Empowering parents to optimize feeding practices with preschool children (EPO-Feeding): A study protocol for a feasibility randomized controlled trial.

BACKGROUND: Parental feeding practices (PFPs) play a key role in fostering preschoolers' dietary habits and in mitigating the risk of childhood obesity. Nevertheless, parents often employ inappropriate feeding practices, leading to children's potential nutrition-related issues. Thus, research is needed to inform interventions that focus on optimizing feeding practices. METHODS: This protocol describes the evaluation of a novel intervention-Empowering Parents to Optimize Feeding Practices (EPO-Feeding Program). The program will be evaluated with a two-arm feasibility randomized controlled trial (RCT) in Yangzhou, China. The program includes four weekly group-based training sessions led by healthcare professionals for parents of preschool children. The intervention incorporates sessions, group discussions, motivational interviewing, and supplementary materials (e.g., key messages and educational videos) aimed at enhancing parents' knowledge, skills, and behaviours related to feeding practices. The primary outcomes include i) implementation feasibility, primarily assessed through retention rates; and ii) program acceptability through a survey and qualitative process evaluation. Secondary outcomes encompass the potential impacts on i) PFPs, ii) parental perception of child weight (PPCW), iii) parenting sense of competence, iv) children's eating behaviours, and v) child weight status. Quantitative analyses include descriptive estimates for evaluating the feasibility and linear mixed regression analysis for testing the potential effects. Qualitative valuation will use thematic framework analysis. DISCUSSION: If this study shows this program to be feasible to implement and acceptable to parents, it will be used to inform a fully powered trial to determine its effectiveness. The research will also help inform policy and practices in the context of child nutrition promotion, particularly regarding implementing group-based training sessions by healthcare providers in similar settings. TRIAL REGISTRATION: Clinicaltrials.gov, Protocol #NCT06181773, 20/11/2023.

Improving foot self-care in people with diabetes in Ghana: A development and feasibility randomised trial of a context appropriate, family-orientated diabetic footcare intervention.

OBJECTIVE: Africa presents a higher diabetic foot ulcer prevalence estimate of 7.2% against global figures of 6.3%. Engaging family members in self-care education interventions has been shown to be effective at preventing diabetes-related foot ulcers. This study culturally adapted and tested the feasibility and acceptability of an evidence-based footcare family intervention in Ghana. METHODS: The initial phase of the study involved stakeholder engagement, comprising Patient Public Involvement activities and interviews with key informant nurses and people with diabetes (N = 15). In the second phase, adults at risk of diabetes-related foot ulcers and nominated caregivers (N = 50 dyads) participated in an individually randomised feasibility trial of the adapted intervention (N = 25) compared to usual care (N = 25). The study aimed to assess feasibility outcomes and to identify efficacy signals on clinical outcomes at 12 weeks post randomisation. Patient reported outcomes were foot care behaviour, foot self-care efficacy, diabetes knowledge and caregiver diabetes distress. RESULTS: Adjustments were made to the evidence-based intervention to reflect the literacy, information needs and preferences of stakeholders and to develop a context appropriate diabetic foot self-care intervention. A feasibility trial was then conducted which met all recruitment, retention, data quality and randomisation progression criteria. At 12 weeks post randomisation, efficacy signals favoured the intervention group on improved footcare behaviour, foot self-care efficacy, diabetes knowledge and reduced diabetes distress. Future implementation issues to consider include the staff resources needed to deliver the intervention, family members availability to attend in-person sessions and consideration of remote intervention delivery. CONCLUSION: A contextual family-oriented foot self-care education intervention is feasible, acceptable, and may improve knowledge and self-care with the potential to decrease diabetes-related complications. The education intervention is a strategic approach to improving diabetes care and prevention of foot disease, especially in settings with limited diabetes care resources. Future research will investigate the possibility of remote delivery to better meet patient and staff needs. TRIAL REGISTRATION: Pan African Clinical Trials Registry (PACTR) - PACTR202201708421484: https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=19363 or pactr.samrc.ac.za/Search.aspx.

