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Background The aim of this study was to identify similarities and differences in the unmet supportive care needs (USCN) of families of children with major chronic health conditions (CHCs) using a universal need assessment tool. Methods A cross-sectional online survey involving parents of children with congenital heart disease (CHD), type 1 diabetes mellitus (T1D), cancer, and asthma diagnosed within the last 5 years recruited via social media and support organizations. Thirty-four items assessing the USCN across six domains (care needs, physical and social needs, informational needs, support needs, financial needs, child-related emotional needs) were responded to on a 4-point Likert scale [no need (1) to high need (4)]. Descriptive statistics identified the level of need, and linear regressions identified factors associated with higher need domain scores. Due to small numbers, the asthma group was excluded from comparisons across CHCs. Results One hundred and ninety-four parents completed the survey (CHD: n = 97, T1D: n = 50, cancer: n = 39, and asthma: n = 8). Parents of children with cancer were most likely to report at least one USCN (92%), followed by parents of children with T1D (62%). The five most commonly reported USCN across CHCs were drawn from four domains: child-related emotional, support, care, and financial. Three need items were included in the top five needs for all conditions. A higher USCN was associated with a greater frequency of hospital visits and the absence of parental support. Conclusions Using a universal need assessment tool, this is one of the first studies to characterize USCN in families of children diagnosed with common CHCs. While proportions endorsing different needs varied across conditions, the most endorsed needs were similar across the illness groups. This suggests that support programs or services could be shared across different CHCs.

Background This study examined the feasibility and acceptability of the Low Intensity mental health Support via Telehealth Enabled Network (LISTEN) intervention, for adults with diabetes, facilitated by diabetes health professionals (HPs). Methods LISTEN training. Three HPs participated in three half-day online workshops, and applied their learnings during training cases (maximum four). Competency was assessed with a validated tool and achieving ‘satisfactory’ ratings for three consecutive sessions. LISTEN pilot. A single-group, pre-post study (up to four LISTEN sessions) with online assessments at baseline, post-intervention, and 4-week follow-up. Eligible participants were adults with type 1 or type 2 diabetes, with diabetes distress, but excluded if they had moderate/severe depressive and/or anxiety symptoms. Feasibility was assessed via recruitment and session completion rates. Acceptability was assessed with post-intervention self-report data. Changes in diabetes distress and general emotional well-being from baseline (T1) were explored at post-intervention (T2) and at 4-week follow-up (T3). Results Two HPs achieved competency (median training case sessions required: 7) and progressed to deliver LISTEN in the pilot study. In the pilot, N = 16 adults (Med[IQR] age: 60 [37–73] years; 13 women) with diabetes participated (median sessions per participant: 2). Twelve participants (75%) completed the post-intervention assessment (T2): 92% endorsed the number of sessions offered as ‘just right’, 75% felt comfortable talking with the HP, and 67% were satisfied with LISTEN. Perceived limitations were the structured format and narrow scope of problems addressed. Diabetes distress scores were lower post-intervention. Conclusions This pilot demonstrates the feasibility of training HPs to deliver LISTEN; and the acceptability and potential benefits of LISTEN for adults with diabetes. The findings highlight adaptations that may enhance delivery of, and satisfaction with, LISTEN that will be tested in a hybrid type 1 effectiveness-implementation trial.

There is limited evidence supporting the recommendation that drivers with insulin-treated diabetes need to start journeys with glucose90 mg/dL. Glucose levels of drivers with type 1 diabetes were monitored for 3 weeks using masked continuous glucose monitoring (CGM). Eighteen drivers (median [IQR] age 40 [35, 51] years; 11 men) undertook 475 trips (duration 15 [13, 21] min). Hypoglycemia did not occur in any trip starting with glucose90 mg/dL (92%

