RESUMO
The role of probiotic supplementation in type 2 diabetes (T2D) treatment is controversial. The present study aimed to assess the effects of a multi-strain probiotic supplement (LactoLevureR (containing Lactobacillus acidophilus, Lactobacillus plantarum, Bifidobacterium lactis, and Saccharomyces boulardii)) over 6 months, primarily on glycemic control as well as on lipid levels and alterations in the gut microbiome, among individuals with T2D residing in Greece. A total of 91 adults with T2D (mean age [±SD] 65.12 ± 10.92 years, 62.6% males) were randomized to receive the probiotic supplement or a matching placebo capsule, once daily, for 6 months. Blood chemistries and anthropometric parameters were conducted every 3 months, and stool samples were collected at baseline and at 6 months. Significant reductions in HbA1c, fasting blood glucose, and total cholesterol were observed in participants treated with the probiotic supplement (n = 46) compared to the controls (n = 45), even after adjustment for a greater decrease in adiposity (waist circumference). Although there were no statistically significant differences in the diversity of the gut microbiome (α and ß diversity), the administration of probiotics did influence several genera, metabolites, and key enzymes associated with diabetes. Overall, the administration of the multi-strain probiotic LactoLevureR over a 6-month period in individuals with T2D was well-tolerated and had a positive impact on metabolic parameters, alongside improvements in indices of adiposity.
Assuntos
Diabetes Mellitus Tipo 2 , Probióticos , Adulto , Masculino , Humanos , Pessoa de Meia-Idade , Idoso , Feminino , Diabetes Mellitus Tipo 2/terapia , Grécia , Glicemia/metabolismo , Suplementos Nutricionais , Probióticos/uso terapêutico , Obesidade , Método Duplo-CegoRESUMO
BACKGROUND: Type 2 diabetes (T2D), a major risk factor for cardiovascular disease and other adverse health conditions, is on the rise in Singapore. TRIPOD is a randomized controlled trial aimed to determine whether complementing usual care with an evidence-based diabetes management package (DMP) -comprising access to an evidence-based app, health coaching, pedometer, glucometer and weighing scale, with or without a financial rewards scheme (M-POWER rewards), can improve mean HbA1c levels at months 6 and 12. METHODS: The protocol was published in Trials, accessible via https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-019-3749-x 1. This manuscript updates the protocol with changes to the study design due to challenges with recruitment and presents baseline characteristics. Key updates include changing the arm allocation ratio from 1:1:1 (Arm 1-Usual Care: Arm 2-DMP: Arm 3-DMP+M-POWER rewards) to 10:1:10, the sample size from 339 to 269, the intervention period from two to one year, and the primary hypothesis to focus solely on differences between Usual Care and DMP+M-POWER rewards. Recruitment for the study began on 19 October 2019 and ended on 4 June 2022. RESULTS: The average age of participants was 55.0 (SD9.7) years old and 64.2% were male. The majority of participants (76.8%) were Chinese, 4.9% Malay and 18.3% Indian and of other ethnicities. 67.0% had a monthly household income of SGD$4000 or more. The mean baseline HbA1c was 8.10% (SD 0.95) and the mean body mass index was 26.8 kg/m2 (SD 5.3). DISCUSSION: The final participant completed month 12 follow-up data collection on 8 June 2023. All pre-planned analyses will be conducted and final results reported. TRIAL REGISTRATION: ClinicalTrials.gov NCT03800680 . Registered on 11 January 2019.
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Doenças Cardiovasculares , Diabetes Mellitus Tipo 2 , Humanos , Masculino , Criança , Feminino , Diabetes Mellitus Tipo 2/diagnóstico , Diabetes Mellitus Tipo 2/terapia , Projetos de Pesquisa , Tamanho da Amostra , Fatores de Risco , Ensaios Clínicos Controlados Aleatórios como AssuntoRESUMO
The scourge of type-1 diabetes (T1D) is the morbidity and mortality it and its complications cause at a younger age. This propels the constant search for better diagnostic, treatment, and management strategies, with the ultimate quest being a cure for T1D. Recently, the therapeutic potential of exosomes has generated a lot of interest. Among the characteristics of exosomes of particular interest are (a) their regenerative capacity, which depends on their "origin", and (b) their "content", which determines the cell communication and crosstalk they influence. Other functional capacities, including paracrine and endocrine homeostatic regulation, pathogenic response ability resulting in insulin secretory defects or ß-cell death under normal metabolic conditions, immunomodulation, and promotion of regeneration, have also garnered significant interest. Exosome "specificity" makes them suitable as biomarkers or predictors, and their "mobility" and "content" lend credence to drug delivery and therapeutic suitability. This review aims to highlight the functional capacities of exosomes and their established as well as novel contributions at various pathways in the onset and progression of T1D. The pathogenesis of T1D involves a complex crosstalk between insulin-secreting pancreatic ß-cells and immune cells, which is partially mediated by exosomes. We also examine the potential implications for type 2 diabetes (T2D), as the link in T2D has guided T1D exploration. The collective landscape presented is expected to help identify how a deeper understanding of exosomes (and their cargo) can provide a framework for actionable solutions to prevent, halt, or change the very course of T1D and its complications.
