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Unveiling the effects of living standards on diabetes and hypertension with the mediating role of overweight and obesity: a cross-sectional study in Bangladesh

Por: Sen · K. K. · Jamee · A. R. · Islam · U. N. · Bari · W.
Objective

The purpose of the study was to ascertain how the standard of living is associated with the likelihood of developing diabetes and hypertension directly as well as indirectly through overweight and obesity.

Study design

The study used 2017–2018 Bangladesh Demographic and Health Survey data. It examined the household living standard (LSD) as the main factor, and body mass index (BMI) as a mediator. Outcomes included diabetes status, hypertension status and their co-occurrence. Structural equation modelling with logistic regression and bootstrapping were used for mediation analysis and computing bias-corrected SEs.

Setting

The research was carried out in Bangladesh and included both male and female adults.

Participants

The study encompassed a total of 11 961 adults (5124 males and 6837 females) aged 18 years or older.

Results

Among the participants, 10.3% had diabetes, 28.6% had hypertension and 4.9% had both conditions. The prevalence of diabetes, hypertension or both conditions was 18.5%, 33.5% and 9.7%, respectively, among those with a high LSD. Regression analysis demonstrated that individuals with high LSD had significantly elevated risks of these conditions compared with those with low LSD: 133% higher odds for diabetes (OR 2.22; 95% CI 1.97 to 2.76), 25% higher odds for hypertension (OR 1.25; 95% CI 1.10 to 1.42) and 148% higher odds for both conditions (OR 2.48; 95% CI 1.96 to 3.14). Moreover, the indirect effects of high LSD through obesity surpassed its direct effects for developing diabetes, hypertension or both conditions.

Conclusion

This study emphasises that with the enhancement of LSD, individuals often experience weight gain, resulting in elevated BMI levels. This cascade effect significantly amplifies the risks of diabetes, hypertension or both conditions. To counteract this concerning trajectory, policy interventions and targeted awareness campaigns are imperative. These efforts must prioritise the promotion of heightened physical activity and the mitigation of the overweight/obesity surge associated with rising LSD.

What are the perceptions and concerns of people living with diabetes and National Health Service staff around the potential implementation of AI-assisted screening for diabetic eye disease? Development and validation of a survey for use in a secondary car

Por: Willis · K. · Chaudhry · U. A. R. · Chandrasekaran · L. · Wahlich · C. · Olvera-Barrios · A. · Chambers · R. · Bolter · L. · Anderson · J. · Barman · S. A. · Fajtl · J. · Welikala · R. · Egan · C. · Tufail · A. · Owen · C. G. · Rudnicka · A. · On behalf of the ARIAS Research Group · S
Introduction

The English National Health Service (NHS) Diabetic Eye Screening Programme (DESP) performs around 2.3 million eye screening appointments annually, generating approximately 13 million retinal images that are graded by humans for the presence or severity of diabetic retinopathy. Previous research has shown that automated retinal image analysis systems, including artificial intelligence (AI), can identify images with no disease from those with diabetic retinopathy as safely and effectively as human graders, and could significantly reduce the workload for human graders. Some algorithms can also determine the level of severity of the retinopathy with similar performance to humans. There is a need to examine perceptions and concerns surrounding AI-assisted eye-screening among people living with diabetes and NHS staff, if AI was to be introduced into the DESP, to identify factors that may influence acceptance of this technology.

Methods and analysis

People living with diabetes and staff from the North East London (NEL) NHS DESP were invited to participate in two respective focus groups to codesign two online surveys exploring their perceptions and concerns around the potential introduction of AI-assisted screening.

Focus group participants were representative of the local population in terms of ages and ethnicity. Participants’ feedback was taken into consideration to update surveys which were circulated for further feedback. Surveys will be piloted at the NEL DESP and followed by semistructured interviews to assess accessibility, usability and to validate the surveys.

Validated surveys will be distributed by other NHS DESP sites, and also via patient groups on social media, relevant charities and the British Association of Retinal Screeners. Post-survey evaluative interviews will be undertaken among those who consent to participate in further research.

Ethics and dissemination

Ethical approval has been obtained by the NHS Research Ethics Committee (IRAS ID: 316631). Survey results will be shared and discussed with focus groups to facilitate preparation of findings for publication and to inform codesign of outreach activities to address concerns and perceptions identified.

External validation of a cardiovascular risk model for Omani patients with type 2 diabetes mellitus: a retrospective cohort study

Por: Al Oraimi · F. · Al Rawahi · A. · Al Harrasi · A. · Albusafi · S. · Al-Manji · L. M. · Alrawahi · A. H. · Al Salmani · A. A.
Objectives

To externally validate a recently developed cardiovascular disease (CVD) risk model for Omanis with type 2 diabetes mellitus (T2DM).

Design

Retrospective cohort study.

Setting

Nine primary care centres in Muscat Governorate, Oman.

Participants

A total of 809 male and female adult Omani patients with T2DM free of CVD at baseline were selected using a systematic random sampling strategy.

Outcome measures

Data regarding CVD risk factors and outcomes were collected from the patients’ electronic medical records between 29 August 2020 and 2 May 2021. The ability of the model to discriminate CVD risk was assessed by calculating the area under the curve (AUC) of the receiver-operating characteristic curve. Calibration of the model was evaluated using a Hosmer-Lemeshow 2 test and the Brier score.

