AIMS: This study aimed to evaluate the association of stigma related to type 1 diabetes with CGM-derived data and psychological outcomes in adults with type 1 diabetes. METHODS: In this cross-sectional study, 104 adults...AIMS: This study aimed to evaluate the association of stigma related to type 1 diabetes with CGM-derived data and psychological outcomes in adults with type 1 diabetes. METHODS: In this cross-sectional study, 104 adults with type 1 diabetes undergoing continuous glucose monitoring (CGM) completed the Type 1 Diabetes Stigma Assessment Scale (DSAS-1), Patient Health Questionnaire-9 (PHQ-9), generalized anxiety disorder-7 (GAD-7), and Diabetes Distress Scale (DDS). Thirty-day standard CGM data with ≥70% sensor wear time of CGM was analysed. Linear regression was used to evaluate the potential relationship between the DSAS-1 scores and CGM-derived hypoglycaemia metrics. RESULTS: Higher DSAS-1 total score was independently associated with increased time below range <3.0 mmol/L (adjusted β = 0.011 per point; 95% CI: 0.0018,0.0202; p = 0.019) but not with <3.9 mmol/L. Elevated stigma associated with anxiety (adjusted OR, 1.086; 95% CI:, 1.035,1.152; p = 0.002) with no significant link to depression. Item-level analyses identified DSAS-1 items related to differential treatment (items 15 and 19) and blame/judgement (items 11, 14, and 17) as being significantly associated with clinically significant hypoglycaemia. Associations were consistent across subgroups, especially among participants with a longer diabetes duration and a higher coefficient of variation of CGM glucose levels, calculated as glucose standard deviation divided by mean glucose and expressed as a percentage. CONCLUSIONS: In adults with type 1 diabetes using CGM, perceived stigma was significantly correlated with more time spent in hypoglycaemia and greater anxiety. Further studies are needed to identify causal relationships between stigma and clinically significant hypoglycaemia in people with type 1 diabetes.
AIMS: Little is known about how different aspects of social relationships relate to diabetes self-management and glycaemic outcomes in young adults with type 1 diabetes (T1D). We examined relationships of general and dia...AIMS: Little is known about how different aspects of social relationships relate to diabetes self-management and glycaemic outcomes in young adults with type 1 diabetes (T1D). We examined relationships of general and diabetes-specific social variables with diabetes self-management and HbA1c. We hypothesized diabetes-specific factors would more strongly associate with self-management and HbA1c than general social factors. METHODS: We analysed baseline data from 100 young adults with T1D (M = 19.9 ± 1.3 years) enrolled in a randomized controlled trial of a paediatric to adult care transition intervention. We examined associations of self-reported general and diabetes-specific social factors with self-reported self-management behaviours and HbA1c in 4 separate multiple regression models. Models controlled for demographic and medical variables with significant bivariate correlations. RESULTS: In the general social factor models, the only significant predictor of self-management behaviours was general emotional support (Β = 0.208); there were no significant predictors associated with HbA1c. In the diabetes-specific social factor models, getting help with diabetes (Β = 0.37) and pandemic-related diabetes support (Β = -0.33) significantly predicted self-management behaviours and getting help with diabetes (Β = -0.26) and diabetes disclosure/social support (Β = 0.24) significantly predicted HbA1c. CONCLUSIONS: Diabetes-specific social support is important for medical and behavioural diabetes outcomes in young adults with T1D during this transitional period. Preparation for transfer may benefit from assisting young adults in seeking direct help with diabetes management from family and friends. More research is needed on how to help young adults acquire practical diabetes support to enhance clinical care.
