Depression presents in roughly 20% of people with diabetes worldwide, and adversely affects quality of life and treatment outcomes. The causes of depression in diabetes are poorly understood, but ...research suggests a bi-directional association, at least for type 2 diabetes. Inconsistent findings regarding prevalence and depression treatment outcomes in patients with diabetes seem partly attributable to inconsistencies in the definition and measurement of depression and in distinguishing it from diabetes-distress, a psychological concept related to depression. We review evidence suggesting that diabetes-distress and depression are correlated and overlapping constructs, but are not interchangeable. Importantly, diabetes-distress seems to mediate the association between depression and glycaemic control. We propose a model to explain the direct and indirect effects of depression and diabetes-distress on glycaemic control. Additionally, using emerging insights from data-driven approaches, we suggest three distinct symptom profiles to define depression in patients with diabetes that could help explain differential associations between depression and metabolic abnormalities, and to tailor interventions for depression. Future research should focus on further refining depression profiles in patients with diabetes, taking into account the natural history of diabetes and depression, clinical characteristics, and diabetes-distress. The assessment of diabetes-distress and depression in research and clinical practice will be essential to identify high-risk patients with different mental health needs.
The American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD) convened a writing group to develop a consensus statement on the management of type 1 diabetes in ...adults. The writing group has considered the rapid development of new treatments and technologies and addressed the following topics: diagnosis, aims of management, schedule of care, diabetes self-management education and support, glucose monitoring, insulin therapy, hypoglycaemia, behavioural considerations, psychosocial care, diabetic ketoacidosis, pancreas and islet transplantation, adjunctive therapies, special populations, inpatient management and future perspectives. Although we discuss the schedule for follow-up examinations and testing, we have not included the evaluation and treatment of the chronic microvascular and macrovascular complications of diabetes as these are well-reviewed and discussed elsewhere. The writing group was aware of both national and international guidance on type 1 diabetes and did not seek to replicate this but rather aimed to highlight the major areas that healthcare professionals should consider when managing adults with type 1 diabetes. Though evidence-based where possible, the recommendations in the report represent the consensus opinion of the authors.
Graphical abstract
The American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD) convened a writing group to develop a consensus statement on the management of type 1 diabetes in ...adults. The writing group has considered the rapid development of new treatments and technologies and addressed the following topics: diagnosis, aims of management, schedule of care, diabetes self-management education and support, glucose monitoring, insulin therapy, hypoglycemia, behavioral considerations, psychosocial care, diabetic ketoacidosis, pancreas and islet transplantation, adjunctive therapies, special populations, inpatient management, and future perspectives. Although we discuss the schedule for follow-up examinations and testing, we have not included the evaluation and treatment of the chronic microvascular and macrovascular complications of diabetes as these are well-reviewed and discussed elsewhere. The writing group was aware of both national and international guidance on type 1 diabetes and did not seek to replicate this but rather aimed to highlight the major areas that health care professionals should consider when managing adults with type 1 diabetes. Though evidence-based where possible, the recommendations in the report represent the consensus opinion of the authors.
Patients with type 1 diabetes who have impaired awareness of hypoglycaemia have a three to six times increased risk of severe hypoglycaemia. We aimed to assess whether continuous glucose monitoring ...(CGM) improves glycaemia and prevents severe hypoglycaemia compared with self-monitoring of blood glucose (SMBG) in this high-risk population.
We did a randomised, open-label, crossover trial (IN CONTROL) at two medical centres in the Netherlands. Eligible participants were patients diagnosed with type 1 diabetes according to American Diabetes Association criteria, aged 18-75 years, with impaired awareness of hypoglycaemia as confirmed by a Gold score of at least 4, and treated with either continuous subcutaneous insulin infusion or multiple daily insulin injections and doing at least three SMBG measurements per day. After screening, re-education about diabetes management, and a 6-week run-in phase (to obtain baseline CGM data), we randomly assigned patients (1:1) with a computer-generated allocation sequence (block size of four) to either 16 weeks of CGM followed by 12 weeks of washout and 16 weeks of SMBG, or 16 weeks of SMBG followed by 12 weeks of washout and 16 weeks of CGM (where the SMBG phase was the control). During the CGM phase, patients used a real-time CGM system consisting of a Paradigm Veo system with a MiniLink transmitter and an Enlite glucose sensor (Medtronic, CA, USA). During the SMBG phase, patients were equipped with a masked CGM device, consisting of an iPro 2 continuous glucose monitor and an Enlite glucose sensor, which does not display real-time glucose values. The number of SMBG measurements per day and SMBG systems were not standardised between patients, to mimic real-life conditions. During both intervention periods, patients attended follow-up visits at the centres each month and had telephone consultations 2 weeks after each visit inquiring about adverse events, episodes of hypoglycaemia, etc. The primary endpoint was the mean difference in percentage of time spent in normoglycaemia (4-10 mmol/L) over the total intervention periods, analysed on an intention-to-treat basis. Severe hypoglycaemia (requiring third party assistance) was a secondary endpoint. This trial is registered with ClinicalTrials.gov, number NCT01787903.