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Diabetes Mellitus Tipo 1 , Diabetes Mellitus Tipo 2 , Exossomos , Humanos , Diabetes Mellitus Tipo 1/metabolismo , Diabetes Mellitus Tipo 2/terapia , Diabetes Mellitus Tipo 2/metabolismo , Exossomos/metabolismo , Insulina/metabolismo , Biomarcadores/metabolismoRESUMO
Background: The global burden of type 2 diabetes has significantly increased, leading to a considerable impact on healthcare systems worldwide. While the advent of mobile healthcare has provided some relief by addressing the shortage of certain medical resources, its adoption among the Chinese population remains relatively low. To extend the benefits of mHealth to a greater number of Chinese diabetic patients, it is essential to investigate the factors that influence their willingness to utilize it and implement targeted interventions based on these influencing factors. The Technology Acceptance Model (TAM) is widely employed to examine users' ultimate usage behaviors, and previous studies have indicated the potential relevance of the Perceived Risk (PR) theory and the eHealth Literacy Theory to users' usage behaviors. Objective: Our objective was to investigate the determinants that affect the willingness of Chinese patients diagnosed with type 2 diabetes patients to utilize digital disease management applications (DDMAs). Methods: We conducted a cross-sectional study of patients with type 2 diabetes in three tertiary general hospitals in Chengdu using questionnaires designed by the investigators. Participants were sampled using a convenience sampling method. The questionnaire comprised three sections: socio-demographic profile and medical history; current awareness and willingness to use digital disease management applications; and the current level of e-health literacy. Structural equation modeling was employed to assess the impact of patient awareness of DDMAs and e-health literacy on the willingness to use such DDMAs. Results: (1) Patients' attitudes toward using DDMAs were significantly influenced by perceived ease of use (ß = 0.380, P < 0.001) and perceived usefulness (ß = 0.546, P < 0.001); (2) Electronic health literacy exerted a significant impact on patients' perceived usefulness (ß = 0.115, P = 0.018) and perceived ease of use (ß = 0.659, P < 0.001); (3) Patients' willingness to use was significantly influenced by perceived usefulness (ß = 0.137, P < 0.001) and use attitude (ß = 0.825, P < 0.001). Conclusions: The present research findings hold both theoretical and practical significance, and can serve as a guide for healthcare practitioners and researchers to gain a deeper comprehension of the acceptance of digital disease management applications (DDMAs) among type 2 diabetes patients.
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Diabetes Mellitus Tipo 2 , Letramento em Saúde , Telemedicina , Humanos , Estudos Transversais , Diabetes Mellitus Tipo 2/terapia , Atitude , Telemedicina/métodosRESUMO
INTRODUCTION: Women with type 2 diabetes (T2DM) are more likely to experience adverse reproductive outcomes, yet preconception care can significantly reduce these risks. For women with T2DM, preconception care includes reproductive planning and patient education on: (1) the importance of achieving glycaemic control before pregnancy, (2) using effective contraception until pregnancy is desired, (3) discontinuing teratogenic medications if pregnancy could occur, (4) taking folic acid, and (5) managing cardiovascular and other risks. Despite its importance, few women with T2DM receive recommended preconception care. METHODS AND ANALYSIS: We are conducting a two-arm, clinic-randomised trial at 51 primary care practices in Chicago, Illinois to evaluate a technology-based strategy to 'hardwire' preconception care for women of reproductive age with T2DM (the PREPARED (Promoting REproductive Planning And REadiness in Diabetes) strategy) versus usual care. PREPARED leverages electronic health record (EHR) technology before and during primary care visits to: (1) promote medication safety, (2) prompt preconception counselling and reproductive planning, and (3) deliver patient-friendly educational tools to reinforce counselling. Post-visit, text messaging is used to: (4) encourage healthy lifestyle behaviours. English and Spanish-speaking women, aged 18-44 years, with T2DM will be enrolled (N=840; n=420 per arm) and will receive either PREPARED or usual care based on their clinic's assignment. Data will be collected from patient interviews and the EHR. Outcomes include haemoglobin A1c (primary), reproductive knowledge and self-management behaviours. We will use generalised linear mixed-effects models (GLMMs) to evaluate the impact of PREPARED on these outcomes. GLMMs will include a fixed effect for treatment assignment (PREPARED vs usual care) and random clinic effects. ETHICS AND DISSEMINATION: This study was approved by the Northwestern University Institutional Review Board (STU00214604). Study results will be published in journals with summaries shared online and with participants upon request. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Registry (NCT04976881).