COMPAR-EU Recommendations on Self-Management Interventions in Type 2 Diabetes Mellitus.

Self-management interventions (SMIs) offer a promising approach to actively engage patients in the management of their chronic diseases. Within the scope of the COMPAR-EU project, our goal is to provide evidence-based recommendations for the utilisation and implementation of SMIs in the care of adult individuals with type 2 diabetes mellitus (T2DM). A multidisciplinary panel of experts, utilising a core outcome set (COS), identified critical outcomes and established effect thresholds for each outcome. The panel formulated recommendations using the Grading of Recommendations, Assessment, Development, and Evaluations (GRADE) approach, a transparent and rigorous framework for developing and presenting the best available evidence for the formulation of recommendations. All recommendations are based on systematic reviews (SR) of the effects and of values and preferences, a contextual analysis, and a cost-effectiveness analysis. The COMPAR-EU panel is in favour of using SMIs rather than usual care (UC) alone (conditional, very low certainty of the evidence). Furthermore, the panel specifically is in favour of using ten selected SMIs, rather than UC alone (conditional, low certainty of the evidence), mostly encompassing education, self-monitoring, and behavioural techniques. The panel acknowledges that, for most SMIs, moderate resource requirements exist, and cost-effectiveness analyses do not distinctly favour either the SMI or UC. Additionally, it recognises that SMIs are likely to enhance equity, deeming them acceptable and feasible for implementation.

The effectiveness of interventions on changing caregivers' feeding practices with preschool children: A systematic review and meta-analysis.

Caregivers' feeding practices are critical in shaping preschool children's eating habits and preventing childhood obesity. We conducted a systematic review and meta-analysis to evaluate the effectiveness of existing interventions targeting caregivers of preschool children, which aimed to promote child healthy eating and/or manage child weight and/or prevent child nutrition-related problems and included feeding practices as one of the outcomes. Eighteen studies with 18 intervention programs and 3887 respondents that completed baseline evaluations were eligible for data synthesis. Behavior change techniques (BCTs) frequently used included the following: instruction on how to perform the behavior and demonstration of the behavior. The pooled effects of randomized controlled trials (RCTs) on pressure to eat (pooled standardized mean difference [SMD] = 0.61; 95%CI: -1.16, -0.06), use of food as a reward (pooled SMD = -0.31; 95%CI: -0.61, -0.01), and emotional feeding (pooled SMD = -0.36; 95%CI: -0.66, -0.06) were found statistically significant compared with control groups at post-intervention. However, there were no pooled effects on restrictive feeding and pressure to eat at other follow-ups or on other feeding practices at post-intervention. Interventions may have short-term effects on decreasing the adoption of coercive control. Future interventions should directly and adequately optimize feeding practices, include components of individual support, and contribute to the maintenance of the effects over the long term.

The diabetes insulin self-management education (DIME) intervention for people with type 2 diabetes starting insulin: a pilot feasibility randomised controlled trial.

