Perceived glucose levels matter more than CGM-based data in predicting diabetes distress in type 1 or type 2 diabetes: a precision mental health approach using n-of-1 analyses.

AIMS/HYPOTHESIS: Diabetes distress is one of the most frequent mental health issues identified in people with type 1 and type 2 diabetes. Little is known about the role of glucose control as a potential contributor to diabetes distress and whether the subjective perception of glucose control or the objective glycaemic parameters are more important for the experience. With the emergence of continuous glucose monitoring (CGM), this is a relevant question as glucose values are now visible in real-time. We employed a precision monitoring approach to analyse the independent associations of perceived and measured glucose control with diabetes distress on a daily basis. By using n-of-1 analyses, we aimed to identify individual contributors to diabetes distress per person and analyse the associations of these individual contributors with mental health at a 3 month follow-up. METHODS: In this prospective, observational study, perceived (hypoglycaemia/hyperglycaemia/glucose variability burden) and measured glucose control (time in hypoglycaemia and hyperglycaemia, CV) were assessed daily for 17 days using an ecological momentary assessment (EMA) approach with a special EMA app and CGM, respectively. Mixed-effect regression analysis was performed, with daily diabetes distress as the dependent variable and daily perceived and CGM-measured metrics of glucose control as random factors. Individual regression coefficients of daily distress with perceived and CGM-measured metrics were correlated with levels of psychosocial well-being at a 3 month follow-up. RESULTS: Data from 379 participants were analysed (50.9% type 1 diabetes; 49.6% female). Perceived glucose variability (t=14.360; p<0.0001) and perceived hyperglycaemia (t=13.637; p<0.0001) were the strongest predictors of daily diabetes distress, while CGM-based glucose variability was not significantly associated (t=1.070; p=0.285). There was great heterogeneity between individuals in the associations of perceived and measured glucose parameters with diabetes distress. Individuals with a stronger association between perceived glucose control and daily distress had more depressive symptoms (ß=0.32), diabetes distress (ß=0.39) and hypoglycaemia fear (ß=0.34) at follow-up (all p<0.001). Individuals with a stronger association between CGM-measured glucose control and daily distress had higher levels of psychosocial well-being at follow-up (depressive symptoms: ß=-0.31; diabetes distress: ß=-0.33; hypoglycaemia fear: ß=-0.27; all p<0.001) but also higher HbA1c (ß=0.12; p<0.05). CONCLUSIONS/INTERPRETATION: Overall, subjective perceptions of glucose seem to be more influential on diabetes distress than objective CGM parameters of glycaemic control. N-of-1 analyses showed that CGM-measured and perceived glucose control had differential associations with diabetes distress and psychosocial well-being 3 months later. The results highlight the need to understand the individual drivers of diabetes distress to develop personalised interventions within a precision mental health approach.

Roles and competencies of the clinical psychologist in adult diabetes care-A consensus report.

AIMS: Psychological care is recognised as an integral part of quality diabetes care. We set out to describe the roles and competencies of the clinical psychologist as a member of the multidisciplinary adult diabetes care team, focused on secondary care. METHODS: The authors are clinically experienced psychologists involved in adult diabetes care, from Australia, Europe and North America, and active members of the international psychosocial aspects of diabetes study group. Consensus was reached as a group on the roles and competencies of the clinical psychologist working in adult diabetes secondary care, building both on expert opinion and a selective review and discussion of the literature on psychological care in diabetes, clinical guidelines and competency frameworks. RESULTS: The clinical psychologist fulfils multiple roles: (1) as a clinician (psychological assessment and therapy), (2) as advisor to the healthcare team (training, consulting), (3) as a communicator and promotor of person-centred care initiatives and (4) as a researcher. Four competencies that are key to successfully fulfilling the above-mentioned roles in a diabetes setting are as follows: (a) specialised knowledge, (b) teamwork and advice, (c) assessment, (d) psychotherapy (referred to as STAP framework). CONCLUSIONS: The roles and competencies of clinical psychologists working in diabetes extend beyond the requirements of most university and post-graduate curricula. There is a need for a comprehensive, accredited specialist post-graduate training for clinical psychologists working in diabetes care, building on the proposed STAP framework. This calls for a collaborative effort involving diabetes organisations, clinical psychology societies and diabetes psychology interest groups.

Person-reported outcomes in diabetes care: What are they and why are they so important?

