Standardising personalised diabetes care across European health settings: A person-centred outcome set agreed in a multinational Delphi study.

OBJECTIVE: Standardised person-reported outcomes (PRO) data can contextualise clinical outcomes enabling precision diabetes monitoring and care. Comprehensive outcome sets can guide this process, but their implementation in routine diabetes care has remained challenging and unsuccessful at international level. We aimed to address this by developing a person-centred outcome set for Type 1 and Type 2 diabetes, using a methodology with prospects for increased implementability and sustainability in international health settings. METHODS: We used a three-round questionnaire-based Delphi study to reach consensus on the outcome set. We invited key stakeholders from 19 countries via purposive snowball sampling, namely people with diabetes (N = 94), healthcare professionals (N = 65), industry (N = 22) and health authorities (N = 3), to vote on the relevance and measurement frequency of 64 previously identified clinical and person-reported outcomes. Subsequent consensus meetings concluded the study. RESULTS: The list of preliminary outcomes was shortlisted via the consensus process to 46 outcomes (27 clinical outcomes and 19 PROs). Two main collection times were recommended: (1) linked to a medical visit (e.g. diabetes-specific well-being, symptoms and psychological health) and (2) annually (e.g. clinical data, general well-being and diabetes self management-related outcomes). CONCLUSIONS: PROs are often considered in a non-standardised way in routine diabetes care. We propose a person-centred outcome set for diabetes, specifically considering psychosocial and behavioural aspects, which was agreed by four international key stakeholder groups. It guides standardised collection of meaningful outcomes at scale, supporting individual and population level healthcare decision making. It will be implemented and tested in Europe as part of the H2O project.

Which diabetes specific patient reported outcomes should be measured in routine care? A systematic review to inform a core outcome set for adults with Type 1 and 2 diabetes mellitus: The European Health Outcomes Observatory (H2O) programme.

OBJECTIVES: The objective was to identify candidate patient reported outcomes with potential to inform individual patient care and service development for inclusion in a digital outcome set to be collected in routine care, as part of an international project to enhance care outcomes for people with diabetes. METHODS: PubMed, COSMIN and COMET databases were searched. Published studies were included if they recommended patient reported outcomes that were clinically useful and/or important to people with diabetes. To aid selection decisions, recommended outcomes were considered in terms of the evidence endorsing them and their importance to people with diabetes. RESULTS: Twenty-seven studies recommending 53 diabetes specific outcomes, and patient reported outcome measures, were included. The outcomes reflected the experience of living with diabetes (e.g. psychological well-being, symptom experience, health beliefs and stigma) and behaviours (e.g. self-management). Diabetes distress and self-management behaviours were most endorsed by the evidence. CONCLUSIONS: The review provides a comprehensive list of candidate outcomes endorsed by international evidence and informed by existing outcome sets, and suggestions for measures. PRACTICE IMPLICATIONS: The review offers evidence to guide clinical application. Integrated measurement of these outcomes in care settings holds enormous potential to improve provision of care and outcomes in diabetes.

Self-determination theory interventions versus usual care in people with diabetes: a systematic review with meta-analysis and trial sequential analysis.