OBJECTIVE: To determine the feasibility and acceptability of a diabetes insulin self-management education (DIME) group intervention for people with type 2 diabetes starting insulin. DESIGN: Single-centre parallel randomised pilot trial. SETTING: Primary care, South London, UK. SUBJECTS: Adults with type 2 diabetes, requiring insulin treatment, on maximum tolerated dose of 2 or more oral antidiabetic drugs with HbA1c > / = 7.5% (58 mmol/mol) on 2 occasions. We excluded people who were non-fluent in English; morbid obesity (BMI > / = 35 kg/m2); in employment that contraindicates insulin treatment; and those with severe depression, anxiety disorders, psychotic disorders, personality disorders, or cognitive impairment. METHODS: Participants were randomised using blocks of 2 or 4 to 3, 2-h group, face-to-face, DIME sessions or standard insulin group education sessions (control). We assessed feasibility according to consent to randomisation and attendance at intervention (DIME) and standard group insulin education sessions. Acceptability of the interventions was determined using exit interviews. We additionally measured change in self-reported insulin beliefs, diabetes distress and depressive symptoms between baseline and 6-month post-randomisation. RESULTS: There were 28 potentially eligible participants, of which 17 consented to randomisation, 9 were allocated to the DIME group intervention and 8 were allocated to the standard group insulin education. Three people withdrew from the study (1 from DIME and 2 from standard insulin education) before the start of the first session and did not complete baseline questionnaires. Of the remaining participants (n = 14), all DIME participants (n = 8) completed all 3 sessions, and all standard insulin education participants (n = 6) completed at least 1 standard insulin education session. The median group size was 2, the mean age of participants was 57.57 (SD 6.45) years, and 64% were female (n = 9). Exit interviews demonstrated that all participants (n = 7) found the group sessions acceptable, and thematic analysis of interview transcripts indicated social support, the content of group sessions and post-group experiences were positive, especially amongst DIME participants. There was improvement on self-report questionnaires. CONCLUSIONS: The DIME intervention was acceptable and feasible to deliver to participants with type 2 diabetes starting insulin in South London, UK. TRIAL REGISTRATION: International Study Registration Clinical Trial Network (ISRCTN registration number 13339678).

Interventions to enhance pre-pregnancy care for women with type 2 diabetes: A systematic review of the literature.

AIMS: The aim of the study was to examine the content and impact of interventions that have been used to increase the uptake of pre-pregnancy care for women with type 2 diabetes, and their impact on maternal and fetal outcomes. METHODS: A systematic search of multiple databases was conducted in November 2021, and updated July 2022, to identify studies assessing interventions to enhance pre-pregnancy care for women with type 2 diabetes. Over 10% of articles were screened by two reviewers at title and abstract phase, after which all selected full-text articles were screened by two reviewers. Quality assessment was conducted using the Critical Appraisal Skills Programme checklist for cohort studies. Meta-analysis was not possible due to study heterogeneity; therefore, narrative synthesis was conducted. RESULTS: Four eligible cohort studies were identified. The conclusions able to be drawn by this review were limited as women with type 2 diabetes (n = 800) were in the minority in all four studies (35%-40%) and none of the interventions were exclusively tailored for them. The uptake of pre-pregnancy care was lower in women with type 2 diabetes (8%-10%) compared with other participant groups in the studies. Pregnancy preparation indicators generally improved among all groups exposed to pre-pregnancy care, with varying impact on pregnancy outcomes. CONCLUSIONS: This review demonstrates that previous interventions have had a limited impact on pre-pregnancy care uptake in women with type 2 diabetes. Future studies should focus on tailored interventions for improving pre-pregnancy care for women with type 2 diabetes, particularly those from ethnic minorities and living in poorer communities.

Delegation of insulin administration to non-registered healthcare workers in community nursing teams: A qualitative study.

AIMS: To explore stakeholder perspectives on the benefits and/or disadvantages of the delegation of insulin injections to healthcare support workers in community nursing services. DESIGN: Qualitative case study. METHODS: Interviews with stakeholders purposively sampled from three case sites in England. Data collection took place between October 2020 and July 2021. A reflexive thematic approach to analysis was adopted. RESULTS: A total of 34 interviews were completed: patients and relatives (n = 7), healthcare support workers (n = 8), registered nurses (n = 10) and senior managers/clinicians (n = 9). Analysis resulted in three themes: (i) Acceptance and confidence, (ii) benefits and (iii) concerns and coping strategies. Delegation was accepted by stakeholders on condition that appropriate training, supervision and governance was in place. Continuing contact between patients and registered nurses, and regular contact between registered nurses and healthcare support workers was deemed essential for clinical safety. Services were reliant on the contribution of healthcare support workers providing insulin injections, particularly during the COVID-19 pandemic. Benefits for service and registered nurses included: flexible team working, increased service capacity and care continuity. Job satisfaction and career development was reported for healthcare support workers. Patients benefit from timely administration, and enhanced relationships with the nursing team. Concerns raised by all stakeholders included potential missed care, remuneration and task shifting. CONCLUSION: Delegation of insulin injections is acceptable to stakeholders and has many benefits when managed effectively. IMPACT: Demand for community nursing is increasing. Findings of this study suggest that delegation of insulin administration contributes to improving service capacity. Findings highlight the essential role played by key factors such as appropriate training, competency assessment and teamwork, in developing confidence in delegation among stakeholders. Understanding and supporting these factors can help ensure that practice develops in an acceptable, safe and beneficial way, and informs future development of delegation practice in community settings. PATIENT OR PUBLIC CONTRIBUTION: A service user group was consulted during the design phase prior to grant application and provided comments on draft findings. Two people with diabetes were members of the project advisory group and contributed to the study design, development of interview questions, monitoring study progress and provided feedback on study findings.

