Probiotics and synbiotics for glycemic control in diabetes: A systematic review and meta-analysis of randomized controlled trials.

BACKGROUND & AIMS: The escalating prevalence of diabetes mellitus may benefit from add-on therapeutic approaches. Given the recognized need for an updated synthesis of the literature, this systematic review and meta-analysis aimed to synthesize and critically assess the available randomized controlled trials (RCTs) that investigate the efficacy of probiotics and synbiotics on glycemic control in patients with Type 1 (T1DM) and Type 2 (T2DM) diabetes mellitus. METHODS: Comprehensive searches were conducted on PubMed, Embase, CINAHL, Scopus, and Web of Science, focusing on adults with T1DM or T2DM. All comparators were deemed eligible. Primary outcomes included changes in glycated hemoglobin (HbA1c), fasting plasma glucose (FPG), and insulin levels. Only RCTs were included, and the Cochrane RoB2 tool assessed the risk of bias. Random-effect models facilitated data analysis, supplemented by sensitivity, subgroup analyses, and meta-regressions. RESULTS: A total of 537 records were screened, resulting in 41 RCTs for analysis, which comprises 2991 (54% females) patients with diabetes. The meta-analysis revealed statistically significant improvements in HbA1c (standardized mean difference (SMD) = -0.282, 95% CI: [-0.37, -0.19], p < 0.001), FPG (SMD = -0.175, 95% CI: [-0.26, -0.09], p < 0.001), and insulin levels (SMD = -0.273, 95% CI: [-0.35, -0.20], p < 0.001). A medium degree of heterogeneity between studies was found in HbA1c (I2 = 62.5%), FPG (I2 = 71.5%), and insulin levels (I2 = 66.4%) analyses. Subgroup analyses indicated that the efficacy varied based on the type of strains used and the country. Multispecies strains were particularly effective in improving HbA1c levels. CONCLUSION: The study findings suggest that probiotics and synbiotics may be effective as complementary therapies for managing diabetes. Additionally, the study underscores the need for further tailored research that considers variables such as strain types and geographical factors to deepen the understanding of the role of these interventions in diabetes care. REVIEW REGISTRATION NUMBER: PROSPERO (CRD42023396348).

Cross-Cultural Adaptation and Validation of the Revised Brief Diabetes Knowledge Test (DKT2) in Individuals With Type 2 Diabetes Mellitus and Their Caregivers.

PURPOSE: The purpose of the study was to develop an Italian version of the Revised Brief Diabetes Knowledge Test (DKT2), providing a cultural and linguistic validation supported by psychometrics and hypotheses testing. METHODS: This multimethods study was divided into 4 phases: (a) cultural-linguistic validation, with a translation and back-translation process; (b) confirmatory factor analysis (CFA) considering the original scale's structure (knowledge and insulin-specific knowledge); (c) criterion validity via hypotheses testing; and (d) cross-group measurement invariance. The internal consistency reliability was assessed by the Kuder-Richardson Formula 20 (KR-20) of the overall scale. RESULTS: A total of 251 patients and 251 caregivers were enrolled. The CFA showed good goodness of fit for both patients and caregivers. The tested hypotheses supported criterion validity in both groups. Reliability was adequate: All KR-20 values in both groups and domains were higher than 0.60. The mean percentage of knowledge score on DKT2 was lower for patients than caregivers. CONCLUSION: The DKT2 is a valid and reliable scale to assess overall knowledge of diabetes, considering its role in promoting appropriate self-care behaviors in patients with type 2 diabetes mellitus. The Italian version of DKT2 demonstrated reliability and validity, and it can be used by researchers and diabetes care and education specialists to assess a patient's or population's overall knowledge of diabetes.

The Association Between Self-reported Sleep Quality and Self-care in Adults With Heart Failure: A Cross-sectional Study.

BACKGROUND: Sleep disturbance is one of the most common symptoms among patients with heart failure (HF), and it may affect the ability of patients to perform self-care. There is a lack of evidence on the association between sleep quality and its components and self-care in adults with HF. OBJECTIVE: The aim of this study was to evaluate the association between sleep quality and its components and self-care in adults with HF. METHODS: This study is a secondary analysis of baseline data from the MOTIVATE-HF study, a randomized controlled trial on patients with HF and their caregivers. Only patients' data were analyzed in this study (n = 498). Sleep quality and self-care were evaluated with the Pittsburgh Sleep Quality Index and the Self-Care of Heart Failure Index v6.2, respectively. RESULTS: A habitual sleep efficiency of 75% to 84% was associated with lower self-care maintenance compared with a habitual sleep efficiency of 85% or greater ( P = .031), as was taking sleep medications once or twice a week compared with less than once a week ( P = .001). A frequency of daytime dysfunction less than once a week was associated with lower self-care management compared with a frequency of daytime dysfunction of 3 or more times a week ( P = .025). Taking sleep medications less than once a week was associated with lower self-care confidence compared with taking sleep medications 3 or more times a week ( P = .018). CONCLUSION: Poor sleep quality is frequently reported by patients with HF. Sleep efficiency, sleep medications, and daytime dysfunction may influence self-care more than the other sleep quality components.