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Diabetes Mellitus Tipo 2 , Gravidez , Humanos , Feminino , Diabetes Mellitus Tipo 2/terapia , Cuidado Pré-Concepcional/métodos , Reprodução , Anticoncepção , Ácido Fólico , Ensaios Clínicos Controlados Aleatórios como AssuntoRESUMO
OBJECTIVE: To investigate the effect of Bo's abdominal acupuncture (BOAA) on fibroblast growth factor 21 (FGF21) and its related adipokines in type 2 diabetes mellitus (T2DM) rats. METHODS: This study established obese T2DM rat model by high-fat diet (HFD) with a dose of streptozotocin (STZ, 30 mg/kg). Obese T2DM rats were randomly subdivided into four groups (n = 10): negative, BOAA, conventional acupuncture (COA group) and metformin group (Met group) groups. The biochemical parameters, mRNAs, and proteins were analyzed using enzyme-lined immunoassays kits, quantitative polymerase chain reaction and Western blot. RESULTS: Treatment with BOAA attenuated the histopathological changes in visceral fat and restored the alterations in the levels of body weight, fasting blood glucose (FBG), homeostasis model assessment for insulin resistance (HOMA-IR). BOAA treatment significantly decreased the levels of triglyceride, total cholesterol, low density lipoprotein cholesterol, leptin, and increased the serum levels of high-density lipoprotein cholesterol, fibroblast growth factor 21 (FGF21), adiponectin (ADP), peroxisome proliferator-activated receptor γ (PPAR-γ), C-peptide (C-P) in obese T2DM rats. Furthermore, BOAA treatment significantly increased the mRNA expressions of FGF21, ADP, leptin, PPAR-γ, PPAR-α and adenosine 5'-monophosphate (AMP)-activated protein kinase (AMPK). Besides, BOAA treatment upregulated the protein expressions of fibroblast growth factor receptors3 (FGFR3), PPAR-α, extracellular signal-regulated kinase (ERK), phosphorylated ERK (p-ERK), AMPK, p-AMPK, Liver kinase B1 (LKB1), phosphorylated LKB1 (p-LKB1), acetyl-CoA carboxylase (ACC) and phosphorylated ACC (p-ACC), while downregulated the protein expressions of FGF21 and PPAR-γ in visceral fat. CONCLUSIONS: BOAA treatment reduced FBG and body weight, and improved insulin sensitivity through regulating FGF21 signaling pathway and its related adipokine in obese T2DM rats.
Assuntos
Terapia por Acupuntura , Diabetes Mellitus Experimental , Diabetes Mellitus Tipo 2 , Resistência à Insulina , Ratos , Animais , Diabetes Mellitus Tipo 2/complicações , Diabetes Mellitus Tipo 2/terapia , Diabetes Mellitus Tipo 2/metabolismo , Leptina , Adipocinas , Proteínas Quinases Ativadas por AMP/genética , Proteínas Quinases Ativadas por AMP/metabolismo , Diabetes Mellitus Experimental/complicações , Diabetes Mellitus Experimental/terapia , Receptores Ativados por Proliferador de Peroxissomo , Obesidade/complicações , Obesidade/terapia , Fatores de Crescimento de Fibroblastos/genética , Fatores de Crescimento de Fibroblastos/metabolismo , Peso Corporal , Dieta Hiperlipídica/efeitos adversos , ColesterolRESUMO
With an ageing population and improved treatments people live longer with their chronic diseases, and primary care clinics face more costly and difficult-to-treat multimorbid patients. To meet these challenges, current guidelines for the management of type 2 diabetes suggest that an interprofessional team should collaborate to enhance the delivery of worthwhile self-management support interventions. In this study, we aimed to evaluate the effects of an empowerment-based interprofessional follow-up intervention in people with type 2 diabetes in primary care on patient-reported outcomes, biomarkers and weight, and to explore the experiences of patients attending the intervention. We invited patients during regular visits to their general practitioners. The 12-month intervention included 1) empowerment-based counselling; 2) a standardized medical report. The control group received consultations with physicians only. The primary outcome was the Patient Activation Measure, a patient-reported measure assessing individual knowledge, skills, and confidence integral to managing one's health and healthcare. After the trial we conducted qualitative interviews. We observed no difference in the primary outcome scores. On secondary outcomes we found a significant between-group intervention effect in favor of the intervention group, with mean differences in glycemic control after 12 months (B [95% CI] = -8.6 [-17.1, -0.1] mmol/l; p = 0.045), and significant within-group changes of weight (B [95% CI] = -1.8 kg [-3.3, -0.3]; p = 0.02) and waist circumference (B [95% CI] = -3.9 cm [-7.3, -0.6]; p = 0.02). The qualitative data showed that the intervention opened patients' eyes for reflections and greater awareness, but they needed time to take on actions. The patients emphasized that the intervention gave rise to other insights and a greater understanding of their health challenges. We suggest testing the intervention among patients with larger disease burden and a more expressed motivation for change.
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Diabetes Mellitus Tipo 2 , Humanos , Diabetes Mellitus Tipo 2/terapia , Seguimentos , Doença Crônica , Motivação , Atenção Primária à SaúdeRESUMO
Developing ambulatory health services (AHS) of optimal quality is a pending issue for many health systems at a global level, especially in middle- and low-income countries. An effective health response requires indicators to measure the quality of care that are context-specific and feasible for routine monitoring. This paper aimed to design and validate indicators for assessing the technical and interpersonal quality dimensions for type 2 diabetes (T2D) and acute respiratory infections (ARI) care in AHS. The study was conducted in two stages. First, technical and user-centered-based indicators of quality of care for T2D and ARI care were designed following international recommendations, mainly from the American Diabetes Association standards and the National Institute for Health and Care Excellence guidelines. We then assessed the validity, reliability, relevance, and feasibility of the proposed indicators implementing the modified Delphi technique. A panel of 17 medical experts from five countries scored the indicators using two electronic questionnaires, one for each reason for consultation selected, sent by email in two sequential rounds of rating. We defined the levels of consensus according to the overall median for each performance category, which was established as the threshold. Selected indicators included those with scores equal to or higher than the threshold. We designed 36 T2D indicators, of which 16 were validated for measuring the detection of risks and complications, glycemic control, pharmacological treatment, and patient-centered care. Out of the 22 indicators designed for ARI, we validated 10 for diagnosis, appropriate prescription of antimicrobials, and patient-centered care. The validated indicators showed consistency for the dimensions analyzed. Hence, they proved to be a potentially reliable and valuable tool for monitoring the performance of the various T2D and ARI care processes in AHS. Further research will be needed to verify the applicability of the validated indicators in routine clinical practice.