The relationships between caregivers' self-reported and visual perception of child weight and their non-responsive feeding practices: A systematic review and meta-analysis.

BACKGROUND: The impacts of caregivers' perception of child weight on their non-responsive feeding practices are inconclusive. This systematic review aimed to examine their relationships. METHODS: A systematic search of five databases was conducted from inception to March 2022, following PRISMA guidelines. Data synthesis was performed using semi-quantitative approach and meta-analysis. RESULTS: Twenty-two studies with 12005 respondents were included for semi-quantitative analyses. Eighteen studies examined 26 associations between caregivers' perception of child weight and food restriction with 12 statistically significant associations being observed. A total of 22 relationships between caregivers' perception of child weight and pressure to eat were investigated, with 13 being statistically significant. The statistically significant associations consistently reported that caregivers' visual and self-reported perception of child weight was positively associated with their restrictive feeding and negatively associated with pressure to eat. The pooled odds ratios (ORs) indicated that caregivers who perceived their child as overweight were found to apply pressure to eat less frequently (OR = 0.61; 95%CI: 0.44, 0.84) compared with those who did not. However, caregivers' perception of child weight was not statistically significantly associated with restrictive feeding (OR = 1.37; 95%CI: 0.74, 2.55). CONCLUSION: Caregivers' self-reported and visual perception of child weight may be important risk factors for non-responsive feeding practices, particularly food restriction and pressure to eat. Thus, interventions need to consider the role of caregivers' perception of child weight, which may optimize feeding practices. Furthermore, longitudinal and intervention-based studies using validated measurements while controlling for potential covariates are needed to provide more evidence on their causal relationships.

Exploring the Experiences and Perspectives of Insulin Therapy in Type 2 Diabetes via Web-Based UK Diabetes Health Forums: Qualitative Thematic Analysis of Threads.

BACKGROUND: Despite the advent of type 2 diabetes (T2D) remission strategies and novel therapeutic agents, many individuals with T2D will require insulin treatment to achieve target glycemia, with the aim of preventing or delaying diabetes complications. However, insulin refusal and cessation of treatment in this group are common, and their needs are underreported and relatively unexplored. OBJECTIVE: This study aimed to explore the experiences and perspectives of individuals with T2D for whom insulin therapy is indicated as expressed on web-based health forums, in order to inform the development of evidence-based structured educational and support strategies and improve health care provider awareness. METHODS: Retrospective archived forum threads from the 2 largest, freely and publicly accessible diabetes health forums in the United Kingdom were screened over a 12-month period (August 2019-2020). The Diabetes UK and Diabetes.co.uk forums were searched for relevant threads. A total of 3 independent researchers analyzed the forum threads and posts via thematic analysis. Pertinent themes were identified and illustrated by paraphrasing members' quotes to ensure anonymity. A total of 299 posts from 29 threads from Diabetes UK and 295 posts from 28 threads Diabetes.co.uk were analyzed over the study period. In all, 57 threads met the inclusion criteria and were included in the final analysis. RESULTS: Four overarching themes were generated to illustrate the unmet needs that prompted members to seek information, advice, and support regarding insulin therapy outside of their usual care provision via the forums: empowerment through sharing self-management strategies, seeking and providing extended lifestyle advice, relationships with health care professionals, and a source of psychological peer support. CONCLUSIONS: This is the first study to collect data from web-based health forums to characterize the experiences and perspectives of people with T2D for whom insulin therapy is indicated. The observed naturalistic conversations have generated useful insights; our findings suggest that there are significant unmet self-management and psychological needs within this group that are not being met elsewhere, prompting the seeking of information and support on the web. These include practical aspects such as insulin injection technique, storage and dose titration, driving and travel considerations, the emerging use of technology, and a strong interest in the effects of extended lifestyle (diet and activity) approaches to support insulin therapy. In addition, problematic relationships with health care professionals appear to be a barrier to effective insulin therapy for some. In contrast, seeking and offering mutually beneficial, practical, and psychological support from peers was viewed as enabling. The study results will help to directly inform insulin-focused self-management and support strategies to enable individuals in this group to achieve their best outcomes.

