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Negative pressure wound therapy compared with standard moist wound care on diabetic foot ulcers in real-life clinical practice: results of the German DiaFu-RCT

Por: Seidel · D. · Storck · M. · Lawall · H. · Wozniak · G. · Mauckner · P. · Hochlenert · D. · Wetzel-Roth · W. · Sondern · K. · Hahn · M. · Rothenaicher · G. · Krönert · T. · Zink · K. · Neugebauer · E.
Objectives

The aim of the DiaFu study was to evaluate effectiveness and safety of negative pressure wound therapy (NPWT) in patients with diabetic foot wounds in clinical practice.

Design

In this controlled clinical superiority trial with blinded outcome assessment patients were randomised in a 1:1 ratio stratified by study site and ulcer severity grade using a web-based-tool.

Setting

This German national study was conducted in 40 surgical and internal medicine inpatient and outpatient facilities specialised in diabetes foot care.

Participants

368 patients were randomised and 345 participants were included in the modified intention-to-treat (ITT) population. Adult patients suffering from a diabetic foot ulcer at least for 4 weeks and without contraindication for NPWT were allowed to be included.

Interventions

NPWT was compared with standard moist wound care (SMWC) according to local standards and guidelines.

Primary and secondary outcome measures

Primary outcome was wound closure within 16 weeks. Secondary outcomes were wound-related and treatment-related adverse events (AEs), amputations, time until optimal wound bed preparation, wound size and wound tissue composition, pain and quality of life (QoL) within 16 weeks, and recurrences and wound closure within 6 months.

Results

In the ITT population, neither the wound closure rate (difference: n=4 (2.5% (95% CI–4.7% – 9.7%); p=0.53)) nor the time to wound closure (p=0.244) was significantly different between the treatment arms. 191 participants (NPWT 127; SMWC 64) had missing endpoint documentations, premature therapy ends or unauthorised treatment changes. 96 participants in the NPWT arm and 72 participants in the SMWC arm had at least one AE (p=0.007), but only 16 AEs were related to NPWT.

Conclusions

NPWT was not superior to SMWC in diabetic foot wounds in German clinical practice. Overall, wound closure rate was low. Documentation deficits and deviations from treatment guidelines negatively impacted the outcome wound closure.

Trial registration numbers

NCT01480362 and DRKS00003347.

Strategies to identify individuals with monogenic diabetes: results of an economic evaluation

Por: Peters · J. L. · Anderson · R. · Shields · B. · King · S. · Hudson · M. · Shepherd · M. · McDonald · T. J. · Pearson · E. · Hattersley · A. · Hyde · C.
Objectives

To evaluate and compare the lifetime costs associated with strategies to identify individuals with monogenic diabetes and change their treatment to more appropriate therapy.

Design

A decision analytical model from the perspective of the National Health Service (NHS) in England and Wales was developed and analysed. The model was informed by the literature, routinely collected data and a clinical study conducted in parallel with the modelling.

Setting

Secondary care in the UK.

Participants

Simulations based on characteristics of patients diagnosed with diabetes

Interventions

Four test-treatment strategies to identify individuals with monogenic diabetes in a prevalent cohort of diabetics diagnosed under the age of 30 years were modelled: clinician-based genetic test referral, targeted genetic testing based on clinical prediction models, targeted genetic testing based on biomarkers, and blanket genetic testing. The results of the test-treatment strategies were compared with a strategy of no genetic testing.

Primary and secondary outcome measures

Discounted lifetime costs, proportion of cases of monogenic diabetes identified.

Results

Based on current evidence, strategies using clinical characteristics or biomarkers were estimated to save approximately £100–£200 per person with diabetes over a lifetime compared with no testing. Sensitivity analyses indicated that the prevalence of monogenic diabetes, the uptake of testing, and the frequency of home blood glucose monitoring had the largest impact on the results (ranging from savings of £400–£50 per person), but did not change the overall findings. The model is limited by many model inputs being based on very few individuals, and some long-term data informed by clinical opinion.

Conclusions

Costs to the NHS could be saved with targeted genetic testing based on clinical characteristics or biomarkers. More research should focus on the economic case for the use of such strategies closer to the time of diabetes diagnosis.

Trial registration number

NCT01238380.

Assessing the effect of closed-loop insulin delivery from onset of type 1 diabetes in youth on residual beta-cell function compared to standard insulin therapy (CLOuD study): a randomised parallel study protocol

Por: Boughton · C. · Allen · J. M. · Tauschmann · M. · Hartnell · S. · Wilinska · M. E. · Musolino · G. · Acerini · C. L. · Dunger · P. D. · Campbell · F. · Ghatak · A. · Randell · T. · Besser · R. · Trevelyan · N. · Elleri · D. · Northam · E. · Hood · K. · Scott · E. · Lawton · J. · Roze · S.
Introduction

Management of newly diagnosed type 1 diabetes (T1D) in children and adolescents is challenging for patients, families and healthcare professionals. The objective of this study is to determine whether continued intensive metabolic control using hybrid closed-loop (CL) insulin delivery following diagnosis of T1D can preserve C-peptide secretion, a marker of residual beta-cell function, compared with standard multiple daily injections (MDI) therapy.