AIMS: Emerging adulthood is a developmental stage, which presents psychosocial, economic and academic challenges to individuals, which are further complicated for people with type 1 diabetes (T1D). While paediatric-based...AIMS: Emerging adulthood is a developmental stage, which presents psychosocial, economic and academic challenges to individuals, which are further complicated for people with type 1 diabetes (T1D). While paediatric-based care systems have developed programmes to address the needs of young adults with T1D, adult-based systems have been slower to recognize this need. This qualitative study sought to understand the care experiences of emerging adults to identify barriers to engagement in adult-based care systems. METHODS: A total of 20 young adults with T1D (mean age 26.5 ± 4.5) participated in five focus groups. Focus groups obtained participant reflections on care received during and after transfer to adult-based care. Data were analyzed and coded using thematic analysis and organized using the social ecological model. RESULTS: Key themes across each social ecological model strata emerged from focus group discussions. Provider and clinic-level factors were frequently cited as key barriers to engagement in adult-based clinical practices. In addition, system- and institutional-level gaps led young adults to express a sense that systems at all levels were poorly adapted to address their care needs. Specifically, participants noted a need for high levels of self-advocacy to obtain needed support, difficulty navigating complex health systems and gaps in care coordination between providers and clinics as key barriers to care. CONCLUSIONS: The findings of this study highlight the importance of adapting adult care systems and providers' approaches to meet the self-identified needs of young adults to improve engagement with care and potentially avoid adverse outcomes in this high-risk people population.
AIM: Although hybrid closed-loop systems (HCLS) and sensor-augmented pump (SAP) therapy are advanced diabetes management technologies for type 1 diabetes, their relative efficacy in optimising glycaemic control is not fu...AIM: Although hybrid closed-loop systems (HCLS) and sensor-augmented pump (SAP) therapy are advanced diabetes management technologies for type 1 diabetes, their relative efficacy in optimising glycaemic control is not fully established. This meta-analysis evaluated the impact of HCLS versus SAP therapy on glucose regulation across multiple randomised controlled trials (RCTs) and randomised crossover trials (RCOs). The primary aim was to determine the efficacy of HCLS in improving glycaemic control, reducing glucose variability and enhancing time in range (TIR) compared with SAP therapy. METHODS: The review was prospectively registered with the International Prospective Register of Systematic Reviews as CRD42023488722. Data from 27 studies involving over 1000 participants were analysed. The studies included both RCTs and RCOs that compared HCLS with SAP therapy. Key metrics assessed were mean glucose levels, glucose variability (coefficient of variation and standard deviation), low blood glucose index (LBGI), high blood glucose index (HBGI), glycated haemoglobin (HbA1c) and TIR (3.9-10.0 mmol/L). Hyperglycaemia and hypoglycaemia outcomes were also evaluated. RESULTS: HCLS significantly reduced mean glucose levels by 2.0 mg/dL compared with SAP therapy. It also decreased glucose variability, including CV and SD, and reduced LBGI, HBGI and HbA1c. HCLS increased TIR by 8.8%. Regarding hyperglycaemia, HCLS reduced the time spent above 10 mmol/L by 7.8%, above 13.9 mmol/L by 3.63% and above 16.7 mmol/L by 0.88%. Hypoglycaemia outcomes showed modest improvements, with reductions in time below 3 mmol/L by 0.10% and below 3.9 mmol/L by 0.72%. CONCLUSIONS: Our findings support HCLS as a superior modality to SAP therapy in improving glycaemic control, particularly in paediatric populations. HCLS effectively reduces hyperglycaemia and increases TIR, with modest effects on hypoglycaemia. The clinical implications are significant, highlighting the advantages of HCLS in optimising glucose regulation and mitigating glycaemic variability. This technology offers improved glycaemic control and enhanced quality of life for people living with type 1 diabetes.