Results

The incidence of CVD events over the 5-year follow-up period was 4.6%, with myocardial infarction being most frequent (48.6%), followed by peripheral arterial disease (27%) and non-fatal stroke (21.6%). A cut-off risk value of 11.8% demonstrated good sensitivity (67.6%) and specificity (66.5%). The area under the curve (AUC) was 0.7 (95% CI 0.60 to 0.78) and the Brier score was 0.01. However, the overall mean predicted risk was greater than the overall observed risk (11.8% vs 4.6%) and the calibration graph showed a relatively significant difference between predicted and observed risk levels in different subgroups.

Conclusions

Although the model slightly overestimated the CVD risk, it demonstrated good discrimination. Recalibration of the model is required, after which it has the potential to be applied to patients presenting to diabetic care centres elsewhere in Oman.

Can online and app-based interventions be used by people with diabetes to reduce diabetes distress? A protocol for a scoping review

Por: Andersen · C. M. · Mathiesen · A. S. · Pouwer · F. · Mouritsen · J. D. · Mathiasen · K. · Rothmann · M. J.
Introduction

Diabetes distress has been defined as "the negative emotional or affective experience resulting from the challenge of living with the demands of diabetes". Diabetes distress affects 20%–25% of individuals living with diabetes and can have negative effects on both diabetes regulation and quality of life. For people living with diabetes distress, innovative tools/interventions such as online or app-based interventions may potentially alleviate diabetes distress in a cost-effective way. The specific research questions of this scoping review are: (1) what are the effects of online or app-based interventions on diabetes distress for adults with type 1 or type 2 diabetes, and (2) what are the characteristics of these interventions (eg, type of intervention, duration, frequency, mode of delivery, underlying theories and working mechanisms)?

Methods and analysis

A scoping review will be conducted, using the methodological framework of Arksey and O’Malley along with Levac et al. Eligible studies are: studies of adults ≥18 years old with type 1 or 2 diabetes using an online or app-based intervention and assessing diabetes distress as the primary or secondary outcome. Five databases (Medline, EMBASE, CINAHL, PsycINFO and Scopus) will be searched and is limited to articles written in English, Danish, Norwegian, Swedish or Dutch. Two reviewers will independently screen potentially eligible studies in Covidence, select studies, and together chart data, collate, summarise, and report the results. We will adhere to the Preferred reporting Items for Systematic Reviews and Meta-Analysis for Scoping Reviews (PRISMA-ScR).

Ethics and dissemination

The scoping review has been exempt from full ethical review by the Regional Committees on Health Research Ethics for Southern Denmark (case number: S-20232000-88). The results of the review will be published in a peer-reviewed journal and presented at relevant conferences and workshops with relevant stakeholders.

Impact of deintensifying hypoglycaemic drugs in older adults with type 2 diabetes: protocol for an emulation of a target trial

Por: Christiaens · A. · Simon-Tillaux · N. · Thompson · W. · Sinclair · A. J. · Henrard · S. · Boland · B. B. · Slaouti-Jegou · Y. · Lekens · B. · Bonnet-Zamponi · D. · Tubach · F. · Zerah · L.
Introduction

In older adults with type 2 diabetes (T2D), overtreatment with hypoglycaemic drugs (HDs: sulfonylureas, glinides and/or insulins) is frequent and associated with increased 1-year mortality. Deintensification of HD is thus a key issue, for which evidence is though limited. The primary objective of this study will be to estimate the effect of deintensifying HD on clinical outcomes (hospital admission or death) within 3 months in older adults (≥75 years) with T2D.

Methods

We will emulate with real-world data a target trial, within The Health Improvement Network cohort, a large-scale database of data collected from electronic medical records of 2000 general practitioners in France. From 1 January 2010 to 28 February 2019, we will include eligible patients ≥75 years who will have T2D, a stable dose of HDs, glycated haemoglobin A1c (HbA1c) value 75 mmol/mol within 1 year. Participants will be followed from baseline to 12 months after randomisation, administrative censoring, or death, whichever occurs first. A pooled logistic regression will be used to estimate the treatment effect on the incidence of the outcomes.

Dissemination and ethics

No ethical approval is needed for using retrospectively this fully anonymised database. The results will be disseminated during conferences and through publications in scientific journals.

Metformin in the prevention of type 2 diabetes after gestational diabetes in postnatal women (OMAhA): a UK multicentre randomised, placebo-controlled, double-blind feasibility trial with nested qualitative study

Por: Bolou · A. · Drymoussi · Z. · Lanz · D. · Amaefule · C. E. · Gonzalez Carreras · F. J. · Pardo Llorente · M. d. C. · Dodds · J. · Pizzo · E. · Thomas · A. · Heighway · J. · Harden · A. · Sanghi · A. · Hitman · G. · Zamora · J. · Perez · T. · Huda · M. S. B. · Thangaratinam · S.
Objective

To determine the feasibility of a definitive trial of metformin to prevent type 2 diabetes in the postnatal period in women with gestational diabetes.

Design

A multicentre, placebo-controlled, double-blind randomised feasibility trial with qualitative evaluation.

Setting

Three inner-city UK National Health Service hospitals in London.

