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.

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.

HighlightsInformants had several barriers towards the use of digital interventions.Diabetes distress may lead to poor adaption of digital interventions.An appropriate buddy may pave the way to better diabetes management.Informants preferred contact with a designated caregiver rather than digital interventions.Diabetes distress was a central issue requiring attention in this group of patients.

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

BackgroundExisting 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/designWe 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 health care 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 outcome 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.DiscussionSelf-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 The protocol has been registered in PROSPERO ID nr. CRD42020181144 on the 5th July 2020.

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.

IntroductionIn 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 analysisThis 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 disseminationThe 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 numberClinicalTrials.gov identifier: NCT04601311.

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. 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 health care 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 outcome will be glycated haemoglobin. 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 The protocol has been registered in PROSPERO ID nr. 181144 (submitted to PROSPERO 24th April 2020)