How to identify clinically significant diabetes distress using the Problem Areas in Diabetes (PAID) scale in adults with diabetes treated in primary or secondary care? Evidence for new cut points based on latent class analyses.

INTRODUCTION: The Problem Areas of Diabetes (PAID) questionnaire is a frequently used measure to assess diabetes-distress. The aim of this study was to identify clinically meaningful levels of diabetes-distress, using latent class analyses (LCA), and to determine which groups were at increased risk of elevated diabetes-distress in terms of sex, age, type of diabetes and glycaemic control. METHODS: Data were derived from four studies (total N=2966, 49% female, age range 18-95 years, 43% type 1 diabetes, diabetes duration range 0-79 years). LCAs were performed to examine possible latent groups in the distribution of answers on the individual PAID items. Demographic and diabetes-related characteristics were added to the model to estimate their effects on latent class membership and receiver operating curves curves to determine cut-offs. RESULTS: Three levels of diabetes distress were distinguished with defined cut-off scores and labelled as: low, moderate and high diabetes distress. Levels of distress did not associate with distinct clusters of items. Older people were more likely to be part of the low distress class; women and people with high HbA1c were more likely to be part of the high distress class. Sensitivity and specificity of the commonly used cut-off of 40 for high distress are 0.95 and 0.97, respectively. To distinguish the moderate distress group, cut-off scores of 17 and 39 are optimal with a sensitivity of 0.93 and a specificity of 0.94. CONCLUSION: Three levels of diabetes-distress can be distinguished: low, moderate and high diabetes distress. Younger people, women and people with poor glycaemic control are at an increased risk for high levels of distress. A cut-off of 40 is satisfactory to detect people with high levels of diabetes-distress; a score of 0-16 indicates low diabetes distress and a score of 17-39 moderate diabetes distress.

The unexplored role of sedentary time and physical activity in glucose and lipid metabolism-related placental mRNAs in pregnant women who are obese: the DALI lifestyle randomised controlled trial.

OBJECTIVE: We aimed to explore: (i) the association of sedentary time (ST) and physical activity (PA) during pregnancy with the placental expression of genes related to glucose and lipid metabolism in pregnant women who are obese; (ii) maternal metabolic factors mediating changes in these placental transcripts; and (iii) cord blood markers related to the mRNAs mediating neonatal adiposity. DESIGN: Multicentre randomised controlled trial. SETTING: Hospitals in nine European countries. POPULATION: A cohort of 112 pregnant women with placental tissue. METHODS: Both ST and moderate-to-vigorous PA (MVPA) levels were measured objectively using accelerometry at three time periods during pregnancy. MAIN OUTCOME MEASURES: Placental mRNAs (FATP2, FATP3, FABP4, GLUT1 and PPAR-γ) were measured with NanoString technology. Maternal and fetal metabolic markers and neonatal adiposity were assessed. RESULTS: Longer periods of ST, especially in early to middle pregnancy, was associated with lower placental FATP2 and FATP3 expression (P < 0.05), whereas MVPA at baseline was inversely associated with GLUT1 mRNA (P = 0.02). Although placental FATP2 and FATP3 expression were regulated by the insulin-glucose axis (P < 0.05), no maternal metabolic marker mediated the association of ST/MVPA with placental mRNAs (P > 0.05). Additionally, placental FATP2 expression was inversely associated with cord blood triglycerides and free fatty acids (FFAs; P < 0.01). No cord blood marker mediated neonatal adiposity except for cord blood leptin, which mediated the effects of PPAR-γ on neonatal sum of skinfolds (P < 0.05). CONCLUSIONS: In early to middle pregnancy, ST is associated with the expression of placental genes linked to lipid transport. PA is hardly related to transporter mRNAs. Strategies aimed at reducing sedentary behaviour during pregnancy could modulate placental gene expression, which may help to prevent unfavourable fetal and maternal pregnancy outcomes. TWEETABLE ABSTRACT: Reducing sedentary behaviour in pregnancy might modulate placental expression of genes related to lipid metabolism in women who are obese.