Participants

Pregnant women with gestational diabetes treated with medication.

Interventions

2 g of metformin (intervention) or placebo (control) from delivery until 1 year postnatally.

Primary outcome measures

Rates of recruitment, randomisation, follow-up, attrition and adherence to the intervention.

Secondary outcome measures

Preliminary estimates of glycaemic effects, qualitative exploration, acceptability of the intervention and costs.

Results

Out of 302 eligible women, 57.9% (175/302) were recruited. We randomised 82.3% (144/175) of those recruited, with 71 women in the metformin group and 73 women in the placebo group. Of the participants remaining in the study and providing any adherence information, 54.1% (59/109) took at least 75% of the target intervention dose; the overall mean adherence was 64% (SD 33.6). Study procedures were found to be acceptable to women and healthcare professionals. An increased perceived risk of developing type 2 diabetes, or a positive experience of taking metformin during pregnancy, encouraged participation and adherence to the intervention. Barriers to adherence included disruption to the medication schedule caused by the washout periods ahead of each study visit or having insufficient daily reminders.

Conclusions

It is feasible to run a full-scale definitive trial on the effectiveness of metformin to prevent type 2 diabetes in women with gestational diabetes, during the early postnatal period. Adherence and engagement with the study could be improved with more regular reminders and potentially the addition of ongoing educational or peer support to reinforce messages around type 2 diabetes prevention.

Trial registration number

ISRCTN20930880.

Diabetes knowledge and foot care practices among type 2 diabetes patients attending the chronic ambulatory care unit of a public health hospital in eastern Ethiopia: a cross-sectional study

Por: Letta · S. · Goshu · A. T. · Sertsu · A. · Nigussie · K. · Negash · A. · Yadeta · T. A. · Bulti · F. A. · Geda · B. · Dessie · Y.
Objective

To assess diabetes knowledge and foot care practices among type 2 diabetes patients.

Design

An institution-based cross-sectional study was undertaken from 1 January to 31 January 2021.

Setting

Eastern Ethiopia.

Participants

Randomly selected type 2 diabetes patients who were available during the data collection period were included.

Outcomes

Patients’ diabetes knowledge was assessed with the revised diabetes knowledge test questionnaire. Five items were used to evaluate foot self-care practices.

Results

The study population comprised of 549 patients. About 52.5% of the patients had adequate diabetes knowledge (95% CI: 48.2% to 56.7%). Patients with an educational level of secondary school and above (adjusted OR (AOR): 2.04, 95% CI: 1.13 to 3.71), (AOR: 5.28, 95% CI: 2.28 to 12.22), and those with medium and above wealth status (AOR: 3.81, 95% CI: 2.24 to 6.47), (AOR: 3.46, 95% CI: 1.98 to 6.04), were found to have better odds of having adequate diabetes knowledge. However, those aged >55 years (AOR: 0.47, 95% CI: 0.22 to 0.99) were found to have lower odds of adequate diabetes knowledge.Of the total included patients, 20.2% (95% CI: 16.9% to 23.8%) had good foot care practices. Knowledge of the target fasting plasma glucose (AOR: 3.18, 95% CI: 1.94 to 5.22) and adequate diabetes knowledge (AOR: 3.40, 95% CI: 1.95 to 5.91) were significantly associated with good foot care practices.

Conclusion

According to this study, about half of individuals with type 2 diabetes have adequate levels of knowledge about the disease. In addition, only one out of every five patients has good foot care habits. Diabetes education should emphasise the significance of rigorous adherence to daily foot care practices.

Prevalence and risk factors of metabolic syndrome in Ethiopia: describing an emerging outbreak in HIV clinics of the sub-Saharan Africa - a cross-sectional study

Por: Abdela · A. A. · Yifter · H. · Reja · A. · Shewaamare · A. · Ofotokun · I. · Degu · W. A.
Objectives

HIV-induced chronic inflammation, immune activation and combination antiretroviral therapy (cART) are linked with adverse metabolic changes known to cause cardiovascular adversities. This study evaluates the prevalence of lipodystrophy, and metabolic syndrome (MetS), and analyses risk factors in HIV-infected Ethiopians taking cART.

Methods

A multicentre cross-sectional study was conducted at tertiary-level hospitals. Eligible participants attending the HIV clinics were enrolled. Sociodemographic, anthropometric, clinical, HIV treatment variables, lipid profile, fasting blood glucose level, risk factors and components of MetS, also lipodystrophy, were studied. Data were analysed by SPSS statistical package V.25 with descriptive and analytical statistics. For multivariable analysis of risk factors, a logistic regression model was used. Results were presented in frequency and percentages, mean±SD, or median+IQR. Statistical significance was taken as p

Results

Among 518 studied participants, two-thirds were females, and the mean age of the study population was 45 years (SD=11). The mean duration of cART was 10 years (SD=4). Median CD4 count was 460 cells/mm3. The prevalence of MetS according to the Adult Treatment Panel III (2005) criteria was 37.6%. In multivariable analysis, independent risk factors for MetS were age >45 years (aHR 1.8, 95% CI 1.2 to 2.4), female sex (aHR 1.8, 95% CI 1.1 to 2.8), body mass index (BMI)>25 kg/m2 (aHR 2.7, 95% CI 1.8 to 4.1), efavirenz-based cART (aHR 2.8, 95% CI 1.6 to 4.8) and lopinavir/ritonavir-based cART (aHR 3.7, 95% CI 1.0 to 13.3). The prevalence of lipodystrophy was 23.6%. Prior exposure to a stavudine-containing regimen was independently associated with lipodystrophy (aHR 3.1, 95% CI 1.6 to 6.1).