Self-Care of Adults with Type 2 Diabetes During the COVID-19 Pandemic: A Qualitative Interpretive Description Study.

Due to coronavirus disease 2019 (COVID-19), diabetes services have been disrupted, causing difficulties for people with type 2 diabetes mellitus (T2DM), and understanding their experience could help improve diabetes care. Therefore, we used a qualitative interpretive description to explore the experience of self-care of adults with T2DM during the COVID-19 pandemic. Data were collected using semi-structured interviews and analyzed theoretically. The sample (N = 30) was composed of 7 females and 23 males, with a mean age of 69.9 years (60-77) and 19.4 mean years (3-40) of people living with T2DM. Our findings show reduced physical activity and increased smoking and alcohol consumption affected that self-care. Increased food consumption and stress eating, with greater stress and anxiety, caused worsening of glycemic values. Participants were able to contact healthcare professionals via eHealth or telephone. Others, even those with complications, were not able to receive care or advice. These results suggest that easier contact with health providers, continuous engagement, eHealth solutions, and formal peer support could help self-care in T2DM. Advanced nursing roles and services could solve many issues reported in this study during and after the pandemic.

Diabesity in Adults With Type 2 Diabetes Mellitus: A Cross-sectional Study Exploring Self-care and Its Determinants.

OBJECTIVES: The purpose of this study was to describe self-care maintenance, self-care monitoring, self-care management and self-care self-efficacy in adults with type 2 diabetes (T2DM) and body mass index (BMI)<30 kg/m2 and adults with T2DM and BMI≥30 kg/m2 ("diabesity"), and to identify their clinical and sociodemographic determinants. Self-care is one of the main treatments for adults with T2DM. However, self-care has been poorly described in people with diabesity, and differences in clinical and sociodemographic determinants of self-care between patients with diabesity and patients with T2DM and BMI<30 kg/m2 have, to our knowledge, not been assessed. METHODS: A secondary analysis was performed of sociodemographic and clinical data using a multicentre, observational, cross-sectional design, wherein 540 adults diagnosed with T2DM were included in a consecutive and convenience sampling procedure. RESULTS: Self-care maintenance and management were significantly lower among patients with diabesity (p<0.001 and p=0.025, respectively). Among patients with diabesity, low income (relative risk [RR]=3.27, p=0.01) and presence of diabetic neuropathy (RR=4.16; p=0.03) were strongly associated with inadequate self-care maintenance; completion of high school (RR=0.45; p=0.01), availability of a family caregiver (RR=0.52; p=0.04) and the use of insulin as the main treatment (RR=2.09; p=0.01) decreased the likelihood of inadequate self-care monitoring. CONCLUSIONS: The unfavourable behavioural profile of patients with diabesity could be further worsened by their lower level of confidence in performing adequate self-care.

Further Evidence of Psychometric Performance of the Self-care of Diabetes Inventory in Adults With Type 1 and Type 2 Diabetes.

BACKGROUND: The Self-care of Diabetes Inventory (SCODI) is a theory-based tool that measures self-care, a key strategy in the appropriate treatment of diabetes. However, despite the clinical differences between people with Type 1 Diabetes Mellitus (T1DM) and Type 2 Diabetes Mellitus (T2DM), the psychometric properties of the SCODI were only tested in mixed samples. PURPOSE: This study aims to test the psychometric performances of the SCODI in two separate groups of adults with T1DM and T2DM. METHODS: This is a secondary analysis from two previous multicentre cross-sectional observational studies involving patients with T1DM (n = 181) and T2DM (n = 540). We tested dimensionality with confirmatory factor analysis and reliability with a multidimensional model-based coefficient for every scale of the SCODI: self-care maintenance, self-care monitoring, self-care management, and self-care self-efficacy. RESULTS: We found that the SCODI showed the same dimensionality, with minimal variation in factor loadings for each factor and each scale among T1DM and T2DM groups. High reliability for each scale in both groups was also found (self-care maintenance: T1DM = 0.86, T2DM = 0.83; self-care monitoring: T1DM = 0.84, T2DM = 1.00; self-care management: T1DM = 0.87, T2DM = 0.86; self-care self-efficacy: T1DM = 0.88; T2DM = 0.86). CONCLUSION: The SCODI can be used for measuring self-care in people with T1DM, T2DM, or mixed groups using identical scoring procedures. Considering the well-known differences between Type 1 and Type 2 diabetes diseases and patients' characteristics, our results support the generalizability of the self-care theory on which the instrument is based.