Methods and analysis

The study adopts an open-label, multicentre, randomised, parallel design, and aims to randomise 96 participants aged 10–16.9 years, recruited within 21 days of diagnosis with T1D. Following a baseline mixed meal tolerance test (MMTT), participants will be randomised to receive 24 months treatment with conventional MDI therapy or with CL insulin delivery. A further 24-month optional extension phase will be offered to all participants to continue with the allocated treatment. The primary outcome is the between group difference in area under the stimulated C-peptide curve (AUC) of the MMTT at 12 months post diagnosis. Analyses will be conducted on an intention-to-treat basis. Key secondary outcomes are between group differences in time spent in target glucose range (3.9–10 mmol/L), glycated haemoglobin (HbA1c) and time spent in hypoglycaemia (

Ethics and dissemination

Ethics approval has been obtained from Cambridge East Research Ethics Committee. The results will be disseminated by peer-reviewed publications and conference presentations.

Trial registration number

NCT02871089; Pre-results.

Cultural adaptation of a patient decision-aid for insulin therapy

Por: Tan · N. C. · Koong Ying Leng · A. · Phoon Kwong Yun · I. · Wang Zhen · S. · Paulpandi · M. · Lee · Y. K. · Furler · J. · Car · J. · Ng · C. J.
Introduction

Patient decision-aids (PDAs) support patients in selecting evidence-based treatment options. PDA is useful only if the user understands the content to make personalised decisions. Cultural adaptation is a process of adjusting health messages so that the information is accurate, relevant and understandable to users from a different population. A PDA has been developed to assist Malaysian patients with secondary drug failure to initiate insulin therapy to control their type 2 diabetes mellitus (T2DM). Likewise, patients with T2DM in neighbouring Singapore face similar barriers in commencing insulin treatment, which a PDA may facilitate decision-making in selecting personalised therapy.

Objective

The study aimed to explore the views and perceptions of Singaporean primary care providers on the Malaysia PDA to initiate insulin therapy and described the cultural adaptation process used in the design and development of a new PDA, which would be trialled in a Singapore primary healthcare institution.

Method

Qualitative research method was deployed to conduct one-to-one in-depth interviews of the healthcare providers at the trial site (SingHealth Polyclinics—SHP), including six primary care physicians and four nurses to gather their views and feedbacks on the Malaysian PDA. The interviews were transcribed, audited and analysed (standard content analysis) to identify themes relating to the content, layout, concerns of the original PDA and suggestions to the design of the new SHP PDA.

Results

Cultural adaptation of the new PDA includes change to the overall design, graphics (including pictograms), presentation styles, additional contextualised content (personalisation, subheadings, cost and treatment option), modified phrasing of the subtitles and concerns (choice of words) relevant to the new users.

Conclusion

A PDA on insulin therapy underwent cultural adaptation before its implementation in another population in a neighbouring country. Its relevance and effectiveness will be evaluated in future research.

Direct non-medical and indirect costs of diabetes and its associated complications in Vietnam: an estimation using national health insurance claims from a cross-sectional survey

Por: Kieu · T. T. M. · Trinh · H. N. · Pham · H. T. K. · Nguyen · T. B. · Ng · J. Y. S.
Objective

The prevalence of diabetes in Vietnam has increased from 2.5% in 2007 to 5.5% in 2017, but the burden of direct non-medical and indirect costs is unknown. The objective of this study was to estimate the direct non-medical costs and indirect costs due to type 2 diabetes mellitus (T2DM) and its associated complications among Vietnam Health Insurance System (VHIS) enrollees in Vietnam.

Design

The first phase was a cross-sectional survey of patients with T2DM. In the second phase, data from the previous phase were used to predict direct non-medical costs and presenteeism costs of VHIS enrollees diagnosed with T2DM based on demographic and clinical characteristics in 2017. The human-capital approach was used for the calculation of indirect costs.

Setting and participants

This study recruited 315 patients from a national hospital, a provincial hospital and a district hospital aged 18 or above, diagnosed with T2DM, enrolled in VHIS, and having at least one visit to hospitals between 1 June and 30 July 2018. The VHIS dataset contained 1,395,204 patients with T2DM.

Outcome measures

The direct non-medical costs and presenteeism were collected from the survey. Absenteeism costs were estimated from the VHIS database. Costs of premature mortality were calculated based on the estimates from secondary sources.

Results

The total direct non-medical and indirect costs were US$239 million in 2017. Direct non-medical costs were US$78 million, whereas indirect costs were US$161 million. Costs of absenteeism, presenteeism and premature mortality corresponded to 17%, 73% and 10% of the indirect costs. Patients incurred annual mean direct non-medical costs of US$56. Annual mean absenteeism and presenteeism costs for patients in working age were US$61 and US$267, respectively.