Conclusion

Our study revealed 38% of the participants had MetS indicating considerable cardiovascular disease (CVD) risks. Independent risk factors for MetS were BMI≥25 kg/m2, efavirenz and lopinavir/ritonavir-based cART, female sex and age ≥45 years. In addition to prevention, CVD risk stratification and management will reduce morbidity and mortality in people with HIV infection.

Effectiveness, safety and costs of the FreeStyle Libre glucose monitoring system for children and adolescents with type 1 diabetes in Spain: a prospective, uncontrolled, pre-post study

Objectives

This study aimed to evaluate the effectiveness, safety and costs of FreeStyle Libre (FSL) glucose monitoring system for children and adolescents with type 1 diabetes mellitus (T1DM) in Spain.

Design

Prospective, multicentre pre-post study.

Setting

Thirteen Spanish public hospitals recruited patients from January 2019 to March 2020, with a 12-month follow-up.

Participants

156 patients were included.

Primary and secondary outcome measures

Primary: glycated haemoglobin (HbA1c) change. Secondary: severe hypoglycaemic events (self-reported and clinical records), quality of life, diabetes treatment knowledge, treatment satisfaction, adverse events, adherence, sensor usage time and scans. Healthcare resource utilisation was assessed for cost analysis from the National Health System perspective, incorporating direct healthcare costs. Data analysis used mixed regression models with repeated measures. The intervention’s total cost was estimated by multiplying health resource usage with unit costs.

Results

In the whole sample, HbA1c increased significantly (0.32%; 95% CI 0.10% to 0.55%). In the subgroup with baseline HbA1c≥7.5% (n=88), there was a significant reduction at 3 months (–0.46%; 95% CI –0.69% to –0.23%), 6 months (–0.49%; 95% CI –0.73% to –0.25%) and 12 months (–0.43%; 95% CI –0.68% to –0.19%). Well-controlled patients had a significant 12-month worsening (0.32%; 95% CI 0.18% to 0.47%). Self-reported severe hypoglycaemia significantly decreased compared with the previous year for the whole sample (–0.37; 95% CI –0.62 to –0.11). Quality of life and diabetes treatment knowledge showed no significant differences, but satisfaction increased. Adolescents had lower sensor usage time and scans than children. Reduction in HbA1c was significantly associated with device adherence. No serious adverse effects were observed. Data suggest that use of FSL could reduce healthcare resource use (strips and lancets) and costs related to productivity loss.

Conclusions

The use of FSL in young patients with T1DM was associated with a significant reduction in severe hypoglycaemia, and improved HbA1c levels were seen in patients with poor baseline control. Findings suggest cost savings and productivity gains for caregivers. Causal evidence is limited due to the study design. Further research is needed to confirm results and assess risks, especially for patients with lower baseline HbA1c.

Impact of an Acceptance and Commitment Therapy programme on HbA1c, self-management and psychosocial factors in adults with type 1 diabetes and elevated HbA1c levels: a randomised controlled trial

Por: Wijk · I. · Amsberg · S. · Johansson · U.-B. · Livheim · F. · Toft · E. · Anderbro · T.
Objective

To evaluate the impact of an Acceptance and Commitment Therapy (ACT) programme, tailored for people living with type 1 diabetes, on glycated haemoglobin (HbA1c), self-management and psychosocial factors among individuals with HbA1c>60 mmol/mol compared with treatment as usual (TAU).

Setting

An endocrinologic clinic in Sweden.

Participants

In this randomised controlled trial, 81 individuals with type 1 diabetes, aged 18–70 years with HbA1c>60 mmol/mol, were randomly assigned to either an ACT group intervention or TAU. Exclusion criteria were: unable to speak Swedish, untreated or severe psychiatric disease, cortisone treatment, untreated thyroid disease and newly started insulin pump therapy. At the 2-year follow-up, HbA1c was measured in 26 individuals.

Intervention

The ACT programme comprised seven 2-hour sessions held over 14 weeks and focused on acceptance of stressful thoughts and emotions, and to promote value-based committed action.

Outcomes

The primary outcome was HbA1c, and the secondary outcomes were measures of depression, anxiety, general stress, fear of hypoglycaemia, diabetes distress, self-care activities, psychological flexibility (general and related to diabetes) and quality of life. The primary endpoint was HbA1c 2 years after the intervention programme. Linear mixed models were used to test for an interaction effect between measurement time and group.

Results

Likelihood ratio test of nested models demonstrated no statistically significant interaction effect (2=0.49, p=0.485) between measurement time and group regarding HbA1c. However, a statistically significant interaction effect (likelihood ratio test 2=12.63, p

Conclusions

No statistically significant difference was found between the groups regarding the primary outcome measure, HbA1c. However, the ACT programme showed a persistent beneficial impact on psychological flexibility in the intervention group. The dropout rate was higher than expected, which may indicate a challenge in this type of study.