Metabolic phenotypes of early gestational diabetes mellitus and their association with adverse pregnancy outcomes.

AIMS: To describe the metabolic phenotypes of early gestational diabetes mellitus and their association with adverse pregnancy outcomes. METHODS: We performed a post hoc analysis using data from the Vitamin D And Lifestyle Intervention for gestational diabetes prevention (DALI) trial conducted across nine European countries (2012-2014). In women with a BMI ≥29 kg/m2 , insulin resistance and secretion were estimated from the oral glucose tolerance test values performed before 20 weeks, using homeostatic model assessment of insulin resistance and Stumvoll first-phase indices, respectively. Women with early gestational diabetes, defined by the International Association of Diabetes and Pregnancy Study Groups criteria, were classified into three groups: GDM-R (above-median insulin resistance alone), GDM-S (below-median insulin secretion alone), and GDM-B (combination of both) and the few remaining women were excluded. RESULTS: Compared with women in the normal glucose tolerance group (n = 651), women in the GDM-R group (n = 143) had higher fasting and post-load glucose values and insulin levels, with a greater risk of having large-for-gestational age babies [adjusted odds ratio 3.30 (95% CI 1.50-7.50)] and caesarean section [adjusted odds ratio 2.30 (95% CI 1.20-4.40)]. Women in the GDM-S (n = 37) and GDM-B (n = 56) groups had comparable pregnancy outcomes with those in the normal glucose tolerance group. CONCLUSIONS: In overweight and obese women with early gestational diabetes, higher degree of insulin resistance alone was more likely to be associated with adverse pregnancy outcomes than lower insulin secretion alone or a combination of both.

Looking back on 25 years of the PSAD study group.

The year 2020 marks the 25th anniversary of the Psychosocial Aspects of Diabetes (PSAD) study group of the European Association for the Study of Diabetes. At the time, psychosocial diabetes research in Europe was steadily growing, but not well recognized. By establishing an official European Association for the Study of Diabetes study group, PSAD, for which purpose some hurdles had to be overcome, diabetes psychology became more visible and accessible to the scientific diabetes community. Over the years the PSAD study group has been successful in promoting the quality of research in the field through scientific meetings, mentoring, postgraduate education and publications. Looking back we can conclude that starting the PSAD study group signified an important moment in time, where researchers were joining forces to further the quality of the science, raise awareness of the importance of psychosocial aspects and promote the dissemination of psychological interventions in diabetes care.

How has psycho-behavioural research advanced our understanding of hypoglycaemia in type 1 diabetes?

Almost 100 years since the discovery of insulin, hypoglycaemia remains a barrier for people with type 1 diabetes to achieve and maintain blood glucose at levels which prevent long-term diabetes-related complications. Although hypoglycaemia is primarily attributable to the limitations of current treatment and defective hormonal counter-regulation in type 1 diabetes, the central role of psycho-behavioural factors in preventing, recognizing and treating hypoglycaemia has been acknowledged since the early 1980s. Over the past 25 years, as documented in the present review, there has been a substantial increase in psycho-behavioural research focused on understanding the experience and impact of hypoglycaemia. The significant contributions have been in understanding the impact of hypoglycaemia on a person's emotional well-being and aspects of life (e.g. sleep, driving, work/social life), identifying modifiable psychological and behavioural risk factors, as well as in developing psycho-behavioural interventions to prevent and better manage (severe) hypoglycaemia. The impact of hypoglycaemia on family members has also been confirmed. Structured diabetes education programmes and psycho-behavioural interventions with a focus on hypoglycaemia have both been shown to be effective in addressing problematic hypoglycaemia. However, the findings have also revealed the complexity of the problem and the need for a personalized approach, taking into account the individual's knowledge of, and emotional/behavioural reactions to hypoglycaemia. Evidence is emerging that people with persistent and recurrent severe hypoglycaemia, characterized by deeply entrenched cognitions and lack of concern around hypoglycaemia, can benefit from tailored cognitive behavioural therapy.

