Trends in Incidence of Hospitalization for Hypoglycemia and Diabetic Ketoacidosis in Individuals With Type 1 or Type 2 Diabetes With and Without Severe Mental Illness in Denmark From 1996 to 2020: A Nationwide Study.

OBJECTIVE: To examine trends in incidence of acute diabetes complications in individuals with type 1 or type 2 diabetes with and without severe mental illness (SMI) in Denmark by age and calendar year. RESEARCH DESIGN AND METHODS: We conducted a cohort study using nationwide registers from 1996 to 2020 to identify individuals with diabetes, ascertain SMI status (namely, schizophrenia, bipolar disorder, or major depression) and identify the outcomes: hospitalization for hypoglycemia and diabetic ketoacidosis (DKA). We used Poisson regression to estimate incidence rates (IRs) and incidence rate ratios (IRRs) of recurrent hypoglycemia and DKA events by SMI, age, and calendar year, accounting for sex, diabetes duration, education, and country of origin. RESULTS: Among 433,609 individuals with diabetes, 8% had SMI. Risk of (first and subsequent) hypoglycemia events was higher for individuals with SMI than for those without SMI (for first hypoglycemia event, IRR: type 1 diabetes, 1.77 [95% CI 1.56-2.00]; type 2 diabetes, 1.64 [95% CI 1.55-1.74]). Individuals with schizophrenia were particularly at risk for recurrent hypoglycemia events. The risk of first DKA event was higher in individuals with SMI (for first DKA event, IRR: type 1 diabetes, 1.78 [95% CI 1.50-2.11]; type 2 diabetes, 1.85 [95% CI 1.64-2.09]). Except for DKA in the type 2 diabetes group, IR differences between individuals with and without SMI were highest in younger individuals (<50 years old) but stable across the calendar year. CONCLUSIONS: SMI is an important risk factor for acute diabetes complication and effective prevention is needed in this population, especially among the younger population and those with schizophrenia.

Childhood maltreatment and the risk of impaired glucose metabolism or type 2 diabetes in young adults: Findings from the Lifelines Cohort Study.

We examined the associations between childhood maltreatment and the risk of impaired glucose metabolism (IGM) or type 2 diabetes (T2D) in young adults aged 18-35. Participants (N = 8506) from the Lifelines Cohort Study without IGM or diabetes at baseline (2007-2013) were included. Childhood maltreatment was assessed by the Childhood Trauma Questionnaire (CTQ) and incident IGM/T2D was assessed by haemoglobin A1c levels (≥5.7%) in 2014-2017. There were 223 (2.6%) cases of IGM/T2D during the follow-up period. After adjusting for sociodemographic and health/lifestyle covariates and follow-up time, only the CTQ Sexual Abuse subscale was significantly associated with IGM/T2D (RR = 1.05 [95% CI = 1.01, 1.10]). The association remained when additionally accounting for depressive and anxiety symptoms (RR = 1.05 [95% CI = 1.00, 1.09]). Childhood sexual abuse was associated with an increased risk of IGM/T2D in young adults, highlighting the long-term metabolic consequences of childhood maltreatment.

Associations Between Hypoglycemia Awareness Status and Symptoms of Hypoglycemia Among Adults with Type 1 or Insulin-Treated Type 2 Diabetes Using the Hypo-METRICS Smartphone Application.