Conclusions

The impact of T2DM on direct non-medical and indirect costs on diabetes is substantial. Direct non-medical and absenteeism costs were higher in patients with complications.

How valid are projections of the future prevalence of diabetes? Rapid reviews of prevalence-based and Markov chain models and comparisons of different models projections for England

Por: Bevan · G. · De Poli · C. · Keng · M. J. · Raine · R.
Objectives

To examine validity of prevalence-based models giving projections of prevalence of diabetes in adults, in England and the UK, and of Markov chain models giving estimates of economic impacts of interventions to prevent type 2 diabetes (T2D).

Methods

Rapid reviews of both types of models. Estimation of the future prevalence of T2D in England by Markov chain models; and from the trend in the prevalence of diabetes, as reported in the Quality and Outcomes Framework (QOF), estimated by ordinary least squares regression analysis.

Setting

Adult population in England and UK.

Main outcome measure

Prevalence of T2D in England and UK in 2025.

Results

The prevalence-based models reviewed use sample estimates of past prevalence rates by age and sex and projected population changes. Three most recent models, including that of Public Health England (PHE), neither take account of increases in obesity, nor report Confidence Intervals (CIs). The Markov chain models reviewed use transition probabilities between states of risk and death, estimated from various sources. None of their accounts give the full matrix of transition probabilities, and only a minority report tests of validation. Their primary focus is on estimating the ratio of costs to benefits of preventive interventions in those with hyperglycaemia, only one reported estimates of those developing T2D in the absence of a preventive intervention in the general population.

Projections of the prevalence of T2D in England in 2025 were (in millions) by PHE, 3.95; from the QOF trend, 4.91 and by two Markov chain models, based on our review, 5.64 and 9.07.

Conclusions

To inform national policies on preventing T2D, governments need validated models, designed to use available data, which estimate the scale of incidence of T2D and survival in the general population, with and without preventive interventions.

Experiences of pregnant women with gestational diabetes mellitus: a systematic review of qualitative evidence protocol

Por: He · J. · Wang · Y. · Liu · Y. · Chen · X. · Bai · J.
Introduction

The incidence of gestational diabetes mellitus (GDM) is increasing and an issue of global concern. GDM can cause severe adverse effects for pregnant women and their fetuses. This systematic review is proposed to explore women’s experiences during the pregnancy with GDM. This review will provide insights into the physical, psychological and social adaptation experiences of women with GDM that can help to identify challenges of glycaemic control and provide targeted care and interventions to improve maternal and child health.

Methods and analysis

The databases we will search include English databases (ie, PubMed, CINAHL, Embase, the Cochrane Library, Web of Science, Joanna Briggs Institute (JBI) Database of Systematic Reviews, PsycINFO, OpenGrey and Deep Blue) and Chinese databases (ie, China Biology Medicine disc, China National Knowledge Infrastructure, and VIP Database for Chinese Technical Periodicals). Published qualitative evidence of life changes or experiences of the women with GDM will be searched. There will be no limits on publication year. Two reviewers will independently use the JBI Critical Appraisal Checklist for Qualitative Research for methodological validity prior to inclusion in this review. Any disagreements regarding article evaluation will be resolved through discussion or with a third reviewer. Data will be extracted using the standardised data extraction tool from JBI System for the Unified Management, Assessment and Review of Information. Synthesis will include in-depth reading of the original text and the discovery of the results, and then summarising similar categories for more advanced synthesised findings. The final synthesised findings will be graded according to the ConQual approach for establishing confidence.

Ethics and dissemination

This study does not require ethical approval as primary data will not be collected. Results of this systematic review will be submitted to peer-reviewed international journals for publication and be presented in relevant international conferences.

PROSPERO registration number

CRD42019132065.

Effectiveness of a culturally adapted biopsychosocial intervention (POHON SIHAT) in improving self-efficacy in patients with diabetes attending primary healthcare clinics in Putrajaya, Malaysia: study protocol of a randomised controlled trial

Por: Suhaimi · A. F. · Ibrahim · N. · Tan · K.-A. · Silim · U. A. · Moore · G. · Ryan · B. · Castle · D. J.
Introduction

People with diabetes are often associated with multifaceted factors and comorbidities. Diabetes management frameworks need to integrate a biopsychosocial, patient-centred approach. Despite increasing efforts in promotion and diabetes education, interventions integrating both physical and mental health components are still lacking in Malaysia. The Optimal Health Programme (OHP) offers an innovative biopsychosocial framework to promote overall well-being and self-efficacy, going beyond education alone and has been identified as relevant within the primary care system. Following a comprehensive cultural adaptation process, Malaysia’s first OHP was developed under the name ‘Pohon Sihat’ (OHP). The study aims to evaluate the effectiveness of the mental health-based self-management and wellness programme in improving self-efficacy and well-being in primary care patients with diabetes mellitus.