Self-care is Renouncement, Routine, and Control: The Experience of Adults with Type 2 Diabetes Mellitus.

Type 2 Diabetes Mellitus can cause serious complications; it has a severe impact on the quality of life and high costs. One of the key strategies to manage diabetes is self-care, a complex multifactorial process influenced by personal, cultural, and systemic factors, that comprises self-care maintenance, self-care monitoring, and self-care management. Few patients perform adequate self-care. To deepen our understanding of patients' experiences of self-care maintenance, self-care monitoring, and self-care management, we conducted the first qualitative study on this topic. This study used Interpretive Phenomenological Analysis, informed by the Middle-range Theory of Self-care of Chronic Illness, to explore the experience and meaning of self-care maintenance, self-care monitoring, and self-care management in adults with T2DM (n = 10). Three themes were identified: self-care is renouncement, self-care is routine, and self-care is control. A cross-cutting moral pattern connects the three themes. Our findings corroborate the Middle-range Theory of Self-care of Chronic Illness in the field of diabetes self-care and could inform practitioners in understanding the experience of self-care as a complex phenomenon and in developing tailored interventions.

How do self-care maintenance, self-care monitoring, and self-care management affect glycated haemoglobin in adults with type 2 diabetes? A multicentre observational study.

PURPOSE: To evaluate how self-care maintenance, self-care monitoring, and self-care management affect glycated haemoglobin in type 2 diabetes mellitus patients and to set cut-off points of the Self-Care of Diabetes Inventory scales using glycated haemoglobin as outcome of interest. METHODS: A secondary analysis of a previous multicentre observational cross-sectional study was conducted. Overall, 540 adults with type 2 diabetes mellitus confirmed diagnosis were involved. Socio-demographic and clinical data were collected. Self-care maintenance, self-care monitoring, and self-care management were measured by the Self-Care of Diabetes Inventory. Linear regression models were performed to assess the relationship between self-care maintenance, self-care monitoring, and self-care management and glycated haemoglobin. Receiver operating characteristics curves were carried out to identify the best cut-off score for each self-care scale considering glycated haemoglobin >7% as outcome of interest. RESULTS: Self-care monitoring and self-care management were associated to glycated haemoglobin in both patients without (self-care monitoring p = 0.0008; self-care management p = 0.0178) and with insulin therapy (self-care monitoring p = 0.0007; self-care management p = 0.0224). Self-care maintenance was associated to glycated haemoglobin in patients without insulin therapy (p = 0.0118). Cut-off scores providing the best performance were 70 points for self-care maintenance and self-care monitoring, and 60 points for self-care management. CONCLUSIONS: Self-care maintenance, self-care monitoring, and self-care management differently affect glycated haemoglobin in patients with type 2 diabetes mellitus. Clinicians could implement tailored interventions to improve glycaemic control considering the lacking area of self-care.

How Do Basic Human Values Affect Self-Care of Type 2 Diabetes Patients? A Multicentre Observational Study.

In type 2 diabetes mellitus (T2DM) patients, human values have been identified as having a possible impact on self-care. Despite this, basic human values have never been described in the T2DM population and the association between basic human values and self-care has not been assessed. The aims of this study were to describe basic human values and self-care, and investigate the associations between basic human values and self-care in adults with T2DM. The study was cross-sectional multicentre with T2DM patients (n = 390). Sociodemographic and clinical data were collected from charts, and two questionnaires were administered. The Portrait Values Questionnaire (PVQ) measured basic human values and allowed us to group patients into four groups based on the value profile: (A) Openness to Change and Self-Transcendence, (B) Conservation and Self-Transcendence, (C) Conservation and Self-Enhancement, and (D) Openness to Change and Self-Enhancement. The Self-care of Diabetes Inventory measured self-care maintenance, self-care monitoring, self-care management, and self-care confidence, according to the Middle-Range Theory of Self-Care of Chronic Illness. Multiple regression models were used to assess associations between the basic human values and self-care. Group D (Openness to Change and Self-Enhancement) performed significantly lower self-care maintenance (p = .024) and self-care monitoring (p = .031) when compared with Group A, and lower self-care monitoring (p = .008) and self-care management (p = .018) when compared with Group B. Group D showed significantly lower self-care monitoring (p = .027) when compared with Group C. People with T2DM who value more self-enhancement and openness to change might be more prone to perform worse self-care compared with those who value conservation and self-transcendence. Clinicians should consider this when designing interventions aimed at improving self-care behaviors in patients with T2DM.

