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Patient-reported outcomes (PROs) are valuable for shared decision making and research. Patient-reported outcome measures (PROMs) are questionnaires used to measure PROs, such as health-related quality of life (HRQL). Although core outcome sets for trials and clinical practice have been developed separately, they, as well as other initiatives, recommend different PROs and PROMs. In research and clinical practice, different PROMs are used (some generic, some disease-specific), which measure many different things. This is a threat to the validity of research and clinical findings in the field of diabetes. In this narrative review, we aim to provide recommendations for the selection of relevant PROs and psychometrically sound PROMs for people with diabetes for use in clinical practice and research. Based on a general conceptual framework of PROs, we suggest that relevant PROs to measure in people with diabetes are: disease-specific symptoms (e.g. worries about hypoglycaemia and diabetes distress), general symptoms (e.g. fatigue and depression), functional status, general health perceptions and overall quality of life. Generic PROMs such as the 36-Item Short Form Health Survey (SF-36), WHO Disability Assessment Schedule (WHODAS 2.0), or Patient-Reported Outcomes Measurement Information System (PROMIS) measures could be considered to measure commonly relevant PROs, supplemented with disease-specific PROMs where needed. However, none of the existing diabetes-specific PROM scales has been sufficiently validated, although the Diabetes Symptom Self-Care Inventory (DSSCI) for measuring diabetes-specific symptoms and the Diabetes Distress Scale (DDS) and Problem Areas in Diabetes (PAID) for measuring distress showed sufficient content validity. Standardisation and use of relevant PROs and psychometrically sound PROMs can help inform people with diabetes about the expected course of disease and treatment, for shared decision making, to monitor outcomes and to improve healthcare. We recommend further validation studies of diabetes-specific PROMs that have sufficient content validity for measuring disease-specific symptoms and consider generic item banks developed based on item response theory for measuring commonly relevant PROs. Graphical Abstract

Contains fulltext : 291892.pdf (Publisher’s version ) (Open Access) AIMS: To summarize and critically appraise evidence regarding the effectiveness of educational and/or behavioural interventions in reducing fear of hypoglycaemia among adults with type 1 diabetes. METHODS: Systematic searches of medical and psychology databases were conducted. Risk-of-bias was assessed using the Joanna Briggs Institute Critical Appraisal Tools. Data were synthesized using random-effects meta-analyses for randomized controlled trials (RCTs) and narrative synthesis for observational studies. RESULTS: Five RCTs (N = 682) and seven observational studies (N = 1519) met the inclusion criteria, reporting on behavioural, structured education and cognitive-behavioural therapy (CBT) interventions. Most studies assessed fear of hypoglycaemia using the Hypoglycaemia Fear Survey Worry (HFS-W) and Behaviour (HFS-B) subscales. Mean fear of hypoglycaemia at baseline was relatively low across studies. Meta-analyses showed a significant effect of interventions on HFS-W (SMD = -0.17, p = 0.032) but not on HFS-B scores (SMD = -0.34, p = 0.113). Across RCTs, Blood Glucose Awareness Training (BGAT) had the largest effect on HFS-W and HFS-B scores, and one CBT-based program was as effective as BGAT in reducing HFS-B scores. Observational studies showed that Dose Adjustment for Normal Eating (DAFNE) was associated with significant fear of hypoglycaemia reductions. CONCLUSIONS: Current evidence suggests that educational and behavioural interventions can reduce fear of hypoglycaemia. However, no study to date has examined these interventions among people with high fear of hypoglycaemia.

Aims: People with type 1 diabetes have a higher risk for cardiovascular disease (CVD). Reduced heart rate variability (HRV) is a clinical marker for CVD. In this observational study using continuous HRV measurement across 26 days, we investigated whether psychological stressors (diabetes distress, depressive symptoms) and glycaemic parameters (hypo- and hyperglycaemic exposure, glycaemic variability and HbA 1c) are associated with lower HRV in people with type 1 diabetes. Methods: Data from the non-interventional prospective DIA-LINK1 study were analysed. At baseline, depressive symptoms and diabetes distress were assessed. Glucose values and HRV were recorded daily for 26 days using continuous glucose monitoring (CGM) and a wrist-worn health tracker respectively. Multilevel modelling with participant as nesting factor was used to analyse associations between day-to-day HRV and diabetes distress, depressive symptoms and CGM-derived parameters. Results: Data from 149 participants were analysed (age: 38.3 ± 13.1 years, HbA 1c: 8.6 ± 1.9%). Participants with elevated diabetes distress had a significantly lower HRV across the 26 days compared to participants without elevated distress (β = −0.28; p = 0.004). Elevated depressive symptoms were not significantly associated with HRV (β = −0.18; p = 0.074). Higher daily exposure to hyperglycaemia (β = −0.44; p = 0.044), higher average exposure to hypoglycaemia (β = −0.18; p = 0.042) and higher HbA 1c (β = −0.20; p = 0.018) were associated with reduced HRV across the 26 days. Sensitivity analysis with HRV averaged across all days corroborated these results. Conclusions: Diabetes distress is a clinically meaningful psychosocial stressor that could play a role in the cardiovascular health of people with type 1 diabetes. These findings highlight the need for integrated psychosocial care in diabetes management.

AIMS: To identify 11-year HbA1c trajectories in children/adolescents with type 1 diabetes and determine whether baseline caregiver- and/or child/adolescent-reported Adherence in Diabetes Questionnaire (ADQ) scores and multiple covariates predict HbA1c trajectory membership.METHODS: For a 2009 population-based cohort of children/adolescents with type 1 diabetes, we analyzed HbA1c follow-up (2010-2020) data from Danish diabetes registries. HbA1c trajectories were identified with group-based trajectory modeling. Using multinomial logistic regression, we tested whether ADQ scores predicted trajectory membership when adjusting for sex, age at diabetes diagnosis, diabetes duration, family structure, and caregiver education.RESULTS: For 671 children/adolescents (10-17 years at baseline) with 5644 HbA1c observations over 11 years, four trajectories/groups were identified: 1) "on target, gradual decrease" (27%), 2) "above target, mild increase then decrease" (39%), 3) "above target, moderate increase then decrease" (25%), and 4) "well above target, large increase then decrease" (9%). Using group one as the reference, lower caregiver-reported ADQ scores predicted group 2, 3, and 4 membership. Lower child/adolescent-reported ADQ scores predicted group 3 and 4 membership. Low caregiver education predicted group 3 and 4 membership. Single-parent status predicted group 4 membership.CONCLUSIONS: ADQ scores and socio-demographics may serve as tools to predict glycemic control in youth with type 1 diabetes.

Background: Longitudinal studies including parental distress when examining adverse health outcomes in adolescents with type 1 diabetes are lacking. This study examined whether parental depression and anxiety predict adolescent emotional distress and glycated hemoglobin A1c (HbA1c) 1 year later and whether a relation between parental distress and HbA1c is mediated by the level of parental involvement in diabetes care and by treatment behaviors.Methods: Longitudinal path modeling was applied to data from 154 adolescents and parents from diabetes centers participating in the Longitudinal study of Emotional problems in Adolescents with type 1 diabetes and their Parents/caregivers (Diabetes LEAP). At baseline and 1-year follow-up, participants completed measures of depression and anxiety. HbA1c was extracted from medical charts. Responsibility and treatment behavior questionnaires were completed by adolescents at baseline.Results: Baseline parental depressive and anxiety symptoms were not associated with 1-year adolescent depressive symptoms, anxiety symptoms, and HbA1c. Responsibility division and treatment behaviors did not mediate associations between parental emotional distress and 1-year HbA1c.Conclusions: Parental depressive and anxiety symptoms did not predict adolescent health outcomes 1 year later. Future studies may determine whether the link is present in case of mood/anxiety disorders or severe diabetes-specific distress, or whether adolescents are resilient in the face of parental distress.Impact: Adolescents with T1D are a vulnerable group in terms of psychological and health outcomes. Whether parental emotional distress (i.e., depressive and anxiety symptoms) is prospectively associated with adolescent emotional distress and/or HbA1c has been understudied. Our results show that parental distress was not related to adolescent distress or HbA1c 1 year later. Responsibility division and treatment behaviors did not mediate associations between parental emotional distress and 1-year HbA1c. Future studies could determine whether these links are present in case of mood/anxiety disorders or severe diabetes-specific distress, or whether adolescents are resilient in the face of parental distress.