Between March 4, 2013, and Feb 9, 2015, we recruited and randomly assigned 52 patients to either the CGM-SMBG sequence (n=26) or the SMBG-CGM sequence (n=26). The last patient visit was on March 21, 2016. Time spent in normoglycaemia was higher during CGM than during SMBG: 65·0% (95% CI 62·8-67·3) versus 55·4% (53·1-57·7; mean difference 9·6%, 95% CI 8·0-11·2; p<0·0001), with reductions in both time spent in hypoglycaemia (ie, blood glucose ≤3·9 mmol/L 6·8% vs 11·4%, mean difference 4·7%, 3·4-5·9; p<0·0001) and time spent in hyperglycaemia (ie, blood glucose >10 mmol/L 28·2% vs 33·2%, mean difference 5·0%, 3·1-6·9; p<0·0001). During CGM, the number of severe hypoglycaemic events was lower (14 events vs 34 events, p=0·033). Five serious adverse events other than severe hypoglycaemia occurred during the trial, but all were deemed unrelated to the trial intervention. Additionally, no mild to moderate adverse events were related to the trial intervention.
CGM increased time spent in normoglycaemia and reduced severe hypoglycaemia in patients with type 1 diabetes and impaired awareness of hypoglycaemia, compared with SMBG. Our results support the concept of using CGM in this high-risk population.
Eli Lilly and Sanofi.
Little is known about clinically relevant changes in guided Internet-based interventions for depression. Moreover, methodological and power limitations preclude the identification of patients' groups ...that may benefit more from these interventions. This study aimed to investigate response rates, remission rates, and their moderators in randomized controlled trials (RCTs) comparing the effect of guided Internet-based interventions for adult depression to control groups using an individual patient data meta-analysis approach. Literature searches in PubMed, Embase, PsycINFO and Cochrane Library resulted in 13,384 abstracts from database inception to January 1, 2016. Twenty-four RCTs (4889 participants) comparing a guided Internet-based intervention with a control group contributed data to the analysis. Missing data were multiply imputed. To examine treatment outcome on response and remission, mixed-effects models with participants nested within studies were used. Response and remission rates were calculated using the Reliable Change Index. The intervention group obtained significantly higher response rates (OR = 2.49, 95% CI 2.17–2.85) and remission rates compared to controls (OR = 2.41, 95% CI 2.07–2.79). The moderator analysis indicated that older participants (OR = 1.01) and native-born participants (1.66) were more likely to respond to treatment compared to younger participants and ethnic minorities respectively. Age (OR = 1.01) and ethnicity (1.73) also moderated the effects of treatment on remission.Moreover, adults with more severe depressive symptoms at baseline were more likely to remit after receiving internet-based treatment (OR = 1.19). Guided Internet-based interventions lead to substantial positive treatment effects on treatment response and remission at post-treatment. Thus, such interventions may complement existing services for depression and potentially reduce the gap between the need and provision of evidence-based treatments.
•Little is known about clinically relevant changes in guided Internet-based interventions.•Guided Internet-based interventions result in significantly higher remission and response compared to controls•Severity of depression, age and ethnicity significantly moderate treatment outcome.
Baseline imbalances, skewed costs, the correlation between costs and effects, and missing data are statistical challenges that are often not adequately accounted for in the analysis of ...cost-effectiveness data. This study aims to illustrate the impact of accounting for these statistical challenges in trial-based economic evaluations.
Data from two trial-based economic evaluations, the REALISE and HypoAware studies, were used. In total, 14 full cost-effectiveness analyses were performed per study, in which the four statistical challenges in trial-based economic evaluations were taken into account step-by-step. Statistical approaches were compared in terms of the resulting cost and effect differences, ICERs, and probabilities of cost-effectiveness.
In the REALISE study and HypoAware study, the ICER ranged from 636,744€/QALY and 90,989€/QALY when ignoring all statistical challenges to - 7502€/QALY and 46,592€/QALY when accounting for all statistical challenges, respectively. The probabilities of the intervention being cost-effective at 0€/ QALY gained were 0.67 and 0.59 when ignoring all statistical challenges, and 0.54 and 0.27 when all of the statistical challenges were taken into account for the REALISE study and HypoAware study, respectively.
Not accounting for baseline imbalances, skewed costs, correlated costs and effects, and missing data in trial-based economic evaluations may notably impact results. Therefore, when conducting trial-based economic evaluations, it is important to align the statistical approach with the identified statistical challenges in cost-effectiveness data. To facilitate researchers in handling statistical challenges in trial-based economic evaluations, software code is provided.