Self-care in People with Type 2 Diabetes Mellitus Research Protocol of a Multicenter Mixed Methods Study (SCUDO)

About 11% of the adult global populations is estimated to be living with type 2 diabetes mellitus (T2DM) by 2040. T2DM requires people to make decisions regarding complex therapeutic regimes, to maintain their well-being and quality of life, to manage symptoms and to reduce disease complications. All these behaviours, requiring knowledge, motivation, experience, and skills, have been referred to the concept of self-care. The intricacy and multidimensionality of T2DM self-care requires a complex approach to its overall comprehension. This Embedded Mixed Method study aims to investigate the experience of self-care in Type 2 Diabetes Mellitus adult patients. It comprises a prospective observational design, and an interpretive description. Quantitative data will be collected with validated questionnaires from 300 patients at baseline and once a year for two years on: diabetes self-care, quality of life, diabetes related distress, and sleep quality. Socio-demographic and clinical data will be collected from medical records. Qualitative data will be collected using semi-structured interviews on circa 10-20 patients, at baseline and once a year for two years, analysed according to interpretive description. Quantitative and qualitative data will be analysed separately and then merged and interpreted. This study will expand our understanding of self-care in people with T2DM. The expected outcome will be a better understanding of the effect of self-care on glycaemic control and therefore clinical outcomes and costs.

Clinical and socio-demographic determinants of inadequate self-care in adults with type 1 diabetes mellitus: the leading role of self-care confidence.

AIMS: To describe self-care maintenance, monitoring, and management behaviors in adults with type 1 diabetes (T1DM), and to identify clinical and socio-demographic determinants of inadequate self-care. METHODS: A cross-sectional study was conducted in two diabetes outpatient clinics in Italy. Clinical and socio-demographic characteristics were collected from the medical records of 181 consecutively enrolled T1DM patients. The Self-Care of Diabetes Inventory was used to measure self-care maintenance, self-care monitoring, self-care management and self-care confidence. A standardized 0-100 score was used for each self-care dimension. A score < 70 was considered inadequate self-care. Three multiple logistic regression models were run to find determinants of inadequate self-care maintenance, monitoring, and management. RESULTS: The majority of patients had adequate self-care maintenance (74%; n = 134), self-care monitoring (68.5%; n = 124) and self-care confidence (87.3%; n = 158), while self-care management was adequate for only a minority (34.8%; n = 63). The odds of inadequate self-care maintenance increased by 4.5 times when self-care confidence was inadequate (OR adjusted 4.589; 95% CI 1.611-13.071; p = 0.004). The odds of inadequate self-care monitoring increased four times when patients had inadequate self-care confidence (OR adjusted 4.116; 95% CI 1.457-11.628; p = 0.008). Inadequate self-care confidence increased the odds of performing inadequate self-care management more than five times (OR adjusted 5.313; 95% CI 1.143-24.686; p = 0.033). CONCLUSIONS: Self-care management is commonly inadequate in adults with T1DM. Self-care confidence is the most important determinant of self-care behaviors in this population. Educational interventions are recommended to improve self-care confidence in adults with T1DM.

Development and psychometric testing of a theory-based tool to measure self-care in diabetes patients: the Self-Care of Diabetes Inventory.

BACKGROUND: Self-care is essential for patients with diabetes mellitus. Both clinicians and researchers must be able to assess the quality of that self-care. Available tools have various limitations and none are theoretically based. The aims of this study were to develop and to test the psychometric properties of a new instrument based on the middle range-theory of self-care of chronic illness: the Self-Care of Diabetes Inventory (SCODI). METHODS: Forty SCODI items (5 point Likert type scale) were developed based on clinical recommendations and grouped into 4 dimensions: self-care maintenance, self-care monitoring, self-care management and self-care confidence based on the theory. Content validity was assessed by a multidisciplinary panel of experts. A multi-centre cross-sectional study was conducted in a consecutive sample of 200 type 1 and type 2 diabetes patients. Dimensionality was evaluated by exploratory factor analyses. Multidimensional model based reliability was estimated for each scale. Multiple regression models estimating associations between SCODI scores and glycated haemoglobin (HbA1c), body mass index, and diabetes complications, were used for construct validity. RESULTS: Content validity ratio was 100%. A multidimensional structure emerged for the 4 scales. Multidimensional model-based reliabilities were between 0.81 (maintenance) and 0.89 (confidence). Significant associations were found between self-care maintenance and HbA1c (p = 0.02) and between self-care monitoring and diabetes complications (p = 0.04). Self-care management was associated with BMI (p = 0.004) and diabetes complications (p = 0.03). Self-care confidence was a significant predictor of self-care maintenance, monitoring and management (all p < 0.0001). CONCLUSION: The SCODI is a valid and reliable theoretically-grounded tool to measure self-care in type 1 and type 2 DM patients.