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Diabetes Mellitus Tipo 2 , Infecções Respiratórias , Humanos , Diabetes Mellitus Tipo 2/terapia , Reprodutibilidade dos Testes , Infecções Respiratórias/terapia , Consenso , Serviços de SaúdeRESUMO
BACKGROUND: Motivation is an important factor in disease management for diabetic patients. However, motivational strengthening interventions have been inadequately effective in effecting behavior change in this group. PURPOSE: This study was designed to investigate the effect of a motivational interview intervention on self-efficacy, self-care behavior, and blood sugar control in patients with type 2 diabetes. METHODS: The target population comprised patients with type 2 diabetes in two medical wards of a regional hospital in the southern Taiwan. The 112 participants were randomly assigned to the experimental group (n = 56) and control group (n = 56). Over a three month period, the experimental group received 6 motivational interview sessions of 50 minutes each in addition to usual diabetes care, while the control group received usual diabetes care on the ward. Both groups completed the demographic questionnaire, Chinese version of Diabetes Self-Efficacy Scale, Diabetes Self-Care Behavior Scale, glycosylated hemoglobin level pre-test, and 3 months post-test survey. The results were analyzed using SPSS 22.0 for Windows. RESULTS: A total of 55 patients in the experimental group and 52 patients in the control group completed the study. After analysis, significant inter-group differences in self-efficacy and self-care behavior were found between the experimental group and the control group at pre-test and three-month post-test (p < .001). For the experimental group, the three-month post-test score and glycated hemoglobin value were higher than at pre-test. The three-month post-test value was significantly lower (p < .001) than the pre-test value, and the change effect in the experimental group was better than that in the control group. There was a significant difference in the stages of change between pre-test and post-test (χ2 = 43.89, p < .001), and the change effect in the experimental group was better than that in the control group. CONCLUSIONS / IMPLICATIONS FOR PRACTICE: The proposed motivational interview intervention can help patients with type 2 diabetes admitted to medical wards improve their self-efficacy, self-care behavior, and glycated hemoglobin values. In the future, nursing education should improve the teaching of motivational interview skills to allow nurses to conduct effective interviews quickly during treatment, increase their patients' motivation to self-control blood sugar, and enable patients to learn blood sugar control skills before discharge to achieve effective blood sugar control.
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Diabetes Mellitus Tipo 2 , Humanos , Diabetes Mellitus Tipo 2/terapia , Controle Glicêmico , Autoeficácia , Glicemia , Hemoglobinas GlicadasRESUMO
AIMS: There is a paucity of efficient processes for collecting information in a primary care setting to connect patients afflicted with type 2 diabetes to valuable resources. The objective of this research project was to develop a Comprehensive Diabetes Assessment (CDA) instrument which could be used to assess patients' barriers to best outcomes. METHODS: We reviewed published literature and online compilations for validated tools assessing threats to optimal diabetes self-management. We conducted focus groups with patients, clinicians, and service providers who provided feedback on the tools' appropriateness and feasibility. We aggregated the favored tools and did cognitive testing with patients to assess understanding and affective response to the instrument. RESULTS: Five focus groups involved varied stakeholders in Baltimore, MD and Honolulu, HI. We presented 2 tools assessing knowledge barriers, 3 tools assessing psychological barriers, 4 tools assessing literacy, and 1 numeracy. The final instrument included 6 multi-part items and takes 3 minutes to complete. Cognitive interviewing with 8 patients in Baltimore and 8 in Hawaii confirmed that the instrument is understandable, quick to complete, and is acceptable to patients. CONCLUSIONS: Because of the complexity of self-management of diabetes, we suggest that this CDA instrument, plus a social needs assessment, should be administered at least annually and at times of clinical deterioration. We anticipate the instrument will be proven valuable in connecting patients to services from which they will benefit.
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Diabetes Mellitus Tipo 2 , Humanos , Diabetes Mellitus Tipo 2/terapia , Grupos Focais , Comportamentos Relacionados com a Saúde , Determinação de Necessidades de Cuidados de Saúde , Testes NeuropsicológicosRESUMO
BACKGROUND: The Women's Wellness with Type 2 Diabetes Programme (WWDP) is an online behavioural intervention for midlife women living with type 2 diabetes. The gender-specific intervention fosters self-efficacy, encouraging positive wellbeing behaviours to enhance diabetes and menopause outcomes. In 2016, We co-led a feasibility trial and process evaluation with 70 women aged 45-50 years from the UK and Australia. The intervention comprised an e-book, a website, and nurse consultations. The WWDP seemed to improved diabetes distress, self-efficacy, and menopausal symptoms, but with impactful, costly, diabetes nurse input, compromising feasibility and delivery by the NHS. We report WWDP refinement using the 2021 Medical Research Council (MRC) framework for complex interventions to optimise future implementation. METHODS: Intervention refinement was guided by six core MRC elements of context, programme theory, stakeholder engagement, key uncertainties, intervention refinement, and economic considerations. Critical analysis of quantitative and qualitative feasibility data, informed by self-efficacy theory, provided a deeper understanding of how the intervention was used. Eight PPI consultations took place between Sept 1, 2021, and Dec 31, 2022, with three women from diverse cultural and socioeconomic backgrounds and three female diabetes professionals to strengthen the e-book and methods of support for women undertaking the programme. FINDINGS: Context was improved by the feasibility study and the PPI consultations, making the e-book relevant to UK health care. Understanding that self-efficacy was supported through primary use of peer group, and goal setting components supported the existing programme theory. Stakeholder engagement shaped the structure of the online peer support group. The feasibility study revealed uncertainties around goal settings. These uncertainties were addressed by introducing individualised goals focusing on aspects like medication adherence. The nurse support in the intervention was replaced with peer support, which might lead to greater economic feasibility of the programme. An optimised website and individualised goal setting underpin the WWDP. INTERPRETATION: The MRC Framework provides intervention refinement structure, allowing adaptive adjustments based on emerging evidence, feedback, and contextual nuances. Limitations exist. Intervention refinements, including peer support, might affect adherence and unexpected interactions. New components could influence long-term efficacy. FUNDING: Turkish Ministry of National Education.