Methods and analysis

This biopsychosocial intervention randomised controlled trial will engage patients (n=156) diagnosed with type 2 diabetes mellitus (T2DM) from four primary healthcare clinics in Putrajaya. Participants will be randomised to either OHP plus treatment as usual. The 2-hour weekly sessions over five consecutive weeks, and 2-hour booster session post 3 months will be facilitated by trained mental health practitioners and diabetes educators. Primary outcomes will include self-efficacy measures, while secondary outcomes will include well-being, anxiety, depression, self-care behaviours and haemoglobin A1c glucose test. Outcome measures will be assessed at baseline, immediately postintervention, as well as at 3 months and 6 months postintervention. Where appropriate, intention-to-treat analyses will be performed.

Ethics and dissemination

This study has ethics approval from the Medical Research and Ethics Committee, Ministry of Health Malaysia (NMRR-17-3426-38212). Study findings will be shared with the Ministry of Health Malaysia and participating healthcare clinics. Outcomes will also be shared through publication, conference presentations and publication in a peer-reviewed journal.

Trial registration number

NCT03601884.

Effectiveness and cost of integrating a pragmatic pathway for prescribing liraglutide 3.0 mg in obesity services (STRIVE study): study protocol of an open-label, real-world, randomised, controlled trial

Por: Papamargaritis · D. · Al-Najim · W. · Lim · J. · Crane · J. · Lean · M. · le Roux · C. · McGowan · B. · O'Shea · D. · Webb · D. · Wilding · J. · Davies · M. J.
Introduction

In the UK and Ireland, severe and complex obesity is managed in specialist weight management services (SWMS), which provide multicomponent lifestyle interventions to support weight loss, and use of medication if available. Liraglutide 3 mg (LIRA 3 mg) is an effective weight-loss medication, but weight loss in individual patients is variable, and its efficacy has not been assessed in SWMS. This study aims to investigate whether a targeted prescribing pathway for LIRA 3 mg with multiple prespecified stopping rules could help people with severe obesity and established complications achieve ≥15% weight loss in order to determine whether this could be considered a clinically effective and cost-effective strategy for managing severe and complex obesity in SWMS.

Methods and analysis

In this 2-year, multicentre, open-label, real-world randomised controlled trial, 384 adults with severe and complex obesity (defined as body mass index ≥35 kg/m2 plus either prediabetes, type 2 diabetes, hypertension or sleep apnoea) will be randomised via a 2:1 ratio to receive either standard SWMS care (n=128) or standard SWMS care plus a targeted prescribing pathway for LIRA 3 mg with prespecified stopping rules at 16, 32 and 52 weeks (n=256).

The primary outcome is to compare the proportion of participants achieving a weight loss of ≥15% at 52 weeks with a targeted prescribing pathway versus standard care. Secondary outcomes include a comparison of (1) the weight loss maintenance at 104 weeks and (2) the budget impact and cost effectiveness between the two groups in a real-world setting.

Ethics and dissemination

The Health Research Authority and the Medicines and Healthcare products Regulatory Authority in UK, the Health Products Regulatory Authority in Ireland, the North West Deanery Research Ethics Committee (UK) and the St Vincent’s University Hospital European Research Ethics Committee (Ireland) have approved the study. The findings of the study will be published in peer-reviewed journals.

Trial registration number

ClinicalTrials.gov—Identifier: NCT03036800.

European Clinical Trials Database—Identifier: EudraCT Number 2017-002998-20.

Real-world Evaluation of glycemic control and hypoglycemic Events among type 2 Diabetes mellitus study (REEDS): a multicentre, cross-sectional study in Thailand

Por: Satirapoj · B. · Pratipanawatr · T. · Ongphiphadhanakul · B. · Suwanwalaikorn · S. · Benjasuratwong · Y. · Nitiyanant · W.
Objective

Patients with type 2 diabetes mellitus (T2DM) often experience hypoglycaemia and weight gain due to treatment side effects. Sulfonylureas (SU) and the combination of SU and metformin (SU+MET) were the most common monotherapy and combination therapies used in Thailand tertiary care hospitals. This study aimed to assess the glycaemic goal attainment rates, hypoglycaemic episodes, weight gain and treatment compliance among patients with T2DM receiving SU or SU+MET.

Research design and methods

A multicentre cross-sectional survey and retrospective review was conducted in five tertiary care hospitals, Thailand. Patients with T2DM aged ≥30 years were included consecutively during a 12-month period. Glycaemic control, experiences of hypoglycaemia, weight gain and compliance were evaluated. Glycaemic goal attainment was defined by HbA1c level less than 7%.

Results

Out of the 659 patients (mean age (±SD)), 65.5 (10.0) years and median duration of T2DM (IQR), 10 (5–15) years), 313 (47.5%) achieved the glycaemic goal. HbA1c levels in the patients with goal attainment was significantly lower compared with those without (6.3%±0.5% vs 8.1%±1.2%, p

Conclusions

Among patients with T2DM receiving SU or SU+MET, only about half of the patients achieved glycaemic goal and compliance with the treatment. Hypoglycaemia and weight gain posed a significant burden with risk of weight gain higher in the SU group.