AIMS: Gestational diabetes mellitus (GDM) is a well-established independent risk factor for type 2 diabetes mellitus (T2DM) and cardiovascular disease. As risks emerge within the first decade following childbirth, early...AIMS: Gestational diabetes mellitus (GDM) is a well-established independent risk factor for type 2 diabetes mellitus (T2DM) and cardiovascular disease. As risks emerge within the first decade following childbirth, early intervention is required. However, competing postpartum priorities and limited time inhibit many women from prioritising their post-GDM health. Therefore, the study aimed to: (1) Measure dysglycaemia prevalence and identify predictors among Australian women with recent GDM and (2) understand women's views regarding their risk of future T2DM and approach to potential preventive strategies, including post-GDM preventive pharmacotherapy. METHODS: Cross-sectional study of women with recent (within 5 years) GDM, including an online questionnaire and oral glucose tolerance test completion by participants. RESULTS: Participants (n = 505) had a mean age of 37.3 ± 4.9 years, body mass index (BMI) of 27.5 ± 6.4 kg/m and were 2.9 ± 1.4 years postpartum. Of the 248 (49.1%) participants completing an oral glucose tolerance test, 4% had T2DM and 11% had pre-diabetes. Each 1 kg/m increase in BMI was associated with 10% greater odds of dysglycaemia (p = 0.03). On a 10-point scale (10 = highest), the median self-reported 5-year risk of developing T2DM was 5 [IQR: 3-7], and concern about developing T2DM was 7 [5-9]. Women strongly agreed (10 [8-10]) that preventing or delaying T2DM onset was important. Women reported being very likely to adopt lifestyle changes (4 [4-5] out of 5), and somewhat likely to take medication for T2DM prevention (3 [1-4] out of 5). CONCLUSION: Women consider preventing or delaying the onset of diabetes very important. Hence, studies evaluating adjunct therapies, such as pharmacotherapy, are needed to reduce their long-term risk.
AIMS: The objective of this study was to evaluate the Diabetes Eating Problems Survey-Revised (DEPS-R) against the Eating Disorder Diagnostic Interview (EDDI). Specific aims were to (1) assess the ability of the DEPS-R t...AIMS: The objective of this study was to evaluate the Diabetes Eating Problems Survey-Revised (DEPS-R) against the Eating Disorder Diagnostic Interview (EDDI). Specific aims were to (1) assess the ability of the DEPS-R to identify Diagnostic and Statistical Manual-5 (DSM-5) eating disorders, including sensitivity and specificity of the current DEPS-R cutoff ≥20 and (2) report the correlation of each item to the presence of any eating disorder. METHODS: Baseline data from 293 women (14-35 years) with type 1 diabetes (T1D) and body image concerns enrolled in a multinational randomized controlled trial were examined. Receiver operating characteristic (ROC) analysis, univariate logistic regression and two-sample t-test were performed. RESULTS: The ROC analysis demonstrated good accuracy of the DEPS-R with an area under the curve (AUC) of 0.82 (95% CI 0.79-0.94). The cutoff of ≥20 yielded a sensitivity of 87.5% (95% CI 83.6%-91.3%) and a specificity of 60.4% (95% CI 54.8%-66.0%). Univariate logistic regression identified 12 items as significantly correlated with the presence of any eating disorder. The highest odds ratios (OR) were observed for items 9 (OR = 3.64), 8 (OR = 2.85), 13 (OR = 2.36), 14 (OR = 2.23), 15 (OR = 1.99) and 5 (OR = 1.99). CONCLUSIONS: This is the first study to investigate the ability of the DEPS-R to identify DSM-5 eating disorder diagnosis established via a diagnostic interview using a ROC-analysis. DEPS-R cutoff ≥20 correctly identified most cases with eating disorders but showed moderate specificity, considered acceptable as an initial screening tool for disordered eating. In clinical care, specific DEPS-R items may be emphasized to explore the presence of disordered eating behaviours and eating disorders.
