Impact of quarterly professional-mode flash glucose monitoring in adults with type 2 diabetes in general practice (GP-OSMOTIC): Secondary psychological and self-care outcomes of a pragmatic, open-label, 12-month, randomised controlled trial

Abstract

Aims

To investigate the impact of quarterly professional-mode flash glucose monitoring on psychological outcomes in adults with type 2 diabetes in primary care.

Methods

The GP-OSMOTIC trial randomised 299 adults with type 2 diabetes in 25 general practices to quarterly use of professional-mode flash glucose monitoring (sensor worn for 14 days; data discussed at clinic visit) or usual care. At baseline and 12 months, participants completed validated measures: general emotional well-being (WHO-5), diabetes-specific quality of life (DIDP), satisfaction with glucose monitoring (GME-Q), self-care activities (SDSCA) and perceived involvement in clinical care (PICS). Linear mixed-effects models examined between-group differences at 12 months.

Results

At 12 months, there were no clinically important between-arm differences in any secondary psychological or self-care outcomes. Per protocol analyses showed no clinically significant between-group differences.

Conclusions

The GP-OSMOTIC intervention had no significant impact, at 12 months, on general emotional well-being, diabetes-specific quality of life or satisfaction with glucose monitoring, suggesting no added psychological burden. Lack of positive impact on self-reported self-care activities or perceived involvement in clinical care may warrant closer attention to the fidelity of intervention delivery, the context (e.g. the nature of clinician-patient interactions) and/or the sensitivity of the measures, as these will help plan future studies.

Introduction

Achieving and sustaining optimal glycemic levels is crucial to reduce the risk of long-term complications (particularly microvascular: retinopathy, neuropathy, nephropathy) and all-cause mortality [1]. Despite considerable advances in diabetes medications and treatment options over the past two decades [2], approximately 50% of adults with type 2 diabetes have an HbA1c above the recommended clinical target range for reducing risk of complications [3].

Guidelines for the optimal management of type 2 diabetes focus on the use of glycated haemoglobin (HbA1c) values to inform clinical decision making relating to glycemia. However, HbA1c alone does not provide information about day-to-day fluctuations in glucose levels, and may not be sufficient to support shared decisions for optimal diabetes management, including recommendations for changes to diet/physical activity and medications. Several factors influence timely decision making [4], e.g. the knowledge, skills and motivation of both the general practitioner (GP) and the person with type 2 diabetes. Both may be concerned about the challenges and complexity of diabetes management and complex treatment regimens. Reflecting on glycemic profiles at routine clinic visits (e.g. every three months), in addition to HbA1c, may be useful and cost-effective [5], providing relevant detail about time in range, glucose variability and hypo- and hyperglycemia to inform clinical discussion and decision-making, as well as behavior change.

Structured SMBG is an approach in which the glucose data are monitored at specific times, interpreted and used to prompt appropriate therapeutic actions, e.g. a change in food quantity/type, physical activity or medications. Typically, structured SMBG involves several finger pricks per day at set times (e.g. pre/post meals or physical activity) over a short period of time (e.g. three days), providing a glycemic profile to inform future diabetes management. Randomised trials have shown structured monitoring to have multiple benefits, in terms of facilitating changes in treatments [6], improving glycemic outcomes (HbA1c) [6], [7], [8], and weight [8]; and important psychological benefits, such as reduced diabetes distress [6], [9], confidence in diabetes self-care [10], and treatment satisfaction [8], [10]. Perhaps, the most important benefit is the opportunity for the person’s glycemic profile to become more visible and meaningful to both the person with diabetes and their healthcare professionals, providing enhanced understanding, engagement and motivation for changes to optimise diabetes management [8], [10], [11]. Despite the biomedical and psychological benefits shown in clinical trials, even intermittent use (e.g. every three months) may be onerous, as it is manual and intensive. In the STeP trial, up to 50% of participants withdrew or did not adhere to the manual monitoring protocol [6]. This suggests that the intensive finger-pricking required can be a barrier to real-world implementation of structured SMBG. To personalise treatment intensification, clinicians and people with type 2 diabetes need a simple, acceptable, feasible and effective method of accessing glycemic profiles.

Continuous glucose monitoring, either in real-time or retrospective (also known as ‘professional-mode’), can identify day-to-day glucose profiles to guide diabetes management, without the need for multiple daily finger pricks. For the professional-mode version, the ambulatory glucose profile is uploaded from a sensor (worn for up to 14 days) to a computer for review with a health professional. In comparison to real-time glucose monitoring, professional-mode provides at least two important potential opportunities. First, the person with type 2 diabetes is able to ‘wear & forget’, collecting up to 14 days of glucose data with potentially minimal burden on general emotional well-being and quality of life. Second, if used within a collaborative care model, the uploaded sensor data can be a powerful tool, providing ‘discovery learning’ or ‘teachable’ moments for both the person with diabetes and their clinician, with great potential for increasing satisfaction with monitoring, involvement in diabetes care decision-making and motivating changes in diabetes management. However, these hypotheses need to be tested empirically. Alternatively, it may be perceived as an added psychological burden to the person with diabetes with limited behavioral or clinical benefit.

While there is some emerging evidence for the psychological benefits of real-time flash glucose monitoring in type 2 diabetes [12], little is known about the psychological or behavioral impact of professional-mode flash glucose monitoring. In the investigator-initiated GP-OSMOTIC randomised controlled trial, there was no significant between-group difference at 12 months in HbA1c between those allocated to professional-mode flash glucose monitoring and those receiving usual care (8.2 vs 8.5% respectively) [13]. At 12 months, benefits were demonstrated in terms of time in range (7.9% higher in the flash monitoring group) and, at 6 months, HbA1c was significantly lower (difference −0.5%) [13]. There was no increase in diabetes distress, suggesting that professional-mode flash glucose monitoring did not add to the emotional burden of type 2 diabetes self-management [13].

The current study involves secondary analysis of GP-OSMOTIC study to further understand the potential impact of professional-mode flash glucose monitoring on psychological and self-care outcomes. Specifically, our aim was to investigate the impact of quarterly professional-mode flash glucose monitoring (versus usual care), over 12 months in the pragmatic management of type 2 diabetes in general practice, on general emotional well-being, diabetes-specific quality of life, satisfaction with glucose monitoring, perceived involvement in clinical care and diabetes self-care activities.