Consensus report of the coalition for clinical research-self-monitoring of blood glucose

Journal of Diabetes Science and Technology

Volumn 2, Issue 6, 2008, Pages 1030-1053

  Klonoff, David C ^a   Bergenstal, Richard ^b   Blonde, Lawrence ^c   Boren, Suzanne Austin ^d   Church, Timothy S ^e   Gaffaney, Jenifer ^f   Jovanovič, Lois ^f,g   Kendall, David M ^b   Kollman, Craig ^h   Kovatchev, Boris P ^i,j   Leippert, Claudia ^k   Owens, David R ^l,m   Polonsky, William H ⁿ   Reach, Gérard ^o   Renard, Eric ^p   Riddell, Michael C ^q   Rubin, Richard R ^r   Schnell, Oliver ^s   Siminiero, Linda M ^t   Vigersky, Robert A ^u   Wilson, Darrell M ^v   Wollitzer, Alison Okada ^f   more..

^a Mills Peninsula Health Services   (United States)

^b UNIVERSITY OF MINNESOTA   (United States)

^c OCHSNER CLINIC FOUNDATION   (United States)

^d UNIVERSITY OF MISSOURI   (United States)

^e PENNINGTON BIOMEDICAL RESEARCH CENTER   (United States)

^f SANSUM DIABETES RESEARCH INSTITUTE   (United States)

^g UNIVERSITY OF SOUTHERN CALIFORNIA   (United States)

^h JAEB CENTER FOR HEALTH RESEARCH   (United States)

ⁱ UNIVERSITY OF VIRGINIA   (United States)

^j UNIVERSITY OF VIRGINIA   (United States)

^k MTK Kliniken Bad Soden Ts   (Germany)

^l CARDIFF UNIVERSITY   (United Kingdom)

^m LLANDOUGH HOSPITAL   (United Kingdom)

ⁿ Behavioral Diabetes Institute   (United States)

^o AVICENNE HOSPITAL   (France)

^p LAPEYRONIE HOSPITAL   (France)

^q YORK UNIVERSITY   (Canada)

^r JOHNS HOPKINS UNIVERSITY SCHOOL OF MEDICINE   (United States)

^s INSTITUT FÜR DIABETESFORSCHUNG   (Germany)

^t UNIVERSITY OF PITTSBURGH   (United States)

^u WALTER REED ARMY MEDICAL CENTER   (United States)

^v STANFORD UNIVERSITY SCHOOL OF MEDICINE   (United States)

more..

Author keywords

Consensus; Diabetes; Glucose; Self monitoring; Trial; Type 2 diabetes

Indexed keywords

EID: 60249099082     PISSN: None     EISSN: 19322968     Source Type: Journal    
DOI: 10.1177/193229680800200612     Document Type: Article

References (53)