Introduction: This study examined associations between hypoglycemia awareness status and hypoglycemia symptoms reported in real-time using the novel Hypoglycaemia-MEasurement, ThResholds and ImpaCtS (Hypo-METRICS) smartphone application (app) among adults with insulin-treated type 1 (T1D) or type 2 diabetes (T2D). Methods: Adults who experienced at least one hypoglycemic episode in the previous 3 months were recruited to the Hypo-METRICS study. They prospectively reported hypoglycemia episodes using the app for 10 weeks. Any of eight hypoglycemia symptoms were considered present if intensity was rated between "A little bit" to "Very much" and absent if rated "Not at all." Associations between hypoglycemia awareness (as defined by Gold score) and hypoglycemia symptoms were modeled using mixed-effects binary logistic regression, adjusting for glucose monitoring method and diabetes duration. Results: Of 531 participants (48% T1D, 52% T2D), 45% were women, 91% white, and 59% used Flash or continuous glucose monitoring. Impaired awareness of hypoglycemia (IAH) was associated with lower odds of reporting autonomic symptoms than normal awareness of hypoglycemia (NAH) (T1D odds ratio [OR] 0.43 [95% confidence interval {CI} 0.25-0.73], P = 0.002); T2D OR 0.51 [95% CI 0.26-0.99], P = 0.048), with no differences in neuroglycopenic symptoms. In T1D, relative to NAH, IAH was associated with higher odds of reporting autonomic symptoms at a glucose concentration <54 than >70 mg/dL (OR 2.18 [95% CI 1.21-3.94], P = 0.010). Conclusion: The Hypo-METRICS app is sensitive to differences in hypoglycemia symptoms according to hypoglycemia awareness in both diabetes types. Given its high ecological validity and low recall bias, the app may be a useful tool in research and clinical settings. The clinical trial registration number is NCT04304963.

A Comparison of the Rates of Clock-Based Nocturnal Hypoglycemia and Hypoglycemia While Asleep Among People Living with Diabetes: Findings from the Hypo-METRICS Study.

Introduction: Nocturnal hypoglycemia is generally calculated between 00:00 and 06:00. However, those hours may not accurately reflect sleeping patterns and it is unknown whether this leads to bias. We therefore compared hypoglycemia rates while asleep with those of clock-based nocturnal hypoglycemia in adults with type 1 diabetes (T1D) or insulin-treated type 2 diabetes (T2D). Methods: Participants from the Hypo-METRICS study wore a blinded continuous glucose monitor and a Fitbit Charge 4 activity monitor for 10 weeks. They recorded details of episodes of hypoglycemia using a smartphone app. Sensor-detected hypoglycemia (SDH) and person-reported hypoglycemia (PRH) were categorized as nocturnal (00:00-06:00 h) versus diurnal and while asleep versus awake defined by Fitbit sleeping intervals. Paired-sample Wilcoxon tests were used to examine the differences in hypoglycemia rates. Results: A total of 574 participants [47% T1D, 45% women, 89% white, median (interquartile range) age 56 (45-66) years, and hemoglobin A1c 7.3% (6.8-8.0)] were included. Median sleep duration was 6.1 h (5.2-6.8), bedtime and waking time ∼23:30 and 07:30, respectively. There were higher median weekly rates of SDH and PRH while asleep than clock-based nocturnal SDH and PRH among people with T1D, especially for SDH <70 mg/dL (1.7 vs. 1.4, P < 0.001). Higher weekly rates of SDH while asleep than nocturnal SDH were found among people with T2D, especially for SDH <70 mg/dL (0.8 vs. 0.7, P < 0.001). Conclusion: Using 00:00 to 06:00 as a proxy for sleeping hours may underestimate hypoglycemia while asleep. Future hypoglycemia research should consider the use of sleep trackers to record sleep and reflect hypoglycemia while asleep more accurately. The trial registration number is NCT04304963.

Reliability and validity of the Turkish version of the problem areas in diabetes (PAID) survey: Results from diabetes MILES - Turkey.

BACKGROUND AND AIMS: To 1) assess the reliability and validity of the Turkish version of the Problem Areas in Diabetes (PAID), PAID-5 and PAID-1 survey among Turkish adults with type 1 or type 2 diabetes, 2) estimate the level of elevated diabetes-specific distress (DD), and 3) determine the demographic and clinical correlates of DD-symptom severity. METHODS AND RESULTS: From 2017-2019, 252 adults with type 1(n = 80) (T1DM) or type 2 diabetes (n = 172) (T2DM) self-reported demographic factors, DD(PAID) and related psychological and clinical questionnaires. We examined PAID internal consistency, structural and convergent validity. Associations of measures with DD were explored with hierarchical linear regression analysis. PCA yielded a 3-factor solution for PAID-20 and a 2-factor solution for PAID-5. Cronbach's α for PAID/PAID-5 subscales ranged from 0.63-0.90. All PAID versions correlated most strongly to BIPQ and HFS. The prevalence of elevated distress (PAID-20 ≥33) was 40% in T1DM and 15% in T2DM. DD severity was significantly positively associated (p < 0.01) with more negative diabetes perceptions (BIPQ) and type 1 diabetes. CONCLUSIONS: The Turkish translation of the PAID and its short forms appeared to have satisfactory psychometric properties. Elevated diabetes distress was more common in T1DM.