Trial registration number

NCT02914496.

Nationwide survey of physicians familiarity and awareness of diabetes guidelines in China: a cross-sectional study

Por: Jia · L.-y. · Huang · C.-x. · Zhao · N.-j. · Lai · B.-y. · Zhang · Z.-h. · Li · L. · Zhan · N. · Lin · Y.-b. · Cai · M.-n. · Wang · S.-q. · Yan · B. · Liu · J.-p. · Yang · S.-y.
Objective

This study aims to investigate physicians’ familiarity and awareness of four diabetes guidelines and their practice of the recommendations outlined in these guidelines.

Design

A cross-sectional study.

Setting

An online questionnaire survey was conducted among physicians affiliated with the Specialist Committee for Primary Diabetes Care of China Association of Chinese Medicine, using the snowball sampling method to ensure a broader representation of physicians.

Participants

1150 physicians from 192 cities across 30 provinces in China provided complete data.

Results

Tertiary care hospital physicians (TCPs) exhibited the highest familiarity with the Guideline for the Prevention and Treatment of Type 2 Diabetes Mellitus in China (91.3%), followed by the National Guidelines for the Prevention and Control of Diabetes in Primary Care (76.8%), the Standards of Medical Care in Diabetes (72.2%) and the Guidelines for Prevention and Treatment of Diabetes in Chinese Medicine (63.8%). Primary care practitioners (PCPs) exhibited familiarity with these four guidelines at about 50% or less. Self-reported reference to modern diabetes guidelines by physicians is more frequent than traditional Chinese medicine (TCM) diabetes guidelines, with rates at 73.2% and 33.8%, respectively. Approximately 90% of physicians provided instructions on self-monitoring of blood glucose to their patients with diabetes. Less than one-third of physicians referred patients to a specialised nutritionist. In terms of health education management, TCPs reported having a diabetes health management team at the rate of 75.7%, followed by secondary care hospital physicians at 57.0% and PCPs at 27.5%. Furthermore, approximately 40% of physicians did not fully grasp hypoglycaemia characteristics.

Conclusions

Familiarity and awareness of the screening guidelines varied among physicians in different hospital settings. Importantly, significant discrepancies were observed between physicians’ awareness and their self-reported reference to modern medicine guidelines and TCM guidelines. It is essential to consistently provide education and training on diabetes management for all physicians, particularly PCPs.

Determinants of access to and use of gestational diabetes mellitus services in Kenya: a multimethod case study protocol

Por: Obongo · A. · Tallarek · M. · Spallek · J.
Introduction

Gestational diabetes mellitus (GDM) is a growing public health issue in many low and middle-income countries (LMICs), making up about 90% of the global burden of GDM. Additionally, LMICs’ healthcare systems are already overwhelmed by the prevalence of communicable diseases. It is crucial to understand the patterns of GDM in sub-Saharan African countries. Early detection, lifestyle and medication interventions, regular prenatal visits and effective postpartum management can help avert the future development of type 2 diabetes. GDM services present opportunities for preventive and treatment strategies for women with GDM. However, various factors contribute to challenges and obstacles in accessing GDM services, particularly suboptimal postpartum screening and follow-up. This study aims to investigate the societal and healthcare factors that facilitate or hinder access to and use of GDM services, as well as the factors that promote or obstruct the management and treatment of GDM, in Kenya, using a postcolonial theoretical approach.

Methods and analysis

The proposed study design is a multimethod case study of Kenyan GDM services. Data analysis is descriptive and thematic using SPSS software and qualitative content analysis. Data will be drawn from document reviews from the National Health Services (NHS), conversations with experts, on-site observations, semistructured questionnaires and face-to-face interviews. The study subjects are purposively sampled healthcare providers (n=15) working in clinics and hospitals offering diabetes services, purposively sampled women who have been diagnosed with GDM identified from health records (n=15) and NHS experts (n=2). The study will take place in maternal healthcare services sites in national referral hospitals and/or private hospitals (two urban and two semiurban hospitals) in Nairobi and Kisumu, Kenya.

Ethics and dissemination

The study has obtained ethical approval from the ethical committees of three institutions: Brandenburg University of Technology Cottbus-Senftenberg (EK2021-03) in Germany and Jaramogi Oginga Odinga Teaching and Referral Hospital (ISERC/1B/VOL.II/558/21) and Maseno University (MSU/DRPI/MUERC/00969/21) in Kenya. A research permit has been granted by the National Commission for Science, Technology and Innovation in Kenya. Participation in the study requires a signed informed consent form. The study findings will be shared with the scientific community and the study sites through scientific journals, academic presentations and public health and diabetes-related posters.