BACKGROUND: Autonomy-supporting interventions, such as self-determination theory and guided self-determination interventions, may improve self-management and clinical and psychosocial outcomes in people with diabetes. Such interventions have never been systematically reviewed assessing both benefits and harms and concurrently controlling the risks of random errors using trial sequential analysis methodology. This systematic review investigates the benefits and harms of self-determination theory-based interventions compared to usual care in people with diabetes. METHODS: We used the Cochrane methodology. Randomized clinical trials assessing interventions theoretically based on guided self-determination or self-determination theory in any setting were eligible. A comprehensive search (latest search April 2022) was undertaken in CENTRAL, MEDLINE, Embase, LILACS, PsycINFO, SCI-EXPANDED, CINAHL, SSCI, CPCI-S, and CPCI-SSH to identify relevant trials. Two authors independently screened, extracted data, and performed risk-of-bias assessment of included trials using the Cochrane risk-of-bias tool 1.0. Our primary outcomes were quality of life, all-cause mortality, and serious adverse events. Our secondary outcomes were diabetes distress, depressive symptoms, and nonserious adverse events not considered serious. Exploratory outcomes were glycated hemoglobin and motivation (autonomy, controlled, amotivation). Outcomes were assessed at the end of the intervention (primary time point) and at maximum follow-up. The analyses were conducted using Review Manager 5.4 and Trial Sequential Analysis 0.9.5.10. Certainty of the evidence was assessed by GRADE. RESULTS: Our search identified 5578 potentially eligible studies of which 11 randomized trials (6059 participants) were included. All trials were assessed at overall high risk of bias. We found no effect of self-determination theory-based interventions compared with usual care on quality of life (mean difference 0.00 points, 95% CI -4.85, 4.86, I2 = 0%; 225 participants, 3 trials, TSA-adjusted CI -11.83, 11.83), all-cause mortality, serious adverse events, diabetes distress, depressive symptoms, adverse events, glycated hemoglobulin A1c, or motivation (controlled). The certainty of the evidence was low to very low for all outcomes. We found beneficial effect on motivation (autonomous and amotivation; low certainty evidence). CONCLUSIONS: We found no effect of self-determination-based interventions on our primary or secondary outcomes. The evidence was of very low certainty. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42020181144.

Significant reduction in diabetes distress and improvements in psychosocial outcomes: A pilot test of an intervention to reduce diabetes distress in adults with type 1 diabetes and moderate-to-severe diabetes distress (REDUCE).

AIM: To pilot-test an intervention, co-designed with people with type 1 diabetes (T1DM) and diabetes specialist nurses, to reduce diabetes distress (DD) in adults with T1DM and moderate-to-severe DD. METHODS: A group-based programme to reduce DD in people with T1DM and moderate-to-severe DD (REDUCE) was pilot-tested in four groups with five bi-weekly two and a half-hour meetings facilitated by two trained diabetes specialist nurses. Data collection included baseline and post-intervention questionnaires measuring DD and psychosocial outcomes and semi-structured interviews with participants post-intervention (n = 18). Data were analysed using descriptive statistics and systematic text condensation. RESULTS: Twenty-five adults with T1DM participated in the study. The median age and diabetes duration of participants were 50 (IQR: 32;57.5) years and 26 (IQR: 18;45) years, respectively. Seventeen (68%) were women. The pilot study showed a significant reduction in DD (measured by Type 1 Diabetes Distress Scale) between baseline and post-intervention from 2.6 ± 0.7 to 1.9 ± 0.6 (mean ± SD) (p < 0.001). The largest reductions were seen on the subscales: powerlessness 1.2 ± 1.1, eating distress 0.9 ± 1.2 and fear of hypoglycaemia 0.8 ± 1.0 (mean ± SD). Significant improvements were also seen for quality of life, diabetes empowerment and emotion regulation. Qualitative data showed that REDUCE supported participants in verbalizing emotions and seeing worries in a more constructive perspective. Acknowledgement of negative diabetes experiences eased negative self-judgments. Sharing experiences among peers increased relatedness and reduced loneliness. CONCLUSION: Participation in REDUCE was associated with significant reduction in DD and significant increase in quality of life. Larger scale studies are planned to determine sustained effectiveness of REDUCE.

Person-specific evidence has the ability to mobilize relational capacity: A four-step grounded theory developed in people with long-term health conditions.

Person-specific evidence was developed as a grounded theory by analyzing 20 selected case descriptions from interventions using the guided self-determination method with people with various long-term health conditions. It explains the mechanisms of mobilizing relational capacity by including person-specific evidence in shared decision-making. Person-specific self-insight was the first step, achieved as individuals completed reflection sheets enabling them to clarify their personal values and identify actions or omissions related to self-management challenges. This step paved the way for sharing these insights and challenges in a relationship with a supportive health professional, who could then rely on person-specific evidence instead of assumptions or a narrow disease perspective for shared decision-making. Trust in the evidence encouraged the supportive health professional to transfer it to the interdisciplinary team. Person-specific evidence then enhanced the ability of team members to apply general evidence in a meaningful way. The increased openness achieved by individuals through these steps enabled them to eventually share their new self-insights in daily life with other people, decreasing loneliness they experienced in self-management. Relational capacity, the core of the theory, is mobilized in both people with long-term health conditions and healthcare professionals. Further research on person-specific evidence and relational capacity in healthcare is recommended.