Objectives: Diabetes educational programmes should be offered to patients with type 2 diabetes mellitus (T2DM). We assessed the proportion of diabetes educational program participation among adults with T2DM, and its associations with place of residence in Norway, education, and immigrant background. Methods: We identified 28,128 diagnosed with T2DM (2008–2019) in the Outcomes & Multi-morbidity In Type 2 diabetes cohort. To examine associations between sociodemographic factors and participation in diabetes start courses (yes/no), we computed adjusted risk ratios (95% CI) using log-binomial regression. Results: Overall, 18% participated on the diabetes start course, but partaking differed by Norwegian counties (range:12–34%). Individuals with an immigrant background were 29% less likely to participate (RR 0.71, CI 0.65–0.79). Similarly, those with a lower educational level were 23% less likely to participate (RR 0.77, CI 0.72–0.83) than those with the highest education. The association between education and start course participation was not significant in the subgroup of immigrant individuals (RR 0.88 CI 0.70–1.12). Conclusions: We found that diabetes start course participation was overall low, especially in individuals with low education and immigrant background. Practice implications: More efforts are needed to promote diabetes start courses in patients with T2DM.

Objectives The objectives of this study were to investigate the associations of dispositional mindfulness and its facets with diet quality in Dutch adults with type 1 diabetes and type 2 diabetes and to evaluate the potential mediating role of emotional distress in these associations. Methods This was a cross-sectional study using data from the Diabetes MILES-The Netherlands. In total, 296 adults with type 1 diabetes and 364 with type 2 diabetes completed questionnaires. We assessed dispositional mindfulness by the Five Facet Mindfulness Questionnaire-Short Form, including total mindfulness and five facets: observing, describing, acting with awareness, being non-judgmental, and being non-reactive, and diet quality by the Dutch Healthy Diet 2015-index. Linear regression models were used to estimate the association. Mediation effects of depressive symptoms, anxiety symptoms, and diabetes-related distress were evaluated using the PROCESS macro with bias-corrected bootstrapped confidence intervals. Results Higher scores on the total mindfulness (β = 0.14, p = 0.02) and the observing facet (β = 0.15, p = 0.01) were significantly associated with higher diet quality in people with type 1 diabetes only, after adjustment for demographic factors. These associations were not mediated by depressive symptoms, anxiety symptoms, or diabetes-related distress. In adults with type 1 diabetes (but not type 2), higher dispositional mindfulness levels were associated with more optimal diet quality. Conclusions Higher mindfulness in general and observing in particular were related to a healthier diet with higher quality in Dutch adults with type 1 diabetes. Further longitudinal studies are warranted to understand the temporal relationship between mindfulness and diet quality.

OBJECTIVE Hypoglycemia poses an immediate threat for cognitive function. Due to its association with acute cognitive impairment, the International Hypoglycemia Study Group (IHSG) defines a blood glucose level RESEARCH DESIGN AND METHODS Adults with type 1 diabetes with normal (n = 26) or impaired (n = 21) hypoglycemic awareness or with insulin-treated type 2 diabetes (n = 15) and age-matched control subjects without diabetes (n = 32) underwent a hyperinsulinemic-euglycemic-hypoglycemic glucose clamp (2.80 ± 0.13 mmol/L [50.2 ± 2.3 mg/dL]). At baseline and during hypoglycemia, calculation ability, attention, working memory and cognitive flexibility were measured with the Paced Auditory Serial Addition Test (PASAT) and the Test of Attentional Performance (TAP). RESULTS For the whole group, hypoglycemia decreased the mean ± SD proportion of correct answers on the PASAT by 8.4 ± 12.8%, increased reaction time on the TAP Alertness task by 32.1 ± 66.6 ms, and increased the sum of errors and omissions on the TAP Working Memory task by 2.0 ± 5.5 (all P < 0.001). Hypoglycemia-induced cognitive declines were largely irrespective of the presence or type of diabetes, level of symptomatic awareness, diabetes duration, or HbA1c. CONCLUSIONS IHSG level 2 hypoglycemia impairs cognitive function in people with and without diabetes, irrespective of type of diabetes or hypoglycemia awareness status. These findings support the cutoff value of hypoglycemia

IntroductionThe aim of this study was to determine the psychometric properties of the 12-Item Hypoglycemia Impact Profile (HIP12), a brief measure of the impact of hypoglycemia on quality of life (QoL) among adults with type 1 (T1D) or type 2 diabetes (T2D).Research design and methodsAdults with T1D (n=1071) or T2D (n=194) participating in the multicountry, online study, ‘Your SAY: Hypoglycemia’, completed the HIP12. Psychometric analyses were undertaken to determine acceptability, structural validity, internal consistency, convergent/divergent validity, and known-groups validity.ResultsMost (98%) participants completed all items on the HIP12. The expected one-factor solution was supported for T1D, T2D, native English speaker, and non-native English speaker groups. Internal consistency was high across all groups (ω=0.91–0.93). Convergent and divergent validity were satisfactory. Known-groups validity was demonstrated for both diabetes types, by frequency of severe hypoglycemia (0 vs ≥1 episode in the past 12 months) and self-treated episodes (ConclusionsThe HIP12 is an acceptable, internally consistent, and valid tool for assessing the impact of hypoglycemia on QoL among adults with T1D. The findings in the relatively small sample with T2D are encouraging and warrant replication in a larger sample.

OBJECTIVE Hypoglycemia poses an immediate threat for cognitive function. Due to its association with acute cognitive impairment, the International Hypoglycemia Study Group (IHSG) defines a blood glucose level RESEARCH DESIGN AND METHODS Adults with type 1 diabetes with normal (n=26) or impaired (n=21) hypoglycemic awareness, or with insulin-treated type 2 diabetes (n=15) and age-matched controls without diabetes (n=32) underwent a hyperinsulinemic-euglycemic hypoglycemic glucose clamp (2.80 ± 0.13 mmol/L [50.2 ± 2.3 mg/dL]). At baseline and during hypoglycemia, calculation ability, attention, working memory and cognitive flexibility were measured with the Paced Auditory Serial Addition Test (PASAT) and the Test of Attentional Performance (TAP). RESULTS For the whole group, hypoglycemia decreased the proportion of correct answers on the PASAT by 8.4 ± 12.8%, increased the mean reaction time on the TAP Alertness task by 32.1 ± 66.6 ms, and increased the sum of errors and omissions on the TAP Working Memory task by 2.0 ± 5.5 (all p < 0.001). Hypoglycemia-induced cognitive declines were largely irrespective of the presence or type of diabetes, level of symptomatic awareness, diabetes duration or HbA1c. CONCLUSIONS IHSG level 2 hypoglycemia impairs cognitive function in people with and without diabetes, irrespective of type of diabetes or hypoglycemia awareness status. These findings support the cut-off value of hypoglycemia

