Can online and app-based interventions be used by people with diabetes to reduce diabetes distress? A protocol for a scoping review.

INTRODUCTION: Diabetes distress has been defined as "the negative emotional or affective experience resulting from the challenge of living with the demands of diabetes". Diabetes distress affects 20%-25% of individuals living with diabetes and can have negative effects on both diabetes regulation and quality of life. For people living with diabetes distress, innovative tools/interventions such as online or app-based interventions may potentially alleviate diabetes distress in a cost-effective way. The specific research questions of this scoping review are: (1) what are the effects of online or app-based interventions on diabetes distress for adults with type 1 or type 2 diabetes, and (2) what are the characteristics of these interventions (eg, type of intervention, duration, frequency, mode of delivery, underlying theories and working mechanisms)? METHODS AND ANALYSIS: A scoping review will be conducted, using the methodological framework of Arksey and O'Malley along with Levac et al. Eligible studies are: studies of adults ≥18 years old with type 1 or 2 diabetes using an online or app-based intervention and assessing diabetes distress as the primary or secondary outcome. Five databases (Medline, EMBASE, CINAHL, PsycINFO and Scopus) will be searched and is limited to articles written in English, Danish, Norwegian, Swedish or Dutch. Two reviewers will independently screen potentially eligible studies in Covidence, select studies, and together chart data, collate, summarise, and report the results. We will adhere to the Preferred reporting Items for Systematic Reviews and Meta-Analysis for Scoping Reviews (PRISMA-ScR). ETHICS AND DISSEMINATION: The scoping review has been exempt from full ethical review by the Regional Committees on Health Research Ethics for Southern Denmark (case number: S-20232000-88). The results of the review will be published in a peer-reviewed journal and presented at relevant conferences and workshops with relevant stakeholders.

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.

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.

Guided self-determination intervention versus attention control for people with type 2 diabetes in outpatient clinics: a protocol for a randomised clinical trial.

INTRODUCTION: In the management of type 2 diabetes, autonomy-supporting interventions may be a prerequisite to achieving more long-term improvement. Preliminary evidence has shown that the guided self-determination (GSD) method might have an effect on haemoglobin A1c and diabetes distress in people with type 1 diabetes. Previous trials were at risk of uncertainty. Thus, the objective is to investigate the benefits and harms of a GSD intervention versus an attention control group intervention in adults with type 2 diabetes. METHODS AND ANALYSIS: This trial protocol is guided by the The Standard Protocol Items: Recommendations for International Trials Statement. We describe the protocol for a pragmatic randomised, dual-centre, parallel-group, superiority clinical trial testing a GSD intervention versus an attention control for people with type 2 diabetes in outpatient clinics. The participants (n=224) will be recruited from two diverse regions of Denmark. The experimental stepped-care intervention will consist of three to five GSD sessions lasting up to 1 hour with a trained GSD facilitator. The sessions will be conducted face to face, by video conference or over the telephone. The attention controls will receive three to five sessions lasting up to an hour with a communication-trained healthcare professional provided face to-face, by video conference, or over the telephone. Participants will be included if they have type 2 diabetes,>18 years old, are not pregnant. Participants will be assessed before randomisation, at 5-month, and 12-month follow-up, the latter being the primary. The primary outcome is diabetes distress. Secondary outcomes are quality of life, depressive symptoms and non-serious adverse events. Exploratory outcomes are haemoglobin A1c, motivation and serious adverse events. Data will be collected using REDCap and analysed using Stata V.16. ETHICS AND DISSEMINATION: The trial will be conducted in compliance with the protocol, the Helsinki Declaration in its latest form, International Harmonisation of Good Clinical Practice guidelines and the applicable regulatory requirement(s). The trial has been approved by the Danish Data Protection Agency (P-2020-864). The Ethics Committee of the Capital Region of Denmark reviewed the trial protocol, but exempted the trial protocol from full review (H-20003638). The results of the trial will be presented at the outpatient clinics treating people with type 2 diabetes, at national and international conferences as well as to associations for people with diabetes and their relatives. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov identifier: NCT04601311.

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.

Preferring to manage by myself: A qualitative study of the perspectives of hardly reached people with type 2 diabetes on social support for diabetes management.

AIMS AND OBJECTIVES: To explore the perspectives of hardly reached people with type 2 diabetes on social support for diabetes management from their formal and informal networks. BACKGROUND: People with low socioeconomic status and poorly controlled type 2 diabetes may be categorised as hardly reached. Social support is increasingly perceived to be a cornerstone in the management of type 2 diabetes. Few studies have, however, explored social support for diabetes management from the perspective of hardly reached people. METHODS: A qualitative design with individual semi-structured interviews captured the unique perspectives of hardly reached people. Data from 14 participants were analysed using conventional content analysis. The article adheres to the COREQ guidelines for reporting qualitative research. RESULTS: Participants preferred not to involve family and friends (the informal network) in diabetes management due to dysfunctional or lacking networks, existing norms and not wanting to burden vulnerable relationships. Others simply did not perceive themselves as sick and therefore saw no need for support. Opposed to this, participants wished for continuity and a personalised relationship with health professionals (the formal network). This entailed consultations that facilitated discussion of issues of importance to the participants. CONCLUSIONS: Hardly reached people with type 2 diabetes preferred to spare their informal networks from diabetes management. Instead, they wished for more presence and individualised support from health professionals. RELEVANCE TO CLINICAL PRACTICE: It appears timely to rethink the current "one-size-fits-all" approach for people with type 2 diabetes in order to allocate resources to those most in need. It is important that health professionals elicit perceptions of support needs and potential sources of support in hardly reached people with type 2 diabetes both from the formal and from informal networks in regard to managing their diabetes. To better reach hardly reached people with type 2 diabetes, specialised education of health professionals may be necessary to capture the complex underlying dynamics influencing disease management.