The Relationships between Caregivers' Concern about Child Weight and Their Non-Responsive Feeding Practices: A Systematic Review and Meta-Analysis.

BACKGROUND: It is unclear whether caregivers' concern about child weight impacts their non-responsive feeding practices. This systematic review aimed to examine their relationships. METHODS: A systematic search of PubMed, Embase, PsycINFO, Web of Science core collection, CINAHL and grey literature was conducted from inception to March 2022, following PRISMA guidelines. Data synthesis was performed using a semi-quantitative approach and a meta-analysis. RESULTS: A total of 35 studies with 22,933 respondents were included in the review for semi-quantitative analyses. Thirty-four studies examined 52 associations between concern about child weight and restriction with 40 statistically significant associations being observed. A total of 34 relationships between concern about child weight and pressure to eat were investigated, with 12 being statistically significant. The pooled regression coefficients (ß) demonstrated that caregivers' concern about child overweight was positively associated with restriction (ß = 0.22; 95%CI: 0.12, 0.31), negatively associated with use of food as a reward (ß = -0.06; 95%CI: -0.11, -0.01), and not statistically associated with pressure to eat (ß = -0.05; 95%CI: -0.13, 0.04). The pooled odds ratios (ORs) indicated that caregivers who were concerned about child overweight were found to use restrictive feeding more often (OR = 2.34; 95%CI: 1.69, 3.23), while less frequently adopting pressure to eat (OR = 0.76; 95%CI: 0.59, 0.98) compared with those without concerns. The results also showed that caregivers who were concerned about child underweight were more likely to force their children to eat (OR = 1.83; 95%CI: 1.44, 2.33) than those without concerns. CONCLUSION: Caregivers' concern about child weight may be an important risk factor for non-responsive feeding practices. Thus, interventions are needed to focus on managing and relieving caregivers' excessive concern about child weight, especially overweight, which may optimize feeding practices and subsequently contribute to child health.

Prospective study of the association between depressive symptoms at type 2 diabetes diagnosis and time to insulin initiation in the South London diabetes (SOUL-D) cohort.

AIMS: Initiation of insulin is usually delayed even when required. We aim to estimate the association between depressive symptoms on time to become insulin requiring and time to insulin initiation. METHODS: 8-year follow-up of a cohort of newly diagnosed people with T2D recruited in south-east London, UK (2008-2012). Baseline depressive symptoms were assessed using the Patient Health Questionnaire-9. Time to insulin-requiring was defined when optimal glycaemic levels were not achieved (HbA1c >58 mmol/mol) at least three months after the 2nd oral antidiabetic was prescribed, and time to insulin initiation was defined as first insulin prescription. RESULTS: Seventy percent (n = 1166) of the baseline cohort was followed up. Median time to insulin requiring was 84 months (IQR 63-100) and to insulin initiation 93 months (IQR 79-105). Participants with depressive symptoms at baseline required insulin earlier (mean [SD] 73.64 [32.16] vs. 79.05 [29.07] months, p = 0.007) and were prescribed insulin sooner (82.53 [30.19] vs. 89.72 [22.02] months, p < 0.001). In Cox regression, depressive symptoms at baseline were not associated with time to insulin requiring (HR [95 % CI]; 1.16 [0.86-1.57], p = 0.34) nor to insulin initiation (HR = 1.00 [0.99-1.00], p = 0.49). CONCLUSIONS: Depressive symptoms were not associated with time to insulin requiring and initiation after adjusting for potential confounding.

