 10.2337/diacare.23.2.157. PubMed PMID: 10868824. Epub 2000/06/27. eng

Fulcher GR, Gilbert RE, Yue DK: Glargine is superior to neutral protamine Hagedorn for improving glycated haemoglobin and fasting blood glucose levels during intensive insulin therapy. Intern Med J. 2005, 35 (9): 536-542. 10.1111/j.1445-5994.2005.00902.x. PubMed PMID: 16105155. Epub 2005/08/18. eng

Porcellati F, Rossetti P, Pampanelli S, Fanelli CG, Torlone E, Scionti L: Better long-term glycaemic control with the basal insulin glargine as compared with NPH in patients with Type 1 diabetes mellitus given meal-time lispro insulin. Diabet Med. 2004, 21 (11): 1213-1220. 10.1111/j.1464-5491.2004.01323.x. PubMed PMID: 15498088. Epub 2004/10/23. eng

Rossetti P, Pampanelli S, Fanelli C, Porcellati F, Costa E, Torlone E: Intensive replacement of basal insulin in patients with type 1 diabetes given rapid-acting insulin analog at mealtime: a 3-month comparison between administration of NPH insulin four times daily and glargine insulin at dinner or bedtime. Diabetes Care. 2003, 26 (5): 1490-1496. 10.2337/diacare.26.5.1490. PubMed PMID: 12716810. Epub 2003/04/30. eng

De Leeuw I, Vague P, Selam JL, Skeie S, Lang H, Draeger E: Insulin detemir used in basal-bolus therapy in people with type 1 diabetes is associated with a lower risk of nocturnal hypoglycaemia and less weight gain over 12 months in comparison to NPH insulin. Diabetes Obes Metab. 2005, 7 (1): 73-82. 10.1111/j.1463-1326.2004.00363.x. PubMed PMID: 15642078. Epub 2005/01/12. eng

Bartley PC, Bogoev M, Larsen J, Philotheou A: Long-term efficacy and safety of insulin detemir compared to Neutral Protamine Hagedorn insulin in patients with Type 1 diabetes using a treat-to-target basal-bolus regimen with insulin aspart at meals: a 2-year, randomized, controlled trial. Diabet Med. 2008, 25 (4): 442-449. 10.1111/j.1464-5491.2007.02407.x. PubMed PMID: 18387078. Pubmed Central PMCID: 2327220. Epub 2008/04/05. eng

Kolendorf K, Ross GP, Pavlic-Renar I, Perriello G, Philotheou A, Jendle J: Insulin detemir lowers the risk of hypoglycaemia and provides more consistent plasma glucose levels compared with NPH insulin in Type 1 diabetes. Diabet Med. 2006, 23 (7): 729-735. 10.1111/j.1464-5491.2006.01862.x. PubMed PMID: 16842476. Epub 2006/07/18. eng

Vague P, Selam JL, Skeie S, De Leeuw I, Elte JW, Haahr H: Insulin detemir is associated with more predictable glycemic control and reduced risk of hypoglycemia than NPH insulin in patients with type 1 diabetes on a basal-bolus regimen with premeal insulin aspart. Diabetes Care. 2003, 26 (3): 590-596. 10.2337/diacare.26.3.590. PubMed PMID: 12610006. Epub 2003/03/01

National Institute for Clinical Excellence: Technology Appraisal No. 53. Guidance on the use of long-acting insulin analogues for the treatment of diabetes – insulin glargine. 2002, NICE,http://www.nice.org.uk/nicemedia/live/11482/32518/32518.pdf,

Boland EA, Grey M, Oesterle A, Fredrickson L, Tamborlane WV: Continuous subcutaneous insulin infusion. A new way to lower risk of severe hypoglycemia, improve metabolic control, and enhance coping in adolescents with type 1 diabetes. Diabetes Care. 1999, 22 (11): 1779-1784. 10.2337/diacare.22.11.1779. PubMed PMID: 10546007. Epub 1999/11/05. eng

Doyle EA, Weinzimer SA, Steffen AT, Ahern JA, Vincent M, Tamborlane WV: A randomized, prospective trial comparing the efficacy of continuous subcutaneous insulin infusion with multiple daily injections using insulin glargine. Diabetes Care. 2004, 27 (7): 1554-1558. 10.2337/diacare.27.7.1554. PubMed PMID: 15220227. Epub 2004/06/29. eng