AIMS: To identify meaningful clusters of participants with shared baseline characteristics (demographic, clinical, and psychological) from a sample of adults with type 1 diabetes (T1D) completing dose adjustment for norm...AIMS: To identify meaningful clusters of participants with shared baseline characteristics (demographic, clinical, and psychological) from a sample of adults with type 1 diabetes (T1D) completing dose adjustment for normal eating (DAFNE) structured T1D education, or the updated DAFNEplus programme. Further, to determine whether those clusters respond differently, at 6- and 12 months, to DAFNE and DAFNEplus on core outcomes: HbA1c and diabetes-specific quality of life (QoL). METHODS: Latent profile analysis was conducted on the DAFNEplus randomised control trial dataset using relevant indicator variables (age; HbA1c; hypoglycaemia awareness; diabetes-specific QoL, distress, and positive well-being; fear of hypoglycaemia; satisfaction with diabetes management). Model fit indices were used to select the optimal number of clusters and multilevel linear regression models to estimate the effect of DAFNEplus (compared with DAFNE) on HbA1c and diabetes-specific QoL in each cluster. RESULTS: A total of n = 363 participants were included in the analysis (n = 147, 40% randomised to DAFNEplus). The final model included two clusters: the first was consistently worse off on clinical and psychological indicator variables. The multilevel analysis showed a significant adjusted mean difference, at 12 months (first cluster only), between DAFNE and DAFNEplus in diabetes-specific QoL (0.81; 95% CI: 0.19-1.43; p = 0.01), but not at other time points or in HbA1c. CONCLUSIONS: This study suggests that DAFNEplus has significant added benefits in reducing the negative impact of diabetes on QoL for a subgroup of adults with T1D, but not for their HbA1c. This provides important insights for the future real-world implementation of the DAFNEplus programme.
AIMS: Asia faces a rising diabetes burden, with significant subregional variations. This study analyses trends from 1990 to 2021 and projects future burdens to guide targeted interventions. METHODS: Using data from the G...AIMS: Asia faces a rising diabetes burden, with significant subregional variations. This study analyses trends from 1990 to 2021 and projects future burdens to guide targeted interventions. METHODS: Using data from the Global Burden of Disease Study 2021, we assessed type 2 diabetes cases, deaths, disability-adjusted life-years (DALYs) and age-standardized rates across 35 Asian countries/regions. Decomposition analysis identified burden drivers, and the Bayesian Age-Period-Cohort (BAPC) model predicted trends. RESULTS: From 1990 to 2021, Asia witnessed a substantial increase in the burden of type 2 diabetes, with Central Asia having the fastest-growing age-standardized incidence rate (ASIR) at estimated annual percentage change (EAPC) of 2.82. South Asia faced the heaviest burden, with 410,254 diabetes-related deaths and 16,851,968 DALYs in 2021. The age-standardized mortality rate (ASMR) was highest in Southeast Asia at 27.84 per 100,000. Key drivers included population growth, ageing and epidemiological changes, particularly in South Asia, with projections indicating continued increases in diabetes burden in South and Central Asia. CONCLUSION: Asia's diabetes burden has continued to increase, driven by population growth, ageing and epidemiological shifts. Targeted prevention, healthcare access and ageing policies are critical, especially in high-burden regions like South and Central Asia.
AIMS: This study evaluated the incidence and prevalence of type 1 diabetes in children and adolescents in Baden-Wuerttemberg over 38 years considering various subgroups. METHODS: Data were drawn from the German Diabetes...AIMS: This study evaluated the incidence and prevalence of type 1 diabetes in children and adolescents in Baden-Wuerttemberg over 38 years considering various subgroups. METHODS: Data were drawn from the German Diabetes Registry (DIARY) for 11,797 children aged <15 years with clinically diagnosed type 1 diabetes. Incidence rates were calculated per 100,000 person-years and presented as crude, age- and sex-specific rates, including annual percent changes (APC) from 1987 to 2024. RESULTS: In 1987, the crude incidence was 10.1 per 100,000 children per year, rising to 20.2 per 100,000 children per year in 2024. Between 1987 and 2008, the incidence increased steadily at 4.0% annually, followed by a plateau through 2024 despite demographic shifts including declining birth rates and increased immigration. The peak incidence occurred during the COVID-19 pandemic, reaching 31.1 per 100,000 children per year in 2021, before returning to 20.2 per 100,000 children per year by 2024. The highest subgroup incidence was found in boys aged 10-14 years at 25.4 per 100,000 children per year. A marked increase during the pandemic was seen mainly in children under 10 years. The estimated prevalence as of 31 December 2024 was 0.154%. CONCLUSIONS: Incidence rates have doubled since the first documentation in 1987. Since 2008, the rates have remained stable at a high level without further increase. The long-term trend suggests a levelling off in incidence, with pandemic-related increases limited primarily to younger children.