Analysis of factors related to diabetic retinopathy in patients with newly diagnosed type 2 diabetes: a cross-sectional study

Por: Hao · Z. · Huang · X. · Qin · Y. · Li · H. · Tian · F. · Xu · R. · Chang · B. · Shao · H.
Aim

To investigate the related factors of diabetic retinopathy (DR) and explore the correlation between smoking and DR in patients with newly diagnosed type 2 diabetes mellitus (T2DM).

Design

A single-centre cross-sectional study.

Setting

Tianjin 4th Central Hospital.

Participants

Patients with newly diagnosed T2DM who visited the outpatient department of the hospital from December 2018 to April 2019.

Methods

A total of 947 patients were enrolled in the study. They were divided into two groups according to whether they were diagnosed with DR (diabetic retinopathy group, DR group; non-diabetic retinopathy group, NDR group). The smoking index (SI) was calculated to assess smoking status. Factors such as sex, age, hypertension, T2DM diagnosed age, family history of diabetes, drinking history, haemoglobin A1c (HbA1c), body mass index (BMI) and smoking status were compared between the two groups. Logistic regression was used to analyse the relationship between DR and the above factors.

Results

There was no statistically significant difference between the two groups in sex, age, hypertension, DM diagnosed age, family history of diabetes, drinking history and HbA1c. BMI was significantly higher in DR patients (27.7±4.2 vs 26.7±4.4, p=0.004). Smoking status was also different between the two groups (2=6.350, p=0.042). BMI was shown to be a related factor for DR in patients with newly diagnosed diabetes (OR=0.592, p=0.004). When BMI was ≥28 kg/m2, heavy smoking was significantly associated with DR (OR=2.219, p=0.049), and there was a negative correlation between DR and the age of diagnosis of diabetes ≥60 years (OR=0.289, p=0.009).

Conclusions

Heavy smoking was an important related factor for DR in patients with newly diagnosed diabetes mellitus when BMI was ≥28 kg/m2. Delaying the age of diabetes might prevent the occurrence of DR. To elucidate the correlation, long-term cohort studies with large samples are needed.

Effects of switching from a dipeptidyl peptidase-4 inhibitor to luseogliflozin on nocturnal blood pressure in patients with type 2 diabetes: protocol for a multicentre, prospective, randomised, open-label, blinded endpoint parallel-group comparison study

Por: Kameda · R. · Nomoto · H. · Cho · K. Y. · Kawata · S. · Omori · K. · Takeuchi · J. · Nagai · S. · Kurihara · Y. · Aoki · S. · Nakamura · A. · Atsumi · T. · Miyoshi · H.
Introduction

Nocturnal hypertension is clinically important for patients with type 2 diabetes (T2D), considering its strong correlation with cardiovascular events. We aim to test the hypothesis that the sodium-glucose cotransporter 2 inhibitor, luseogliflozin, ameliorates nocturnal hypertension more effectively than a dipeptidyl peptidase (DPP)-4 inhibitor in patients with T2D.

Methods and analysis

This study is a multicentre, prospective, randomised, open-label, blinded endpoint parallel-group trial. Sixty participants with T2D and hypertension who have been treated with a DPP-4 inhibitor for more than 4 weeks and who have a glycated haemoglobin A1c (HbA1c) level of 6.0%–9.0% will be randomised based on age, body mass index (BMI) and HbA1c to continue taking their DPP-4 inhibitor or to switch to luseogliflozin 2.5 mg once daily for 8 weeks. Twenty-four-hour ambulatory blood pressure monitoring (ABPM) will be performed twice at baseline and at the end of the study. All participants will continue their diet and exercise therapy, and the doses of concomitant medications will not be adjusted during the study. The primary endpoint is the effect of luseogliflozin on the mean change in systolic blood pressure (SBP) during the night, as measured by ABPM. The secondary endpoints are mean change in diastolic blood pressure (DBP) during the night, 24 hours of SBP and DBP, daytime SBP and DBP, pulse rate, BP M-value, trough SBP and DBP for 1 hour before the next dose, and other laboratory parameters. The sample size was calculated for a two-sided test at 90% power for the detection of a difference between treatments.

Ethics and dissemination

The Ethics Review Board of Hokkaido University Hospital has approved the protocol. The results will be disseminated in peer-reviewed journals and at scientific conferences.

Trial registration numbers

The University Hospital Medical Information Network (UMIN000031451); Japan Registry of Clinical Trials (jRCTs011180019); Pre-results.