Associations between HbA1c Reduction and Change in Depressive Symptoms following Glucose-lowering Treatment in Adults: A Systematic Review of Intervention Studies.

INTRODUCTION: Hyperglycemia constitutes a likely pathway linking diabetes and depressive symptoms; lowering glycemic levels may help reduce diabetes-comorbid depressive symptoms. Since randomized controlled trials can help understand temporal associations, we systematically reviewed the evidence regarding the potential association of hemoglobin HbA1c lowering interventions with depressive symptoms. METHODS: PubMed, PsycINFO, CINAHL, and EMBASE databases were searched for randomized controlled trials evaluating HbA1c-lowering interventions and including assessment of depressive symptoms published between 01/2000-09/2020. Study quality was evaluated using the Cochrane Risk of Bias tool. PROSPERO registration: CRD42020215541. RESULTS: We retrieved 1,642 studies of which twelve met our inclusion criteria. Nine studies had high and three unclear risks of bias. Baseline depressive symptom scores suggest elevated depressive symptoms in five studies. Baseline HbA1c was <8.0% (<64 mmol/mol) in two, 8.0-9.0% (64-75 mmol/mol) in eight, and ≥10.0% (≥86 mmol/mol) in two studies. Five studies found greater HbA1c reduction in the treatment group; three of these found greater depressive symptom reduction in the treatment group. Of four studies analyzing whether the change in HbA1c was associated with the change in depressive symptoms, none found a significant association. The main limitation of these studies was relatively low levels of depressive symptoms at baseline, limiting the ability to show a lowering in depressive symptoms after HbA1c reduction. CONCLUSIONS: We found insufficient available data to estimate the association between HbA1c reduction and depressive symptom change following glucose-lowering treatment. Our findings point to an important gap in the diabetes treatment literature. Future clinical trials testing interventions to improve glycemic outcomes might consider measuring depressive symptoms as an outcome to enable analyses of this association.

The quest for wellness: How to optimise self-care strategies for diabetic foot management?

Diabetic foot ulceration (DFU) is common and highly recurrent, negatively impacting the individuals' quality of life. The 2023 guidelines of the International Working Group on the Diabetic Foot emphasise that adherence to foot self-care recommendations is one of the most important factors in DFU prevention. These guidelines also briefly mention that depression and other psychosocial problems can hamper treatment and ulcer healing. Moreover, a new clinical question was added on psychological interventions for ulcer prevention, although the evidence regarding the role of psychological and social factors is still limited. To help the field progress, this narrative overview discusses how a stronger focus on psychological factors by both researchers and clinicians could improve the care for people at high DFU risk. The review starts with a testimony of a person living with DFU, explaining that for him, the absence of shared decision-making has been a key barrier to successful foot self-care implementation. Intervention studies that address patient-reported barriers are still scarce, and are therefore urgently needed. Furthermore, the key elements of psychological interventions found to be successful in managing diabetes are yet to be implemented in DFU risk management. Importantly, research evidence indicates that commonly advocated foot self-care recommendations may be insufficient in preventing DFU recurrence, whereas digital technology appears to effectively reduce recurrent DFU. More research is therefore needed to identify determinants of patient acceptance of digital technology.

Hypoglycaemia symptom frequency, severity, burden, and utility among adults with type 1 diabetes and impaired awareness of hypoglycaemia: Baseline and 24-week findings from the HypoCOMPaSS study.