Background: Hypoglycemia and its impact on people with diabetes is typically reported retrospectively and is subject to recall bias. Ecological momentary assessment (EMA) uses repeated sampling to collect real time, granular data about patient experiences, typically over 3-5 days. We developed the Hypo-METRICS app to determine the physical, psychological, and economic impact in people with type 1 (T1D) and type 2 diabetes (T2D) over weeks using EMA. We tested user acceptability of the Hypo-METRICS app. Methods: We recruited 323 adults (T1D=186, T2D=137, 55% men, mean age 54±16 years, diabetes duration 22±13 years) using insulin with ≥1 episode of hypoglycemia in the last month. Participants were prompted to complete three daily EMA and two weekly questionnaires (the Work Productivity and Activity Impairment Questionnaire and PROMIS Sleep Disturbance scale) for weeks. EMA included 29 items over morning, afternoon and evening time points. EMA questions spanned seven categories including experience of hypoglycemia, sleep, and daily functioning. Participants recorded hypoglycemia episodes using a symptom tracker in real time. Results: The overall mean completion rate was 89±10% (T1D=87±11%, T2D=91±8%) , with 86,487 completed items. EMAs had a completion rate of 88±11% (T1D=87±11% T2D=90±9%) . Weekly questionnaires had a completion rate of 92±11% (T1D=91±12 T2D=95±8) . A total of 5,585 episodes of participant-reported hypoglycemia (T1D=4,118, T2D=1,467) were recorded in real time with a mean of 1.7±1.4 episodes reported per participant/week (T1D=2.2±1.4 T2D=1.1±1.0) . Conclusion: The Hypo-METRICS app is an acceptable tool to collect prospective detailed data on the frequency of hypoglycemia episodes and their impact on daily functioning over a prolonged period. Disclosure N.Zaremba: None. R.J.Mccrimmon: Advisory Panel; Novo Nordisk, Sanofi, Research Support; Diabetes UK, European Union, MedImmune. E.Renard: Consultant; Abbott, AstraZeneca, Boehringer Ingelheim International GmbH, Dexcom, Inc., Insulet Corporation, LifeScan, Lilly, Novo Nordisk, Roche Diabetes Care, Sanofi, Tandem Diabetes Care, Inc. S.R.Heller: Advisory Panel; Eli Lilly and Company, Medtronic, Mylan N.V., Zealand Pharma A/S, Zucara Therapeutics, Other Relationship; Eli Lilly and Company, Research Support; Dexcom, Inc., Speaker's Bureau; Novo Nordisk A/S. M.Evans: Advisory Panel; Pila Pharma, Zucara Therapeutics, Other Relationship; Abbott Diabetes, Dexcom, Inc., Medtronic, Novo Nordisk, Research Support; AstraZeneca, Sanofi, Speaker's Bureau; Lilly Diabetes. J.K.Mader: Advisory Panel; Abbott Diabetes, Boehringer Ingelheim International GmbH, Eli Lilly and Company, Medtronic, Merck Sharp & Dohme Corp., Novo Nordisk A/S, Roche Diabetes Care, Sanofi-Aventis Deutschland GmbH, Speaker's Bureau; Abbott Diabetes, Eli Lilly and Company, Medtronic, Merck Sharp & Dohme Corp., Novo Nordisk A/S, Roche Diabetes Care, Sanofi-Aventis Deutschland GmbH, Servier Laboratories, Stock/Shareholder; decide Clinical Software GmbH. A.Seibold: Employee; Abbott Diabetes, Stock/Shareholder; Abbott. S.A.Amiel: Advisory Panel; Medtronic, Novo Nordisk, Other Relationship; Sanofi. P.Choudhary: Advisory Panel; Abbott Diabetes, Lilly Diabetes, Medtronic, Research Support; Novo Nordisk, Speaker's Bureau; Dexcom, Inc., Glooko, Inc., Insulet Corporation, Sanofi. Hypo-resolve consortium: n/a. G.Martine-edith: Other Relationship; Novo Nordisk. P.Divilly: None. Z.Mahmoudi: Employee; Novo Nordisk A/S. U.Soeholm: Research Support; Novo Nordisk A/S. M.M.Broadley: None. F.Pouwer: Research Support; Eli Lilly and Company, Novo Nordisk, Sanofi. B.E.De galan: Research Support; Novo Nordisk. U.Pedersen-bjergaard: Advisory Panel; Novo Nordisk A/S, Sanofi. Funding Innovative Medicines Initiative (777460)

Aim: To examine how hypoglycemia while asleep impacts self-reported daily functioning among adults with type 1 diabetes (T1D) . Methods: On 70 consecutive mornings, 250 people with T1D wearing a continuous glucose monitor reported sleep quality, mood, and alertness via the Hypo-METRICS smartphone app. Each night was categorized based on presence (+) or absence (-) of person-reported hypoglycemia (PRH) and sensor-detected hypoglycemia (SDH) into one of four types (see Figure 1, Type A-D) . Multilevel regression assessed associations between hypoglycemia and daily functioning (unstandardized coefficients (β) on original 0-scale) , adjusted for baseline demographic, clinical and psychological factors. Results: In the first 54 adults (52% women, age[M±SD]: 45±15 years) , nighttime PRH (Type C & D, Figure 1) was associated with reduced subjective sleep quality (C: β=-0.67; D: β=-0.58) , mood (C: β=-0.43; D: β=-0.58) and alertness (C: β=-0.34, p=0.015; D: β=-0.46) (all p0.05) . Conclusion: These novel data show the potentially pivotal role of the subjective experience of hypoglycemia for sleep quality, mood and alertness. Disclosure U.Soeholm: Research Support; Novo Nordisk A/S. E.Renard: Consultant; Abbott, AstraZeneca, Boehringer Ingelheim International GmbH, Dexcom, Inc., Insulet Corporation, LifeScan, Lilly, Novo Nordisk, Roche Diabetes Care, Sanofi, Tandem Diabetes Care, Inc. E.J.Abbink: None. P.M.Baumann: None. S.R.Heller: Advisory Panel; Eli Lilly and Company, Medtronic, Mylan N.V., Zealand Pharma A/S, Zucara Therapeutics, Other Relationship; Eli Lilly and Company, Research Support; Dexcom, Inc., Speaker's Bureau; Novo Nordisk A/S. B.E.De galan: Research Support; Novo Nordisk. U.Pedersen-bjergaard: Advisory Panel; Novo Nordisk A/S, Sanofi. M.Evans: Advisory Panel; Pila Pharma, Zucara Therapeutics, Other Relationship; Abbott Diabetes, Dexcom, Inc., Medtronic, Novo Nordisk, Research Support; AstraZeneca, Sanofi, Speaker's Bureau; Lilly Diabetes. D.Pollard: Other Relationship; Novo Nordisk. R.J.Mccrimmon: Advisory Panel; Novo Nordisk, Sanofi, Research Support; Diabetes UK, European Union, MedImmune. S.A.Amiel: Advisory Panel; Medtronic, Novo Nordisk, Other Relationship; Sanofi. M.M.Broadley: None. C.Hendrieckx: None. J.Speight: Advisory Panel; Insulet Corporation, Research Support; Novo Nordisk, Sanofi. P.Choudhary: Advisory Panel; Abbott Diabetes, Lilly Diabetes, Medtronic, Research Support; Novo Nordisk, Speaker's Bureau; Dexcom, Inc., Glooko, Inc., Insulet Corporation, Sanofi. F.Pouwer: Research Support; Eli Lilly and Company, Novo Nordisk, Sanofi. N.Zaremba: None. P.Divilly: None. G.Martine-edith: Other Relationship; Novo Nordisk. G.Nefs: None. Z.Mahmoudi: Employee; Novo Nordisk A/S. J.K.Mader: Advisory Panel; Abbott Diabetes, Boehringer Ingelheim International GmbH, Eli Lilly and Company, Medtronic, Merck Sharp & Dohme Corp., Novo Nordisk A/S, Roche Diabetes Care, Sanofi-Aventis Deutschland GmbH, Speaker's Bureau; Abbott Diabetes, Eli Lilly and Company, Medtronic, Merck Sharp & Dohme Corp., Novo Nordisk A/S, Roche Diabetes Care, Sanofi-Aventis Deutschland GmbH, Servier Laboratories, Stock/Shareholder; decide Clinical Software GmbH. M.Cigler: None. Funding This work was supported by the Innovative Medicines Initiative 2 Joint Undertaking (JU) under grant agreement 777460