Contains fulltext : 290944.pdf (Publisher’s version ) (Open Access) AIMS: To examine the prevalence and health risks of binge eating in people with diabetes. METHODS: Self-report data were analysed from a subsample (n = 582 type 1 diabetes/735 type 2 diabetes) of Diabetes MILES - the Netherlands, an online survey. Prevalence of binge eating was compared across diabetes type and treatment and between participants with and without binges for eating styles, diabetes treatment and outcomes, weight, BMI and psychological comorbidity. Associations between binge eating, HbA(1c) , BMI, diabetes distress were assessed using hierarchical linear regression analyses. RESULTS: 23% (n = 308) of participants reported eating binges, with 16% at least monthly, and 6% at least weekly. Prevalence and frequency of binges did not differ across diabetes type or treatment. People reporting binges scored higher on dietary restraint, emotional and external eating and reported higher weight and BMI than those without binges. Only people with type 1 diabetes and eating binges had a higher HbA(1c) . Hierarchical regression analyses demonstrated that binge eating was independently associated with higher HbA(1c) (β = 0.12, p=0.001), BMI (β = 0.13, p

The Diabetes Psychosocial Assessment Tool (DPAT) was developed to assess the psychosocial well-being of young adults with type 1 diabetes in clinical practice. The DPAT includes three validated questionnaires (assessing diabetes distress, anxiety/depressive symptoms and emotional well-being) and an agenda-setting tool. It is currently used by the Queensland Statewide Diabetes Clinical Network (available at Clinical Excellence Queensland).To describe agenda items set by young adults with type 1 diabetes and investigate their association with emotional well-being/social support.The DPAT was completed by young adults attending routine diabetes outpatient appointments at the Mater Hospital (Brisbane) between November 2016 and January 2020. For the current analysis, data included responses on agenda-setting and outcomes from three validated questionnaires.Responses of 277 young adults (15-26 years) were analysed. Ninety-four (34%) reported one to three agenda item(s). Common agenda items were diabetes technology and medications, but other topics raised included pregnancy, body image and eating concerns. Participants with moderate diabetes distress or anxiety symptoms were more likely to list at least one agenda item (P = 0.006; P = 0.002), as were females and older participants.Several agenda items for young adults with type 1 diabetes were identified and were more likely to be raised by those with elevated diabetes distress and anxiety symptoms. The DPAT is a valuable and convenient tool that can be easily applied in routine clinical practice to enable clinicians to understand the concerns of the young adult population and deliver personalised medicine to optimise long-term outcomes.

Racial and ethnic disparities exist in gestational diabetes prevalence and risk of subsequent type 2 diabetes mellitus (T2DM). Postpartum engagement in healthy behaviours is recommended for prevention and early detection of T2DM, yet uptake is low among women from diverse cultural backgrounds. Greater understanding of factors impacting postpartum health behaviours is needed. Applying the Theoretical Domains Framework (TDF) and Capability, Opportunity, Motivation-Behaviour (COM-B) model, our aim was to synthesise barriers to and enablers of postpartum health behaviours among women from diverse cultural backgrounds with prior GDM and identify relevant intervention components.Databases, reference lists and grey literature were searched from September 2017 to April 2021. Two reviewers screened articles independently against inclusion criteria and extracted data. Using an inductive-deductive model, themes were mapped to the TDF and COM-B model.After screening 5148 citations and 139 full texts, we included 35 studies (N = 787 participants). The main ethnicities included Asian (43%), Indigenous (15%) and African (11%). Barriers and enablers focused on Capability (e.g. knowledge), Opportunity (e.g. competing demands, social support from family, friends and healthcare professionals, culturally appropriate education and resources) and Motivation (e.g. negative emotions, perceived consequences and necessity of health behaviours, social/cultural identity). Five relevant intervention functions are identified to link the barriers and enablers to evidence-based recommendations for communications to support behaviour change.We provide a conceptual model to inform recommendations regarding the development of messaging and interventions to support women from diverse cultural backgrounds in engaging in healthy behaviours to reduce risk of T2DM.

Objective: An emerging group of people with type 1 diabetes are building and using their own artificial pancreas systems (APS). Currently, these “user-led,” open-source systems are not endorsed by ...