Psychosocial aspects and perspectives of adult-onset type 1 diabetes: A systematic scoping review.

AIM: To map existing research on psychosocial aspects of adult-onset type 1 diabetes (T1D), including psychosocial health status, ways psychosocial aspects may affect management of T1D in everyday life, and interventions targeting management of adult-onset T1D. METHODS: We conducted a systematic search in MEDLINE, EMBASE, CINAHL and PsycInfo. Search results were screened with predefined eligibility criteria, followed by data extraction of the included studies. Charted data were summarized in narrative and tabular form. RESULTS: We included 10 reports describing nine studies from the 7302 identified in the search. All studies were conducted in Europe. Participant characteristics were missing in several studies. Five of the nine studies incorporated psychosocial aspects as the main aim of the study. Limited information on psychosocial aspects was available in the remaining studies. We identified three overarching themes related to psychosocial aspects: (1) the impact of the diagnosis on everyday life, (2) the influence of psychosocial health on metabolic levels and adaptation, and (3) provision of self-management support. CONCLUSIONS: Research focussing on psychosocial aspects of the adult-onset population is scarce. Future research should involve participants across the adult life age span and from a wider geographical area. Sociodemographic information should be collected to explore different perspectives. Further exploration of suitable outcome measures considering adults' limited experience of living with the condition is needed. This would help to better understand how psychosocial aspects may affect management of T1D in everyday life and thus enable healthcare professionals to provide appropriate support to adults with new-onset T1D.

Psychosocial interventions for adults with newly diagnosed chronic disease: A systematic review.

While the need for psychosocial interventions in the early formative period of chronic disease diagnosis is widely acknowledged, little is known about the currently available interventions and what they entail. This review sought to collate existing interventions to synthesize their active ingredients. A systematic search on five electronic databases yielded 2910 records, 12 of which were eligible for this review. Evidence synthesis revealed three broad categories of interventions which used at least two out of eight active techniques. Future studies should adhere to known frameworks for intervention development, and focus on developing core outcome measures to enhance evidence synthesis.

A co-design study to develop supportive interventions to improve psychological and social adaptation among adults with new-onset type 1 diabetes in Denmark and the UK.

OBJECTIVE: To develop supportive interventions for adults with new-onset type 1 diabetes (T1D) to facilitate positive adaptive strategies during their transition into a life with diabetes. DESIGN: The study used a co-design approach informed by Design Thinking to stimulate participants' reflections on their experiences of current care and generate ideas for new supportive interventions. Visual illustrations were used to depict support needs and challenges. Initial discussions of these needs and challenges were facilitated by researchers and people with diabetes in workshops. Data comprising transcribed audio recordings of the workshop discussions and materials generated during the workshops were analysed thematically. SETTINGS: Specialised diabetes centres in Denmark and the United Kingdom. PARTICIPANTS: Adults with new-onset T1D (n=24) and healthcare professionals (HCPs) (n=56) participated in six parallel workshops followed by four joint workshops with adults (n=29) and HCPs (n=24) together. RESULTS: The common solution prioritised by both adults with new-onset T1D and HCP participants was the development of an integrated model of care addressing the psychological and social elements of the diagnosis, alongside information on diabetes self-management. Participants also indicated a need to develop the organisation, provision and content of care, along with the skills HCPs need to optimally deliver that care. The co-designed interventions included three visual conversation tools that could be used flexibly in the care of adults with new-onset T1D to support physical, psychological and social adaptation to T1D. CONCLUSION: This co-design study has identified the care priorities for adults who develop T1D, along with some practical conversational tools that may help guide HCPs in attending to the disruptive experience of the diagnosis and support adults in adjusting into a life with diabetes.