AIMS: To utilise Fremantle Diabetes Study Phase II (FDS2) data to examine the association between Type 2 diabetes and incident aortic valve replacement (AVR) and to investigate potential risk factors in Type 2 diabetes....AIMS: To utilise Fremantle Diabetes Study Phase II (FDS2) data to examine the association between Type 2 diabetes and incident aortic valve replacement (AVR) and to investigate potential risk factors in Type 2 diabetes. METHODS: We followed 1430 FDS2 participants (mean age 66 years, 53% males) and 5720 age-, sex-, and postcode-matched people without diabetes from entry (2008-2011) to end-2021 for AVR ascertained from validated linked databases. Incidence rate ratios (IRRs) were calculated. Cox proportional hazards and competing risk models generated cause-specific (cs) and subdistribution (sd) hazard ratios (HRs) for incident AVR. RESULTS: At baseline, 11 participants with Type 2 diabetes (0.8%) and 37 without diabetes (0.6%) had undergone AVR (p = 0.589). There were 24 (1.7%) and 40 (0.7%) first incident AVR hospitalisations, respectively, in the two groups during 73,498 person-years of follow-up (IRR 2.40 [95% confidence interval (CI) 1.38, 4.08], p = 0.0007). In pooled analyses, Type 2 diabetes had similar csHR (2.38 [1.43, 3.96]) and sdHR (2.34 [1.41, 3.88]), with increasing age and male sex as other statistically significant covariates. In Type 2 diabetes, incident AVR was bivariably associated with baseline blood glucose-lowering treatment intensity (p = 0.003) and with distal symmetrical polyneuropathy (DSPN) after age and sex adjustment (p = 0.025). CONCLUSIONS: Type 2 diabetes more than doubles the risk of AVR after adjusting for the competing risk of death. People with Type 2 diabetes going on to require AVR were more intensively managed and were more likely to have DSPN at baseline.
AIMS: Rapid changes in diabetes therapy combined with limitations of traditional methodological approaches challenge the field of psychosocial research to adequately capture the experiences of people with diabetes. This...AIMS: Rapid changes in diabetes therapy combined with limitations of traditional methodological approaches challenge the field of psychosocial research to adequately capture the experiences of people with diabetes. This narrative review provides an overview of emerging qualitative and quantitative approaches that can advance the study of psychosocial aspects of diabetes. METHODS: We searched PubMed and Google Scholar for English-language articles regarding novel qualitative and quantitative methodologies. RESULTS: Emerging qualitative methodologies aim to increase the transferability of lived experiences to other contexts and populations by employing novel ways to stimulate interactions and using digital tools. Culturally sensitive methods (e.g. yarning) and the use of pictures (e.g. photovoice) and storytelling methods (e.g. story completion) can capture more diverse experiences and sensitive topics while being able to minimise social desirability. Online qualitative surveys can increase the reach while artificial intelligence (AI) can be implemented in qualitative research protocols. Emerging quantitative methodologies aim to better understand dynamic within-person processes. With repeated daily smartphone-based assessments (e.g. ecological momentary assessment) and passive sensor-based data collections (e.g. digital phenotyping), intensive longitudinal data can be collected that allow for n-of-1 trials, especially in combination with continuous glucose monitoring. Quantitative data can also be used to identify clusters/subgroups of people with shared experiences. Innovative digital twin technology and AI offer intriguing possibilities that can advance the field towards precision mental health care. CONCLUSIONS: Several innovative methodologies (will) enrich our understanding of psychosocial aspects in diabetes. To fully capitalise on these methodologies, co-design and mixed methods approaches are necessary.