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Pesquisa Biomédica , Diabetes Mellitus Tipo 2 , Humanos , Feminino , Diabetes Mellitus Tipo 2/terapia , Promoção da Saúde , Menopausa , Reino Unido , Estudos de ViabilidadeRESUMO
BACKGROUND: Interventions with community health workers, trained to provide basic medical education and holistic support, have been used to enhance type 2 diabetes outcomes in various settings. Evidence of their effectiveness is poor because of variations in intervention design and duration. We did a systematic review of randomised trials evaluating the effectiveness of community health worker interventions integrated into conventional care to improve glycaemic control in adults with diabetes. METHODS: In this systematic review and meta-analysis, we included randomised trials of community health worker interventions of at least-12 months' duration in adults with type 2 diabetes that compared HbA1c levels with usual care. We searched Ovid MEDLINE, the Cochrane Central Register of Controlled Trials, CINAHL and the Web of Science Core Collection for studies published in English between Jan 1, 2000, and March 1, 2023, for studies containing "community health worker" or "lay health worker", and "type 2 diabetes". We extracted both qualitative and quantitative data to assimilate community health worker intervention characteristics. We did a meta-analysis comparing changes in HbA1c levels from baseline between intervention groups and usual care groups. To be included in the meta-analysis, studies had to have HbA1c values at baseline and after 12 months and a patient dropout rate of less than 25% at 12 months follow-up. The main outcome was the mean weighted difference of % change in HbA1c after at least 12 months, assessed using Revman, the inverse variance-weighted average model (IVW). Quality was assessed using the Cochrane Rob2 tool. FINDINGS: Seven of 86 retrieved studies were eligible for inclusion; six studies were conducted in the USA and one study in Indigenous Australia. Participants in all studies were recruited from Latino, African American and Indigenous Australian ethnic minority groups. The meta-analysis of six studies including 1280 participants (mean age 52·6 years [SD 3·68]; 832 [65%] female and 448 [35%] male) showed a significant improvement in HbA1c level at 12 months follow-up, with a mean weighted difference of 0·5% (95% CI 0·31-0·68) in the community health worker intervention group (p<0·0001), that reached the generally accepted minimal clinically important difference (≥0·5%). Outcome heterogeneity was low. INTERPRETATION: Community health worker interventions showed a significant reduction in HbA1c level adjunct to usual care, but caution must be taken given the point effect estimate is only just the MCID, and the true effect could be smaller. Given the current resource constraints faced by primary care, community health worker interventions could be innovative in informing the primary and secondary management of diabetes care in UK practice. A cost-effectiveness analysis of these interventions is required before implementation in routine diabetes care can be recommended. FUNDING: None.
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Diabetes Mellitus Tipo 2 , Adulto , Masculino , Feminino , Humanos , Pessoa de Meia-Idade , Diabetes Mellitus Tipo 2/terapia , Agentes Comunitários de Saúde , Etnicidade , Controle Glicêmico , Grupos Minoritários , AustráliaRESUMO
BACKGROUND: In economic evaluations, average intervention effects are usually applied to a population. However, this fails to reflect the change in the distribution of HbA1c due to heterogeneous responses to weight loss. We aimed to investigate whether allowing heterogeneous treatment effects using a beta regression better represented the distribution of HbA1c after a weight-loss intervention, and how this affected cost effectiveness. METHODS: The Glucose Lowering through Weight Management (GLoW) trial evaluated the effectiveness of a diabetes education and weight-loss intervention against a standard diabetes education programme. Adults diagnosed with type 2 diabetes within 3 years were recruited from Clinical Commissioning Groups across 159 sites in England from July 20, 2018, to July 22, 2018. Ethics approval (18/ES/0048) and participant informed consent were obtained. Considering the between-treatment-arm difference in HbA1c after 12 months, we compared a mean-effect estimated from a mixed-effects regression to a heterogeneous effect estimated from a beta regression performed on 12-month HbA1c conditional on baseline HbA1c, gender, diabetes duration and intervention group. We used the School of Public Health Research (SPHR) Diabetes Treatment model to apply these treatment effects and evaluate the lifetime NHS costs and quality-adjusted life-years (QALYs), discounted at 3·5%. The microsimulation model estimated diabetes-related health outcomes using the UK Prospective Diabetes Study Outcomes Model 2 risk equations and risk factor trajectory equations, alongside estimating diabetes remission, osteoarthritis, and cancer. We calculated the incremental net benefit (INB) of the intervention using a £20â000 per QALY valuation, by deterministic analysis. The GLoW trial is registered with the ISRCTN Registry, ISRCTN18399564. FINDINGS: The trial recruited 577 participants (mean age 60 years; 278 [53%] female, 247 [47%] male; 474 [91%] white ethnic background). Applying heterogeneous HbA1c changes better reproduced the skewness in post-intervention HbA1c than applying a mean-effect (Kolmogorov-Smirnov test p=0·02 compared with p=0·0000007). The beta-regression method suggested the intervention was more cost-effective, estimating an INB of £736 per person, compared with £584 when applying the mean-effect. INTERPRETATION: Alternative regression specification methods should be considered when evaluating the cost-effectiveness of interventions if the key intervention outcomes are not normally distributed. However, this alternative method requires further investigation to conclude its appropriateness in evaluating cost-effectiveness in different contexts. FUNDING: National Institute for Health and Care Research (NIHR) Programme Grants for Applied Research Programme (Reference Number RP-PG0216-20010).