Self-determination theory interventions versus usual care in people with diabetes: a protocol for a systematic review with meta-analysis and trial sequential analysis.

BACKGROUND: Existing self-management and behavioural interventions for diabetes vary widely in their content, and their sustained long-term effectiveness is uncertain. Autonomy supporting interventions may be a prerequisite to achieve 'real life' patient engagement and more long-term improvement through shared decision-making and collaborative goal setting. Autonomy supportive interventions aim to promote that the person with diabetes' motivation is autonomous meaning that the person strives for goals they themselves truly believe in and value. This is the goal of self-determination theory and guided self-determination interventions. Self-determination theory has been reviewed but without assessing both benefits and harms and accounting for the risk of random errors using trial sequential analysis. The guided self-determination has not yet been systematically reviewed. The aim of this protocol is to investigate the benefits and harms of self-determination theory-based interventions versus usual care in adults with diabetes. METHODS/DESIGN: We will conduct the systematic review following The Cochrane Collaboration guidelines. This protocol is reported according to the PRISMA checklist. A comprehensive search will be undertaken in the CENTRAL, MEDLINE, EMBASE, LILACS, PsycINFO, SCI-EXPANDED, CINAHL, SSCI, CPCI-S and CPCI-SSH to identify relevant trials. We will include randomised clinical trials assessing interventions theoretically based on guided self-determination or self-determination theory provided face-to-face or digitally by any healthcare professional in any setting. The primary outcomes will be quality of life, mortality, and serious adverse events. The secondary will be diabetes distress, depressive symptoms and adverse events not considered serious. Exploratory outcomes will be glycated haemoglobin and motivation. Outcomes will be assessed at the end of the intervention and at maximum follow-up. The analyses will be performed using Stata version 16 and trial sequential analysis. Two authors will independently screen, extract data from and perform risk of bias assessment of included studies using the Cochrane risk of bias tool. Certainty of the evidence will be assessed by GRADE. DISCUSSION: Self-determination theory interventions aim to promote a more autonomous patient engagement and are commonly used. It is therefore needed to evaluate the benefit and harms according to existing trials. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42020181144.

Couples living with type 1 diabetes: An integrative review of the impacts on health and wellbeing.

Impacts of type 1 diabetes and relationship factors on health and wellbeing of both persons with diabetes and partners (T1D partners) have not been investigated. Integrative review methods evaluated the evidence. From 323 titles, we included 24 studies involving 16,083 persons with diabetes and 1020 T1D partners. Studies were quantitative (n = 13), qualitative (n = 9) and mixed methods (n = 2). Maintaining resilient, good quality, intimate relationships optimises physical and psychological outcomes for persons with diabetes. Partners experience disturbed sleep and while general psychological health is maintained, distress surrounding hypoglycaemia is overwhelming for over a third of partners. Nurturing quality relationships could reap significant health benefits.

The impact of the COVID-19 pandemic on people with diabetes and diabetes services: A pan-European survey of diabetes specialist nurses undertaken by the Foundation of European Nurses in Diabetes survey consortium.

AIM: To describe diabetes nurses' perspectives on the impact of the COVID-19 pandemic on people with diabetes and diabetes services across Europe. METHODS: An online survey developed using a rapid Delphi method. The survey was translated into 17 different languages and disseminated electronically in 27 countries via national diabetes nurse networks. RESULTS: Survey responses from 1829 diabetes nurses were included in the analysis. The responses indicated that 28% (n = 504) and 48% (n = 873) of diabetes nurses felt the COVID-19 pandemic had impacted 'a lot' on the physical and psychological risks of people with diabetes, respectively. The following clinical problems were identified as having increased 'a lot': anxiety 82% (n = 1486); diabetes distress 65% (n = 1189); depression 49% (n = 893); acute hyperglycaemia 39% (n = 710) and foot complications 18% (n = 323). Forty-seven percent (n = 771) of respondents identified that the level of care provided to people with diabetes had declined either extremely or quite severely. Self-management support, diabetes education and psychological support were rated by diabetes nurse respondents as having declined extremely or quite severely during the COVID-19 pandemic by 31% (n = 499), 63% (n = 1,027) and 34% (n = 551), respectively. CONCLUSION: The findings show that diabetes nurses across Europe have seen significant increases in both physical and psychological problems in their patient populations during COVID-19. The data also show that clinical diabetes services have been significantly disrupted. As the COVID-19 situation continues, we need to adapt care systems with some urgency to minimise the impact of the pandemic on the diabetes population.