1. Klonoff DC. New evidence demonstrates that self-monitoring of blood glucose does not improve outcomes in type 2 diabetes-when this practice is not applied properly. J Diabetes Sci Technol. 2008;2(3):342-8.
2. McAndrew L, Schneider SH, Burns E, Leventhal H. Does patient blood glucose monitoring improve diabetes control? A systematic review of the literature. Diabetes Educ. 2007;33(6):991-1011.
3. Sarol JN Jr, Nicodemus NA Jr, Tan KM, Grava MB. Self-monitoring of blood glucose as part of a multi-component therapy among noninsulin requiring type 2 diabetes patients: a meta-analysis (1966-2004). Curr Med Res Opin. 2005;21(2):173-84.
4. Jansen JP. Self-monitoring of glucose in type 2 diabetes mellitus: a Bayesian meta-analysis of direct and indirect comparisons. Curr Med Res Opin. 2006;22(4):671-81.
5. Welschen LM, Bloemendal E, Nijpels G, Dekker JM, Heine RJ, Stalman WA, Bouter LM. Self-monitoring of blood glucose in patients with type 2 diabetes who are not using insulin: a systematic review. Diabetes Care. 2005;28(6):1510-7.
6. Kempf K, Neukirchen W, Martin S, Kolb H. Self-monitoring of blood glucose in type 2 diabetes: a new look at published trials. Diabetologia. 2008;51(4):686-8.
7. Poolsup N, Suksomboon, N, Jiamsathit W. Systematic review of the benefits of self-monitoring of blood glucose on glycemic control in type 2 diabetes patients. Diabetes Technol Ther. 2008;10(Suppl 1):S51-66.
8. Towfigh A, Romanova M, Weinreb JE, Munjas B, Suttorp MJ, Zhou A, Shekelle PG. Self-monitoring of blood glucose levels in patients with type 2 diabetes mellitus not taking insulin: a metaanalysis. Am J Manag Care. 2008;14(7):468-75.
9. Moreland EC, Volkening LK, Lawlor MT, Chalmers KA, Anderson BJ, Laffel LM. Use of a blood glucose monitoring manual to enhance monitoring adherence in adults with diabetes: a randomized controlled trial. Arch Intern Med. 2006;166(6):689-95.
10. Brown SA, Garcia AA, Kouzekanani K, Hanis CL. Culturally competent diabetes self-management education for Mexican Americans: the Starr County border health initiative. Diabetes Care. 2002;25(2):259-68.
11. Jones H, Edwards L, Vallis TM, Ruggiero L, Rossi SR, Rossi JS, Greene G, Prochaska JO, Zinman B. Changes in diabetes self-care behaviors make a difference in glycemic control: the Diabetes Stages of Change (DiSC) study. Diabetes Care. 2003;26(3):732-7.
12. Kibriya MG, Ali L, Banik NG, Khan AK. Home monitoring of blood glucose (HMBG) in type-2 diabetes mellitus in a developing country. Diabetes Res Clin Pract. 1999;46(3):253-7.
13. Miles P, Everett J, Murphy J, Kerr D. Comparison of blood or urine testing by patients with newly diagnosed non-insulin dependent diabetes: patient survey after randomised crossover trial. BMJ. 1997;315(7104):348-9.
14. [Erratum appears in BMJ 1998;316(7126):195.]
15. Jaber LA, Halapy H, Fernet M, Tummalapalli S, Diwakaran H. Evaluation of a pharmaceutical care model on diabetes management. Ann Pharmacother. 1996;30(3):238-43.
16. Wing RR, Epstein LH, Nowalk MP, Scott N, Koeske R, Hagg S. Does self-monitoring of blood glucose levels improve dietary compliance for obese patients with type II diabetes? Am J Med. 1986;81(5):830-6.
17. O'Kane MJ, Bunting B, Copeland M, Coates VE, ESMON study group. Efficacy of self monitoring of blood glucose in patients with newly diagnosed type 2 diabetes (ESMON study): randomised controlled trial. BMJ. 2008;336(7654):1174-7.
18. Farmer A, Wade A, Goyder E, Yudkin P, French D, Craven A, Holman R, Kinmonth AL, Neil A. Impact of self monitoring of blood glucose in the management of patients with non-insulin treated diabetes: open parallel group randomised trial. BMJ. 2007;335(7611):132.