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Diabetes Mellitus Tipo 2 , Programas de Redução de Peso , Adulto , Humanos , Masculino , Feminino , Pessoa de Meia-Idade , Análise Custo-Benefício , Diabetes Mellitus Tipo 2/terapia , Estudos Prospectivos , Qualidade de Vida , Redução de Peso , Anos de Vida Ajustados por Qualidade de VidaRESUMO
BACKGROUND: Type 2 diabetes is a public health priority for the UK. A growing body of evidence has indicated ethnic and socioeconomic disparities in rates of diabetes prevalence and complications. Attendance at diabetes follow-up checks is key to ensuring complications are identified and managed at an early stage. The aim of this rapid review was to identify and summarise evidence of ways to improve diabetes management in ethnic minority groups. METHODS: In this rapid review, we searched PubMed, PsycInfo, and CINAHL for studies published in English between Jan 1, 2000, and Jan 31, 2023. Studies were included if the population was from ethnic minority groups and if the intervention was community-based and aimed to improve diabetes self-care. The comparisons were persuasion and behaviour change, and the outcomes were improved diabetes self-management including, glycaemic control, attending eye tests, kidney, and foot screening follow-up checks. This study is registered with PROSPERO 2023, CRD42023399283. FINDINGS: Nine studies were included, from Mexico (n=1), USA (n=7), and UK (n=1). Most studies reported on community engagement (n=8), and one focussed on peer support and diabetes self-management. Peer support and diabetes self-management education were found to significantly improve diabetes control in a Mayan community (n=29) in Mexico (p<0·0001) and in the Korean American (n=105), African American (n=107), and Latino American (n=56) communities in the USA. Another study showed that women from the Pakistani community in England also benefitted from a culturally appropriate and socially supportive environment when learning about diabetes self-management. Diabetic eye screening rates could be increased through education but not through incentive payments. INTERPRETATION: Culturally competent health-care policies and programmes have been shown to increase diabetes self-management including uptake of diabetes screening for people with diabetes from ethnic minority communities to avoid potential harmful and life limiting conditions. A strength of this review is that robust, recent, and relevant papers regarding self-management of diabetes were included. The main limitations were that none of the nine studies included any cost analyses, and only one UK-based study was included, indicating that further research is required to fill the evidence gap. FUNDING: Research for Patient and Public Benefit (RfPPB), Health and Care Research Wales.
Assuntos
Diabetes Mellitus Tipo 2 , Grupos Minoritários , Humanos , Feminino , Diabetes Mellitus Tipo 2/epidemiologia , Diabetes Mellitus Tipo 2/terapia , Etnicidade , Seguimentos , Comportamentos Relacionados com a SaúdeRESUMO
BACKGROUND: The increasing prevalence of type 2 diabetes in working-age people imposes a substantial societal burden. Although physical activity is crucial for diabetes management, limited evidence exists to inform optimal strategies for promoting physical activity in this population. We aimed to determine and compare the effectiveness of interventions for increasing physical activity level in working-age people with diabetes. METHODS: In this systematic review and meta-analysis, we searched Web of Science, the Cochrane Library, Medline, Embase, PsycINFO, ClinicalTrials.gov, and ICTRP for papers published between Jan 1, 1931, and June 30, 2022, in English. Search terms included "physical activity", "diabetes", and "randomised controlled trial". We included trials reporting the effects of interventions on physical activity level (objectively or subjectively measured) in people with type 2 diabetes aged 18-60 years. Two independent reviewers conducted summary data extraction and quality assessment. We used pairwise random-effects, frequentist network meta-analyses, and meta-regression to obtain pooled effects. Heterogeneity was evaluated using I2 statistic. The risk of bias and certainty of evidence were assessed using the Cochrane risk-of-bias 2 tool and the Grading of Recommendations Assessment, Development, and Evaluation. This study is registered with PROSPERO (CRD42022323165). FINDINGS: We identified 52 trials (6257 participants) from 21 countries (32 Asia, ten North America, eight Europe, one Australia, one Africa). The overall risk of bias was classified as "some concerns" for included studies. Four types of interventions (structured exercise training, physical activity education, psychological intervention, physical activity education plus psychological intervention) were identified. Compared with control groups, the interventions showed significant effects in objectively measured (standardised mean difference 0·77, 95% CI 0·27-1·27, low certainty), subjectively measured (0·88, 0·40-1·35, very low certainty), and overall physical activity (0·82, 0·48-1·16, moderate certainty). Physical activity education exerted large effect in overall physical activity compared with control groups. Psychological intervention exerted large effects in overall physical activity compared with other interventions. Heterogeneity was high (I2=96-97%). Intervention setting (p=0·04) and facilitator (p=0·03) showed effects on heterogeneity. INTERPRETATION: Psychologically modelled education might be the most beneficial way of promoting physical activity. Intervention setting and facilitator type should be considered when designing interventions for improving physical activity level in working-age people with type 2 diabetes. Limitations of this review include restriction to the English language and considerable heterogeneity between studies. FUNDING: King's-China Scholarship Council PhD Scholarship (202108440151).