Hirsch IB, Bode BW, Garg S, Lane WS, Sussman A, Hu P: Continuous subcutaneous insulin infusion (CSII) of insulin aspart versus multiple daily injection of insulin aspart/insulin glargine in type 1 diabetic patients previously treated with CSII. Diabetes Care. 2005, 28 (3): 533-538. 10.2337/diacare.28.3.533. PubMed PMID: 15735183. Epub 2005/03/01. eng

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 of Systematic Reviews. 2010, CD005103-10.1002/14651858.CD005103.pub2. Issue 1

Bode BW, Steed RD, Davidson PC: Reduction in severe hypoglycemia with long-term continuous subcutaneous insulin infusion in type I diabetes. Diabetes Care. 1996, 19 (4): 324-327. 10.2337/diacare.19.4.324. PubMed PMID: 8729154. Epub 1996/04/01. eng

National Institute for Health and Clinical Excellence NICE technology appraisal guidance 151: Continuous subcutaneous insulin infusion for the treatment of diabetes mellitus (review of technology appraisal guidance 57). 2008, NICE,http://guidance.nice.org.uk/TA151/Guidance/pdf/English,

Deiss D, Bolinder J, Riveline JP, Battelino T, Bosi E, Tubiana-Rufi N: Improved glycemic control in poorly controlled patients with type 1 diabetes using real-time continuous glucose monitoring. Diabetes Care. 2006, 29 (12): 2730-2732. 10.2337/dc06-1134. PubMed PMID: 17130215. Epub 2006/11/30. eng

Tamborlane WV, Beck RW, Bode BW, Buckingham B, Chase HP, Clemons R: Continuous glucose monitoring and intensive treatment of type 1 diabetes. N Engl J Med. 2008, 359 (14): 1464-1476. PubMed PMID: 18779236. Epub 2008/09/10. eng

Bergenstal RM, Tamborlane WV, Ahmann A, Buse JB, Dailey G, Davis SN: Effectiveness of sensor-augmented insulin-pump therapy in type 1 diabetes. N Engl J Med. 2010, 363 (4): 311-320. 10.1056/NEJMoa1002853. PubMed PMID: 20587585. Epub 2010/07/01. eng

Hermanides J, Nørgaard K, Bruttomesso D, Mathieu C, Frid A, Dayan C: Sensor augmented pump therapy substantially lowers HbA1c; a randomized controlled trial. Diabetologia. 2009, 52 (Suppl 1): S43-Abstract

Battelino T, Phillip M, Bratina N, Nimri R, Oskarsson P, Bolinder J: Effect of continuous glucose monitoring on hypoglycemia in type 1 diabetes. Diabetes Care. 2011, 34 (4): 795-800. 10.2337/dc10-1989. PubMed PMID: 21335621. Pubmed Central PMCID: 3064030. Epub 2011/02/22. eng

Davis RE, Morrissey M, Peters JR, Wittrup-Jensen K, Kennedy-Martin T, Currie CJ: Impact of hypoglycaemia on quality of life and productivity in type 1 and type 2 diabetes. Curr Med Res Opin. 2005, 21 (9): 1477-1483. 10.1185/030079905X61929. PubMed PMID: 16197667. Epub 2005/10/04. eng

Thomas RM, Aldibbiat A, Griffin W, Cox MA, Leech NJ, Shaw JA: A randomized pilot study in Type 1 diabetes complicated by severe hypoglycaemia, comparing rigorous hypoglycaemia avoidance with insulin analogue therapy, CSII or education alone. Diabet Med. 2007, 24 (7): 778-783. 10.1111/j.1464-5491.2007.02196.x. PubMed PMID: 17535290. Epub 2007/05/31. eng

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 (4): 517-522. 10.2337/diacare.18.4.517. PubMed PMID: 7497862. Epub 1995/04/01. eng

Moher D, Schulz KF, Altman DG: The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomised trials. Lancet. 2001, 357 (9263): 1191-1194. 10.1016/S0140-6736(00)04337-3. PubMed PMID: 11323066. Epub 2001/04/27. eng

Diagnosis and classification of diabetes mellitus. Diabetes Care. 2011, 34 (Suppl 1): S62-S69. PubMed PMID: 21193628. Pubmed Central PMCID: 3006051. Epub 2011/01/14. eng

World Health Organisation: Definition and diagnosis of diabetes mellitus and intermediate hyperglycemia: report of a WHO/IDF consultation. 2006, WHO,http://whqlibdoc.who.int/publications/2006/9241594934_eng.pdf,