Effectiveness of a culturally tailored diabetes education curriculum with real-time continuous glucose monitoring in a Latinx population with type 2 diabetes: the CUT-DM with CGM for Latinx randomised controlled trial study protocol

Por: Ehrhardt · N. · Cedeno · B. · Montour · L. · Sinclair · K. · Ferguson · G. · Berberian · P. · Comstock · B. · Wright · L.
Introduction

The prevalence of type 2 diabetes (T2D) is increasing in the Latinx community. Despite telehealth and technology becoming more available, these resources are not reaching the Latinx population. Diabetes education is a cornerstone of treatment; however, access to culturally tailored content is a barrier to the Latinx population. Real-time continuous glucose monitoring (RT-CGM) is a patient-empowering tool that can improve glycaemic control, but it is not readily available for Latinx patients with T2D. We aim to evaluate a culturally tailored diabetes self-management education and support (DSMES) curriculum, using a team-based approach to improve glycaemic control, promote healthy behaviours and enhance patient access with the use of telehealth in Latinx individuals. The primary aim of the study is to evaluate the additive effectiveness of RT-CGM on glycaemia and behavioural changes among Latinx patients undergoing a culturally tailored DSMES. A sub aim of the study is to evaluate family members’ change in behaviours.

Methods

We propose a randomised controlled trial of blinded versus RT-CGM with 100 Latinx participants with T2D who will receive DSMES via telemedicine over 12 weeks (n=50 per group). The study will be conducted at a single large federally qualified health centre system. The control group will receive culturally tailored DSMES and blinded CGM. The intervention group will receive DSMES and RT-CGM. The DSMES is conducted by community health educators weekly over 12 weeks in Spanish or English, based on participant’s language preference. Patients in the RT-CGM group will have cyclical use with a goal of 50 days wear time. The primary outcomes are changes in haemoglobin A1c and CGM-derived metrics at 3 and 6 months. The secondary outcomes include participants’ self-management knowledge and behaviour and household members’ change in lifestyle.

Ethics and dissemination

The study proposal was approved by the University of Washington ethics/institutional review board (IRB) Committee as minimal risk (IRB ID: STUDY00014396) and the Sea Mar IRB committee.

Trial registration number

ClinicalTrials.gov identifier: NCT05394844

South Asian individuals experiences on the NHS low-calorie diet programme: a qualitative study in community settings in England

Por: Dhir · P. · Maynard · M. · Drew · K. J. · Homer · C. V. · Bakhai · C. · Ells · L. J.
Background

Existing literature examines barriers to the provision of ethnically diverse dietary advice, however, is not specific to total diet replacement (TDR). There is a lack of literature from the UK, limiting the potential applicability of existing findings and themes to the UK context. This study addresses this gap in research by interviewing participants of South Asian ethnicity who have undertaken the National Health Service (NHS) low-calorie diet programme (LCD) for people with type 2 diabetes living with overweight or obesity. This study explores factors that may affect the uptake and acceptability of its TDR, food reintroduction and weight maintenance stages. This aims to provide rich data that can inform effective tailoring of future programmes with South Asian participants.

Objective

To explore the perspectives of individuals of South Asian ethnicity on an NHS programme using TDR approaches for the management of type 2 diabetes (T2D).

Design

Qualitative study.

Setting

Individuals in the community undertaking the NHS LCD programme.

Participants

Twelve one-to-one interviews were conducted with individuals from a South Asian ethnicity participating in the NHS LCD.

Main outcome measures

Qualitative semistructured interviews conducted through different stages of the programme. Reflexive thematic analysis was used to analyse the transcripts.

Results

Key themes highlighted positive and negative experiences of the programme: (1) more work is needed in the programme for person centeredness; (2) it is not the same taste; (3) needing motivation to make changes and feel better; (4) a mixed relationship with the coach; (5) social experiences; (6) culture-related experiences.

Conclusion

This study provides important experience-based evidence of the need for culturally tailored T2D programmes. Action to address these findings and improve the tailoring of the NHS LCD may improve experience, retention and outcomes on the programme for people of South Asian ethnicity and thereby reduce inequalities.

Diabetes distress as mediators of loneliness and health promotion behaviour: a cross-sectional study

Por: Zhou · F. · Deng · L. · Guo · C. · Long · K. · Xie · L. · Yang · T. · Lv · Q.
Objectives

The purpose of this study was to explore whether diabetes distress mediated the relationship between loneliness and health promotion in older adults with diabetes.

Design

A cross-sectional study.

Setting

The study was conducted at three tertiary hospitals in Changsha, Hunan Province, China.

Participants

The sample included 140 patients with diabetes (65 years and older, mean age 72.6 years, SD=4.6).

Methods

We employed path models to analyse data on diabetes distress, loneliness and health promotion behaviours. We collected diabetes distress, loneliness and health promotion behaviour with self-reported questionnaires including the Diabetes Distress Scale, the University of California at Los Angeles (UCLA) Loneliness Scale and the Elderly Health Promotion Scale from January 2022 to October 2022. Mediation analysis was performed by SPSS V.26.0’s PROCESS macro.

Result

The findings of this study indicated diabetes distress acted as a mediator between loneliness and health promotion behaviour. According to bootstrapping results, the total effect of loneliness on health promotion behaviour was significantly negative (β=–0.312, p=0.006). Loneliness significantly and negatively correlated with diabetes distress (β=–0.043, p

Conclusion

Our study illustrated that loneliness was negatively associated with health promotion behaviours, and diabetes distress acted as a mediator in this relationship. It is suggested that healthcare providers should prioritise the identification and management of diabetes distress in older patients with diabetes who experience loneliness to improve health promotion behaviours and optimise disease management outcomes.