19. Simon J, Gray A, Clarke P, Wade A, Neil A, Farmer A, Diabetes Glycaemic Education and Monitoring Trial Group. Cost effectiveness of self monitoring of blood glucose in patients with non-insulin treated type 2 diabetes: economic evaluation of data from the DiGEM trial. BMJ. 2008;336(7654):1177-80.
20. Martínez YV, Prado-Aguilar CA, Rascón-Pacheco RA, Valdivia-Martínez JJ. Quality of life associated with treatment adherence in patients with type 2 diabetes: a cross-sectional study. BMC Health Serv Rese. 2008;8:164.
21. Grootenhuis PA, Snoek FJ, Heine RJ, Bouter LM. Development of a type 2 diabetes symptom checklist: a measure of symptom severity. Diabet Med. 1994;11(3):253-61.
22. Cho JH, Chang SA, Kwon HS, Choi YH, Ko SH, Moon SD, Yoo SJ, Song KH, Son HS, Kim HS, Lee WC, Cha BY, Son HY, Yoon KH. Long-term effect of the Internet-based glucose monitoring system on HbA1c reduction and glucose stability: a 30-month follow-up study for diabetes management with a ubiquitous medical care system. Diabetes Care. 2006;29(12):2625-31.
23. Johnson JA, Majumdar SR, Bowker SL, Toth EL, Edwards A. Self-monitoring in type 2 diabetes: a randomized trial of reimbursement policy. Diabet Med. 2006;23(11):1247-51.
24. Davidson MB, Castellanos M, Kain D, Duran P. The effect of self monitoring of blood glucose concentrations on glycated hemoglobin levels in diabetic patients not taking insulin: a blinded, randomized trial. Am J Med. 2005;118(4):422-5.
25. Kwon HS, Cho JH, Kim HS, Song BR, Ko SH, Lee JM, Kim SR, Chang SA, Kim HS, Cha BY, Lee KW, Son HY, Lee JH, Lee WC, Yoon KH. Establishment of blood glucose monitoring system using the internet. Diabetes Care. 2004;27(2):478-83.
26. Guerci B, Drouin P, Grangé V, Bougnères P, Fontaine P, Kerlan V, Passa P, Thivolet CH, Vialettes B, Charbonnel B, ASIA Group. Self-monitoring of blood glucose significantly improves metabolic control in patients with type 2 diabetes mellitus: the Auto-Surveillance Intervention Active (ASIA) study. Diabetes Metab. 2003;29(6):587-94.
27. Schwedes U, Siebolds M, Mertes G, SMBG Study Group. Mealrelated structured self-monitoring of blood glucose: effect on diabetes control in non-insulin-treated type 2 diabetic patients. Diabetes Care. 2002;25(11):1928-32.
28. Muchmore DB, Springer J, Miller M. Self-monitoring of blood glucose in overweight type 2 diabetic patients. Acta Diabetol. 1994;31(4):215-9.
29. Rutten G, Van Eijk J, De Nobel E, Beek M, Van Der Velden H. Feasibility and effects of a diabetes type II protocol with blood glucose self-monitoring in general practice. Fam Pract. 1990;7(4):273-8.
30. Allen BT, De Long ER, Feussner JR. Impact of glucose self-monitoring on non-insulin-treated patients with type II diabetes mellitus. Randomized controlled trial comparing blood and urine testing. Diabetes Care. 1990;13(10):1044-50.
31. Estey AL, Tan MH, Mann K. Follow-up intervention: its effect on compliance behavior to a diabetes regimen. Diabetes Educ. 1990;16(4):291-5.
32. Fontbonne A, Billault B, Acosta M, Percheron C, Varenne P, Besse A, Eschwege E, Monnier (unnumbered in original) L, Slama G, Passa P. Is glucose self-monitoring beneficial in non-insulin-treated diabetic patients? Results of a randomized comparative trial. Diabete Metab. 1989;15(5):255-60.
33. Barnett AH, Krentz AJ, Strojek K, Sieradzki J, Azizi F, Embong M, Imamoglu S, Perušičová J, Uličiansky V, Winkler G. The efficacy of self-monitoring of blood glucose in the management of patients with type 2 diabetes treated with a gliclazide modified releasebased regimen. A multicentre, randomized, parallel-group, 6-month evaluation (DINAMIC 1 study). Diabetes Obes Metab. 2008.
