Flash Glucose-Sensing Technology as a Replacement for Blood Glucose Monitoring for the Management of Insulin-Treated Type 2 Diabetes: a Multicenter, Open-Label Randomized Controlled Trial

Diabetes Therapy

Volumn 8, Issue 1, 2017, Pages 55-73

  Haak, Thomas ^a   Hanaire, Hélène ^b   Ajjan, Ramzi ^c   Hermanns, Norbert ^a   Riveline, Jean Pierre ^d   Rayman, Gerry ^e  

^a Diabetes Zentrum Mergentheim   (Germany)

^b TOULOUSE UNIVERSITY HOSPITAL   (France)

^c UNIVERSITY OF LEEDS   (United Kingdom)

^d HÔPITAL LARIBOISIÈRE   (France)

^e IPSWICH HOSPITAL NHS TRUST   (United Kingdom)

Author keywords

Flash sensor glucose technology; Glucose monitoring; Insulin; Type 2 diabetes

Indexed keywords

GLUCOSE; HEMOGLOBIN A1C; INSULIN;

ADULT; ARTICLE; BLOOD GLUCOSE MONITORING; CLINICAL TRIAL (TOPIC); CONTROLLED STUDY; DIABETIC KETOACIDOSIS; DIAGNOSTIC PROCEDURE; FEMALE; FLASH GLUCOSE SENSING TECHNOLOGY; FOOD PREFERENCE; GLYCEMIC CONTROL; HUMAN; HYPEROSMOLARITY; HYPOGLYCEMIA; LIFESTYLE; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; NON INSULIN DEPENDENT DIABETES MELLITUS; OPEN STUDY; PATIENT SATISFACTION; PHYSICAL ACTIVITY; PRIORITY JOURNAL; PROSPECTIVE STUDY; QUALITY OF LIFE; QUESTIONNAIRE; RANDOMIZED CONTROLLED TRIAL; TREATMENT OUTCOME;

EID: 85012186707     PISSN: 18696953     EISSN: 18696961     Source Type: Journal    
DOI: 10.1007/s13300-016-0223-6     Document Type: Article

References (35)