Acute hypoglycemia impacts negatively on cognitive function. However, it remains unclear which specific domains of cognitive function are affected, and the extent to which level of hypoglycemia modifies this relationship. We conducted a systematic review and meta-analysis to investigate the impact of controlled hyperinsulinaemic hypoglycemia on cognitive function in adults with type 1 diabetes, following PRISMA guidelines. Experimental studies comparing cognitive function task performance during euglycemia and hypoglycemia were eligible for inclusion. Preliminary analyses were conducted on 38 studies, involving 54 cognitive task outcomes across three domains of cognitive function of varying complexity: attention/information processing speed (simplest) , working memory, and complex reasoning (most complex) . Three-level meta-analyses of the standardized mean differences (SMD) in performance during euglycemia and hypoglycemia, moderated by hypoglycemia level (Mdn=2.51; range=1.98-3.5 mmol/l) were conducted for each domain, with study and task as random effects to allow inclusion of multiple effect sizes per study. Hypoglycemia significantly impaired performance on all domains, with large effect sizes for attention/information processing speed (SMD=-1.17, 95% CI:-1.60 to -0.74) and working memory (SMD=-0.84, CI:-1.to -0.63) , and a medium effect size for complex reasoning (SMD=-0.61, CI:-0.99 to -0.23) . The degree of hypoglycemia significantly moderated this relationship for working memory only, such that for every 1mmol/l decrease in glucose level, performance was reduced by SMD=0.84 (CI:0.2 to 1.49) . These findings suggest that the impact of hypoglycemia on cognitive function is related to the cognitive domain complexity, with more impaired performance on simpler relative to more complex tasks. Further, degree of hypoglycemia may be differentially related to performance depending on the domain of cognitive function. Disclosure M.M.Broadley: None. C.Hendrieckx: None. R.J.Mccrimmon: Advisory Panel; Novo Nordisk, Sanofi, Research Support; Diabetes UK, European Union, MedImmune. G.Nefs: None. U.Pedersen-bjergaard: Advisory Panel; Novo Nordisk A/S, Sanofi. C.E.Verhulst: None. J.Speight: Advisory Panel; Insulet Corporation, Research Support; Novo Nordisk, Sanofi. F.Pouwer: Research Support; Eli Lilly and Company, Novo Nordisk, Sanofi. The hypo-resolve consortium: n/a. H.Chatwin: None. U.Soeholm: Research Support; Novo Nordisk A/S. J.Axelsen: None. S.A.Amiel: Advisory Panel; Medtronic, Novo Nordisk, Other Relationship; Sanofi. P.Choudhary: Advisory Panel; Abbott Diabetes, Lilly Diabetes, Medtronic, Research Support; Novo Nordisk, Speaker's Bureau; Dexcom, Inc., Glooko, Inc., Insulet Corporation, Sanofi. B.E.De galan: Research Support; Novo Nordisk. T.W.Fabricius: None. S.R.Heller: Advisory Panel; Eli Lilly and Company, Medtronic, Mylan N.V., Zealand Pharma A/S, Zucara Therapeutics, Other Relationship; Eli Lilly and Company, Research Support; Dexcom, Inc., Speaker's Bureau; Novo Nordisk A/S. Funding Innovative Medicines Initiative 2 Joint Undertaking (777460)

To determine which factors other than child age play a role in the division and transfer of diabetes care responsibilities between parents and children with type 1 diabetes.Qualitative focus group study.Across four sites in the Netherlands, 18 parents (13 mothers) of children (9-14 years) with type 1 diabetes participated in four focus groups in 2015-2016, as part of the research project 'Whose diabetes is it anyway?'. Qualitative content analysis and the constant comparison method were used to analyse the data.According to parents, the transfer process included both direct and indirect tasks, had different levels (remembering, deciding, performing), was at times a difficult and stressful process, and showed large variation between families. A large number of child, parent and context factors were identified that affected the division and transfer of diabetes care responsibilities according to parents. Both positive and negative consequences of the transfer process were described for parental and child health, behaviour and well-being. Parental final evaluations of the division and transfer of diabetes care responsibilities appeared to be dependent on parenting values.How families divide and transfer diabetes care tasks appeared to be affected by a complex interplay of child, parent and context characteristics, which had an impact on several parent and child domains.Parents struggle with the right timing of transfer, which calls for more support from diabetes nurses. The identified factors can be used as input for integrating a more family-based approach into current age-based guidelines, to improve regular care.目的: 确定除儿童年龄外, 哪些因素可能对父母和患有1型糖尿病的儿童的糖尿病护理责任划分和转移产生影响。 设计: 定性焦点小组研究。 方法: 2015-2016年间, 在荷兰境内四地展开研究, 研究对象为18名患有1型糖尿病的儿童 (9-14岁) 的父母 (13名母亲) , 共分为四个重点小组, 此类研究作为‘谁患有糖尿病’研究项目的一部分。此外, 采用定性含量分析法和持续比较法对数据进行分析。 结果: 父母表示, 转移过程中, 需执行不同难度的直接和间接任务 (记忆、决定、执行) , 部分情况下, 面临较大困难和压力, 并且, 不同家庭的差异较大。经确定, 大量儿童、父母和背景因素可能对糖尿病护理责任的划分和转移造成影响。现已对转移过程对父母和儿童健康、行为和幸福的积极和消极后果进行描述。父母对糖尿病护理责任划分和转移的最终评估取决于其价值观。 结论: 家庭分配和转移糖尿病护理责任的方式似乎与儿童、父母及背景特征的复杂作用相关, 而此类作用对父母和儿童均有一定程度的影响。 影响: 父母忙于确定准确的转移时间, 因此, 糖尿病护士需予以更多支持。可考虑此类已确定的因素, 以便将更多家庭方法整合至现有基于年龄的指南中, 从而改善常规护理。.