Matheou A, Zavlis O, White S
… +11 more, McDonnell T, Warner-Levy A, Warner-Levy J, Wilkins L, Habte-Asres H, Lay A, Shalamanova L, Whyte M, Gibson M, Kalra PA, Heald A
INTRODUCTION: The pathophysiology of chronic kidney disease (CKD) and type 2 diabetes (T2D) is multifactorial and associated with a plethora of underlying conditions and complications. Their link is reciprocal and unders...INTRODUCTION: The pathophysiology of chronic kidney disease (CKD) and type 2 diabetes (T2D) is multifactorial and associated with a plethora of underlying conditions and complications. Their link is reciprocal and understanding its nature, particularly over time, could improve the health of many. METHODS: A prospective study was conducted to examine the development of the two main components of CKD (urine albumin/creatinine ratio (ACR) and estimated glomerular filtration rate (eGFR)) over 24 years (2001-2024) in a sample of 718 individuals with a diagnosis of T2D. Longitudinal modelling was conducted to examine the rate of change of ACR and eGFR over the 24 years, as well as whether sex, smoking status, glycated haemoglobin (HbA1c), systolic blood pressure (SBP), diastolic blood pressure (DBP), body mass index (BMI) influenced that rate of change in both our total sample and three sub-groups (no CKD, CKD with increased ACR and preserved eGFR, and CKD with increased ACR and reduced eGFR). RESULTS: At baseline, 428 (59.6%) patients were male while 290 (40.4%) were female. Mean age at baseline was 56.6 ± 12.4 years. Mean follow-up period was 16.4 ± 2.1 years. 451 (62.8%) patients had a normal ACR and eGFR ≥60 mL/min/1.73 m, no CKD. At 24-year follow-up, 196 (43%) of these patients had progressed to an ACR >3 mg/mmol and/or eGFR<60 mL/min/1.73 m, developing CKD. At final follow-up, 282 patients were still alive. In the whole cohort, 10 (1.4%) patients progressed to end-stage kidney disease eGFR<15 mL/min/1.73 m. For the whole cohort ACR increased exponentially, while eGFR decreased linearly by 1.02 mL/min/1.73 m per year. For ACR: SBP (β = 0.36, 95% CI [0.24, 0.48]) and DBP (β = 0.40, 95% CI [0.16, 0.64]) were the only significant independent predictors of ACR progression particularly in the sub-group with increased ACR and preserved eGFR. For eGFR: Female sex (β = -3.79, 95% CI [1.96, 5.63]), SBP (β = -0.12, 95% CI [-0.17, -0.06]), DBP (β = -0.19, 95% CI [-0.08, -0.31]), HbA1c (β = -1.17, 95% CI [-0.63, -1.71]), baseline cholesterol (β = 0.86, 95% CI [0.29, 1.43]) and smoking (β = -2.05, 95% CI [-3.80, -1.30]) were significant independent predictors of eGFR progression, but only in the non-CKD at baseline sub-group. At the end of follow-up 436 (60%) of people had died including 219 (48.6%) of the patients with no CKD at baseline, compared to 158 (76.7%) of people with increased urine ACR/preserved eGFR and 59 (96.7%) of those with increased urine ACR and reduced eGFR, with 10 year mortality rates of 6.6%, 14.5% and 26.6%, respectively. In the whole cohort only 10 (1.4%) patients progressed to end-stage kidney disease (eGFR<15 mL/min/1.73 m). CONCLUSION: This study revealed several factors that are associated with accelerated progression of CKD over 20 + years, including female sex and current/previous smoking. At baseline, the group with ACR >3 mg/mmol exhibited the highest rate of ACR increase. Multiple factors influenced eGFR decrease in those with baseline eGFR ≥60 mL/min/1.73 m. Mortality rate was profoundly influenced by historical CKD status.