Celotno besedilo
Dostopno za:
CEKLJ, DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
Abstract Aim Recently, efforts have been made to use and report person‐reported outcomes (PROs) in randomised clinical trials (RCTs). Here, we aim to (1) assess the status of inclusion of PROs in ...registered RCTs over 5 years in people with type 1 or 2 diabetes, and (2) map the PRO measures (PROMs) onto predefined domains. Methods The largest trial registries ( Clinicatrials.gov , International Clinical Trial Platform and ISRCTN) were systematically searched for RCTs in people with type 1 and/or type 2 diabetes of all ages between 2018 and 2023. Coding of PROs comprised: (1) PRO measure(s) included yes or no; if yes: (2) PRO(s) as primary outcome yes or no; and (3) mapping PROMs onto predefined PRO domains and per type of intervention. Results N = 1543 trials met our inclusion criteria, of which n = 673 (44%) included PROs, assessed by 545 different measures. Twenty per cent of drug trials ( n = 112) and 71% of behavioural interventions ( n = 405) included PROs. In 149 trials (9.6%), a PRO was the primary outcome. The psychological functioning domain was most often assessed across all trials (21.6%), specifically in behavioural (44.8%) and medical device interventions (29.7%). In drug trials, the physical functioning and functional health domain was most included (9%). Across all trials, the social and family functioning domain was least assessed (3%). Conclusions We noticed an increase in the inclusion of PROs in diabetes RCTs. However, PROs are rarely included as primary outcomes in the majority of studies, particularly in drug trials. The heterogeneity of PROMs used in RCTs underscores the need for standardisation of PROs.
Evidence suggests that many adults with type 1 diabetes (T1D) experience clinically relevant levels of diabetes distress, indicating coping difficulties. Studies have primarily focused on emotion ...regulation as a possible construct to be addressed in psychological interventions to alleviate diabetes distress. This study extends the literature by investigating the cross-sectional association between emotion regulation, diabetes distress and the construct of emotional self-awareness as an additional variable to be considered in potentially reducing diabetes distress.
Via an online survey, data was collected on emotional self-awareness dimensions (attention to feelings, clarity of feelings), emotion regulation strategies (cognitive reappraisal, expressive suppression, mood repair) and diabetes distress, along with self-reported clinical and sociodemographic information. Multiple linear regression with stepwise backward method was used to examine associations, controlling for country.
= 262 Italian and Dutch adults with T1D (80.5% women,
= 38.12 years, SD = 12.14) participated. Clarity of feelings was significantly negatively associated with diabetes distress, resulting in a medium effect size (
= -0.22,
< 0.001). Likewise, mood repair was negatively related to diabetes distress, showing a small effect size (
= -0.26,
< 0.001).
These findings shed light on the importance of a dimension of emotional self-awareness, namely clarity of feelings. This represents the ability to identify one's emotional states and discriminate between them. Thus, it should be considered in psychological interventions, such as mentalization-based treatment, that might contribute to alleviating T1D-related distress.
Aims
Disordered eating behaviour (DEB) and diabetes distress are prevalent in adults with type 1 diabetes (T1D). Emotion regulation strategies, such as cognitive reappraisal and expressive ...suppression, are associated with DEB and managing stress in general. Here we examine the associations between DEB, diabetes distress, and emotion regulation strategies in the context of T1D.
Methods
Adults with T1D in The Netherlands and Italy completed an online survey, covering DEB (DEPS‐R), diabetes distress (PAID‐5), and emotion regulation strategies (ERQ). Associations between DEB, diabetes distress, and emotion regulation strategies were examined using path analysis.
Results
N = 291 participants completed the survey (78.9% women, 39 ± 13 years, HbA1c: 55 ± 16 mmol/mol (7.2% 3.6%); TIR: 66% ± 25). N = 79 participants (27.1%) reported DEB (DEPS‐R ≥ 20) and n = 159 participants (54.6%) reported elevated diabetes distress (PAID‐5 ≥ 8). The path analysis, with small‐to‐medium effect sizes, revealed that more diabetes distress was associated with more DEB (β = 0.23, 95% CI 0.13, 0.34). Less diabetes distress was associated with more use of cognitive reappraisal (β = −0.24, 95% CI −0.36, −0.12). More DEB was associated with more use of expressive suppression (β = 0.14, 95% CI 0.04, 0.24).
Conclusions
This cross‐sectional study suggests an association between DEB and diabetes distress, between cognitive reappraisal and less diabetes distress and between expressive suppression and more DEB. The results suggest that it may prove beneficial to prioritize strengthening emotion regulation strategies in interventions for people with T1D and DEB. Future research should help clarify causality with regard to emotion regulation and DEB in adults with T1D.
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