AIMS: To determine the frequency, severity, burden, and utility of hypoglycaemia symptoms among adults with type 1 diabetes (T1D) and impaired awareness of hypoglycaemia (IAH) at baseline and week 24 following the HypoCOMPaSS awareness restoration intervention. METHODS: Adults (N = 96) with T1D (duration: 29 ± 12 years; 64% women) and IAH completed the Hypoglycaemia Burden Questionnaire (HypoB-Q), assessing experience of 20 pre-specified hypoglycaemia symptoms, at baseline and week 24. RESULTS: At baseline, 93 (97%) participants experienced at least one symptom (mean ± SD 10.6 ± 4.6 symptoms). The proportion recognising each specific symptom ranged from 15% to 83%. At 24 weeks, symptom severity and burden appear reduced, and utility increased. CONCLUSIONS: Adults with T1D and IAH experience a range of hypoglycaemia symptoms. Perceptions of symptom burden or utility are malleable. Although larger scale studies are needed to confirm, these findings suggest that changing the salience of the symptomatic response may be more important in recovering protection from hypoglycaemia through regained awareness than intensifying symptom frequency or severity.

Psychosocial Care for People With Diabetic Neuropathy: Time for Action.

Psychological factors and psychosocial care for individuals with diabetic neuropathy (DN), a common and burdensome complication of diabetes, are important but overlooked areas. In this article we focus on common clinical manifestations of DN, unremitting neuropathic pain, postural instability, and foot complications, and their psychosocial impact, including depression, anxiety, poor sleep quality, and specific problems such as fear of falling and fear of amputation. We also summarize the evidence regarding the negative impact of psychological factors such as depression on DN, self-care tasks, and future health outcomes. The clinical problem of underdetection and undertreatment of psychological problems is described, together with the value of using brief assessments of these in clinical care. We conclude by discussing trial evidence regarding the effectiveness of current pharmacological and nonpharmacological approaches and also future directions for developing and testing new psychological treatments for DN and its clinical manifestations.

Responses to the Strengths and Difficulties Questionnaire predict HbA1c trajectories in children and adolescents with type 1 diabetes: a population-based study.

INTRODUCTION: We aimed to determine whether caregiver responses to the Strengths and Difficulties Questionnaire (SDQ) are predictive of HbA1c trajectory membership in children and adolescents with type 1 diabetes, when adjusting for covariates. RESEARCH DESIGN AND METHODS: For a Danish 2009 national cohort of children and adolescents with type 1 diabetes, we analyzed yearly HbA1c follow-up data during 2010-2020 including sociodemographic data from Danish national registries. Using group-based trajectory modeling and multinomial logistic regression, we tested whether caregiver SDQ scores predicted HbA1c trajectory membership when adjusting for sex, age at diabetes diagnosis, diabetes duration, family structure, and caregiver education. RESULTS: In total, 835 children and adolescents (52% females) with a mean (SD) age of 12.5 (3.3) years, and a mean diabetes duration of 5.2 (3.1) years, were included. Based on 7247 HbA1c observations, four HbA1c trajectories were identified: (1) 'on target, gradual decrease' (26%), (2) 'above target, mild increase then decrease' (41%), (3) 'above target, moderate increase then decrease' (24%), and (4) 'well above target, large increase then decrease' (9%). Higher SDQ total difficulties scores predicted trajectories 3 and 4 (p=0.0002 and p<0.0001, respectively). Regarding the SDQ subscale scores, emotional symptoms predicted trajectories 3 and 4, and conduct problems and hyperactivity/inattention predicted trajectories 2, 3, and 4. Single-parent family and low caregiver education level both predicted trajectories 3 and 4. CONCLUSIONS: Caregiver SDQ responses and sociodemographic information may help detect children and adolescents with type 1 diabetes, who need intensive multidisciplinary medical and psychological interventions.

Elevated risk of developing type 2 diabetes in people with a psychiatric disorder: What is the role of health behaviors and psychotropic medication?