The Process of Adaptation Following a New Diagnosis of Type 1 Diabetes in Adulthood: A Meta-Synthesis.

While Type 1 diabetes (T1D) is generally associated with childhood, half of all cases occur in adulthood. The adaptive strategies individuals employ during the initial adaptive phase may have an important impact on their risk of future diabetes complications and their psychosocial well-being. We conducted a systematic review of six databases and included nine qualitative studies in a meta-synthesis, the aims of which were to develop a better understanding of how adults newly diagnosed with T1D experience the diagnosis and the phenomena associated with the early process of adaptation to life with diabetes. The meta-synthesis identified five constructs that shaped and influenced the early adaptive process: disruption, constructing a personal view of diabetes, reconstructing a view of self, learning to live with diabetes, and behavioral adaptations. The adaptive processes of adults to a diabetes diagnosis are highly referenced to prior life experiences, social habitus, and psychological orientation.

The detection and management of diabetes distress in people with type 1 diabetes.

Diabetes distress (DD) represents a significant clinical burden in which levels of DD are related to both glycated haemoglobin (HbA1c) and some self-management behaviours. DD is related to, but different from, depression. Differences in DD experienced in people with type 1 and type 2 diabetes have been observed. Commonly measured using the Problem Areas in Diabetes Scale (PAID) and the Diabetes Distress Scale (DDS), rates of elevated DD in research study participants range from 20 to 30 %. Risk factors for elevated DD in type 1 diabetes are longer duration of diabetes, severe hypoglycaemia, younger age and being female. A systematic review of intervention studies assessing DD identified eight randomised controlled trials (RCTs) and nine pre-post design studies. Only three studies targeted DD with the intervention. Intervention types were diabetes self-management education (DSME), psychologically informed self-management and devices. DSME pre-post studies, namely the Dose Adjustment For Normal Eating (DAFNE) programme, produced more consistent improvements in DD and HbA1c at follow-up. Psychologically informed self-management was more heterogeneous, but several RCTs were effective in reducing DD. Group interventions offered the greatest benefits across intervention designs.

Out-of-office hours nurse-driven acute telephone counselling service in a large diabetes outpatient clinic: A mixed methods evaluation.

OBJECTIVE: To map the usage of out-of-office hours acute telephone counselling (ATC) provided by diabetes specialist nurses (n=18) for diabetes patients to explore potentials for improvement. METHODS: A mixed methods study involved mapping of ATC-usage during 6 months and a retrospective audit of frequent users. RESULTS: Altogether, 3197 calls were registered that were related to 592 individual patients, corresponding to 10% of the population. Proportionally more users suffered from type 1 diabetes (p<0.001). ATC-users' mean HbA1c was 8.8% (73 mmol/mol) compared to 8.1% (65 mmol/mol) for all patients attending the clinic (p<0.001). Hyperglycaemia was the most frequent reason for calling. The use of ATC likely prevented 15 admissions. More than half of the calls came from general nurses based in the community (n=619) and general nurses and nursing assistants based in care homes (n=1018). The majority (75%) of patients called less than five times. However, 8% called 16 times or more accounting for 52% of all calls. A retrospective audit identified them as physically and/or psychologically fragile patients. CONCLUSION: Hyperglycaemia was the most frequent reason for calling, and insulin dose adjustment the most frequent advice given. PRACTICE IMPLICATIONS: Frequent users identified need additional support.