The cognitive and psychological effects of living with type 1 diabetes: a narrative review.

Across the lifespan, type 1 diabetes mellitus has a profound (neuro)psychological impact. In young people, type 1 diabetes can interfere with psychosocial development and hamper school performance. In adulthood, it can interfere with work life, relationships and parenting. A substantial minority of adults with type 1 diabetes experience coping difficulties and high diabetes-related distress. In youth and adulthood, type 1 diabetes is related to mild cognitive decrements as well as affective disorders, such as depression and anxiety. There is limited literature available that explores the interaction between cognitive and psychological comorbidity and underlying mechanisms. The aims of the present narrative review were to summarize the current state of the literature regarding both cognitive and psychological comorbidities in type 1 diabetes across the lifespan, and to explore potential links between the two domains of interest to make suggestions for future research and clinical practice.

Effectiveness of psychoeducational interventions for the treatment of diabetes-specific emotional distress and glycaemic control in people with type 2 diabetes: A systematic review and meta-analysis.

AIMS: Psychological comorbidity, such as depression and/or diabetes-specific emotional distress (DSD), is highly prevalent in people with type 2 diabetes (T2DM) and associated with poorer treatment outcomes. While treatments for depression are well established, interventions specifically designed for DSD are sparse. The aim of this study was to determine interventions that successfully address DSD and HbA1c in people with T2DM. METHODS: Seven databases were searched to identify potentially relevant studies. Eligible studies were selected and appraised independently by two reviewers. Multiple meta-analyses and meta-regression analyses were performed to synthesise the data; the primary analyses determined the effect of interventions on DSD, with secondary analyses assessing the effect on HbA1c. RESULTS: Thirty-two studies (n = 5206) provided sufficient DSD data, of which 23 (n = 3818) reported data for HbA1c. Meta-analyses demonstrated that interventions significantly reduced DSD (p = 0.034) and HbA1c (p = 0.006) compared to controls, although subgroup meta-analyses and meta-regression to explore specific intervention characteristics that might mediate this effect yielded non-significant findings. CONCLUSIONS: The findings demonstrate that existing interventions successfully reduce DSD and HbA1c in people with T2DM. While promising, deductions should be interpreted tentatively, highlighting a stark need for further focused exploration of how best to treat psychological comorbidity in people with T2DM.

Systematic review and meta-analysis of psychological interventions in people with diabetes and elevated diabetes-distress.

AIMS: The clinical relevance of diabetes-distress is increasingly recognized, but little is known about the efficacy of interventions specifically targeted to treat elevated diabetes-distress. Therefore, this systematic review sought to determine the efficacy of psychological interventions aimed at treating elevated diabetes-distress in people with Type 1 or Type 2 diabetes. METHODS: We systematically searched literature from five databases. Randomized controlled trials (RCTs) with an English abstract, describing the results of a psychological intervention in adults with diabetes were included. Articles were eligible for inclusion if the primary outcome was diabetes-distress measured by the Problem Areas in Diabetes Scale (PAID-5/PAID-20) or the Diabetes Distress Scale (DDS-17). Only mean group diabetes-distress values above cut-off at baseline or the results of a subgroup above cut-off (PAID-5 ≥ 8, PAID-20 ≥ 40 or DDS-17 ≥ 3) were included. RESULTS: The search yielded 8907 articles. After removing 2800 duplicates, 6107 articles remained. Titles and abstracts were screened, leaving 394 potential articles of interest, nine of which were RCTs. In a random-effects meta-analysis, the pooled effect size for diabetes-distress was 0.48 (Cohen's d), Z = 3.91, P < 0.0001. Statistical heterogeneity was I² = 46.67% (confidence intervals 45.06% to 48.28%). Diabetes-tailored psychological interventions reduced HbA1c (Cohen's d = 0.57), whereas mindfulness-based interventions did not (Cohen's d = 0.11). CONCLUSIONS: This systematic review shows that specifically diabetes-tailored psychological interventions are effective in reducing elevated diabetes-distress and HbA1c . More rigorous studies are warranted to establish the full potential of these interventions. PROSPERO database registration ID: CRD42017075290.