AIMS: Several psychiatric disorders are linked with an increased risk of developing type 2 diabetes (T2D), but the mediating mechanisms are unclear. We aimed to investigate health behaviors, obesity, psychotropic medication use, and comorbidity as potential mediating mechanisms explaining these associations. METHODS: We combined data from a large population-based survey with register-based data and followed a sample of 250,013 Danes (≥16 years) for up to 8.9 years. We conducted mediation analyses investigating 10 potential mediators of the associations between psychiatric disorders and incident T2D. RESULTS: Individuals with a substance use disorder, schizophrenia, mood disorder, neurotic disorder, eating disorder, or a personality disorder had a significantly higher risk of developing T2D. Organic disorders, intellectual disabilities, developmental and behavioral disorders were not associated with T2D-risk. For all psychiatric disorders significantly associated with T2D, the use of antidepressant medication had the largest proportional mediating effect on the association (13-32 %). CONCLUSIONS: Use of antidepressant medication had the largest contribution to the associations between psychiatric disorders and incident T2D. Future epidemiological studies and prevention studies should focus on optimizing the use of antidepressant medication with minimal side effects, and the promotion of health behaviors in individuals with a psychiatric disorder to prevent T2D.

Assessing the Content Validity, Acceptability, and Feasibility of the Hypo-METRICS App: Survey and Interview Study.

BACKGROUND: The Hypoglycaemia - MEasurement, ThResholds and ImpaCtS (Hypo-METRICS) smartphone app was developed to investigate the impact of hypoglycemia on daily functioning in adults with type 1 diabetes mellitus or insulin-treated type 2 diabetes mellitus. The app uses ecological momentary assessments, thereby minimizing recall bias and maximizing ecological validity. It was used in the Hypo-METRICS study, a European multicenter observational study wherein participants wore a blinded continuous glucose monitoring device and completed the app assessments 3 times daily for 70 days. OBJECTIVE: The 3 aims of the study were to explore the content validity of the app, the acceptability and feasibility of using the app for the duration of the Hypo-METRICS study, and suggestions for future versions of the app. METHODS: Participants who had completed the 70-day Hypo-METRICS study in the United Kingdom were invited to participate in a brief web-based survey and an interview (approximately 1h) to explore their experiences with the app during the Hypo-METRICS study. Thematic analysis of the qualitative data was conducted using both deductive and inductive methods. RESULTS: A total of 18 adults with diabetes (type 1 diabetes: n=10, 56%; 5/10, 50% female; mean age 47, SD 16 years; type 2 diabetes: n=8, 44%; 2/8, 25% female; mean age 61, SD 9 years) filled out the survey and were interviewed. In exploring content validity, participants overall described the Hypo-METRICS app as relevant, understandable, and comprehensive. In total, 3 themes were derived: hypoglycemia symptoms and experiences are idiosyncratic; it was easy to select ratings on the app, but day-to-day changes were perceived as minimal; and instructions could be improved. Participants offered suggestions for changes or additional questions and functions that could increase engagement and improve content (such as providing more examples with the questions). In exploring acceptability and feasibility, 5 themes were derived: helping science and people with diabetes; easy to fit in, but more flexibility wanted; hypoglycemia delaying responses and increasing completion time; design, functionality, and customizability of the app; and limited change in awareness of symptoms and impact. Participants described using the app as a positive experience overall and as having a possible, although limited, intervention effect in terms of both hypoglycemia awareness and personal impact. CONCLUSIONS: The Hypo-METRICS app shows promise as a new research tool to assess the impact of hypoglycemia on an individual's daily functioning. Despite suggested improvements, participants' responses indicated that the app has satisfactory content validity, overall fits in with everyday life, and is suitable for a 10-week research study. Although developed for research purposes, real-time assessments may have clinical value for monitoring and reviewing hypoglycemia symptom awareness and personal impact.

Structural and Metabolic Retinal Changes Associated With Mild Cognitive Impairment in Type 2 Diabetes.

