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12-20-2016 | Flash glucose monitoring | Article

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

Journal: Diabetes Therapy

Authors: Thomas Haak, Hélène Hanaire, Ramzi Ajjan, Norbert Hermanns, Jean-Pierre Riveline, Gerry Rayman

Publisher: Springer Healthcare

Abstract

Introduction

Glycemic control in participants with insulin-treated diabetes remains challenging. We assessed safety and efficacy of new flash glucose-sensing technology to replace self-monitoring of blood glucose (SMBG).

Methods

This open-label randomized controlled study (ClinicalTrials.gov, NCT02082184) enrolled adults with type 2 diabetes on intensive insulin therapy from 26 European diabetes centers. Following 2 weeks of blinded sensor wear, 2:1 (intervention/control) randomization (centrally, using biased-coin minimization dependant on study center and insulin administration) was to control (SMBG) or intervention (glucose-sensing technology). Participants and investigators were not masked to group allocation. Primary outcome was difference in HbA1c at 6 months in the full analysis set. Prespecified secondary outcomes included time in hypoglycemia, effect of age, and patient satisfaction.

Results

Participants (n = 224) were randomized (149 intervention, 75 controls). At 6 months, there was no difference in the change in HbA1c between intervention and controls: −3.1 ± 0.75 mmol/mol, [−0.29 ± 0.07% (mean ± SE)] and −3.4 ± 1.04 mmol/mol (−0.31 ± 0.09%) respectively; p = 0.8222. A difference was detected in participants aged <65 years [−5.7 ± 0.96 mmol/mol (−0.53 ± 0.09%) and −2.2 ± 1.31 mmol/mol (−0.20 ± 0.12%), respectively; p = 0.0301]. Time in hypoglycemia <3.9 mmol/L (70 mg/dL) reduced by 0.47 ± 0.13 h/day [mean ± SE (p = 0.0006)], and <3.1 mmol/L (55 mg/dL) reduced by 0.22 ± 0.07 h/day (p = 0.0014) for intervention participants compared with controls; reductions of 43% and 53%, respectively. SMBG frequency, similar at baseline, decreased in intervention participants from 3.8 ± 1.4 tests/day (mean ± SD) to 0.3 ± 0.7, remaining unchanged in controls. Treatment satisfaction was higher in intervention compared with controls (DTSQ 13.1 ± 0.50 (mean ± SE) and 9.0 ± 0.72, respectively; p < 0.0001). No serious adverse events or severe hypoglycemic events were reported related to sensor data use. Forty-two serious events [16 (10.7%) intervention participants, 12 (16.0%) controls] were not device-related. Six intervention participants reported nine adverse events for sensor-wear reactions (two severe, six moderate, one mild).

Conclusion

Flash glucose-sensing technology use in type 2 diabetes with intensive insulin therapy results in no difference in HbA1c change and reduced hypoglycemia, thus offering a safe, effective replacement for SMBG.

Trial registration

ClinicalTrials.gov identifier: NCT02082184.

Funding

Abbott Diabetes Care.
Literature
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.PubMed
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.CrossRefPubMed
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.CrossRef
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.CrossRefPubMedPubMedCentral
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.CrossRefPubMedPubMedCentral
7.
Amiel SA, Dixon T, Mann R, Jameson K. Hypoglycemia in type 2 diabetes. Diabet Med. 2008;25:245–54.CrossRefPubMedPubMedCentral
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.CrossRefPubMed
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.PubMedPubMedCentral
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.CrossRefPubMedPubMedCentral
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.CrossRef
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.CrossRef
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.CrossRef
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.CrossRefPubMed
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.CrossRefPubMed
19.
Clarke W, Kovatchev B. Statistical tools to analyze continuous glucose monitor data. Diabetes Technol Ther. 2009;11(S1):S45–54.CrossRefPubMed
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.CrossRef
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.CrossRef
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.CrossRef
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.CrossRef
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.CrossRefPubMed
28.
American Diabetes Association Standards of Medical Care in. Diabetes. Diabete, Care. 2016;39:1.CrossRef
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.PubMed
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.CrossRefPubMed
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.CrossRefPubMed
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.CrossRef

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