Real-time continuous glucose monitoring versus self-monitoring of blood glucose in adults with insulin-treated type 2 diabetes: a protocol for a randomised controlled single-centre trial

Nanna Lind, Dorte Lindqvist Hansen, Signe Sætre Rasmussen, Kirsten Nørgaard, Nanna Lind, Dorte Lindqvist Hansen, Signe Sætre Rasmussen, Kirsten Nørgaard

Abstract

Introduction: Medical treatment options for type 2 diabetes (T2D) have increased over the last decade and enhance the possibility of individualised treatment strategies where insulin is still one of them. In spite of the advancements in treatment options, less than one-third of the population with T2D obtain their optimal glycaemic goal. In persons with type 1 diabetes, continuous glucose monitoring (CGM) has shown to be the most important driver for improvement in glycaemic control, even more than insulin-pump therapy. The use of technology in T2D has only been investigated in few studies.The overall objective of the research study is to examine the effectiveness of the use of CGM versus self-monitoring of blood glucose (SMBG) in persons with insulin-treated T2D on glycaemic variables and patient-reported outcomes on treatment satisfaction, health behaviour and well-being. The independent effect of peer support will also be studied.

Methods and analysis: The study is a single centre, prospective, randomised, open-labelled, three-armed study with the randomisation 2:1:2 in group A with CGM, group B with CGM and peer support, and group C as a control group with SMBG. The participants receive a training course unique for the allocation group. The study runs for 12 months and includes 100 adult participants with insulin-treated T2D, treated at the outpatient clinic at Steno Diabetes Center Copenhagen. Primary outcome is difference in change in time in range. Recruitment begins in August 2020 and ends in July 2021. Final 12-month follow-up is anticipated to be in August 2022.

Ethics and dissemination: The study will be carried out in accordance with the Helsinki Declaration and is approved by the Scientific Ethics Committee of the Capital Region (H-20000843). Data collection and handling will be performed in accordance with the General Data Protection Regulation and is approved by the Danish Data Protection Agency (J-2020-100). Dissemination will be in international peer-reviewed journals, conferences and a plain-language summary for participants.

Trial registration number: ClinicalTrials.gov Registry (NCT04331444).

Protocol version: V.3, 11 December 2020.

Keywords: general diabetes; medical education & training; quality in healthcare.

Conflict of interest statement

Competing interests: KN is a shareholder of Novo Nordisk; has received research support from Novo Nordisk, Roche Diagnostics, Medtronic, DexCom and Zealand Pharma; has received lecture fees from Medtronic, Roche Diagnostics, Rubin Medical, Sanofi, Zealand Pharma, Novo Nordisk and DexCom; and has served on advisory panels for Medtronic, Abbott and Novo Nordisk. DLH is on the advisory board for Sanofi and Mundipharma. NL and SSR do not have any competing interests. None of the investigators have personal financial interest in the conduct or the outcome of the project.

© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

References

    1. Holman RR, Paul SK, Bethel MA, et al. . 10-Year follow-up of intensive glucose control in type 2 diabetes. N Engl J Med Overseas Ed 2008;359:1577–89. 10.1056/NEJMoa0806470
    1. American Diabetes Association 5. Lifestyle Management: Standards of Medical Care in Diabetes-2019. Diabetes Care 2019;42:S46–60. 10.2337/dc19-S005
    1. Zinman B, Marso SP, Poulter NR, et al. . Day-To-Day fasting glycaemic variability in DEVOTE: associations with severe hypoglycaemia and cardiovascular outcomes (DEVOTE 2). Diabetologia 2018;61:48–57. 10.1007/s00125-017-4423-z
    1. Battelino T, Danne T, Bergenstal RM, et al. . Clinical targets for continuous glucose monitoring data interpretation: recommendations from the International consensus on time in range. Diabetes Care 2019;42:1593–603. 10.2337/dci19-0028
    1. Beck RW, Bergenstal RM, Riddlesworth TD, et al. . Validation of time in range as an outcome measure for diabetes clinical trials. Diabetes Care 2019;42:400–5. 10.2337/dc18-1444
    1. Vigersky R, Shrivastav M. Role of continuous glucose monitoring for type 2 in diabetes management and research. J Diabetes Complications 2017;31:280–7. 10.1016/j.jdiacomp.2016.10.007
    1. Pickup JC. Is insulin pump therapy effective in type 1 diabetes? Diabet Med 2019;36:269–78. 10.1111/dme.13793
    1. Beck RW, Riddlesworth T, Ruedy K, et al. . Effect of continuous glucose monitoring on glycemic control in adults with type 1 diabetes using insulin injections: the diamond randomized clinical trial. JAMA 2017;317:371–8. 10.1001/jama.2016.19975
    1. Foster NC, Beck RW, Miller KM, et al. . State of type 1 diabetes management and outcomes from the T1D exchange in 2016-2018. Diabetes Technol Ther 2019;21:66–72. 10.1089/dia.2018.0384
    1. Šoupal J, Petruželková L, Grunberger G, et al. . Glycemic outcomes in adults with T1D are impacted more by continuous glucose monitoring than by insulin delivery method: 3 years of follow-up from the COMISAIR study. Diabetes Care 2020;43:dc190888. 10.2337/dc19-0888
    1. Beck RW, Riddlesworth TD, Ruedy K, et al. . Continuous glucose monitoring versus usual care in patients with type 2 diabetes receiving multiple daily insulin injections: a randomized trial. Ann Intern Med 2017;167:365–74. 10.7326/M16-2855
    1. Ehrhardt NM, Chellappa M, Walker MS, et al. . The effect of real-time continuous glucose monitoring on glycemic control in patients with type 2 diabetes mellitus. J Diabetes Sci Technol 2011;5:668–75. 10.1177/193229681100500320
    1. Vigersky RA, Fonda SJ, Chellappa M, et al. . Short- and long-term effects of real-time continuous glucose monitoring in patients with type 2 diabetes. Diabetes Care 2012;35:32–8. 10.2337/dc11-1438
    1. McNabb WL. Adherence in diabetes: can we define it and can we measure it? Diabetes Care 1997;20:215–8. 10.2337/diacare.20.2.215
    1. Cramer JA. A systematic review of adherence with medications for diabetes. Diabetes Care 2004;27:1218–24. 10.2337/diacare.27.5.1218
    1. Yoo HJ, An HG, Park SY, et al. . Use of a real time continuous glucose monitoring system as a motivational device for poorly controlled type 2 diabetes. Diabetes Res Clin Pract 2008;82:73–9. 10.1016/j.diabres.2008.06.015
    1. Allen NA, Fain JA, Braun B, et al. . Continuous glucose monitoring counseling improves physical activity behaviors of individuals with type 2 diabetes: a randomized clinical trial. Diabetes Res Clin Pract 2008;80:371–9. 10.1016/j.diabres.2008.01.006
    1. Allen N, Whittemore R, Melkus G. A continuous glucose monitoring and problem-solving intervention to change physical activity behavior in women with type 2 diabetes: a pilot study. Diabetes Technol Ther 2011;13:1091–9. 10.1089/dia.2011.0088
    1. Battelino T, Liabat S, Veeze HJ, et al. . Routine use of continuous glucose monitoring in 10 501 people with diabetes mellitus. Diabet Med 2015;32:1568–74. 10.1111/dme.12825
    1. Taylor PJ, Thompson CH, Brinkworth GD. Effectiveness and acceptability of continuous glucose monitoring for type 2 diabetes management: a narrative review. J Diabetes Investig 2018;9:713–25. 10.1111/jdi.12807
    1. Fisher EB, Boothroyd RI, Elstad EA, et al. . Peer support of complex health behaviors in prevention and disease management with special reference to diabetes: systematic reviews. Clin Diabetes Endocrinol 2017;3:4. 10.1186/s40842-017-0042-3
    1. Dale JR, Williams SM, Bowyer V. What is the effect of peer support on diabetes outcomes in adults? A systematic review. Diabet Med 2012;29:1361–77. 10.1111/j.1464-5491.2012.03749.x
    1. Dexcom Dexcom continuous glucose monitoring, 2019. Available:
    1. Harris PA, Taylor R, Thielke R, et al. . Research electronic data capture (REDCap)-a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform 2009;42:377–81. 10.1016/j.jbi.2008.08.010
    1. Engelund G, Vinther-Andersen N, Hansen UM. In balance with chronic illness. Tools for patient education. 1 Gentofte, Denmark: Steno Diabetes Center Copenhagen, 2011: 7–150.
    1. Pedersen-Bjergaard U, Pramming S, Thorsteinsson B. Recall of severe hypoglycaemia and self-estimated state of awareness in type 1 diabetes. Diabetes Metab Res Rev 2003;19:232–40. 10.1002/dmrr.377
    1. Høi-Hansen T, Pedersen-Bjergaard U, Thorsteinsson B. Classification of hypoglycemia awareness in people with type 1 diabetes in clinical practice. J Diabetes Complications 2010;24:392–7. 10.1016/j.jdiacomp.2009.07.006
    1. Topp CW, Østergaard SD, Søndergaard S, et al. . The WHO-5 well-being index: a systematic review of the literature. Psychother Psychosom 2015;84:167–76. 10.1159/000376585
    1. Schmitt A, Reimer A, Kulzer B, et al. . How to assess diabetes distress: comparison of the problem areas in diabetes scale (paid) and the diabetes distress scale (DDS). Diabet Med 2016;33:835–43. 10.1111/dme.12887
    1. Grabman J, Vajda Bailey K, Schmidt K, et al. . An empirically derived short form of the hypoglycaemia fear survey II. Diabet Med 2017;34:500–4. 10.1111/dme.13162
    1. Polonsky WH, Fisher L, Hessler D, et al. . Development of a new measure for assessing glucose monitoring device-related treatment satisfaction and quality of life. Diabetes Technol Ther 2015;17:657–63. 10.1089/dia.2014.0417
    1. Bradley C, Gamsu DS. Guidelines for encouraging psychological well-being: report of a working group of the world Health organization regional office for Europe and international diabetes Federation European region St Vincent Declaration action programme for diabetes. Diabet Med 1994;11:510–6. 10.1111/j.1464-5491.1994.tb00316.x
    1. Bradley C, Plowright R, Stewart J, et al. . The diabetes treatment satisfaction questionnaire change version (DTSQc) evaluated in insulin Glargine trials shows greater responsiveness to improvements than the original DTSQ. Health Qual Life Outcomes 2007;5:57. 10.1186/1477-7525-5-57
    1. Saisho Y. Use of diabetes treatment satisfaction questionnaire in diabetes care: importance of patient-reported outcomes. Int J Environ Res Public Health 2018;15:947–7. 10.3390/ijerph15050947
    1. Olsson SJG, Ekblom Örjan, Andersson E, et al. . Categorical answer modes provide superior validity to open answers when asking for level of physical activity: a cross-sectional study. Scand J Public Health 2016;44:70–6. 10.1177/1403494815602830
    1. Asaad G, Sadegian M, Lau R, et al. . The reliability and validity of the perceived dietary adherence questionnaire for people with type 2 diabetes. Nutrients 2015;7:5484–96. 10.3390/nu7075231
    1. Fischer HH, Jørgensen SF. Prævalens og prædiktorer for medicinsk non-adhærens blandt tidligere indlagte medicinske patienter (Danish), 2017. Available:

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