Type 2 diabetes is associated with cognitive impairment and a twofold increased risk of dementia compared with age-matched individuals without diabetes. Given that the eye and the brain share similar embryologic origin and anatomical features, the retina offers a unique window to the brain. In this study, we wanted to determine whether there was a difference in retinal imaging-based neuronal and vascular markers in individuals with type 2 diabetes with or without mild cognitive impairment (MCI). We included 134 persons with type 2 diabetes. Based on neuropsychological tests, the prevalence of MCI was 28%. We performed seven-field color fundus photos, optical coherence tomography (OCT), OCT-angiography (OCT-A), and retinal oximetry to analyze retinal markers. In a multivariable cluster analysis, persons with MCI had a significantly thinner macular retinal nerve fiber layer and macular ganglion cell layer, and less venular oxygen saturation in the nasal quadrant compared with those without MCI. There were no differences in retinal vessel density, fractal dimension, width, tortuosity, or OCT-A markers. People with type 2 diabetes and MCI demonstrate alterations in retinal structure and metabolism, suggesting noninvasive retinal markers may be useful to detect people with type 2 diabetes at risk for cognitive dysfunction. ARTICLE HIGHLIGHTS: Type 2 diabetes is associated with mild cognitive impairment (MCI). Therefore, retinal and cerebral neurodegeneration may run in parallel. To assess whether there was a difference in retinal structure, vessel, and metabolic parameters in individuals with MCI. We found those with MCI had a thinner macular retinal nerve fiber layer, macular ganglion cell layer, and less venular oxygen saturation. We suggest noninvasive retinal markers may be useful to detect those at risk of cognitive dysfunction.

Longitudinal bidirectional associations between diabetic retinopathy and diagnosed depression: Results from a Danish nationwide registry-based cohort study.

OBJECTIVE: Diabetic retinopathy (DR) is a feared complication and a leading course of visual impairment, but the connection between DR and depression including the direction has never been studied in a nationwide cohort. We aimed to assess, whether the associations between DR and diagnosed depression are bidirectional. METHODS: We performed a national register-based cohort study of individuals with type 2 diabetes, who attended diabetic eye screening between January 2013 and June 2022. Level of DR was extracted from the Danish Registry of Diabetic Retinopathy. The severity of DR was assessed according to the International Clinical Diabetic Retinopathy severity scale. Diagnosed depression was ascertained by physician diagnostic codes of unipolar depression (F32), recurrent depression (F33) or dysthymia (F34.1) from the Danish National Patient Register. We estimated presence of diagnosed depression according to DR level at index date and risk of diagnosed depression during follow-up using multivariable logistic and Cox regression, respectively. Secondly, we assessed whether diagnosed depression at index date could predict incident DR. RESULTS: We included 240,893 individuals with type 2 diabetes with baseline rates of diagnosed depression ranging from 5.2 to 6.0 % for DR level 1-4. At index date, individuals with type 2 diabetes and DR were less likely to have a history of diagnosed depression (multivariable adjusted OR, 0.77 [95 % CI 0.73-0.82]). In 226,523 individuals with type 2 diabetes followed for 1,159,755 person-years, 1.7 % developed at least one episode of diagnosed depression. In a model adjusted for age and sex, individuals with DR at index date had an increased risk of incident diagnosed depression compared to those without DR (HR 1.25 [95 % CI 1.16-1.36]). Adjusting for marital status, use of glucose-, lipid- and blood pressure lowering medication, HbA1c, diabetic neuropathy and Charlson comorbidity index waived the above risk (multivariable adjusted HR 1.02 [95 % CI 0.93-1.12]). Furthermore a previous history of diagnosed depression was not associated with increased risk of incident DR (multivariable adjusted HR 0.89 [95 % CI 0.77-1.03]). CONCLUSION: In this nationwide cohort study, individuals with DR at first screening were 23 % less likely to have a history of depression, but our data did not support a bidirectional association between DR and depression. Selection bias may have occurred as diagnosed depression is a known barrier for attending DR-screening.

Associations between disordered eating behaviors and HbA1c in young people with type 1 diabetes: a systematic review and meta-analysis.