Risk factors for cognitive impairment in middle-aged type 2 diabetic patients: a cross-sectional study

Por: Li · Y.-S. · Li · J.-B. · Wang · J.-J. · Wang · X.-H. · Jiang · W.-R. · Qiu · H.-N. · Xia · L.-F. · Wu · F. · Lin · C.-Y. · Liu · Y.-L. · Lin · J.-N.
Objective

The aim of this study was to investigate risk factors for cognitive impairment (CI) and explore the relationship between obesity and cognition in hospitalised middle-aged patients with type 2 diabetes (T2DM).

Methods

Subjects were divided into normal cognitive function (NCF) (n=320) and CI (n=204) groups based on the results of the Montreal Cognitive Assessment (MoCA) and Mini-Mental State Examination (MMSE). The risk factors for CI were determined by logistic regression analysis and generalised linear modelling. The associations between obesity parameters (body mass index (BMI) and waist circumference (WC)) and cognitive ability were studied with the use of linear regression analysis, piecewise regression modelling and interaction analysis. The receiver operating characteristic curve analysis was used to examine the diagnostic value of influencing factors for cc

Results

The prevalence of CI was 38.9% in hospitalised middle-aged T2DM patients (median age, 58 years). Age, WC, hypoglycaemic episode within past 3 months and cerebrovascular disease (CVD) were identified as independent risk factors for CI, while the independent protective factors were education, diabetic dietary pattern, overweight and obesity. BMI was a protective factor for the MoCA score within a certain range, whereas WC was a risk factor for the MMSE and MoCA scores. The area under the curve for the combination of BMI and WC was 0.754 (p

Conclusion

Age, education, diabetic dietary pattern, WC, overweight, obesity, hypoglycaemic episode in 3 months and CVD may be potential influencing factors for the occurrence of CI in hospitalised middle-aged population with T2DM. The combination of BMI and WC may represent a good predictor for early screening of CI in this population. Nevertheless, more relevant prospective studies are still needed.

Diabetes-related distress and its associated factors among people with type 2 diabetes in Southeast Ethiopia: a cross-sectional study

Por: Adugnew · M. · Fetene · D. · Assefa · T. · Kedir · S. · Asmamaw · K. · Feleke · Z. · Gomora · D. · Mamo · H.
Background

Diabetes-related distress lowers the motivation for self-care, often leading to lowered physical and emotional well-being, poor diabetes control, poor medication adherence and increased mortality among individuals with diabetes.

Objective

To assess factors associated with diabetes-related distress among people living with type 2 diabetes in Southeast Ethiopia.

Design

Institution-based cross-sectional study was conducted.

Setting

Six diabetic follow-up care units at public hospitals in Southeast Ethiopia.

Participants

All adult people living with type 2 diabetes from the diabetic follow-up clinic.

The main outcome measures

Diabetes Distress Scale-17 questionnaire was used to assess diabetes-related distress.

Results

Out of the total 871 study participants intended, 856 participated in the study with a response rate of 98.3%. The findings showed that about 53.9% (95% CI 50.4% to 57.2%) of the patients have diabetes-related distress. Physical activity (adjusted OR, AOR 2.22; 95% CI 1.36 to 3.63), social support (AOR 4.41; 95% CI 1.62 to 12.03), glycaemic control (AOR 2.36; 95% CI 1.35 to 4.12) and other comorbidities (AOR 3.94; 95% CI 2.01 to 7.73) were factors that significantly associated with diabetes-related distress at p

Conclusion

This study demonstrated that more than half of the participants had diabetes-related distress. Therefore, the identified factors of diabetes-related distress need to be a concern for health institutions and clinicians in the management of people living with type 2 diabetes.

Integrated health system intervention aimed at reducing type 2 diabetes risk in women after gestational diabetes in South Africa (IINDIAGO): a randomised controlled trial protocol

Por: Norris · S. A. · Zarowsky · C. · Murphy · K. · Ware · L. J. · Lombard · C. · Matjila · M. · Chivese · T. · Muhwava · L. S. · Mutabazi · J. C. · Harbron · J. · Fairall · L. R. · Lambert · E. · Levitt · N.
Introduction

South Africa has a high prevalence of gestational diabetes mellitus (GDM; 15%) and many of these women (48%) progress to type 2 diabetes mellitus (T2DM) within 5 years post partum. A significant proportion (47%) of the women are not aware of their diabetes status after the index pregnancy, which may be in part to low postnatal diabetes screening rates. Therefore, we aim to evaluate a intervention that reduces the subsequent risk of developing T2DM among women with recent GDM. Our objectives are fourfold: (1) compare the completion of the nationally recommended 6-week postpartum oral glucose tolerance test (OGTT) between intervention and control groups; (2) compare the diabetes risk reduction between control and intervention groups at 12 months’ post partum; (3) assess the process of implementation; and (4) assess the cost-effectiveness of the proposed intervention package.

Methods and analyses

Convergent parallel mixed-methods study with the main component being a pragmatic, 2-arm individually randomised controlled trial, which will be carried out at five major referral centres and up to 26 well-baby clinics in the Western Cape and Gauteng provinces of South Africa. Participants (n=370) with GDM (with no prior history of either type 1 or type 2 diabetes) will be recruited into the study at 24–36 weeks’ gestational age, at which stage first data collection will take place. Subsequent data collection will take place at 6–8 weeks after delivery and again at 12 months. The primary outcome for the trial is twofold: first, the completion of the recommended 2-hour OGTT at the well-baby clinics 6–8 weeks post partum, and second, a composite diabetes risk reduction indicator at 12 months. Process evaluation will assess fidelity, acceptability, and dose of the intervention.