In this review, we aim to show how person-reported outcomes (PROs) and person-reported experiences (PREs) can significantly contribute to the way diabetes care is delivered, the involvement of people with diabetes in diabetes care, and the collaboration between health care professionals and people with diabetes. This review focuses on the definition and measurement of PROs and PREs, the importance of PROs and PREs for person-centred diabetes care, and integrating the perspectives of people with diabetes in the evaluation of medical, psychological and technological interventions. PROs have been increasingly accepted by Health Technology Assessment bodies and are therefore valued in the context of reimbursement decisions and consequently by regulators and other health care stakeholders for the allocation of health care resources. Furthermore, the review identified current challenges to the assessment and use of PROs and PREs in clinical care and research. These challenges relate to the combination of questionnaires and ecological momentary assessment for measuring PROs and PREs, lack of consensus on a core outcome set, limited sensitivity to change within many measures and insufficient standardization of what can be considered a minimal clinically important difference. Another issue that has not been sufficiently addressed is the involvement of people with diabetes in the design and development of measures to assess PROs and PREs.

Fear of Hypoglycemia and Diabetes Distress: Expected Reduction by Glucose Prediction.

BACKGROUND: Extended glucose predictions are novel in diabetes management. Currently, there is no solution widely available. People with diabetes mellitus (DM) are offered features like trend arrows and limited predictions linked to predefined situations. Thus, the impact of extended glucose predictions on the burden of diabetes and person-reported outcomes (PROs) is unclear. METHODS: In this online survey, 206 people with type 1 and type 2 diabetes (T1D and T2D), 70.9% and 29.1%, respectively, who participated in the dia·link online panel and were current continuous glucose monitoring (CGM) users, were presented with different scenarios of hypothetical extended glucose predictions. They were asked to imagine how low glucose predictions of 30 minutes and overnight as well as glucose predictions up to 2 hours would influence their diabetes management. Subsequently, they completed the Hypoglycemia Fear Survey II (HFS-II) and the T1 Diabetes Distress Scale (T1-DDS) by rating each item on a 5-point scale (-2: strong deterioration to +2: strong improvement) according to the potential change due to using glucose predictions. RESULTS: For all glucose prediction periods, 30 minutes, up to 2 hours, and at nighttime, the surveyed participants expected moderate improvements in both fear of hypoglycemia (HFS-II: 0.57 ± 0.49) and overall diabetes distress (T1-DDS = 0.44 ± 0.49). The T1-DDS did not differ for type of therapy or diabetes. CONCLUSIONS: People with T1D and T2D would see glucose predictions as a potential improvement regarding reduced fear of hypoglycemia and diabetes distress. Therefore, glucose predictions represent a value for them in lowering the burden of diabetes and its management.

Efficacy of a Digital Diabetes Logbook for People With Type 1, Type 2, and Gestational Diabetes: Results From a Multicenter, Open-Label, Parallel-Group, Randomized Controlled Trial.

BACKGROUND: In a randomized controlled trial, the efficacy of a digital diabetes diary regarding a reduction of diabetes distress was evaluated. METHODS: A randomized controlled trial with a 12-week follow-up was conducted in 41 study sites across Germany. Key eligibility criteria were a diagnosis of type 1, type 2, or gestational diabetes and regular self-monitoring of blood glucose. Participants were randomly assigned (2:1 ratio) to either use the digital diabetes logbook (mySugr PRO), or to the control group without app use. The primary outcome was the reduction in diabetes distress at the 12-week follow-up. All analyses were based on the intention-to-treat population with all randomized participants. The trial was registered at the German Register for Clinical Studies (DRKS00022923). RESULTS: Between February 11, 2021, and June 24, 2022, 424 participants (50% female, 50% male) were included, with 282 being randomized to the intervention group (66.5%) and 142 to the control group (33.5%). A total of 397 participants completed the trial (drop-out rate: 6.4%). The median reduction in diabetes distress was 2.41 (interquartile range [IQR]: -2.50 to 8.11) in the intervention group and 1.25 (IQR: -5.00 to 7.50) in the control group. The model-based adjusted between-group difference was significant (-2.20, IQR: -4.02 to -0.38, P = .0182) favoring the intervention group. There were 27 adverse events, 17 (6.0%) in the intervention group, and 10 (7.0%) in the control group. CONCLUSIONS: The efficacy of the digital diabetes logbook was demonstrated regarding improvements in mental health in people with type 1, type 2, and gestational diabetes.