Background: This prerandomization analysis from the Australian HCL-Adult trial (registration number: ACTRN12617000520336) compared masked continuous glucose monitoring (CGM) metrics among adults using insulin pumps versus multiple daily injections (MDIs), who were all self-monitoring blood glucose (SMBG). Methods: Adults with type 1 diabetes, using an insulin pump or MDIs without real-time CGM (and entering a trial of closed-loop technology), were eligible. MDI users were given an insulin dosage calculator. All participants received diabetes and carbohydrate-counting education, then wore masked CGM sensors for 3 weeks. Ethics Approval: HREC-D 088/16 Results: Adults using MDIs (n = 61) versus pump (n = 59) did not differ by age, sex, diabetes duration, insulin total daily dose, or HbA1c at baseline. After education, median (interquartile range) CGM time in range (TIR) 70-180 mg/dL (3.9-10.0 mmol/L) was 54% (47, 62) for those using MDIs and 56% (48, 66) for those using pump (P = 0.40). All CGM metrics were equivalent for 24 h/day for MDI and pump users. Overnight, those using MDIs (vs. pump) spent more time with glucose

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.

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

Background: Use of open-source automated insulin delivery (AID) is associated with improved psychosocial outcomes among people with type 1 diabetes (T1D) . However, research to date has been qualitative or used study-specific single items. There is a need for quantitative research using validated measures in larger samples. Method: We conducted an international online survey to examine the psychosocial outcomes of open-source AID users and non-users. Validated questionnaires assessed diabetes-specific quality of life (QoL) , impact of the COVID-pandemic on diabetes-specific QoL, diabetes specific-positive well-being, diabetes treatment satisfaction, diabetes distress, fear of hypoglycaemia, general emotional well-being, and subjective sleep quality. Results: 587 participants completed at least one questionnaire, including 447 adults using open-source AID (mean age 43, 42% women) and 140 non-users (mean age 40, 64% women) . Table 1 shows significant between-group differences for all questionnaire scores. Discussion: Adults with T1D using open-source AID report significantly better psychosocial outcomes than non-users. Due to the cross-sectional design of this study, we cannot make any causal inferences about the use of these devices. Further research is needed to examine the reasons for these differences. Disclosure J.Schipp: None. T.C.Skinner: None. J.Speight: Advisory Panel; Insulet Corporation, Research Support; Novo Nordisk, Sanofi. C.Hendrieckx: None. K.Braune: None. S.O'donnell: None. H.Ballhausen: None. B.Cleal: None. M.Wäldchen: None. C.Knoll: None. K.A.Gajewska: None. Funding European Commission Horizon 2020 (823902)

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)

Objective: To examine whether symptoms of depression or anxiety predict glycaemia and incident diabetes complications four years later, and whether diabetes self-care behaviours mediate these associations, in adults with type 1 diabetes (T1DM). Methods: Data of 205 adults with T1DM from the 2011 and 2015 Diabetes MILES–Australia surveys were analysed. Variables of interest were: baseline depression and anxiety (PHQ-8 and GAD-7, respectively) symptoms; HbA1c and incident complications at four-year follow-up; and self-care behaviours at both time points. Longitudinal associations were analysed using structural equation modelling. Results: Forty-two participants (20.6%) reported incident complications. Baseline depressive symptoms predicted higher HbA1c at follow-up indirectly via less optimal self-care at follow-up (β = 0.19, P = 0.011). Baseline anxiety was not independently associated with HbA1c or self-care at follow-up (P ≥ 0.64). Neither depressive nor anxiety symptoms predicted incident complications, although depressive symptoms were associated with less optimal self-care at baseline (β = -0.67, P < 0.001), and this predicted microvascular complications (β = -0.38, P = 0.044); however, the indirect association via self-care was not significant (β = 0.25, P = 0.067). Limitations: Participants were self-selected; all study variables were assessed using self-report measures; and adjusting for baseline HbA1c was not possible. Conclusions: Depressive symptoms predicted suboptimal self-care behaviour and glycaemic outcome four years later, while anxiety symptoms did not. The findings suggest that tailored diabetes care should take the potential impact of comorbid depression into consideration to help people improve their diabetes self-care and achieve best possible health outcomes.