Study protocol for a comparative diagnostic accuracy study of bedside tests used to detect arterial disease in diabetes: TEsting for Arterial disease in Diabetes (TrEAD) study

Por: Normahani · P. · Poushpas · S. · Alaa · M. · Bravis · V. · Aslam · M. · Jaffer · U.
Introduction

In the UK, over 7000 amputations are performed each year because of diabetes. Up to 80% of these are preceded by a foot ulcer and could therefore be prevented with improvements in ulcer care. Peripheral arterial disease is an important risk factor for the development of diabetic foot ulceration. However, its diagnosis in diabetes is challenging due to the presence of neuropathy and arterial calcification. Commonly used bedside tests either have low sensitivities or little supporting evidence to justify their use. Duplex ultrasound (DUS) has good correlation to angiography findings but a full scan is difficult to learn and time consuming to perform. We have previously demonstrated that a focused DUS of the distal anterior and posterior tibial arteries at the ankle (podiatry ankle duplex scan (PAD-scan)) can be readily learnt by novices and performed rapidly and accurately. The primary aim of this study is to determine the diagnostic accuracy of the PAD-scan and other commonly used bedside tests in detecting arterial disease in diabetes.

Methods and analysis

The study will include 305 patients presenting to diabetic foot clinics at two centres. Arterial assessment will be performed using the following index tests: the PAD-scan, pulse palpation, audible handheld Doppler, Ankle Brachial Pressure Index, Toe Brachial Pressure Index and transcutaneous pressure of oxygen. Patients will then undergo a full lower limb arterial DUS by a blinded vascular scientist as a reference test.

Ethics and dissemination

Approval was gained from NRES Committee London (REC reference 17/LO/1447). Findings will be disseminated by various methods including international presentations and publication in a peer-reviewed journal.

Trial registration number

ClinicalTrials.gov Registry (NCT04058626).

Type 1 diabetes mellitus and educational attainment in childhood: a systematic review

Por: Oakley · N. J. · Kneale · D. · Mann · M. · Hilliar · M. · Dayan · C. · Gregory · J. W. · French · R.
Objectives

The primary objective of this systematic review was to evaluate available literature on whether type 1 diabetes mellitus (T1DM) has an impact on educational attainment in individuals undertaking high stakes standardised testing at the end of compulsory schooling.

Design

A systematic review was undertaken comparing educational attainment for individuals with and without T1DM who have undertaken high stakes testing at the end of compulsory schooling.

Data sources

A comprehensive search of MEDLINE, MEDLINE (epub ahead of print, in-process and other non-indexed citations), EMBASE, Web of Science, British Education Index, Education Resources Information Center and Cumulative Index to Nursing and Allied Health Literature was undertaken on 15 January 2018 and updated on 17 January 2019.

Eligibility criteria

Included studies fulfilled the following criteria: observational study or randomised controlled trial; included individuals who have undertaken high stakes testing at the end of compulsory schooling; compared the grades obtained by individuals with T1DM with a representative population control.

Data extraction and synthesis

Two reviewers performed study selection and data extraction independently. Quality and risk of bias in the observational studies included were assessed using the Newcastle-Ottawa Scale. A detailed narrative synthesis of the included studies was completed.

Results

3103 articles were identified from the database search, with two Swedish cohort studies (using the same linked administrative data) meeting final inclusion criteria. A small but statistically significant difference was reported in mean final grades, with children with T1DM found to have lower mean grades than their non-diabetic counterparts (adjusted mean difference 0.07–0.08).

Conclusions

More contemporary research is required to evaluate the impact of T1DM in childhood on educational attainment in individuals undertaking high stakes standardised testing at the end of compulsory schooling, taking into consideration the substantial advances in management of T1DM in the last decade.

PROSPERO registration number

CRD42017084078.

Prevalence of pre-diabetes and undiagnosed diabetes in the Mollerussa prospective observational cohort study in a semi-rural area of Catalonia

Por: Falguera · M. · Vilanova · M. B. · Alcubierre · N. · Granado-Casas · M. · Marsal · J. R. · Miro · N. · Cebrian · C. · Mollo · A. · Franch-Nadal · J. · Mata-Cases · M. · Castelblanco · E. · Mauricio · D.
Objectives

To assess the prevalence of undiagnosed diabetes and pre-diabetes in the healthy population in the Mollerussa cohort. As a secondary objective, to identify the variables associated with these conditions and to describe the changes in glycaemic status after 1 year of follow-up in subjects with pre-diabetes.

Design

Prospective observational cohort study.

Setting

General population from a semi-rural area.

Participants

The study included 583 participants without a diagnosis of diabetes recruited between March 2011 and July 2014.

Results

The prevalence of undiagnosed diabetes was 20, 3.4% (95% CI 2.6 to 4.2) and that of pre-diabetes was 229, 39.3% (37.3 to 41.3). Among those with pre-diabetes, 18.3% had isolated impaired fasting plasma glucose (FPG) (FPG: 100 to

Conclusions

Among adults in our region, the estimated prevalence of undiagnosed diabetes was 3.4% and that of pre-diabetes was 39.3%. After a 1-year follow-up, a small proportion of subjects (0.6%) with pre-diabetes progressed to diabetes, while a high proportion (41.6%) returned to normoglycaemia. Individuals with pre-diabetes who returned to normoglycaemia were younger and had a lower body mass index.