Ethics and dissemination

Ethics approval has been granted from University of Cape Town (829/2016), University of the Witwatersrand, Johannesburg (M170228), University of Stellenbosch (N17/04/032) and the University of Montreal (2019-794). The results of the trial will be disseminated through publication in peer-reviewed journals and presentations to key South African Government stakeholders and health service providers.

Protocol version

1 December 2022 (version #2). Any protocol amendments will be communicated to investigators, Human Ethics Research Committees, trial participants, and trial registries.

Trial registration number

PAN African Clinical Trials Registry (https://pactr.samrc.ac.za) on 11 June 2018 (identifier PACTR201805003336174).

Is male gynaecomastia associated with an increased risk of death? A nationwide register-based cohort study

Por: Bräuner · E. V. · Uldbjerg · C. · Lim · Y.-H. · Beck · A. · Hueg · T. · Juul · A.
Objective

Recent evidence supports that gynaecomastia may predict long-term morbidity, but evidence on the association with death and causes of death in males with gynaecomastia is lacking. The objective of this work is to estimate the risk of death in men diagnosed with gynaecomastia and evaluate whether this was conditional on underlying aetiologies of gynaecomastia.

Design

A nationwide register-based cohort study.

Setting

Nationwide Danish national health registries.

Participants

Males were diagnosed with incident gynaecomastia (n=23 429) from 1 January 1995 to 30 June 2021, and each was age and calendar matched to five randomly population-based males without gynaecomastia (n=117 145).

Interventions

Not applicable.

Primary and secondary outcomes

Gynaecomastia was distinguished between males without (idiopathic) and males with a known pre-existing risk factor. Cox regression models and Kaplan-Meier analyses estimated associations between gynaecomastia and death (all cause/cause specific).

Results

We identified a total of 16 253 males with idiopathic gynaecomastia and 7176 with gynaecomastia and a known pre-existing risk factor. Of these, 1093 (6.7%) and 1501 (20.9%) died during follow-up, respectively. We detected a 37% increased risk of all-cause death in males with gynaecomastia in the entire cohort (HR 1.37; 95% CI 1.31 to 1.43). Death risk was highest in males diagnosed with gynaecomastia and a known pre-existing risk factor (HR 1.75; 95% CI 1.64 to 1.86) compared with males with idiopathic gynaecomastia (HR 1.05; 95% CI 0.98 to 1.13). Specific causes of increased death were malignant neoplasms and circulatory, pulmonary and gastrointestinal diseases. Of the latter, an over fivefold risk of death from liver disease was detected (HR 5.05; 95% CI 3.97 to 6.42).

Conclusions

Males diagnosed with gynaecomastia are at higher risk of death, observed mainly in males with a known pre-existing risk factor of gynaecomastia. These findings will hopefully stimulate more awareness among healthcare providers to potentially apply interventions that aid in alleviating underlying risk factors in males with this condition.

Implementing a contextually appropriate foot-ankle exercise programme in primary care for the prevention of modifiable risk factors for ulcers in people with diabetes: protocol for a hybrid type 2 study

Por: Rodrigues · C. B. · Soares · P. N. C. · Schmitt · A. C. B. · Sacco · I. C. N.
Introduction

Diabetes is a highly prevalent disease that negatively impacts people’s health and quality of life. It can result in diabetic peripheral neuropathy (DPN) and foot complications, which in turn lead to ulcers and amputations. The international guidelines on diabetic foot included specific foot-ankle exercises as preventive strategy capable of modifying the risk factors for ulcers. Our aim is to test the effectiveness and to implement a contextually appropriate preventive intervention—a foot-ankle exercises programme alongside educational strategies—in a primary care setting to improve range of motion (ROM), strength, functionality of foot-ankle, and quality of life in people with diabetes.

Methods and analysis

This is a hybrid type 2 implementation-effectiveness study organised in four phases, being undertaken in Limeira, São Paulo. Phase 1, preimplementation, aims to gather information about the contextual characteristics, barriers, and facilitators and to form the implementation team. In phase 2, the implementation team will structure the foot-ankle programme, adapting it to the context of primary healthcare, and develop the training for health professionals. In phase 3, effectiveness of the 12 week group-based intervention will be tested by a cluster randomised controlled trial. Primary care units (18 clusters) will be randomly allocated to a control or intervention group, with a total sample of 356 people. Primary outcomes will be DPN symptoms and ankle and first metatarsal phalangeal joint ROM. Reach, adoption, and implementation will be evaluated by Reach, Effectiveness, Adoption, Implementation, and Maintenance framework. In phase 4, maintenance and expansion of the programme in the municipality will be assessed.

Ethics and dissemination

This protocol and the informed consent to be signed by the participants were approved by the Ethics Committee of the School of Medicine of the University of São Paulo (CAAE:63457822.0.0000.0068, 29 November 2022). The project will generate and share data in a public repository. Results will be disseminated through peer-reviewed journals, conference proceedings, and electronic communications for health professionals.

Trial registration number

NCT05639478.

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