Does hypoglycaemia affect the improvement in QoL after the transition to insulin in people with type 2 diabetes?

PURPOSE: Quality of Life (QoL) of insulin-naïve people with type 2 diabetes mellitus (T2DM) improves after transition to insulin. Little is known about the role of hypoglycaemia in this context. Secondary analyses of the Study of the Psychological Impact in Real care of Initiating insulin glargine Treatment (SPIRIT) aimed to investigate the relationship between hypoglycaemia and QoL when transitioning to insulin. METHODS: Insulin-naïve Dutch people with T2DM in suboptimal glycaemic control (HbA1c >53 mmol/mol; 7.0%) on maximum dose of oral glucose-lowering medications were included from 363 primary care practices (n = 911). Participants started insulin glargine and completed QoL-questionnaires (WHO-5 Well-being Index (WHO-5; emotional well-being), Hypoglycaemia Fear Survey-worry scale (HFS-w; hypoglycaemia fear) and Diabetes Symptom Checklist-revised (DSC-r; diabetes symptom distress) at baseline, 3 and 6 months follow-up. Linear GEE analyses were used to investigate the association between symptomatic, nocturnal, severe hypoglycaemia (number of episodes during 3 months prior to visit) and QoL over time. RESULTS: 52.5% men participated, mean age 62.2 years (SD ± 10.92), and median HbA1c 67 mmol/mol (range 61-77) (8.3%). More symptomatic hypoglycaemic episodes were associated with higher HFS-w and DSC-r scores (P < 0.01). Experiencing multiple nocturnal or severe episodes was related to higher symptom distress as well, when compared to no episodes. These associations did not change significantly over time. CONCLUSIONS: Hypoglycaemia is associated with lower QoL in terms of hypoglycaemia fear and diabetes symptom distress. The transition to insulin does not affect this relationship, suggesting hypoglycaemia in itself has a detrimental effect on diabetes-related QoL independent of treatment regimen.

Cost-effectiveness of the psycho-educational blended (group and online) intervention HypoAware compared with usual care for people with Type 1 and insulin-treated Type 2 diabetes with problematic hypoglycaemia: analyses of a cluster-randomized controlled trial.

AIMS: To evaluate the cost-effectiveness of HypoAware, a blended (group and online) psycho-educational intervention based on the evidence-based Blood Glucose Awareness Training, in comparison with usual care in people with Type 1 and Type 2 diabetes with a high risk of severe hypoglycaemia. METHODS: We performed an economic evaluation, from a societal and healthcare perspective, that used data from a 6-month, multicentre, cluster-randomized controlled trial (n = 137). RESULTS: The proportion of people with at least one severe hypoglycaemic event per 6 months was 0.22 lower (95% CI -0.39 to -0.06) and the proportion of people with impaired hypoglycaemia awareness was 0.16 lower (95% CI -0.34 to 0.02) in the HypoAware group. There was no difference in quality-adjusted life-years (-0.0; 95% CI -0.05 to 0.05). The mean total societal costs in the HypoAware group were EUR708 higher than in the usual care group (95% CI -951 to 2298). The mean incremental cost per severe hypoglycaemic event prevented was EUR2,233. At a willingness-to-pay threshold of EUR20,000 per event prevented, the probability that HypoAware was cost-effective in comparison with usual care was 54% from a societal perspective and 55% from a healthcare perspective. For quality-adjusted life-years the incremental cost-effectiveness ratio was EUR119,360/quality-adjusted life-year gained and the probability of cost-effectiveness was low at all ceiling ratios. CONCLUSIONS: Based on the present study, we conclude that HypoAware is not cost-effective compared to usual care. Further research in less well-resourced settings and more severely affected patients is warranted. (Clinical Trials Registry no: Dutch Trial Register NTR4538.).