Does intensive glycaemic control promote healing in diabetic foot ulcers? - a feasibility study

Por: Dissanayake · A. · Vandal · A. C. · Boyle · V. · Park · D. · Milne · B. · Grech · R. · Ng · A.
Introduction

One in four diabetes patients will develop a foot ulcer over their lifetime. The role of glycaemic control in the healing of foot ulcers in diabetes patients is not supported by randomised controlled trial (RCT) data.

Objectives

To determine the feasibility of an RCT of glycaemic control with intensive insulin therapy in diabetic foot ulcer, by assessing: entry criteria, fasting capillary blood glucose (FCBG) medication satisfaction and sensitivity of different ulcer-healing endpoints to glycaemic control.

Design

Two substudies: one cross-sectional and one single-arm prospective.

Setting

Single-centre secondary care diabetic foot clinic in New Zealand.

Participants

Substudy 1: 78 participants consisting of all people ≥18 years with a diabetic foot ulcer presenting to the clinic over 35 weeks in 2015.

Substudy 2: 15 participants from Substudy 1 consenting to intensive insulin therapy.

Intervention

Substudy 1: None.

Substudy 2: Intensive insulin therapy with standard podiatry care over 24 weeks.

Outcome

Substudy 1: Proportion of participants satisfying potential RCT entry criteria; medication satisfaction (Diabetes Medication Satisfaction).

Substudy 2: FCBG, index ulcer healing time, index ulcer size, health-related quality of life (HRQoL; EuroQol 5 Dimensions 5 Levels and Diabetic Foot Ulcer Scale-Short Form).

Results

Proportion in Substudy 1 satisfying all entry criteria was 31% (95% CI 21 to 42). FCBG values decreased between baseline and study end (difference –3.7 mmol/L, 95% CI –6.5 to –0.8); 83% (95% CI 44 to 95) of ulcers healed by 24 weeks. FCBG correlated negatively with medication satisfaction. Ulcer area logarithm was most sensitive to FCBG changes, displaying significant negative correlation with HRQoL outcomes. Detecting a 30% between-group difference in this outcome (80% power, α=5%) requires 220 participants per arm, achievable within 1 year with 15 centres similar to study setting.

Conclusions

An adequately powered RCT requires cooperation between a large number of centres. Ulcer area logarithm should be primary endpoint.

Trial registration number

ANZCTR ACTRN12617001414303

Effectiveness of non-pharmacological strategies in the management of type 2 diabetes in primary care: a protocol for a systematic review and network meta-analysis

Por: Leite · R. G. O. F. · Banzato · L. R. · Galendi · J. S. C. · Mendes · A. L. · Bolfi · F. · Veroniki · A. A. · Thabane · L. · Nunes-Nogueira · V. d. S.
Introduction

Despite the increasing number of drugs and various guidelines on the management of type 2 diabetes mellitus (T2DM), several patients continue with the disease uncontrolled. There are several non-pharmacological treatments available for managing T2DM, but various of them have never been compared directly to determine the best strategies.

Objective

This study will evaluate the comparative effects of non-pharmacological strategies in the management of T2DM in primary care or community settings.

Methods and analysis

We will perform a systematic review and network meta-analysis (NMA), and will include randomised controlled trials if one of the following interventions were applied in adult patients with T2DM: nutritional therapy, physical activity, psychological interventions, social interventions, multidisciplinary lifestyle interventions, diabetes self-management education and support (DSMES), technology-enabled DSMES, interventions delivered only either by pharmacists or by nurses, self-blood glucose monitoring in non-insulin-treated T2DM, health coaching, benchmarking and usual care. The primary outcome will be glycaemic control (glycated haemoglobin (HbA1c) (%)), and the secondary outcomes will be weight loss, quality of life, patient satisfaction, frequency of cardiovascular events and deaths, number of patients in each group with HbA1c

Ethics and dissemination

As no primary data collection will be undertaken, no formal ethical assessment is required. We plan to present the results of this systematic review in a peer-reviewed scientific journal, conferences and the popular press.

PROSPERO registration number

CRD42019127856.

Targeted and tailored pharmacist-led intervention to improve adherence to antihypertensive drugs among patients with type 2 diabetes in Indonesia: study protocol of a cluster randomised controlled trial

Por: Alfian · S. D. · Abdulah · R. · Denig · P. · van Boven · J. F. M. · Hak · E.
Introduction

Current intervention programme to improve drug adherence are either too complex or expensive for implementation and scale-up in low-middle-income countries. The aim of this study is to assess the process and effects of implementing a low-cost, targeted and tailored pharmacist intervention among patients with type 2 diabetes who are non-adherent to antihypertensive drugs in a real-world primary care Indonesian setting.