Eliciting the mechanisms of action of care navigators in the management of type 2 diabetes in people with severe mental illness: A qualitative study.

BACKGROUND: People with severe mental illness and type 2 diabetes have a reduced life expectancy compared to the general population. One factor that contributes to this is the inability to provide optimal management, as the two conditions are typically managed by separate physical and mental health systems. The role of care navigators in coordinating diabetes care in people with severe mental illness may provide a solution to better management. AIM: To explore the views of clinicians and people with severe mental illness and type 2 diabetes on an integrated health service model with a focus on the care navigator to identify potential mechanisms of action. DESIGN: Qualitative one-to-one semi-structured interviews and part of a wider pilot intervention study. SETTING: Community Mental Health Unit in South London. METHOD: Topic guides explored the perspectives and experiences of both clinicians and people with severe mental illness and diabetes. Data analysis was conducted using Thematic Analysis. RESULTS: From the analysis of 19 participants, five main themes emerged regarding the care navigator role: administrative service; signposting to local services; adhering to lifestyle changes and medication; engaging in social activities; further skills and training needed. The key findings from this study emphasise the benefits that the role of a care navigator has in helping people with severe mental illness to better manage their diabetes i.e. through diet, exercise medication and attending essential health check-ups. CONCLUSION: This study illustrates that having a care navigator in place empowers those with severe mental illness to improve the management of their diabetes. Future research should focus on the extent to which care navigators are effective in improving specific outcomes.

Needs, concerns and self-management experiences of people with type 2 diabetes during the COVID-19 pandemic: A qualitative study.

BACKGROUND: Type 2 diabetes is associated with increased COVID-19 severity. Little is understood about the needs, concerns and self-management experiences of people with type 2 diabetes during the COVID-19 pandemic. AIM: To examine the lived experiences of people with type 2 diabetes during the COVID-19 pandemic. METHOD: This qualitative study recruited people with type 2 diabetes from the SOUth-London Diabetes (SOUL-D) cohort. Semi-structured interviews via telephone were conducted between September 2020 and January 2021. Deductive thematic analysis derived themes from the data to explore needs, concerns and self-management experiences of people with type 2 diabetes. RESULTS: Twenty-nine people with type 2 diabetes were interviewed. Three themes with subthemes were outlined: (1) information needs of people with type 2 diabetes during the Covid-19 pandemic, (2) concerns about Covid-19 from people with type 2 diabetes and (3) diabetes self management and well-being during the Covid-19 pandemic. CONCLUSION: During a pandemic, there is a need for consistent, diabetes-specific, messaging from healthcare professionals for people with type 2 diabetes. People with type 2 diabetes need support to access digital resources to aid remote communication. Future research could help develop recourses to prevent social isolation and loneliness for people with type 2 diabetes during a pandemic.

Prevention and Management of Diabetes-Related Foot Ulcers through Informal Caregiver Involvement: A Systematic Review.