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

Diabetes distress is experienced by up to 36% of adults with type 2 diabetes. Australian type 2 diabetes guidelines recommend annual assessment of diabetes distress in general practice. This study explores general practitioners' knowledge, current practice, and factors influencing implementation of guidelines, including Person Reported Outcome Measure (PROM) use.A cross-sectional online survey was disseminated via e-mail to 4776 Australian general practitioners listed on the Australasian Medical Publishing Company database.264 (5%) surveys were returned. 75% indicated that general practitioners were the most appropriate professionals to assess diabetes distress. Sixteen percent reported asking about diabetes distress during type 2 diabetes consultations more than half the time, with 13% using a PROM more than half the time: 64% use the Kessler-10, and 1.9% use the Problem Areas in Diabetes (PAID) scale. While general practitioners had positive beliefs about the consequences of assessing and addressing diabetes distress, they also reported barriers in motivation, environment, and knowledge of guidelines.Most respondents endorsed general practitioners' role in assessing diabetes distress, but few ask about or assess diabetes distress in routine consultations. To support uptake of guideline recommendations for diabetes-specific PROM use, environmental factors, specifically time, need to be addressed.

To explore the association between the use of glycaemic technologies and person-reported outcomes (PROs) in adults with type 1 diabetes (T1D).We included T1D and technology publications reporting on PROs since 2014. Only randomised controlled trials and cohort studies that used validated PRO measures (PROMs) were considered.T1D studies reported on a broad range of validated PROMs, mainly as secondary outcome measures. Most studies examined continuous glucose monitoring (CGM), intermittently scanned CGM (isCGM), and the role of continuous subcutaneous insulin infusion (CSII), including sensor-augmented CSII and closed loop systems. Generally, studies demonstrated a positive impact of technology on hypoglycaemia-specific and diabetes-specific PROs, including reduced fear of hypoglycaemia and diabetes distress, and greater satisfaction with diabetes treatment. In contrast, generic PROMs (including measures of health/functional status, emotional well-being, depressive symptoms, and sleep quality) were less likely to demonstrate improvements associated with the use of glycaemic technologies. Several studies showed contradictory findings, which may relate to study design, population and length of follow-up. Differences in PRO findings were apparent between randomised controlled trials and cohort studies, which may be due to different populations studied and/or disparity between trial and real-world conditions.PROs are usually assessed as secondary outcomes in glycaemic technology studies. Hypoglycaemia-specific and diabetes-specific, but not generic, PROs show the benefits of glycaemic technologies, and deserve a more central role in future studies as well as routine clinical care.

Fear of hypoglycemia (FOH) is anxiety or extreme worry about having a low blood glucose and its consequences. FOH is common in individuals with type 1 diabetes (T1D) of all ages, as well as their caregivers, and can lead to inappropriate T1D self-management and suboptimal health outcomes. Despite its prevalence and serious health consequences, there has been very little attention focused on developing interventions to reduce FOH and its associated maladaptive T1D management behaviors. The primary aim of the present study, Bring BG Down!, was to implement a pilot intervention targeting FOH in mothers of adolescents with T1D. Exploratory aims included determining if the intervention had an impact on the adolescent's FOH, glycemia, as well as other generalized anxiety symptoms or symptoms of obsessive-compulsive disorder in both the mother and adolescent. Caregiver participants and their adolescents with T1D were randomized to either the Bring BG Down! group or the Control group. Individuals in the Bring BG Down! group participated in intervention sessions for 6 months via telehealth and they completed questionnaires, whereas those in the Control group only completed questionnaires. Follow-up occurred at 7-months and 10-months. The purpose of this paper is to describe the Bring BG Down! study design and rationale, and participant characteristics at the start of the study.

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

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.