Methods and analysis

A cluster randomised controlled trial with a 3-month follow-up will be conducted in 10 community health centres (CHCs) in Indonesia. Type 2 diabetes patients aged 18 years and older who reported non-adherence to antihypertensive drugs according to the Medication Adherence Report Scale (MARS) are eligible to participate. Patients in CHCs randomised to the intervention group will receive a tailored intervention based on their personal adherence barriers. Interventions may include reminders, habit-based strategies, family support, counselling to educate and motivate patients, and strategies to address other drug-related problems. Interventions will be provided at baseline and at a 1-month follow-up. Simple question-based flowcharts and an innovative adherence intervention wheel are provided to support the pharmacy staff. Patients in CHCs randomised to the control group will receive usual care based on the Indonesian guideline. The primary outcome is the between-group difference in medication adherence change from baseline to 3-month follow-up assessed by MARS. Secondary outcomes include changes in patients’ blood pressure, their medication beliefs assessed by the Beliefs about Medicines Questionnaire (BMQ)-specific, as well as process characteristics of the intervention programme from a pharmacist and patient perspective.

Ethics and dissemination

Ethical approval was obtained from the Ethical Committee of Universitas Padjadjaran, Indonesia (No. 859/UN6.KEP/EC/2019) and all patients will provide written informed consent prior to participation. The findings of the study will be disseminated through international conferences, one or more peer-reviewed journals and reports to key stakeholders.

Trial registration number

NCT04023734.

Study protocol for the road to hierarchical diabetes management at primary care (ROADMAP) study in China: a cluster randomised controlled trial

Por: Jia · W. · Zhang · P. · Duolikun · N. · Zhu · D. · Li · H. · Bao · Y. · Li · X. · Liu · Y. · ROADMAP study group
Introduction

Diabetes management in primary care remains suboptimal in China, despite its inclusion in the essential public health service (EPHS). We aimed to evaluate the effectiveness of a mobile health (mHealth) based and three-tiered diabetes management system in diverse Chinese contexts.

Methods and analysis

This is a cluster randomised controlled trial, named road to hierarchical diabetes management at primary care (ROADMAP). 19 008 patients with type 2 diabetes (T2D) were recruited from primary care clinics in 864 communities across 144 counties/districts of 24 provinces. Eligible participants were adult patients diagnosed with T2D and registered for diabetes management in communities. Patients within the same communities (clusters) were randomly allocated into the intervention or control arm for 1 year in a 2:1 ratio. The control arm patients received usual care as EPHS packaged: at least four blood glucose (BG) and blood pressure (BP) tests, and lifestyle and medication instruction, yearly, from primary care providers. The intervention arm patients received at least two BG and one BP tests, monthly, and lifestyle and treatment instruction from a three-tiered contracted team. A mHealth platform, Graded ROADMAP, enabled test results uploading and sharing, and patient referral within the team. The intervention participants will be further divided into basic or intensive intervention group according to whether they were actively using the Your Doctor App. The primary outcome is the BG control rate with glycated haemoglobin (HbA1c)

Ethics and dissemination

The trial has been approved by the Institutional Review Board at Shanghai Sixth People's Hospital. Findings on the intervention effectiveness will be disseminated through peer-reviewed journals, conference presentations and other relevant mechanisms.

Trial registration number

ChiCTR-IOC-17011325.

All-cause mortality following low-dose aspirin treatment for patients with high cardiovascular risk in remote Australian Aboriginal communities: an observational study

Por: Zhao · Y. · Jeyaraman · K. · Burgess · P. · Connors · C. · Guthridge · S. · Maple-Brown · L. · Falhammar · H.
Objectives

To evaluate the benefit and risk of low-dose acetylsalicylic acid (aspirin) in patients from remote Aboriginal communities in the Northern Territory, Australia.

Design

Retrospective cohort study using primary care and hospital data routinely used for healthcare. Aspirin users and non-users were compared before and after controlling confounders by matching. Marginal structural models (MSM) were applied to ascertain the benefit and risk.

Setting

The benefit and harm of aspirin were investigated in patients aged ≥18 years from 54 remote Aboriginal communities.

Participants

None had a previous cardiovascular event or major bleeds. Patients on anticoagulants or other antiplatelets were excluded.

Intervention

Aspirin at a dose of 75–162 mg/day.

Outcome measures

Endpoints were all-cause, cardiovascular mortality and incidences of cardiovascular events and major bleeds.

Results

8167 predominantly Aboriginal adults were included and followed between July 2009 and June 2017 (aspirin users n=1865, non-users n=6302, mean follow-up 4 years with hospitalisations 6.4 per person). Univariate analysis found material differences in demographics, prevalence of chronic diseases and outcome measures between aspirin users and non-users before matching. After matching, aspirin was significantly associated with reduced all-cause mortality (HR=0.45: 95% CI 0.34 to 0.60; p

Conclusion

Aspirin was associated with reduced all-cause mortality. Bleeding risk was less compared with survival benefits. Aspirin should be considered for primary prevention in Aboriginal people with high cardiovascular risk.

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