Original researchProfessional flash glucose monitoring and health service utilisation in type 2 diabetes: A secondary analysis of the GP-OSMOTIC study
Introduction
Type 2 diabetes mellitus (T2D) affects over one million Australians and costs over $14 billion dollars annually [1]. Most T2D care takes place in primary care where complications, and their associated costs, can be reduced with evidence-based interventions to achieve glycaemic targets [2,3]. Emerging evidence suggests that HbA1c, traditionally used to monitor glycaemia and guide treatment decisions, has limitations as it does not capture parameters such as time in range and glycaemic variability [4], which are increasingly seen as key measures associated with progression to complications [5,6]. Structured self-monitoring of blood glucose (s-SMBG), where people with diabetes check blood glucose level seven times per day over three consecutive days prior to their diabetes consultation, can identify such parameters and contribute to improvement in glycaemia in patients with T2D not using insulin. However, s-SMBG is frequently discontinued due to factors including inconvenience and avoidance due to stigma, pain associated with testing and cost [[7], [8], [9]].
Continuous glucose monitoring (CGM) may be a more acceptable alternative to s-SMBG. CGM in real-time or retrospective (also known as professional) modes, allows measurement of time in range and glycaemic variability. The increased data available may facilitate increased engagement in care and individualisation of treatment [10]. Flash glucose monitoring (FGM) can also be used in real-time or retrospective (professional) modes. In contrast to CGM, it does not require finger prick glucose measures for calibration, which may reduce barriers to use. In professional mode, people with diabetes wear a FGM for up to two weeks, with the data downloaded by their health professional, and the information used to help guide treatment [11].
Studies of professional FGM have had mixed glycaemic outcomes, had short follow up and only included select populations [12,13]. The GP-OSMOTIC study was a pragmatic real-world two-arm randomised controlled trial (RCT) of 299 patients in 25 Victorian general practices evaluating the absolute difference in mean HbA1c levels at 12-months with use of professional FGM versus usual care [14]. At 6 months, HbA1c was lower in the FGM group than in the usual care group (difference −5 mmol/mol, 95% CI −9 to −3), although at 12 months there was no significant between-group difference in estimated mean HbA1c 8·2% (95% CI 8·0–8·4) for FGM vs 8·5% (8·3–8·7) for usual care [15]. While modest effects were observed in the outcomes of participants wearing FGM, it is not known if this was associated with increased use of health care services. The aim of this secondary data analysis was to determine if the use of professional FGM was associated with differences in health services utilisation (HSU) identified in administrative claims data compared to those receiving usual care.
Section snippets
GP-OSMOTIC study design and participants
GP-OSMOTIC has been described in detail elsewhere [14,16]. Essentially 299 patients aged 18–80 years, with T2D for at least one year with a most recent HbA1c ≥5.5 mmol/mol above their individualised target, while prescribed at least two non-insulin hypoglycaemic agents and/or insulin were recruited. All participants wore the FGM sensor at baseline, and after the sensor was attached randomisation (using permuted block sizes of four and six, stratified by clinic) was performed. Intervention
Results
Of the 299 participants in the GP-OSMOTIC study data from 288 (96.3%) were used in this analysis as six participants did not consent to MBS, VAED and VEMD data linkage and a further five participants were billed through an alternative provider (Department of Veterans Affairs). Of these 288 participants, 143 were allocated to the intervention arm and 145 to the control arm. Baseline characteristics are outlined in Table 1. The mean (±SD) age of participants was 60.1 (10) years and the percentage
Discussion
Participants in the GP-OSMOTIC study in the professional FGM group had increased GP and practice nurse visits compared to those allocated to usual care despite patients in both study arms being advised to attend general practice 3-monthly in line with current clinical guidelines. The increase in GP consultations was likely due increased visits to discuss the results of the FGM reports, with practice nurse visits increasing due to visits for sensor application. We did see an overall increase in
Conclusion
The burden of T2D is growing and most of this care takes place in the primary care setting where evidence-based care can improve outcomes. We found a small increase in primary care health service utilisation associated with professional flash glucose monitoring. This study adds to the evidence surrounding professional flash glucose monitoring use in primary care by people with T2D.
Conflict of interest
JF has received unrestricted educational grants for research support from Roche,Sanofi, and Medtronic. JMN has received funding for travel from MSD, payment for presenting education sessions from Sanofi (content was developed independently) and funding from Boehringer Ingelheim and Eli Lilly for an independent investigator-led study.
Funding
This research project is supported by the Royal Australian College of General Practitioners with funding from the Australian Government under the Australian General Practice Training program.
The GP-OSMOTIC trial was supported by a National Health and Medical Research Council Project Grant (ID APP1104241). Additional funding was provided by Sanofi Australia and In-kind support was provided by Abbott Diabetes Care, which has provided the Libre Pro reader devices, sensors and software.
Acknowledgments
We would like to thank all the GPs and people with type 2 diabetes who participated in this research and the work of the GP-OSMOTIC research team.
References (23)
- et al.
Use of professional-mode flash glucose monitoring, at 3-month intervals, in adults with type 2 diabetes in general practice (GP-OSMOTIC): a pragmatic, open-label, 12-month, randomised controlled trial
Lancet Diabetes Endocrinol.
(2020) - et al.
Research electronic data capture (REDCap)–a metadata-driven methodology and workflow process for providing translational research informatics support
J. Biomed. Inform.
(2009) - et al.
Effectiveness of quality improvement strategies on the management of diabetes: a systematic review and meta-analysis
Lancet
(2012) - et al.
The clinical effectiveness of nursing models of diabetes care: a synthesis of the evidence
Int. J. Nurs. Stud.
(2019) - et al.
1: epidemiology and prevention of type 2 diabetes and the metabolic syndrome
Med. J. Aust.
(2003) - et al.
Effect of a multifactorial intervention on mortality in type 2 diabetes
N. Engl. J. Med.
(2008) - et al.
Five-year cost-effectiveness of the multidisciplinary risk assessment and management programme–diabetes mellitus (RAMP-DM)
Diabetes Care
(2018) - et al.
Metrics beyond hemoglobin A1C in diabetes management: time in range, hypoglycemia, and other parameters
Diabetes Technol. Ther.
(2017) - et al.
Validation of time in range as an outcome measure for diabetes clinical trials
Diabetes Care
(2019) - et al.
International consensus on use of continuous glucose monitoring
Diabetes Care
(2017)