Background: The literature remains unclear whether involving informal caregivers in diabetes self-care could lead to improved diabetic foot outcomes for persons at risk and/or with foot ulcer. In this review, we synthesized evidence of the impact of interventions involving informal caregivers in the prevention and/or management of diabetes-related foot ulcers. Methods: A systematic review based on PRISMA, and Synthesis Without Meta-analysis (SWiM) guidelines was conducted. MEDLINE (Ovid), Embase (Ovid), PsycINFO, CINAHL, and Cochrane Central Register of Controlled Trial of the Cochrane Library databases were searched from inception to February 2021. The following MESH terms were used: diabetic foot, foot ulcer, foot disease, diabetes mellitus, caregiver, family caregiver ,and family. Experimental studies involving persons with diabetes, with or at risk of foot ulcers and their caregivers were included. Data were extracted from included studies and narrative synthesis of findings undertaken. Results: Following the search of databases, 9275 articles were screened and 10 met the inclusion criteria. Studies were RCTs (n = 5), non-RCTs (n = 1), and prepoststudies (n = 4). Informal caregivers through the intervention programmes were engaged in diverse roles that resulted in improved foot ulcer prevention and/or management outcomes such as improved foot care behaviors, increased diabetes knowledge, decreased HbA1c (mmol/mol or %), improved wound healing, and decreased limb amputations rates. Engaging both caregivers and the person with diabetes in education and hands-on skills training on wound care and foot checks were distinctive characteristics of interventions that consistently produced improved foot self-care behavior and clinically significant improvement in wound healing. Conclusion: Informal caregivers play diverse and significant roles that seem to strengthen interventions and resulted in improved diabetes-related foot ulcer prevention and/or management outcomes. However, there are multiple intervention types and delivery strategies, and these may need to be considered by researchers and practitioners when planning programs for diabetes-related foot ulcers.

An integrated primary care-based programme of PRE-Pregnancy cARE to improve pregnancy outcomes in women with type 2 Diabetes (The PREPARED study): protocol for a multi-method study of implementation, system adaptation and performance.

BACKGROUND: The number of women of childbearing age with Type 2 diabetes(T2DM) is increasing, and they now account for > 50% of pregnancies in women with pre-existing diabetes. Diabetes pregnancies without adequate pre-pregnancy care have higher risk for poor outcomes (miscarriages, birth-defects, stillbirths) and are associated with increased complications (caesarean deliveries, macrosomic babies, neonatal intensive-care admissions). The risks and costs of these pregnancies can be reduced with pregnancy preparation (HbA1c, ≤ 6.5%, 5 mg folic acid and stopping potentially harmful medicines). However, 90% of women with T2DM, most of whom are based in primary care, are not adequately prepared for pregnancy. This study will evaluate a programme of primary care-based interventions (decision-support systems; pre-pregnancy care-pathways; pregnancy-awareness resources; professional training; and performance monitoring) to improve pregnancy preparation in women with T2DM. METHODS: The study aims to optimise the programme interventions and estimate their impact on pregnancy preparation, pre-pregnancy care uptake and pregnancy outcomes. To evaluate this multimodal intervention, we will use a multi-method research design following Complex Adaptive Systems (CAS) theory, refining the interventions iteratively during the study. Thirty GP practices with ≥ 25 women with T2DM of reproductive age (18-45 years) from two South London boroughs will be exposed to the intervention. This will provide > 750 women with an estimated pregnancy incidence of 80-100 to study. The research involves: a clinical audit of processes and outcomes; a process evaluation informing intervention feasibility, implementation, and behaviour change; and a cost-consequences analysis informing future economic evaluation. Performance data will be collected via audits of GP systems, hospital antenatal clinics and pregnancy outcomes. Following CAS theory, we will use repeated measurements to monitor intervention impact on pregnancy preparation markers at 4-monthly intervals over 18-months. We will use performance and feasibility data to optimise intervention effects iteratively. The target performance for the intervention is a 30% increase in the proportion of women meeting pre-pregnancy care criteria. DISCUSSION: The primary output will be development of an integrated programme of interventions to improve pregnancy preparation, pre-pregnancy care uptake, and reduce adverse pregnancy outcomes in women with T2DM. We will also develop an implementation plan to support the introduction of the interventions across the NHS. TRIAL REGISTRATION: ISRCTN47576591 ; February 8, 2022.

Systematic review and meta-analysis of diabetes specialist delivered insulin education for adults with type 2 diabetes in outpatient settings.