Psychosocial interventions for reducing diabetes distress in vulnerable people with type 2 diabetes mellitus: a systematic review and meta-analysis.

Diabetes distress (DD) disproportionately affects vulnerable people with type 2 diabetes mellitus and interventions targeting this population are therefore relevant. A systematic review and meta-analysis was performed to assess the evidence for an effect of psychosocial interventions for reducing DD, and, secondly HbA1c, depression, and health-related quality of life in vulnerable people with type 2 diabetes mellitus. Vulnerability encompasses poor glycemic control (HbA1c >7.5%) and at least one additional risk factor for poor diabetes outcomes such as low educational level, comorbidity, and risky lifestyle behavior. The interventions should be theoretically founded and include cognition- or emotion-focused elements. We systematically searched four databases for articles published between January 1995 and March 2018. Eighteen studies testing a variety of psychosocial interventions in 4,066 patients were included. We adhered to the Cochrane methodology and PRISMA guidelines. Review Manager 5.3 was used for data extraction and risk of bias assessment, and Grades of Recommendation, Assessment, Development and Evaluation for assessing the quality of the evidence. Data were pooled using the fixed or random effects method as appropriate. We investigated effects of individual vs group, intensive vs brief interventions, and interventions with and without motivational interviewing in subgroup analyses. To assess the robustness of effect estimates, sensitivity analyses excluding studies with high risk of bias and attrition >20% were conducted. We found low to moderate quality evidence for a significant small effect of psychosocial interventions on DD, and very low to moderate quality evidence for no effect on HbA1c, both outcomes assessed at 3, 6, 12, and 24 months follow-up. The effect on depression was small, while there was no effect on health-related quality of life. Exploratory subgroup analyses suggested that interventions using motivational interviewing and individual interventions were associated with incremental effects on DD. Likewise, intensive interventions were associated with significant reductions in both DD and HbA1c.

The influence of diabetes distress on digital interventions for diabetes management in vulnerable people with type 2 diabetes: A qualitative study of patient perspectives.

BACKGROUND: Digital interventions for improving diabetes management in Type 2 diabetes mellitus (T2DM) are used universally. Digital interventions are defined as any intervention accessed and taking input from people with T2DM in the form of a web-based or mobile phone-based app to improve diabetes self-management. However, the current confidence in digital interventions threatens to augment social inequalities in health, also known as the "digital divide". To counteract dissemination of the digital divide, we aimed to assess the potential of a tailored digital intervention for improving diabetes management in vulnerable people with T2DM. METHODS: A qualitative design using semi-structured in-depth interviews to explore the perspectives of 12 vulnerable people with T2DM. Interviews were analyzed using inductive content analysis. Vulnerability was defined by the presence of one or more comorbidities, one or more lifestyle risk factors, poor diabetes management, low educational level and low health literacy. RESULTS: The main themes identified were: "Dealing with diabetes distress" characterized by psychological avoidance mechanisms; "Suffering informational confusion" dealing with inconsistent information; "Experiencing digital alienation" dealing with loss of freedom when technology invades the private sphere; and "Missing the human touch" preferring human interaction over digital contact. CONCLUSION: Vulnerable people with T2DM are unprepared for digital interventions for disease management. Experiencing diabetes distress may be an intermediate mechanism leading to nonadherence to digital interventions and the preference for human interaction in vulnerable people with T2DM. Future interventions could include a designated caregiver and an allocated buddy to provide support and assist uptake of digital interventions for diabetes management.

Cardiovascular autonomic neuropathy and subclinical cardiovascular disease in normoalbuminuric type 1 diabetic patients.

Cardiovascular autonomic neuropathy (CAN) is associated with increased mortality in diabetes. Since CAN often develops in parallel with diabetic nephropathy as a confounder, we aimed to investigate the isolated impact of CAN on cardiovascular disease in normoalbuminuric patients. Fifty-six normoalbuminuric, type 1 diabetic patients were divided into 26 with (+) and 30 without (-) CAN according to tests of their autonomic nerve function. Coronary artery plaque burden and coronary artery calcium score (CACS) were evaluated using computed tomography. Left ventricular function was evaluated using echocardiography. Blood pressure and electrocardiography were recorded through 24 h to evaluate nocturnal drop in blood pressure (dipping) and pulse pressure. In patients +CAN compared with -CAN, the CACS was higher, and only patients +CAN had a CACS >400. A trend toward a higher prevalence of coronary plaques and flow-limiting stenosis in patients +CAN was nonsignificant. In patients +CAN, left ventricular function was decreased in both diastole and systole, nondipping was more prevalent, and pulse pressure was increased compared with -CAN. In multivariable analysis, CAN was independently associated with increased CACS, subclinical left ventricular dysfunction, and increased pulse pressure. In conclusion, CAN in normoalbuminuric type 1 diabetic patients is associated with distinct signs of subclinical cardiovascular disease.