Light therapy: is it safe for the eyes?

OBJECTIVE: Light therapy has become an increasingly popular treatment for depression and a range of other neuropsychiatric conditions. Yet, concerns have been raised about the ocular safety of light therapy. METHOD: We conducted the first systematic review into the ocular safety of light therapy. A PubMed search on January 4, 2017, identified 6708 articles, of which 161 were full-text reviewed. In total, 43 articles reporting on ocular complaints and ocular examinations were included in the analyses. RESULTS: Ocular complaints, including ocular discomfort and vision problems, were reported in about 0% to 45% of the participants of studies involving light therapy. Based on individual studies, no evident relationship between the occurrence of complaints and light therapy dose was found. There was no evidence for ocular damage due to light therapy, with the exception of one case report that documented the development of a maculopathy in a person treated with the photosensitizing antidepressant clomipramine. CONCLUSION: Results suggest that light therapy is safe for the eyes in physically healthy, unmedicated persons. The ocular safety of light therapy in persons with preexisting ocular abnormalities or increased photosensitivity warrants further study. However, theoretical considerations do not substantiate stringent ocular safety-related contraindications for light therapy.

The prevalence of diabetes-specific emotional distress in people with Type 2 diabetes: a systematic review and meta-analysis.

AIMS: Psychological comorbidity, such as depression and/or diabetes-specific emotional distress (diabetes distress), is widespread in people with Type 2 diabetes and is associated with poorer treatment outcomes. Although extensive research into the prevalence of depression has been conducted, the same attention has not been given to diabetes distress. The aim of this systematic review was to determine the overall prevalence of diabetes distress in people with Type 2 diabetes. METHODS: Seven databases were searched to identify potentially relevant studies; eligible studies (adult population aged > 18 years with Type 2 diabetes and an outcome measure of diabetes distress) were selected and appraised independently by two reviewers. Multiple fixed- and random-effects meta-analyses were performed to synthesize the data; with primary analyses to determine the overall prevalence of diabetes distress in people with Type 2 diabetes, and secondary meta-analyses and meta-regression to explore the prevalence across different variables. RESULTS: Fifty-five studies (n = 36 998) were included in the meta-analysis and demonstrated an overall prevalence of 36% for diabetes distress in people with Type 2 diabetes. Prevalence of diabetes distress was significantly higher in samples with a higher prevalence of comorbid depressive symptoms and a female sample majority. CONCLUSIONS: Diabetes distress is a prominent issue in people with Type 2 diabetes that is associated with female gender and comorbid depressive symptoms. It is important to consider the relationship between diabetes distress and depression, and the significant overlap between conditions. Further work is needed to explore psychological comorbidity in Type 2 diabetes to better understand how best to identify and appropriately treat individuals.

Keeping safe. Continuous glucose monitoring (CGM) in persons with Type 1 diabetes and impaired awareness of hypoglycaemia: a qualitative study.

AIM: To further our understanding of individual use and experience of continuous glucose monitoring (CGM) in adults with Type 1 diabetes and impaired awareness of hypoglycaemia, we conducted a qualitative study supplementary to a randomized controlled trial, using semi-structured interviews. METHODS: Twenty-three participants of the IN CONTROL trial were interviewed within 4 weeks after the last study visit. The interview centred around experiences of CGM, taking into account the person's expectations prior to the trial. The interview was semi-structured, using open-ended questions and, if needed, prompts were offered to elicit further responses. Using thematic analysis, the interview transcripts were coded independently by three members of the research team. The consolidated criteria for reporting qualitative research (COREQ) were followed. RESULTS: Overall, CGM was experienced as helpful in gaining more insight into glucose variability, and temporarily improved sense of control, reduced distress and made participants less dependent on others. However, some participants experienced confrontation with CGM output as intrusive, while some reported frustration due to failing technique and difficulty trusting the device. Participants reported active and passive self-management behaviours mirroring individual differences in attitudes and coping styles. CONCLUSIONS: In adults with Type 1 diabetes at risk of recurrent hypoglycaemia due to impaired awareness of hypoglycaemia, CGM use enhances a sense of control and safety for most, but not all. Future studies should further explore differential use of CGM in this population in the context of active and passive self-management styles.