34. Glasgow RE, Peeples M, Skovlund SE. Where is the patient in diabetes performance measures? The case for including patient-centered and self-management measures. Diabetes Care. 2008;31(5):1046-50.
35. Trochim, W. The research methods knowledge base. 2nd ed. Cincinnati: Atomic Dog Publishing; 2001.
36. Erdfelder E, Faul F, Buchner A. GPOWER: a general power analysis program. Behav Res Meth Instrum Comput. 1996;28:1-11.
37. Hahn S, Puffer S, Torgerson DJ, Watson J. Methodological bias in cluster randomised trials. BMC Med Res Methodol. 2005;5(1):10.
38. Eldridge SM, Ashby D, Feder GS, Rudnicka AR, Ukoumunne OC. Lessons for cluster randomized trials in the twenty-first century: a systematic review of trials in primary care. Clin Trials. 2004;1(1):80-90.
39. Borm GF, Melis R J F, Teerenstra S, Peer PG. Pseudo cluster randomization: a treatment allocation method to minimize contamination and selection bias. Stat Med. 2005;24(23):3535-47.
40. Teerenstra S, Melis RJ, Peer PG, Borm GF. Pseudo cluster randomization dealt with selection bias and contamination in clinical trials. J Clin Epidemiol. 2006;59(4):381-6.
41. Melis RJ, Teerenstra S, Rikkert MG, Borm GF. Pseudo cluster randomization performed well when used in practice. J Clin Epidemiol. 2008.
42. http://www.diabetes.ca/cpg2003. Accessed August 1, 2008.
43. Sigal RJ, Kenny GP, Boulé NG, Wells GA, Prud'homme D, Fortier M, Reid RD, Tulloch H, Coyle D, Phillips P, Jennings A, Jaffey J. Effects of aerobic training, resistance training, or both on glycemic control in type 2 diabetes: a randomized trial. Ann Intern Med. 2007;147(6):357-69.
44. [Summary for patients appears in Ann Intern Med. 2007;147(6):I16.]
45. Marliss EB, Vranic M. Intense exercise has unique effects on both insulin release and its roles in glucoregulation: implications for diabetes. Diabetes. 2002;51(Suppl 1):S271-83.
46. Sriwijitkamol A, Coletta DK, Wajcberg E, Balbontin GB, Reyna SM, Barrientes J, Eagan PA, Jenkinson CP, Cersosimo E, De Fronzo RA, Sakamoto K, Musi N. Effect of acute exercise on AMPK signalling in skeletal muscle of subjects with type 2 diabetes: a time-course and dose-response study. Diabetes. 2007;56(3):836-48.
47. Gaudet-Savard T, Ferland A, Broderick TL, Garneau C, Tremblay A, Nadeau A, Poirier P. Safety and magnitude of changes in blood glucose levels following exercise performed in the fasted and the postprandial state in men with type 2 diabetes. Eur J Cardiovasc Prev Rehabil. 2007;14(6):831-6.
48. Kjaer M, Hollenbeck CB, Frey-Hewitt B, Galbo H, Haskell W, Reaven GM. Glucoregulation and hormonal responses to maximal exercise in non-insulin-dependent diabetes. J Appl Physiol. 1990;68(5):2067-74.
49. Musi N, Fujii N, Hirshman MF, Ekberg I, Fröberg S, Ljungqvist O, Thorell A, Goodyear LJ. AMP-activated protein kinase (AMPK) is activated in muscle of subjects with type 2 diabetes during exercise. Diabetes. 2001;50(5):921-7.
50. Sigal RJ, Kenny GP, Wasserman DH, Castaneda-Sceppa C, White RD. Physical activity/exercise and type 2 diabetes: a consensus statement from the American Diabetes Association. Diabetes Care. 2006;29(6):1433-8.
51. Galbo H, Tobin L, Van Loon LJ. Responses to acute exercise in type 2 diabetes, with an emphasis on metabolism and interaction with oral hypoglycemic agents and food intake. Appl Physiol Nutr Metab. 2007;32(3):567-75.
52. http://www.health.gov/PAguidelines. Accessed August 1, 2008.
53. Nathan DM, Buse JB, Davidson MB, Ferrannini E, Holman RR, Sherwin R, Zinman B. Management of hyperglycemia in type 2 diabetes: a consensus algorithm for the initiation and adjustment of therapy: update regarding thiazolidinediones: a consensus statement from the American Diabetes Association and the European Association for the Study of Diabetes. Diabetes Care. 2008;31(1):173-5.