In this article the bio-medical and psychological aspects of diabetes mellitus and their interactions are reviewed. Main types of diabetes are distinguished, all characterized by elevated blood glucose levels (hyperglycemia) and related health risks, but with different risk factors, age of onset, clinical features and treatment requirements. The cognitive, emotional and behavioral ramifications of living with and self-managing diabetes are reviewed, along with psychological co-morbidities. There is a clear need for integrating psychological assessment and support into diabetes care, with an important role for diabetes health professionals as well as clinical health psychologists and other mental health workers. The article concludes with some future directions for behavioral research in diabetes.

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.

Aims An emerging group of people with type 1 diabetes are not waiting for commercial solutions, choosing to manage their condition with open-source artificial pancreas systems (APS). Our aim was to explore their perspectives on the future of APS. Methods Semi-structured telephone interviews were conducted (in Australia, October 2018 to January 2019) with 23 adults with type 1 diabetes currently using open-source APS. Interviews were recorded, transcribed, and analysed thematically. Results Participants described five key features of open-source APS they value: compatibility, user-led design, customisability, ability to evolve faster, and community-driven. They attributed the success of the open-source APS movement to benefits they derive from these features: choice, solutions that meet their needs, ownership, staying one step ahead, and real-time support. They expressed hope that future commercial products and healthcare would benefit from their learnings and from collaboration with the open-source APS community. Conclusions Participants believed that there will always be a place for the open-source community. It will continue to build upon and advance commercial products, respond to user needs, offering a higher degree of control and customisation than afforded by commercial products, and generating optimism for the future. Participants desired that future commercial diabetes technologies would be inspired by the open-source community and developed collaboratively with people with diabetes.

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.

Women with prior gestational diabetes have nearly 10 times the risk of developing type 2 diabetes. Postpartum screening for type 2 diabetes is recommended for early diagnosis and management, yet uptake is low. This work updates a previous systematic review and advances it through the application of the Theoretical Domains Framework (TDF) to synthesise personal-level factors impacting type 2 diabetes screening and the Capability, Opportunity, Motivation-Behaviour model (COM-B), to develop messaging recommendations for use in clinical practice and screening promotion interventions.We searched seven academic databases from September 2017 (prior review) to April 2021, reference lists and grey literature. Two reviewers independently screened articles against inclusion criteria (qualitative studies exploring factors impacting postpartum diabetes screening, any language) and extracted data. Using an inductive-deductive model, we coded determinants to the TDF and mapped onto the COM-B model.We identified 38 eligible papers from 34 studies (N = 1291 participants). Most (71%) reported sample sizes of N ≥ 16. The ratio of barriers to enablers was three to one. Eight key TDF domains were identified. Evidence-based recommendations include addressing knowledge, risk perception, fear of diabetes diagnosis, low prioritisation of personal health and fatalism. The risk of bias was low and confidence in findings was moderate to high. A limitation was conceptual overlap between TDF domains, which we addressed via the study procedure.The theoretical categorisation of determinants enables the development of messaging and interventions at the personal level, to promote women's uptake of postpartum type 2 diabetes screening.

Type 1 diabetes is a demanding, complex lifelong condition. Optimal self-care involves repetitive behavioural tasks, undertaken ‘24/7’: administering multiple daily insulin doses, adjusted for food/activity and monitoring glucose levels to avoid hyper- and hypoglycaemia. This requires a comprehensive understanding of diabetes, as well as healthy coping, resilience, problem-solving, and risk reduction skills. It is unsurprising that many experience emotional distress as a consequence of living with type 1 diabetes, which impacts not only on their well-being but also on self-management and outcomes. Clinical guidelines acknowledge that diabetes affects both physical and emotional health. However, the misguided perception persists that the psychosocial care is separate from the diabetes care, and that it requires mental health specialists to assist. A paradigm shift is needed. Diabetes health professionals need to enhance their consultation skills to identify and address psychological needs, if they are to support people to live well with this challenging condition.