1. Chiu C-J, Wray LA. Factors predicting glycemic control in middle-aged and older adults with type 2 diabetes. Prev Chronic Dis. 2010;7(1):A08.
2. Nichols GA, Hillier TA, Javor K, Brown JB. Predictors of glycemic control in insulin-using adults with type 2 diabetes. Diabetes Care. 2000;23(3):273–7.
3. Holman RR, Paul SK, Bethel MA, et al. 10-year follow up of intensive glucose control in type 2 diabetes. N Eng J Med. 2008;359:577–89.
4. UK Prospective Diabetes Study (UKPDS) Group. Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). UK Prospective Diabetes Study (UKPDS) Group. Lancet. 1998;352:837–53.
5. Bonds DE, Miller ME, Bergenstal RM, et al. The association between symptomatic, severe hypoglycaemia and mortality in type 2 diabetes: retrospective epidemiological analysis of the ACCORD study. BMJ. 2010;340:b4909.
6. Alvarez-Guisasola F, Yin DD, Nocea G, Qui Y, Mavros P. Association of hypoglycemic symptoms with patients’ rating of their health-related quality of life state: a cross sectional study. Health Qual Life Outcomes. 2010;8:86.
7. Amiel SA, Dixon T, Mann R, Jameson K. Hypoglycemia in type 2 diabetes. Diabet Med. 2008;25:245–54.
8. Lin CC, Li CI, Yang SY, et al. Variation of fasting plasma glucose: a predictor of mortality in patients with type 2 diabetes. Am J Med. 2012;125(416):e9–18.
9. Schisano B, Tripathi G, McGee K, McTernan PG, Ceriello A. Glucose oscillations, more than constant high glucose, induce activation and a metabolic memory in human endothelial cells. Diabetologia. 2011;54:1219–26.
10. Ong WM, Chua SS, Ng CJ. Barriers and facilitators to self-monitoring of blood glucose in people with type 2 diabetes using insulin: a qualitative study. Patient Prefer Adherence. 2014;8:237–46.
11. Hortensius J, Kars MC, Wierenga WS, Kleefstra N, Bilo HJ, van der Bijl JJ. Perspectives of patients with type1 or insulin treated type 2 diabetes on self-monitoring of blood glucose: a qualitative study. BMC Public Health. 2012;12:167–77.
12. Abbott Diabetes Care. FreeStyle Libre Software. http://www.FreeStyleLibre.com. Accessed 11 April 2016.
13. ADA. Defining and reporting hypoglycemia in diabetes: a report from the American Diabetes Association Workgroup on Hypoglycemia. Diabet Care. 2005;28:1245–9.
14. Polonsky WH, Fisher L, Earles J, et al. Assessing psychosocial distress in diabetes: development of the diabetes distress scale. Diabet Care. 2005;28:626–31.
15. The DCCT. Research group reliability and validity of a diabetes quality-of-life measure for the diabetes and complications trial (DCCT). Diabet Care. 1988;11:725–32.
16. Bradley C. Diabetes treatment satisfaction questionnaire. In: Bradley C, editor. Handbook of psychology and diabetes. Chur: Harwood Academic; 1994.
17. Kovatchev BP, Clarke WL, Breton M, Brayman K, McCall A. Quantifying temporal glucose variability in diabetes via continuous glucose monitoring: mathematical methods and clinical application. Diabetes Technol Ther. 2005;7:849–62.
18. McDonnell CM, Donath SM, Vidmar SI, Werther GA, Cameron FJ. A novel approach to continuous glucose analysis utilizing glycemic variation. Diabetes Technol Ther. 2005;7(2):253–63.
19. Clarke W, Kovatchev B. Statistical tools to analyze continuous glucose monitor data. Diabetes Technol Ther. 2009;11(S1):S45–54.
20. Abbott Diabetes Care. Randomised controlled study to evaluate the impact of novel glucose sensing technology on HbA1c in type 2 diabetes (REPLACE) ADC-CI-APO 12018. Data on file. 2015.
21. Food and Drug Administration. Guidance for industry diabetes mellitus: developing drugs and therapeutic biologics for treatment and prevention 2008; page 23 http://www.fda.gov/downloads/Drugs/…/Guidances/ucm071624.pdfm. Accessed 15 Dec 2016.
22. The Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study Group. Continuous glucose monitoring and intensive treatment of type 1 diabetes. N Engl J Med. 2008;359:1464–76.
23. Vickers AJ, Altman DG. Statistics notes: analysing controlled trials with baseline and follow up measurements. BMJ 2001;10(323, 7321):1123–4.
24. Ehrhardt NM, Chellappa M, Walker SM, Fonda SJ, Vigersky RA. The effect of real-time continuous glucose monitoring on glycaemic control in patients with type 2 diabetes. J Diabet Sci Technol. 2011;5(3):668–75.
25. Vigersky RA, Fonda SJ, Chellappa M, Walker SM, Ehrhardt NM. Sort and long term effect of real-time continuous glucose monitoring in patients with type 2 diabetes. Diabet Care. 2012;35:32–8.
26. Fonda SJ, Salkind SJ, Walker SM, Chellappa M, Ehrhardt N, Vigersky RA. Heterogeneity of responses to real-time continuous glucose monitoring (RT_CGM) in patients with type 2 diabetes and its implications for application. Diabet Care. 2013;36:786–92.
27. McCoy RG, Kasia MS, Lipska J, et al. Intensive treatment and severe hypoglycemia among adults with type 2 diabetes. JAMA Intern Med. 2016;176(7):969–78.
28. American Diabetes Association Standards of Medical Care in. Diabetes. Diabete, Care. 2016;39:1.
29. Battelino T, Conget I, Olsen B, et al, for the SWITCH Study Group. The use and efficacy of continuous glucose monitoring in type 1 diabetes treated with insulin pump therapy: a randomised controlled trial. Diabetologia 2012;55:3155–62.
30. Kovatchev BP, Cox DJ, Farhy LS, Straume M, Gonder-Frederick L, Clarke WL. Episodes of severe hypoglycemia in type 1 diabetes are preceded and followed within 48 hours by measurable disturbances in blood glucose. J Clin Endocrinol Metab. 2000;85:4287–92.
31. Qu Y, Jacober SJ, Zhang Q, Wolka LL, Hans DeVries J. Rate of hypoglycemia in insulin-treated patients with type 2 diabetes can be predicted from glycemic variability data. Diabetes Technol Ther. 2012;14(11):1008–12.
32. Ward JEF, Stetson BA, Mokshagundam SPL. Patient perspectives on self-monitoring of blood glucose: perceived recommendations, behaviours and barriers in a clinic sample of adults with type 2 diabetes. J Diabetes Metab Disord. 2015;14(43):1–7.
33. Polonsky WH, Hassler D. What are the quality of life-related benefits and losses associated with real-time continuous glucose monitoring? A survey of current users. Diabetes Technol Ther. 2013;15:295–301.
34. Bolinder J, Antuna R, Geelhoed-Duijvestijn P, Kroeger J, Weitgasser R. Novel glucose-sensing technology and hypoglycaemia in type 1 diabetes: a multicentre, non-masked, randomised controlled trial. Lancet. 2016. doi:10.1016/S0140-6736(16)31535-5.
35. Maahs DM, Buckingham B, Castle J, et al. Outcome measures for artificial pancreas clinical trials: a consensus report. Diabet Care. 2016;39:1175–9.