BACKGROUND: Diabetic vascular complications (DVCs) are among the most serious issues faced by individuals with diabetes. The pathogenesis of DVC involves various pathological processes, including lipid metabolism disorde...BACKGROUND: Diabetic vascular complications (DVCs) are among the most serious issues faced by individuals with diabetes. The pathogenesis of DVC involves various pathological processes, including lipid metabolism disorders, inflammatory responses, apoptosis and neovascularisation. While exosomes, the phosphatidylinositol 3-Kinase/Protein Kinase B (PI3K/Akt) pathway and autophagy have been extensively studied individually in DVC, a gap exists in understanding their integrative crosstalk and feedback mechanisms as a cohesive regulatory network. METHODS: Based on a review of the literature, we analyse the individual and interactive roles of exosomes, the PI3K/Akt pathway and autophagy in DVC pathogenesis, with a focus on their integrative regulatory network. RESULTS: Exosomes carrying specific miRNAs, proteins, and other bioactive molecules regulate intracellular autophagy via the PI3K/Akt pathway. At the same time, autophagy is bidirectionally regulated by the PI3K/Akt pathway. Through this mutual regulation, they collectively influence exosome biogenesis and secretion, which in turn modulates cell survival, proliferation, and inflammatory responses to maintain intracellular homeostasis. Both processes co-regulate cellular metabolic homeostasis and inflammatory responses through the PI3K/Akt pathway, affecting vascular endothelial function. CONCLUSIONS: In this review, we propose the novel conceptual framework of the "exosome-PI3K/Akt-autophagy axis" and investigate the role and mechanism in DVC, aiming to provide novel therapeutic targets and strategies for its treatment.
AIMS: To evaluate the feasibility, acceptability, and implementation of HEALing (Healing through Empowerment and Active Listening)-a clinic-integrated self-care intervention delivered by trained wound care nurses in thre...AIMS: To evaluate the feasibility, acceptability, and implementation of HEALing (Healing through Empowerment and Active Listening)-a clinic-integrated self-care intervention delivered by trained wound care nurses in three 30-min face-to-face sessions over 6 weeks to support diabetic foot ulcer healing. METHODS: A mixed-methods, single-arm hybrid effectiveness-implementation pilot and qualitative study was conducted. Feasibility was evaluated through enrolment, retention, attendance and data completeness; acceptability via qualitative interviews; and implementation by tracking intervention delivery time. Potential effectiveness was assessed through changes in psychological (illness beliefs, foot care confidence, diabetes distress, quality of life, autonomy support), behavioural (foot care practices), knowledge (of wound deterioation), and clinical (HbA1c) outcomes from baseline to 4 weeks post intervention. Data were analysed using descriptive statistics, paired-sample t-tests and thematic analysis. RESULTS: A total of 29 individuals living with DFU participated in the study (response rate: 78%), with enrolment occurring between August and September 2024. Retention was 90% (N = 26). The average HEALing session lasted 32 min (range: 15-50 min). Statistically significant improvements were observed across psychological, behavioural, knowledge and clinical outcomes from baseline to post-intervention (all p < 0.005; Cohen's d = 0.8-1.1). Qualitative findings reinforced the intervention's acceptability, highlighting how HEALing enhanced knowledge, emotional healing and empowerment through autonomy,fostering greater motivation and engagement in self-care. CONCLUSIONS: This pilot suggests the feasibility and acceptability of HEALing in nurse-led DFU care, with preliminary indications of psychological and clinical benefits. The findings support the potential for scalable integration of psychological support, warranting further evaluation in larger, controlled trials with extended follow-up.