Aim Hypoglycaemia affects many people with Type 2 diabetes using insulin and other glucose-lowering therapies. This systematic review examined the impact of severe hypoglycaemia (episodes requiring external assistance) on psychological outcomes (e.g. emotional well-being, health status and quality of life) in adults with Type 2 diabetes. Methods MEDLINE Complete, PsycINFO and CINAHL databases were searched for peer-reviewed empirical studies, published in English, reporting the occurrence and severity of hypoglycaemia and its relationship with patient-reported outcomes (PROs) in adults with Type 2 diabetes. Data were extracted from published reports and analysed. Results Of 3756 potentially relevant abstracts, 29 studies met the inclusion criteria. Most reported cross-sectional data and sample sizes varied widely (N = 71 to 17 563). Although definitions of mild and severe hypoglycaemia were largely consistent between studies, additional non-standard categorizations (e.g. moderate, very severe) were apparent and recall periods varied. Overall, severe hypoglycaemia was associated with increased fear of hypoglycaemia and decreased emotional well-being, health status and diabetes-specific quality of life. Effect sizes show that the association with fear of hypoglycaemia was stronger than with general health status. Conclusions Notwithstanding the limitations of the empirical studies, these findings indicate that severe hypoglycaemia in adults with Type 2 diabetes (insulin- and non-insulin-treated) is associated with impaired psychological outcomes. Healthcare professionals should address the psychological impact of severe hypoglycaemia during clinical consultations, to support individuals to minimize exposure to, and the psychological consequences of, severe hypoglycaemia.

Aims: We examined: (a) the prevalence of comorbid elevated symptoms of anxiety/depression; (b) its demographic/clinical correlates; (c) associations with self-care behaviors, by diabetes type.Methods: Cross-sectional self-report data of 6590 adults with diabetes (42% type 1; 58% type 2) from the Australian and Dutch Diabetes MILES studies were used. Elevated symptoms of anxiety/depression were defined as GAD-7 >= 10/PHQ-9 >= 10.Results: In both diabetes types, comorbid elevated symptoms of anxiety/depression were present in 9% and symptoms of anxiety alone in 2%; symptoms of depression alone were present in 8% of adults with type 1 diabetes and 11% with type 2 diabetes. Shorter diabetes duration (type 1 only) was the only characteristic that distinguished those with comorbid elevated symptoms of anxiety/depression but not those with symptoms of anxiety/depression alone from the reference group (no/minimal symptoms of anxiety/depression). Those with comorbid elevated symptoms of anxiety/depression had increased odds of sub-optimal diabetes self-care behaviors compared with the reference group, with higher odds than those with symptoms of anxiety or depression alone.Conclusions: Comorbid elevated symptoms of anxiety/depression affected one in ten respondents, who also had increased odds of suboptimal diabetes self-care. Those with shorter type 1 diabetes duration may be at increased risk. (C) 2019 Elsevier Inc. All rights reserved.

IntroductionType 2 diabetes is a global health priority. People with diabetes are more likely to experience mental health problems relative to people without diabetes. Diabetes guidelines recommend assessment of depression and diabetes distress during diabetes care. This systematic review will examine the effect of routinely assessing and addressing depression and diabetes distress using patient-reported outcome measures in improving outcomes among adults with type 2 diabetes.Methods and analysisMEDLINE, Embase, CINAHL Complete, PsycInfo, The Cochrane Library and Cochrane Central Register of Controlled Trials will be searched using a prespecified strategy using a prespecified Population, Intervention, Comparator, Outcomes, Setting and study design strategy. The date range of the search of all databases will be from inception to 3 August 2020. Randomised controlled trials, interrupted time-series studies, prospective and retrospective cohort studies, case–control studies and analytical cross-sectional studies published in peer-reviewed journals in the English language will be included. Two review authors will independently screen abstracts and full texts with disagreements resolved by a third reviewer, if required, using Covidence software. Two reviewers will undertake risk of bias assessment using checklists appropriate to study design. Data will be extracted using prespecified template. A narrative synthesis will be conducted, with a meta-analysis, if appropriate.Ethics and disseminationEthics approval is not required for this review of published studies. Presentation of results will follow the Preferred Reporting Items for Systematic reviews and Meta-Analyses guidance. Findings will be disseminated via peer-reviewed publication and conference presentations.PROSPERO registration numberCRD42020200246.