Aims/hypothesis It is generally accepted that hypoglycaemia can negatively impact the quality of life (QoL) of people living with diabetes. However, the suitability of patient-reported outcome measures (PROMs) used to assess this impact is unclear. The aim of this systematic review was to identify PROMs used to assess the impact of hypoglycaemia on QoL and examine their quality and psychometric properties. Methods Systematic searches (MEDLINE, EMBASE, PsycINFO, CINAHL and The Cochrane Library databases) were undertaken to identify published articles reporting on the development or validation of hypoglycaemia-specific PROMs used to assess the impact of hypoglycaemia on QoL (or domains of QoL) in adults with diabetes. A protocol was developed and registered with PROSPERO (registration no. CRD42019125153). Studies were assessed for inclusion at title/abstract stage by one reviewer. Full-text articles were scrutinised where considered relevant or potentially relevant or where doubt existed. Twenty per cent of articles were assessed by a second reviewer. PROMS were evaluated, according to COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) guidelines, and data were extracted independently by two reviewers against COSMIN criteria. Assessment of each PROM’s content validity included reviewer ratings (N = 16) of relevance, comprehensiveness and comprehensibility: by researchers (n = 6); clinicians (n = 6); and adults with diabetes (n = 4). Results Of the 214 PROMs used to assess the impact of hypoglycaemia on QoL (or domains of QoL), eight hypoglycaemia-specific PROMS were identified and subjected to full evaluation: the Fear of Hypoglycemia 15-item scale; the Hypoglycemia Fear Survey; the Hypoglycemia Fear Survey version II; the Hypoglycemia Fear Survey-II short-form; the Hypoglycemic Attitudes and Behavior Scale; the Hypoglycemic Confidence Scale; the QoLHYPO questionnaire and the Treatment-Related Impact Measure-Non-severe Hypoglycemic Events (TRIM-HYPO) questionnaire. Content validity was rated as ‘inconsistent’, with most as ‘(very) low’ quality, while structural validity was deemed ‘unsatisfactory’ or 'indeterminate'. Other measurement properties (e.g. reliability) varied, and evidence gaps were apparent across all PROMs. None of the identified studies addressed cross-cultural validity or measurement error. Criterion validity and responsiveness were not assessed due to the lack of a ‘gold standard’ measure of the impact of hypoglycaemia on QoL against which to compare the PROMS. Conclusions/interpretation None of the hypoglycaemia-specific PROMs identified had sufficient evidence to demonstrate satisfactory validity, reliability and responsiveness. All were limited in terms of content and structural validity, which restricts their utility for assessing the impact of hypoglycaemia on QoL in the clinic or research setting. Further research is needed to address the content validity of existing PROMs, or the development of new PROM(s), for the purpose of assessing the impact of hypoglycaemia on QoL. Prospero registration CRD42019125153 Graphical abstract

IntroductionThe 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.MethodsData 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.ResultsThree 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.ConclusionThree 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.

Cognitive impairment; Diabetes mellitus; Diabetic retinopathy Discapacidad cognitiva; Diabetes mellitus; Retinopatía diabética Discapacitat cognitiva; Diabetis mellitus; Retinopatia diabètica Background: Retinal neurodegeneration is evident in early diabetic retinopathy (DR) which may be associated with other neurodegenerative diseases like Alzheimer's disease (AD). Objective: To investigate diabetes and DR as a risk marker of present and incident AD. Methods: A register-based cohort study was performed. We included 134,327 persons with diabetes above 60 years of age, who had attended DR screening, and 651,936 age- and gender-matched persons without diabetes. Results: At baseline, the prevalence of AD was 0.7% and 1.3% among patients with and without diabetes, respectively. In a multivariable regression model, patients with diabetes were less likely to have AD at baseline (adjusted OR 0.63, 95% CI 0.59–0.68). During follow-up, incident AD was registered for 1473 (0.35%) and 6,899 (0.34%) persons with and without diabetes, respectively. Compared to persons without diabetes, persons with diabetes and no DR had a lower risk to develop AD (adjusted HR 0.87, 95% CI 0.81–0.93), while persons with diabetes and DR had higher risk of AD (adjusted HR 1.24, 95% CI 1.08–1.43). When persons with diabetes and no DR were used as references, a higher risk of incident AD was observed in persons with DR (adjusted HR 1.34, 95% CI 1.18–1.53). Conclusion: Individuals with diabetes without DR were less likely to develop AD compared to persons without diabetes. However, individuals with DR had a 34% higher risk of incident AD, which raise the question whether screening for cognitive impairment should be done among individuals with DR. This work was supported by VELUX FONDEN (grant number 00028744) and Odense University Hospital PhD Foundation (grant number 4339).

OBJECTIVE Previous studies have investigated the incidence of type 2 diabetes in individuals with psychiatric disorders, but most studies have focused on a specific psychiatric disorder or a selected sample. More population-based studies are needed to determine these associations in representative samples. We therefore aimed to determine these associations in a nationwide, register-based dynamic cohort study. RESEARCH DESIGN AND METHODS We analyzed data from 5,005,612 adults living in Denmark between 1995 and 2018, without prior diabetes. We investigated 10 different categories of psychiatric disorders and a composite group with any psychiatric disorder. Individuals with a psychiatric disorder were compared with individuals without using multivariable-adjusted Poisson regression to estimate incidence rate ratios (IRR) of type 2 diabetes. We modeled age-specific incidence rates (IR) for individuals with and without the specific psychiatric disorder. All models were stratified by sex. RESULTS In total, 334,739 individuals developed type 2 diabetes during follow-up. For all investigated categories of psychiatric disorders, we found increased IR of type 2 diabetes for individuals with versus those without a psychiatric disorder (IRR: men, 1.47 [95% CI 1.45–1.50]; women, 1.65 [95% CI 1.62–1.68]). When we examined age-specific IR, the largest differences were found in the younger population ( CONCLUSIONS We found that the IR of type 2 diabetes was higher in individuals with a psychiatric disorder compared with individuals without a psychiatric disorder and particularly high in the younger people with a psychiatric disorder. New studies into the prevention and early detection of type 2 diabetes in these groups are warranted.

Background: Severe hypoglycemia is a burdensome complication of diabetes mellitus that can induce fear of hypoglycemia and contribute to suboptimal glycemic control. The challenge is to achieve and maintain adequate glycemic control while avoiding episodes of severe hypoglycemia. The purpose of the study was to determine how common fear of hypoglycemia was in Zambian out-patients with diabetes and also to explore correlates of fear of hypoglycemia. Methods: One hundred fifty-seven individuals with types 1 and 2 diabetes participated in the study. Fear of Hypoglycemia Scale, Diabetes Self-Care Inventory, Problem Areas in Diabetes, and the Major Depression Inventory were completed. Multiple linear regression models were computed to assess the association between fear of hypoglycemia and psychological factors. Results: About 19% [16.3% type 1 and 12.6% type 2] of individuals with diabetes based on item endorsement expressed fear of hypoglycemia especially among individuals with type 1 diabetes. After controlling for demographic variables, diabetes self-care (ß = 0.24, p < 0.05), and diabetes specific distress (ß = 0.41, p < 0.001) were associated with fear of hypoglycemia. Conclusion: Fear of hypoglycemia was common and was positively associated with diabetes specific emotional distress and diabetes self-care. Interventions to avert fear of hypoglycemia are needed while optimizing glycemic control through managing diabetes care and emotion distress in individuals with diabetes.

Contains fulltext : 220541.pdf (Publisher’s version ) (Open Access) BACKGROUND: Hypoglycaemia is the most frequent complication of treatment with insulin or insulin secretagogues in people with diabetes. Severe hypoglycaemia, i.e. an event requiring external help because of cognitive dysfunction, is associated with a higher risk of adverse cardiovascular outcomes and all-cause mortality, but underlying mechanism(s) are poorly understood. There is also a gap in the understanding of the clinical, psychological and health economic impact of 'non-severe' hypoglycaemia and the glucose level below which hypoglycaemia causes harm. AIM: To increase understanding of hypoglycaemia by addressing the above issues over a 4-year period. METHODS: Hypo-RESOLVE is structured across eight work packages, each with a distinct focus. We will construct a large, sustainable database including hypoglycaemia data from >100 clinical trials to examine predictors of hypoglycaemia and establish glucose threshold(s) below which hypoglycaemia constitutes a risk for adverse biomedical and psychological outcomes, and increases healthcare costs. We will also investigate the mechanism(s) underlying the antecedents and consequences of hypoglycaemia, the significance of glucose sensor-detected hypoglycaemia, the impact of hypoglycaemia in families, and the costs of hypoglycaemia for healthcare systems. RESULTS: The outcomes of Hypo-RESOLVE will inform evidence-based definitions regarding the classification of hypoglycaemia in diabetes for use in daily clinical practice, future clinical trials and as a benchmark for comparing glucose-lowering interventions and strategies across trials. Stakeholders will be engaged to achieve broadly adopted agreement. CONCLUSION: Hypo-RESOLVE will advance our understanding and refine the classification of hypoglycaemia, with the ultimate aim being to alleviate the burden and consequences of hypoglycaemia in people with diabetes.