The 6-month effectiveness of Internet-based guided self-help for depression in adults with Type 1 and 2 diabetes mellitus.

AIM: The aim of this research is to examine the 6-month effects of an Internet-based guided self-help intervention for comorbid depressive symptoms in people with diabetes. METHODS: Participants (n = 260) with Type 1 or 2 diabetes and elevated depressive symptoms [Center for Epidemiological Studies Depression Scale (CES-D) ≥ 23] were randomly assigned to a guided Internet-based self-help intervention or a control condition (treatment as usual + online psychoeducation about depression). The primary outcome was a change in depressive symptom severity (CES-D) from baseline to 6-month follow-up. The secondary outcomes included numbers of people achieving treatment response (reliable change of depressive symptoms) and remission (CES-D ≤ 16), as well as the effects on glycaemic control, diabetes-related emotional distress and diabetes acceptance. Repeated measures analysis of variance examined between-group differences using intent-to-treat principles. RESULTS: Both conditions showed improvements in depression severity: intervention condition, d = 1.48 [95% confidence interval (95% CI): 1.21 to 1.76]; control condition d = 0.55 (95% CI: 0.30 to 0.80). Changes were significantly greater in the intervention condition with a large between-group effect size (d = 0.83, 95% CI: 0.57 to 1.08). Accordingly, effects on response [relative risk (RR) = 2.60 (95% CI: 2.01 to 3.36), P < 0.001] and remission [RR = 3.36 (95% CI: 2.98 to 5.44), P < 0.001] were in favour of the intervention group, as were differences in change in diabetes emotional distress (d = 0.50, 95% CI: 0.04 to 0.54), and physical and mental functioning [Short Form Health Survey (SF-12) Physical d = 0.27 (95% CI: 0.01 to 0.51) and SF-12 Mental d = 0.68 (95% CI: 0.11 to 0.40)]. The intervention group was not superior with regard to glycaemic control, diabetes self-management and diabetes acceptance. CONCLUSIONS: The trial indicates that Internet-based guided self-help treatments for depression in people with diabetes can have sustained effects on depressive symptoms, well-being and emotional distress associated with diabetes.

Does Internet-based guided-self-help for depression cause harm? An individual participant data meta-analysis on deterioration rates and its moderators in randomized controlled trials.

BACKGROUND: Almost nothing is known about the potential negative effects of Internet-based psychological treatments for depression. This study aims at investigating deterioration and its moderators within randomized trials on Internet-based guided self-help for adult depression, using an individual patient data meta-analyses (IPDMA) approach. METHOD: Studies were identified through systematic searches (PubMed, PsycINFO, EMBASE, Cochrane Library). Deterioration in participants was defined as a significant symptom increase according to the reliable change index (i.e. 7.68 points in the CES-D; 7.63 points in the BDI). Two-step IPDMA procedures, with a random-effects model were used to pool data. RESULTS: A total of 18 studies (21 comparisons, 2079 participants) contributed data to the analysis. The risk for a reliable deterioration from baseline to post-treatment was significantly lower in the intervention v. control conditions (3.36 v. 7.60; relative risk 0.47, 95% confidence interval 0.29-0.75). Education moderated effects on deterioration, with patients with low education displaying a higher risk for deterioration than patients with higher education. Deterioration rates for patients with low education did not differ statistically significantly between intervention and control groups. The benefit-risk ratio for patients with low education indicated that 9.38 patients achieve a treatment response for each patient experiencing a symptom deterioration. CONCLUSIONS: Internet-based guided self-help is associated with a mean reduced risk for a symptom deterioration compared to controls. Treatment and symptom progress of patients with low education should be closely monitored, as some patients might face an increased risk for symptom deterioration. Future studies should examine predictors of deterioration in patients with low education.