BACKGROUND: In type 1 diabetes, disordered eating behaviors (DEBs) can adversely impact HbA1c. Diabetes-adapted DEB questionnaires assess intentional insulin omission, whereas generic questionnaires do not. Given the number of studies describing DEB-HbA1c associations published over the past decade, an updated systematic review is warranted. OBJECTIVE: The study aimed to examine the associations between disordered eating behaviors (DEBs) assessed by generic and diabetes-adapted questionnaires (and subscales) and HbA1c among young people (<29 years) with type 1 diabetes. METHODS: A systematic search was conducted in PubMed, Embase, PsycInfo, and CINAHL databases. Observational studies examining associations between DEB as assessed by questionnaires and HbA1c were included. Publication information, DEB and HbA1c characteristics, and DEB-HbA1c associations were extracted. Hedges' g was calculated for mean HbA1c differences between groups with and without DEB. RESULTS: The systematic search yielded 733 reports, of which 39 reports representing 35 unique studies met the inclusion criteria. Nineteen studies assessing DEB by diabetes-adapted questionnaires (n=5,795) and seven using generic questionnaires (n=2,162) provided data for meta-analysis. For diabetes-adapted questionnaires, DEB was associated with higher HbA1c (g=0.62 CI=0.52; 0.73) with a similar effect size when restricted to validated questionnaires (g=0.61; CI=0.50; 0.73). DEB was not associated with HbA1c for generic questionnaires (g=0.19; CI=-0.17; 0.55), but significantly associated with higher HbA1c for validated generic questionnaires (g=0.32; 95% CI=0.16-0.48). Participant and HbA1c collection characteristics were often inadequately described. CONCLUSION: Diabetes-adapted DEB questionnaires should be used in youth with type 1 diabetes because they capture intentional insulin omission and are more strongly associated with HbA1c than generic DEB questionnaires.

Patient-reported outcomes for people with diabetes: what and how to measure? A narrative review.

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.

Psychometric properties of an innovative smartphone application to investigate the daily impact of hypoglycemia in people with type 1 or type 2 diabetes: The Hypo-METRICS app.

INTRODUCTION: The aim of this study was to determine the acceptability and psychometric properties of the Hypo-METRICS (Hypoglycemia MEasurement, ThResholds and ImpaCtS) application (app): a novel tool designed to assess the direct impact of symptomatic and asymptomatic hypoglycemia on daily functioning in people with insulin-treated diabetes. MATERIALS AND METHODS: 100 adults with type 1 diabetes mellitus (T1DM, n = 64) or insulin-treated type 2 diabetes mellitus (T2DM, n = 36) completed three daily 'check-ins' (morning, afternoon and evening) via the Hypo-METRICs app across 10 weeks, to respond to 29 unique questions about their subjective daily functioning. Questions addressed sleep quality, energy level, mood, affect, cognitive functioning, fear of hypoglycemia and hyperglycemia, social functioning, and work/productivity. Completion rates, structural validity, internal consistency, and test-retest reliability were explored. App responses were correlated with validated person-reported outcome measures to investigate convergent (rs>±0.3) and divergent (rs<±0.3) validity. RESULTS: Participants' mean±SD age was 54±16 years, diabetes duration was 23±13 years, and most recent HbA1c was 56.6±9.8 mmol/mol. Participants submitted mean±SD 191±16 out of 210 possible 'check-ins' (91%). Structural validity was confirmed with multi-level confirmatory factor analysis showing good model fit on the adjusted model (Comparative Fit Index >0.95, Root-Mean-Square Error of Approximation <0.06, Standardized Root-Mean-square Residual<0.08). Scales had satisfactory internal consistency (all ω≥0.5), and high test-retest reliability (rs≥0.7). Convergent and divergent validity were demonstrated for most scales. CONCLUSION: High completion rates and satisfactory psychometric properties demonstrated that the Hypo-METRICS app is acceptable to adults with T1DM and T2DM, and a reliable and valid tool to explore the daily impact of hypoglycemia.

Adherence in Diabetes Questionnaire (ADQ) score as predictor of 11-year HbA1c trajectories in children and adolescents with type 1 diabetes: A population-based longitudinal study.

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.

Effectiveness of educational and behavioural interventions for reducing fear of hypoglycaemia among adults with type 1 diabetes: Systematic review and meta-analyses.

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.