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Diabetes Mellitus Tipo 2 , Humanos , Diabetes Mellitus Tipo 2/terapia , Exercício Físico , África , Ásia , AustráliaRESUMO
BACKGROUND: Self-care remains an effective model for diabetes management and care in low-and-middle-income countries due to the limited resources available for the clinical management of the disease and its complications This study examined adherence to self-care behaviors and associated factors among people with type 2 diabetes in Ghana. METHODS: PubMed, PsycINFO, Scopus, Web of Science, Embase and Google scholar were used to identify quantitative observational studies published between 1990 and September 30, 2023. Studies exclusive to persons with type 2 diabetes ≥ 18 years of age in a Ghanaian setting were included in this review. Findings of primary studies were analyzed using narrative synthesis. RESULTS: Twelve studies, presenting data on a total of 2,671 persons with type 2 diabetes, were included. All the studies were published in the last decade (2015-2022) and a majority of them were from the Greater Accra Region. The mean number of days (per week) participants adhered to a self-care behavior were in the ranges of 3.9-4.4 for diet, 4.2-4.8 for physical activity, 0.5-2.2 for self-monitoring of blood glucose (SMBG), and 2.9-5.0 for foot care. Adherence rates for medication were in the range of 33.5-84.5%. Patient-related factors, sociodemographic/economic-related factors, condition-related factors, and healthcare system-related factors were associated with various self-care behaviors. CONCLUSION: Adherence to self-care behaviors among persons with type 2 diabetes in Ghana remains an ongoing challenge with significant variations in adherence among patients with different characteristics.
Assuntos
Diabetes Mellitus Tipo 2 , Humanos , Diabetes Mellitus Tipo 2/terapia , Diabetes Mellitus Tipo 2/tratamento farmacológico , Gana/epidemiologia , Autocuidado , Automonitorização da Glicemia , DietaRESUMO
BACKGROUND: Nutritional management for patients with diabetes in China is a significant challenge due to the low supply of registered clinical dietitians. To address this, an artificial intelligence (AI)-based nutritionist program that uses advanced language and image recognition models was created. This program can identify ingredients from images of a patient's meal and offer nutritional guidance and dietary recommendations. OBJECTIVE: The primary objective of this study is to evaluate the competence of the models that support this program. METHODS: The potential of an AI nutritionist program for patients with type 2 diabetes mellitus (T2DM) was evaluated through a multistep process. First, a survey was conducted among patients with T2DM and endocrinologists to identify knowledge gaps in dietary practices. ChatGPT and GPT 4.0 were then tested through the Chinese Registered Dietitian Examination to assess their proficiency in providing evidence-based dietary advice. ChatGPT's responses to common questions about medical nutrition therapy were compared with expert responses by professional dietitians to evaluate its proficiency. The model's food recommendations were scrutinized for consistency with expert advice. A deep learning-based image recognition model was developed for food identification at the ingredient level, and its performance was compared with existing models. Finally, a user-friendly app was developed, integrating the capabilities of language and image recognition models to potentially improve care for patients with T2DM. RESULTS: Most patients (182/206, 88.4%) demanded more immediate and comprehensive nutritional management and education. Both ChatGPT and GPT 4.0 passed the Chinese Registered Dietitian examination. ChatGPT's food recommendations were mainly in line with best practices, except for certain foods like root vegetables and dry beans. Professional dietitians' reviews of ChatGPT's responses to common questions were largely positive, with 162 out of 168 providing favorable reviews. The multilabel image recognition model evaluation showed that the Dino V2 model achieved an average F1 score of 0.825, indicating high accuracy in recognizing ingredients. CONCLUSIONS: The model evaluations were promising. The AI-based nutritionist program is now ready for a supervised pilot study.