Aim: To investigate whether there is a bidirectional longitudinal association of depression with HbA1c. \ud \ud \ud Methods: We conducted a systematic literature search in PubMed, PsycINFO, CINAHL and EMBASE for observational, longitudinal studies published from January 2000 to September 2020, assessing the association between depression and HbA in adults. We assessed study quality with the Newcastle-Ottawa-Scale. Pooled effect estimates were reported as partial correlation coefficients (rp) or odds ratios (OR). \ud \ud \ud Results: We retrieved 1,642 studies; 26 studies were included in the systematic review and eleven in the meta-analysis. Most studies (16/26) focused on type 2 diabetes. Study quality was rated as good (n = 19), fair (n = 2) and poor (n = 5). Of the meta-analysed studies, six investigated the longitudinal association between self-reported depressive symptoms and HbA1c and five the reverse longitudinal association, with a combined sample size of n = 48,793 and a mean follow-up of 2 years. Higher levels of baseline depressive symptoms were associated with subsequent higher levels of HbA1c (partial r = 0.07; [95% CI 0.03, 0.12]; I238%). Higher baseline HbA1c values were also associated with 18% increased risk of (probable) depression (OR = 1.18; [95% CI 1.12,1.25]; I20.0%).\ud \ud \ud Conclusions: Our findings support a bidirectional longitudinal association between depressive symptoms and HbA1c. However, the observed effect sizes were small and future research in large-scale longitudinal studies is needed to confirm this association. Future studies should investigate the role of type of diabetes and depression, diabetes distress and diabetes self-management behaviours. Our results may have clinical implications, as depressive symptoms and HbA1c levels could be targeted concurrently in the prevention and treatment of diabetes and depression.\ud \ud \ud Registration: PROSPERO ID CRD42019147551.

Contains fulltext : 237447.pdf (Publisher’s version ) (Closed access) Background and aims: The prevalence of sexual dysfunctions in people with diabetes is still debated and understudied in women. This study examines the prevalence of sexual dysfunction in men and women with type 1 or type 2 diabetes (T1D or T2D) and the associations with clinical and psychological variables. Methods: Adults with diabetes (n = 756) completed an online survey including questions on sexual functioning (adapted Short Sexual Functional Scale), general emotional well-being (WHO-5), symptoms of anxiety (GAD-7) and diabetes distress (PAID-20). Results: One third of participants reported a sexual dysfunction. Men reported erectile dysfunction (T1D: 20%; T2D: 33%), and orgasmic dysfunction (T1D: 22%; T2D: 27%). In men, sexual dysfunction was independently associated with, older age (OR = 1.05, p = 0.022), higher waist circumference (OR = 1.04; p

This narrative review aims to examine the value of addressing mental disorders as part of the care of people with type 1 and type 2 diabetes in terms of four components of precision medicine. First, we review the empirical literature on the role of common mental disorders in the development and outcomes of diabetes (precision prevention and prognostics). We then review interventions that can address mental disorders in individuals with diabetes or at risk of diabetes (precision treatment) and highlight recent studies that have used novel methods to individualise interventions, in person and through applications, based on mental disorders. Additionally, we discuss the use of detailed assessment of mental disorders using, for example, mobile health technologies (precision monitoring). Finally, we discuss future directions in research and practice and challenges to addressing mental disorders as a factor in precision medicine for diabetes. This review shows that several mental disorders are associated with a higher risk of type 2 diabetes and its complications, while there is suggestive evidence indicating that treating some mental disorders could contribute to the prevention of diabetes and improve diabetes outcomes. Using technologically enabled solutions to identify mental disorders could help individuals who stand to benefit from particular treatments. However, there are considerable gaps in knowledge and several challenges to be met before we can stratify treatment recommendations based on mental disorders. Overall, this review demonstrates that addressing mental disorders as a facet of precision medicine could have considerable value for routine diabetes care and has the potential to improve diabetes outcomes. Graphical abstract

Contains fulltext : 286827.pdf (Publisher’s version ) (Open Access) AIM: To conduct a systematic review of published studies reporting on the longitudinal impacts of hypoglycaemia on quality of life (QoL) in adults with type 2 diabetes. METHOD: Database searches with no restrictions by language or date were conducted in MEDLINE, Cochrane Library, CINAHL and PsycINFO. Studies were included for review if they used a longitudinal design (e.g. cohort studies, randomised controlled trials) and reported on the association between hypoglycaemia and changes over time in patient-reported outcomes related to QoL. RESULTS: In all, 20 longitudinal studies published between 1998 and 2020, representing 50,429 adults with type 2 diabetes, were selected for review. A descriptive synthesis following Synthesis Without Meta-analysis guidelines indicated that self-treated symptomatic hypoglycaemia was followed by impairments in daily functioning along with elevated symptoms of generalised anxiety, diabetes distress and fear of hypoglycaemia. Severe hypoglycaemic events were associated with reduced confidence in diabetes self-management and lower ratings of perceived health over time. Frequent hypoglycaemia was followed by reduced energy levels and diminished emotional well-being. There was insufficient evidence, however, to conclude that hypoglycaemia impacted sleep quality, depressive symptoms, general mood, social support or overall diabetes-specific QoL. CONCLUSIONS: Longitudinal evidence in this review suggests hypoglycaemia is a common occurrence among adults with type 2 diabetes that impacts key facets in the physical and psychological domains of QoL. Nonetheless, additional longitudinal research is needed-in particular, studies targeting diverse forms of hypoglycaemia, more varied facets of QoL and outcomes assessed using hypoglycaemia-specific measures.

Aims\ud \ud Research on hypoglycaemia and quality of life (QoL) has focused mostly on severe hypoglycaemia and psychological outcomes, with less known about other aspects of hypoglycaemia (e.g., self-treated episodes) and impacts on other QoL domains (e.g., relationships). Therefore, we examined the impact of all aspects of hypoglycaemia on QoL in adults with type 1 diabetes (T1DM).\ud \ud \ud \ud Methods\ud \ud Participants completed an online survey, including assessment of hypoglycaemia-specific QoL (using the 12-item Hypoglycaemia Impact Profile). Mann-Whitney U tests examined differences in hypoglycaemia-specific QoL by hypoglycaemia frequency, severity, and awareness. Hierarchical linear regression examined associations with QoL.\ud \ud \ud \ud Results\ud \ud Participants were 1028 adults with T1DM (M ± SD age: 47 ± 15 years; diabetes duration: 27 ± 16 years). Severe and self-treated hypoglycaemia and impaired awareness negatively impacted on overall QoL and several QoL domains, including leisure activities, physical health, ability to keep fit/be active, sleep, emotional well-being, spontaneity, independence, work/studies, and dietary freedom. Diabetes distress was most strongly associated with hypoglycaemia-specific QoL, followed by generic emotional well-being, fear of hypoglycaemia, and confidence in managing hypoglycaemia. Hypoglycaemia frequency and awareness were no longer significantly associated with QoL once psychological factors were considered.\ud \ud \ud \ud Conclusions\ud \ud Hypoglycaemia negatively impacts on several QoL domains. Psychological factors supersede the effect of hypoglycaemia frequency and awareness in accounting for this negative impact.