Cigler M, Søholm U, Broadley M
… +17 more, Pouwer F, Abbink EJ, Ali N, de Galan BE, Renard E, Evans M, Bøggild Brøsen JM, Pedersen-Bjergaard U, Mc Crimmon RJ, Heller S, Caunt S, Amiel SA, Divilly P, Zaremba N, Choudhary P, Mader JK, Hypo‐RESOLVE consortium
AIMS: Hypoglycaemia remains a barrier to optimal diabetes management, with few tools for capturing real-time person-reported hypoglycaemia (PRH). This study evaluated the Hypo-METRICS app, originally developed for a mult...AIMS: Hypoglycaemia remains a barrier to optimal diabetes management, with few tools for capturing real-time person-reported hypoglycaemia (PRH). This study evaluated the Hypo-METRICS app, originally developed for a multinational 10-week prospective study of hypoglycaemia. It enables real-time reporting of hypoglycaemic episodes and their impact on daily functioning using Ecological Momentary Assessment (EMA), thereby overcoming limitations of retrospective self reports. METHODS: After completing the Hypo-METRICS study, 120 participants with type 1 diabetes mellitus (T1D) or type 2 diabetes mellitus (T2D) from Austria, Denmark, the Netherlands, and the United Kingdom were invited to complete a web-based questionnaire assessing app content, functionality, intervention effects, user engagement and the influence of the Covid-19 pandemic. RESULTS: Ninety-six participants (80%; 29 T1D, 67 T2D) completed the questionnaire (40% women; mean age 57.2 ± 16.1 years; 26% impaired hypoglycaemia awareness; HbA1c 60 ± 13 mmol/mol (7.6 ± 1.1%); diabetes duration 20.4 ± 11.3 years). App content and functionality were rated highly (>8/10 and >7/10, respectively). Some reported declining engagement, likely due to study length. COVID-19 had a minimal impact on app use. CONCLUSIONS: The Hypo-METRICS app was well accepted, with strong ratings for usability and functionality. Given its unique strengths, the app has the potential to become an essential instrument for researchers aiming to capture the real-world burden and impact of hypoglycaemia.
AIMS: To evaluate the real-world user experience of young people (7-25 years) with type 1 diabetes and previously very elevated glycaemia (≥69 mmol/mol) transitioning from the MiniMed™ 780G advanced hybrid closed-loop (A...AIMS: To evaluate the real-world user experience of young people (7-25 years) with type 1 diabetes and previously very elevated glycaemia (≥69 mmol/mol) transitioning from the MiniMed™ 780G advanced hybrid closed-loop (AHCL) system with Guardian™ 4 continuous glucose monitoring systems (CGM) and 3-day infusion sets to the upgraded system with Simplera Sync™ all-in-one CGM and 7-day Extended™ wear infusion sets (EIS). METHODS: Qualitative interviews were conducted with 11 participants from the CO-PILOT trial extension phase who had used the upgraded system for at least 4 weeks. Thematic analysis was used to identify aspects of the technology transition that reduced, continued, or did not affect the burden of diabetes care and technology. RESULTS: Participants reported several burden-reducing aspects of the upgraded system, including easier, independent insertion of both sensors and infusion sets, improved device design (slimmer profile, one-piece disposable design), reduced frequency of equipment changes, and decreased psychosocial burden. Aspects with ongoing burden included premature sensor failures, connection issues between pump and sensor, adhesion problems, and concerns about alarm functionality. Trust in the AHCL system remained high across both systems for most participants. CONCLUSION: The transition from Guardian™ 4 and 3-day infusion sets to Simplera Sync™ and EIS was overall positive, with participants reporting enhanced user experience, greater convenience, and improved autonomy. However, challenges with premature sensor failure and alarm functionality were identified at times. These findings highlight the importance of continued technological advancement while maintaining multiple options to accommodate individual needs and preferences.