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Diabetes Mellitus Tipo 2 , Nutricionistas , Humanos , Diabetes Mellitus Tipo 2/terapia , Inteligência Artificial , Projetos Piloto , Idioma , RefeiçõesRESUMO
OBJECTIVES: There is growing evidence that type 2 diabetes (T2D) can be put into remission through lifestyle intervention. Current focus on remission in terms of physiological considerations and biomedical scales, means there is limited understanding of the role psycho-social factors play in moderating the efficacy of lifestyle interventions for T2D remission. In the current review we aimed to synthesise the emerging literature on psycho-social factors associated with T2D remission, specifically from lifestyle interventions. METHODS: Five databases (EMBASE, MEDLINE, CINAHL ultimate, PsychINFO and PsycArticles) were searched to identify studies from 2009 onwards that reported remission outcomes from lifestyle interventions in participants ≥ 18years old, with a clinical diagnosis of T2D. Studies included were of an interventional or observational design and restricted to English language. Screening and data extraction was performed independently by two reviewers using prespecified criteria. RESULTS: In total 6106 studies were screened, 36 studies meeting the inclusion criteria were included. Studies were globally diverse, with 30 (83%) being published ≥ 2017. Psycho-social scales were under-utilised with 22 (67%) of studies failing to include any psycho-social measures. Single arm, prospective studies were most frequently utilised, however study quality was perceived to be heterogeneous. Further disparity in the quality, content and delineation of the psycho-social interventions was also identified. Education and self-monitoring interventions were the most frequently incorporated. Self-monitoring was also identified as an important facilitator to remission, in addition to social support. CONCLUSIONS: Our findings indicate that psycho-social factors in T2D remission are under-explored. We have identified a number of methodological issues (comparability, conflicting remission criteria and poorly defined psycho-social interventions) suggesting knowledge gaps which could inform the methodology of future research design. There is significant opportunity for future research to incorporate the social model of disease, conceptualise remission more holistically, and build a more comprehensive evidence base to guide clinical practice.
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Diabetes Mellitus Tipo 2 , Humanos , Diabetes Mellitus Tipo 2/terapia , Estudos Prospectivos , Fatores Sociais , Estilo de Vida , Apoio SocialRESUMO
OBJECTIVES: Whether the routine delivery of diabetes-related knowledge can change patients' attitudes and hence influence their self-management activities remains unknown in primary healthcare settings in China. Thus, this study aims to explore the complex transformation process between knowledge, attitude and practice (KAP) among patients with diabetes in a city in China. DESIGN: A cross-sectional study. SETTING: Yuhuan City, Zhejiang Province, China. PARTICIPANTS: A total of 803 patients with diabetes were invited to attend a questionnaire survey and 782 patients with type 2 diabetes completed the survey. The average age of participants was 58.47 years old, 48.21% of whom only attended primary school or below. PRIMARY AND SECONDARY OUTCOME MEASURES: A questionnaire based on existing scales and expert consultation was applied to assess patients' socio-demographic information (SI), disease progression risk and diabetes-related KAP. A structural equation model was built to analyse the relationships between patients' characteristics and KAP. RESULTS: No significant association was found between patients' knowledge and attitude (ß=0.01, p=0.43). Better knowledge and attitude were both found to be associated with better diet and physical activities (ß=0.58, p<0.001; ß=0.46, p=0.01). However, patients with a more positive attitude toward diabetic care showed worse foot care practice (ß=-0.13, p=0.02), while better knowledge was associated with better foot care practice (ß=0.29, p<0.001). In addition, patients with higher SI (ß=0.88, p<0.001) and/or disease progression risk (ß=0.42, p<0.001) tended to present higher levels of disease knowledge. CONCLUSIONS: While successful KAP transformation has been achieved in practice for diet and physical activities, there is a need to improve foot care practice. Health education should also prioritise the prevention, detection and care of diabetic foot. Also, appropriate methods should be adopted to deliver health education to vulnerable patients, such as the elderly, those living in rural areas, those with minimal education, the unemployed and low-income patients.
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Diabetes Mellitus Tipo 2 , Humanos , Idoso , Pessoa de Meia-Idade , Diabetes Mellitus Tipo 2/terapia , Diabetes Mellitus Tipo 2/complicações , Estudos Transversais , Conhecimentos, Atitudes e Prática em Saúde , Inquéritos e Questionários , China , Progressão da DoençaRESUMO
BACKGROUND: Improving the coordination and integration of health services is recognised nationally and internationally as a key strategy for improving the quality of diabetes care. The Australian Diabetes Alliance Program (DAP) is an integrated care model implemented in the Hunter New England Local Health District (HNELHD), New South Wales (NSW), in which endocrinologists and diabetes educators collaborate with primary care teams via case-conferencing, practice performance review, and education sessions. The objective of this study was to report on general practitioners' (GPs) perspectives on DAP and whether the program impacts on their skills, knowledge, and approach in delivering care to adult patients with type 2 diabetes. METHODS: Four primary care practices with high rates of monitoring haemoglobin A1c (HbA1c) levels (> 90% of patients annually) and five practices with low rates of monitoring HbA1c levels (< 80% of patients annually) from HNELHD, NSW provided the sampling frame. A total of nine GPs were interviewed. The transcripts from the interviews were reviewed and analysed to identify emergent patterns and themes. RESULTS: Overall, GPs were supportive of DAP. They considered that DAP resulted in significant changes in their knowledge, skills, and approach and improved the quality of diabetes care. Taking a more holistic approach to care, including assessing patients with diabetes for co-morbidities and risk factors that may impact on their future health was also noted. DAP was noted to increase the confidence levels of GPs, which enabled active involvement in the provision of diabetes care rather than referring patients for tertiary specialist care. However, some indicated the program could be time consuming and greater flexibility was needed. CONCLUSIONS: GPs reported DAP to benefit their knowledge, skills and approach for managing diabetes. Future research will need to investigate how to improve the intensity and flexibility of the program based on the workload of GPs to ensure long-term acceptability of the program.