Contains fulltext : 288353.pdf (Publisher’s version ) (Open Access) OBJECTIVE: To examine the associations between mental health and lifestyle in adults with type 1 and type 2 diabetes mellitus (T1DM and T2DM). METHODS: Online survey data from the cross-sectional Diabetes MILES - The Netherlands Study was analysed, including 270 adults with T1DM and 325 with T2DM. Mental health status (flourishing, moderate and languishing) in relation to diet, physical activity, alcohol consumption and smoking was analysed with ANCOVA and logistic regressions (adjusted for confounders). RESULTS: 47% of T1DM-, and 55% of T2DM participants reported flourishing mental health. Due to an insufficient number, participants with languishing mental health were excluded. In T2DM, participants with flourishing mental health had more optimal diet quality (mean ± SEM: 70 ± 1 vs 68 ± 1 diet quality score, p = 0.015), and physical activity levels (mean ± SEM: 3484 ± 269 vs 2404 ± 273 MET minutes/week, p = 0.001) than those with moderate mental health, but did not differ with respect to alcohol consumption and smoking. In T1DM, no significant associations were found. CONCLUSION: Only in T2DM, people with flourishing mental health had more optimal lifestyle behaviours compared to people with moderate mental health. Further research is needed to determine if mental health is more important for specific lifestyle behaviours, and if the mental health effect differs across diabetes types.

Context Individuals with severe mental illness (SMI) are at increased risk of developing type 2 diabetes. Objective This work explores whether individuals with diabetes and SMI are also at increased risk of diabetes complications and the potential age-specific differences in development of these. Methods Using nationwide registry data, we followed the entire Danish population with type 2 diabetes from January 1, 1996 to December 31, 2018. Exposure was SMI (schizophrenia, bipolar, or depression disorders). Outcome was diabetes complications (nephropathy, retinopathy, lower limp amputations, and cardiovascular disease). We applied Poisson regression models to estimate overall incidence rate ratios (IRRs) and age-specific incidence rates (IRs) and IRRs of the first event of each complication in individuals with SMI compared to individuals without SMI. The models were adjusted for sex, age, diabetes duration, calendar year, education, and migration status. Results We followed 371 625 individuals with type 2 diabetes, of whom 30 102 had coexisting diagnosed SMI. Individuals with SMI had a higher IR of nephropathy (IRR: 1.15; 95% CI, 1.12-1.18), amputations (IRR: 1.15; 95% CI, 1.04-1.28), and cardiovascular disease (men: IRR: 1.10; 95% CI, 1.05-1.15, women: IRR: 1.18; 95% CI, 1.13-1.22) but a lower IR of retinopathy (IRR: 0.75; 95% CI, 0.70-0.81) when compared to individuals without SMI, after adjustment for confounders. For all complications except amputations, the difference in IR was highest in the younger age groups. Conclusion Individuals with type 2 diabetes and SMI had a higher risk and an earlier onset of several diabetes complications diagnoses, emphasizing focusing on improving diabetes management in younger age groups with SMI.

Contains fulltext : 286868.pdf (Publisher’s version ) (Open Access) OBJECTIVE: Hypoglycaemic episodes and fear of hypoglycaemia can be burdensome for adults with type 1 diabetes. This study explored support needs relating to hypoglycaemia among adults with type 1 diabetes living in Denmark, Germany, the Netherlands and the United Kingdom. RESEARCH DESIGN AND METHODS: Respondents participated in a web-based qualitative study involving four open-ended questions that asked what they wished other people understood about hypoglycaemia and what other people could do differently to support them with hypoglycaemia. Responses were analyzed using reflexive thematic analysis. RESULTS: Participants were 219 adults with type 1 diabetes (mean ± SD age 39 ± 13 years; mean ± SD diabetes duration 20 ± 14 years). They described unmet needs relating to: (1) Clinical support, involving access to new diabetes technologies, training on hypoglycaemia prevention, personalised care and psychological support; (2) Practical support, involving family and friends better supporting them with hypoglycaemia management and prevention; (3) Education for other people, involving others becoming more informed about hypoglycaemia; and (4) An appreciation of the burden, involving others recognizing the experience and impact of episodes, and the burden of living with the risk of hypoglycaemia. CONCLUSIONS: Adults with type 1 diabetes report several unmet support needs relating to hypoglycaemia. Service delivery should be person-centred and prioritise the individual's support needs. Clinical conversations are needed to identify the individual's support needs and develop tailored support plans. People with diabetes and their family members should be offered hypoglycaemia-specific education and training.

IntroductionAchieving glycemic targets and optimizing quality of life (QoL) are important goals of type 1 diabetes care. Hypoglycemia is a common barrier to achieving targets and can be associated with significant distress. However, the impact of hypoglycemia on QoL is not fully understood. The aim of this study was to explore how adults with type 1 diabetes are impacted by hypoglycemia in areas of life that are important to their overall QoL.Research design and methodsParticipants responded to a web-based qualitative survey involving a novel ‘Wheel of Life’ activity. Responses were analyzed using reflexive thematic analysis.ResultsThe final sample included 219 adults with type 1 diabetes from Denmark, Germany, the Netherlands, and the UK. They had a mean±SD age of 39±13 years and diabetes duration of 20±14 years. Participants identified eight areas of life important to their overall QoL, including relationships and social life, work and studies, leisure and physical activity, everyday life, sleep, sex life, physical health, and mental health. Participants reported emotional, behavioral, cognitive, and social impacts of hypoglycemia within domains. Across domains, participants described interruptions, limited participation in activities, exhaustion, fear of hypoglycemia, compensatory strategies to prevent hypoglycemia, and reduced spontaneity.ConclusionsThe findings emphasize the profound impact of hypoglycemia on QoL and diabetes self-care behaviors. Diabetes services should be aware of and address the burden of hypoglycemia to provide person-centered care. Clinicians could ask individuals how hypoglycemia affects important areas of their lives to better understand the personal impact and develop tailored management plans.

Having a psychiatric disorder may increase the risk of developing type 2 diabetes[T2D] and this umbrella review aims to determine whether people with a psychiatric disorder have an increased risk of developing T2D and to investigate potential underlying mechanisms. A literature search was performed to identify systematic reviews of longitudinal studies investigating different psychiatric disorders as risk factors for incident T2D in humans (>18 years). A total of 8612 abstracts were identified, 180 full-text articles were read, and 25 systematic reviews were included. Six categories of psychiatric disorders were identified. Except for eating disorders, all psychiatric disorders were associated with increased risk of incident T2D ranging from RR = 1.18 [95% CI 1.12-1.24] to RR = 1.60 [95% CI 1.37-1.88] for depression; from RR = 1.27 [95% CI 1.19-1.35] to OR = 1.50 [95% CI 1.08-2.10] for use of antidepressant medication; from OR = 1.93 [1.37-2.73] to OR = 1.94 [1.34-2.80] for use of antipsychotic medication; from RR = 1.55 [95% CI 1.21-1.99] to RR = 1.74 [95% CI 1.30- 2.34] for insomnia, and finally showed OR = 1.47 [95% CI 1.23-1.75] for anxiety disorders. Plausible underlying mechanisms were discussed, but in most reviews corrections for mechanisms did not explain the association. Notable, only 16% of the systematic reviews had a high methodological quality. (c) 2021 The Authors. Published by Elsevier B.V. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).