Tesfaye S, Boulton AJ, Dyck PJ, Freeman R, Horowitz M, Kempler P: Diabetic neuropathies: update on definitions, diagnostic criteria, estimation of severity, and treatments. Diabetes Care. 2010, 33 (10): 2285-2293. 10.2337/dc10-1303. PubMed PMID: 20876709. Pubmed Central PMCID: 2945176

Suarez GA, Opfer-Gehrking TL, Offord KP, Atkinson EJ, O’Brien PC, Low PA: The Autonomic Symptom Profile: a new instrument to assess autonomic symptoms. Neurology. 1999, 52 (3): 523-528. 10.1212/WNL.52.3.523. PubMed PMID: 10025781. Epub 1999/02/20. eng

Cox D, Ritterband L, Magee J, Clarke W, Gonder-Frederick L: Blood glucose awareness training delivered over the internet. Diabetes Care. 2008, 31 (8): 1527-1528. 10.2337/dc07-1956. PubMed PMID: 18477813. Pubmed Central PMCID: 2494647. Epub 2008/05/15. eng

Roden M: Clinical Diabetes Research: Methods and Techniques; Chapter 4 Glucose Clamp Techniques and Chapter 5 Methods of Assessment of Counterregulation to Hypoglycaemia. 2007, Wiley-Blackwell, 20 July 2007, 1

Cranston I, Lomas J, Maran A, Macdonald I, Amiel SA: Restoration of hypoglycaemia awareness in patients with long-duration insulin-dependent diabetes. Lancet. 1994, 344 (8918): 283-287. 10.1016/S0140-6736(94)91336-6. PubMed PMID: 7914259. eng

Maran A, Lomas J, Macdonald IA, Amiel SA: Lack of preservation of higher brain function during hypoglycaemia in patients with intensively-treated IDDM. Diabetologia. 1995, 38 (12): 1412-1418. 10.1007/BF00400601. PubMed PMID: 8786014. eng

Heller SR, Macdonald IA: The measurement of cognitive function during acute hypoglycaemia experimental limitations and their effect on the study of hypoglycaemia unawareness. Diabet Med. 1996, 13 (7): 607-615. 10.1002/(SICI)1096-9136(199607)13:7<607::AID-DIA159>3.0.CO;2-I. PubMed PMID: ISI:A1996UZ37800003. English

Lezak MD: Orientation and Attention. Neuropsychological Assessment. 1995, Oxford: Oxford University Press, Chapter 9, 3

Bench CJ, Frith CD, Grasby PM, Friston KJ, Paulesu E, Frackowiak RSJ: Investigations of the Functional-Anatomy of Attention Using the Stroop Test. Neuropsychologia. 1993, 31 (9): 907-922. 10.1016/0028-3932(93)90147-R. PubMed PMID: ISI:A1993LZ62000003. English

McAulay V, Deary IJ, Frier BM: Symptoms of hypoglycaemia in people with diabetes. Diabet Med. 2001, 18 (9): 690-705. 10.1046/j.1464-5491.2001.00620.x. PubMed PMID: 11606166. Epub 2001/10/19. eng

Deary IJ, Hepburn DA, MacLeod KM, Frier BM: Partitioning the symptoms of hypoglycaemia using multi-sample confirmatory factor analysis. Diabetologia. 1993, 36 (8): 771-777. 10.1007/BF00401150. PubMed PMID: 8405746. Epub 1993/08/01. eng

Bradley C, Lewis KS: Measures of psychological well-being and treatment satisfaction developed from the responses of people with tablet-treated diabetes. Diabet Med. 1990, 7 (5): 445-51. 10.1111/j.1464-5491.1990.tb01421.x. Epub 1990/06/01

Anderson RT, Skovlund SE, Marrero D, Levine DW, Meadows K, Brod M: Development and validation of the insulin treatment satisfaction questionnaire. Clin Ther. 2004, 26 (4): 565-10.1016/S0149-2918(04)90059-8. Epub 2004/06/11

The EuroQol Group: EuroQol-a new facility for the measurement of health-related quality of life. Health Policy. 1990, 16 (3): 199-208. Epub 1990/11/05

Bradley C, Brewin CR, Gamsu DS, Moses JL: Development of scales to measure perceived control of diabetes mellitus and diabetes-related health beliefs. Diabet Med. 1984, 1 (3): 213-8. 10.1111/j.1464-5491.1984.tb01955.x. Epub 1984/09/01

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