Background: Severe mental illness (SMI) is linked with a higher incidence of type 2 diabetes (T2D); however, it is unclear whether persons with SMI and T2D have a higher incidence of diabetes complications compared to persons with T2D only. We calculated incidence rate ratios (IRR) and incidence rates (IR) of micro- and macrovascular diabetes complications among persons with T2D and SMI compared to those with T2D only. Methods: We used Danish nationwide registers to follow all persons with T2D from 1996 to 2018. IRR and age-specific IR of first event of each diabetes complication was estimated using Poisson regression models with risk time as offset comparing persons with T2D with and without SMI, while adjusting for sex, age, diabetes duration, calendar year, substance abuse and Charlson’s Comorbidity Index. Results: A total of 371,625 persons with T2D were on average followed for 6.9 - 7.6 year depending on the complication outcome. Persons with T2D and SMI (n=29,249) were younger at T2D diagnosis than persons with T2D only (mean [SD], 59 [15] vs. 63 [14] year). In total, 73,598 (27%) developed cardiovascular disease (CVD), 25,846 (7%) developed retinopathy, 20,191 (5%) developed nephropathy, and 6,796 (2%) underwent an amputation during follow-up. Persons with T2D and SMI had an increased risk of CVD (IRR: 1.14 (95% CI: 1.11-1.18)) and nephropathy (IRR: 1.11 (95% CI: 1.03-1.16)), and a decreased risk of retinopathy (IRR: 0.83 (95% CI: 0.78-0.86)) compared to persons with T2D only when adjusting for confounders. The risk for amputations were similar in persons with T2D with and without SMI (IRR: 1.00 (95% CI: 0.90-1.12)). The increased risk of CVD and nephropathy in persons with SMI were persistent in all ages except for the ages 80-95 year. Conclusion: Persons with T2D and SMI have a slightly higher risk of CVD and nephropathy and a lower risk of retinopathy compared to persons with T2D only. Disclosure S. H. Scheuer: None. V. Kosjerina: None. N. Lindekilde: None. F. Pouwer: None. B. Carstensen: Stock/Shareholder; Self; Novo Nordisk. M. E. Jørgensen: Research Support; Self; Boehringer Ingelheim International GmbH, Sanofi-Aventis, Stock/Shareholder; Self; Novo Nordisk A/S. M. E. Benros: None. G. S. Andersen: Stock/Shareholder; Self; Novo Nordisk A/S.

Aims: Prospective memory has been long considered a fundamental cognitive ability for optimal medication taking, but the role of prospective memory errors (termed ‘slips’) in diabetes self-care is unclear. Our aim was to examine associations between prospective memory and medication taking in adults with Type 1 and Type 2 diabetes mellitus. Methods: Some 901 adults with Type 1 diabetes and 927 with Type 2 diabetes completed a cross-sectional survey focused on the psychological and behavioural aspects of living with diabetes. Respondents reported whether they had forgotten to take their diabetes medication over the previous 14 days. Results: Twenty-four per cent (n = 220) of adults with Type 1 diabetes and 23% (n = 211) with Type 2 diabetes reported that they had forgotten their medication at least once over the previous 14 days. This was associated with more prospective memory slips in adults with Type 1 diabetes [odds ratio (OR) 1.09, 95% confidence interval (CI) 1.05 to 1.13; P 1c (Type 1 diabetes). Conclusions: These findings suggest that forgetting medication is relatively common among adults with Type 1 or Type 2 diabetes, and provide preliminary evidence for its relationship with self-reported prospective memory slips.

PurposeThe purpose of this study is to investigate medication intake, perceived barriers and their correlates in adults with type 1 or type 2 diabetes.MethodsIn this cross-sectional study, 3,383 Dutch adults with diabetes (42% type 1; 58% type 2) completed the 12-item ‘Adherence Starts with Knowledge’ questionnaire (ASK-12; total score range: 12-60) and reported socio-demographics, clinical and psychological characteristics and health behaviors. Univariable and multivariable logistic regression analyses were used.ResultsAdults with type 1 diabetes had a slightly lower mean ASK-12 score (i.e. more optimal medication intake and fewer perceived barriers) than adults with non-insulin-treated type 2 diabetes. After adjustment for covariates, correlates with suboptimal intake and barriers were fewer severe hypoglycemic events and more depressive symptoms and diabetes-specific distress. In type 2 diabetes, correlates were longer diabetes duration, more depressive symptoms and diabetes-specific distress.ConclusionsAdults with type 1 diabetes showed slightly more optimal medication intake and fewer perceived barriers than adults with non-insulin treated type 2 diabetes. Correlates differed only slightly between diabetes types. The strong association with depressive symptoms and diabetes-specific distress in both diabetes types warrants attention, as improving these outcomes in some people with diabetes might indirectly improve medication intake.

Estimates of the global prevalence of type 2 diabetes vary between 6% and 9%. The prevalence of type 2 diabetes has been investigated in psychiatric populations but a critical appraisal of the existing evidence is lacking, and an overview is needed. This umbrella review summarises existing systematic reviews of observational studies investigating the prevalence of type 2 diabetes in people with a psychiatric disorder.We searched PubMed, EMBASE, PsycINFO and the Cochrane Database of Systematic Reviews from inception to 17 January 2021 and screened reference lists of included systematic reviews. On the basis of prespecified criteria, we included systematic reviews investigating the prevalence of type 2 diabetes in adults (aged ≥18 years) with a psychiatric disorder. Titles and abstracts of 5155 identified records and full texts of 431 selected studies were screened by two independent reviewers, based on predefined eligibility criteria and an a priori developed extraction form, following the PRISMA and MOOSE guidelines. Risk of bias was assessed with the ROBIS instrument. Data extracted from primary studies were synthesised using random-effects meta-analyses.A total of 32 systematic reviews with 245 unique primary studies were identified and met inclusion criteria. Twelve had low risk of bias. They reported type 2 diabetes prevalence estimates ranging from 5% to 22% depending on the specific psychiatric disorder. We meta-analysed data for ten categories of psychiatric disorders and found the following prevalence estimates of type 2 diabetes: in people with a sleep disorder: 40%; binge eating disorder: 21%; substance use disorder: 16%; anxiety disorder: 14%; bipolar disorder: 11%; psychosis: 11%; schizophrenia: 10%; a mixed group of psychiatric disorders: 10%; depression: 9%; and in people with an intellectual disability 8%. All meta-analyses revealed high levels of heterogeneity.Type 2 diabetes is a common comorbidity in people with a psychiatric disorder. Future research should investigate whether routine screening for type 2 diabetes and subsequent prevention initiatives for these people are warranted. PROSPERO registration no. CRD42020159870.

Aims: To examine whether frequency, perceived severity and fear of hypoglycaemia are independently associated with diabetes-specific quality of life in adolescents with type 1 diabetes. Methods: Cross-sectional self-reported data on demographics, frequency and perceived severity of both self-treated and severe hypoglycaemia, fear of hypoglycaemia (Hypoglycaemia Fear Survey—Child version) and diabetes-specific quality of life (Pediatric Quality of Life Diabetes Module; PedsQL-DM) were obtained from the project ‘Whose diabetes is it anyway?’. Hierarchical regression analyses were performed for the total scale and recommended summary scores of the PedsQL-DM as dependent variables; independent variables were entered in the following steps: (1) age, gender and HbA 1c, (2) frequency of hypoglycaemia, (3) perceived severity of hypoglycaemia and (4) fear of hypoglycaemia. Results: Adolescents (12–18 years; n = 96) completed questionnaires. In the first three steps, female gender (p 1c (p