OBJECTIVE: We conducted a systematic review and meta-analysis of insulin education for people with type 2 diabetes to assess its effectiveness in improving glycaemic levels. METHODS: We searched the following online databases from the earliest record to 17 February 2020: MEDLINE, EMBASE, PsycINFO, CINAHL, Web of science, Cochrane Library and https://clinicaltrials.gov. Data was extracted on publication status, participants' characteristics at baseline, intervention and control group, study design, and data for primary and secondary outcomes, change in HbA1c(%), change in weight (Kilogram). The review was registered with international prospective register of systematic reviews registration (PROSPERO):CRD42020167769. RESULTS: Eighteen papers were included in the systematic review. In the meta-analysis there was a small statistically significant improvement in HbA1c (0.39% points/4.4 mmol/mol reduction) in the insulin education group compared to control conditions (N = 10 studies, n = 3307 participants, SMD = -0.22, 95% CI = -0.34, -0.10, I2 = 66% p = 0.002). There was a small non-significant increase in weight (0.54 Kg) in the insulin education group compared to control conditions (N = 6 studies, n = 470 participants, SMD = 0.03, 95% CI = -0.10, 0.17, I2 = 0.0%, p = 0.82). Quality of evidence was rated low to very low. CONCLUSIONS: Enhanced insulin education delivered by diabetes specialists is potentially more effective than standard care. Further research is required to reach robust conclusions.

Delegation of medication administration from registered nurses to non-registered support workers in community care settings: A systematic review with critical interpretive synthesis.

INTRODUCTION: Healthcare workforces are currently facing multiple challenges, including aging populations; increasing prevalence of long-term conditions; and shortfall of registered nurses. Employing non-registered support workers is common across many countries to expand service capacity of nursing teams. One task delegated to non-registered support workers is medication administration, which is considered a complex task, with associated risks. This is an important topic given the predicted global increase in patients requiring assistance with medication in community settings. This review explores the evidence on delegation of medication administration from registered nurse to non-registered support workers within community settings, to better understand factors that influence the process of delegation and its impact on service delivery and patient care. METHODS: The review followed key principles of Critical Interpretative Synthesis and was structured around Preferred Reporting Items for Systematic Reviews and Meta-analysis guidelines. Literature searches were conducted in MEDLINE, CINAHL, Embase, and ProQuest-British Nursing Index databases. Twenty studies were included. RESULTS: Findings are reported under four themes: 1, Regulatory and contextual factors; 2, Individual and team level factors; 3, Outcomes of delegation; and 4, Process of implementation and evaluation. Delegation was found to be a complex phenomenon, influenced by a myriad of interconnecting factors at the macro, meso, micro level. At the macro level, the consistency and clarity of government and state level regulations was found to facilitate or impede delegation of medication administration. Lack of clarity at the macro level, impacted at meso and micro levels, resulting in confusion around what medication administration could be delegated and who held responsibility. At the micro level, central to the interpretation of success was the relationship between the delegator and delegatee. This relationship was influenced by personal views, educational and systems factors. Many benefits were reported as an outcome of delegation, including service efficiency and improved patient care. The implementation of delegating medication administration was influenced by regulatory factors, communication, stakeholder engagement, and service champions. CONCLUSION: Delegation of medication administration is a complex process influenced by many interrelating factors. Due to the increased risk associated with medication administration, clear and consistent regulatory and governance frameworks and procedures are crucial. Delegation of medication administration is more acceptable within a framework that adequately supports the process, backed by appropriate policy, skills, training, and supervisory arrangements. There is a need for further research around implementation, clinical outcomes and medication errors associated with delegation of medication administration.

Sexual health and function in women with diabetes.

Sexual dysfunction for women with diabetes is more common than for women without diabetes. The reasons why women with diabetes are a high-risk group are numerous. For example, lack of vaginal lubrication, pain during sex and inability to orgasm can be a consequence of high or low blood glucose levels. Higher rates of depression in people with diabetes can lead to low sexual drive. Wearing of diabetes devices, such as pumps, glucose monitors or lumps from lipohypertrophy around insulin injection sites may affect body image and self-esteem and the inconvenience of self-managing diabetes may affect the spontaneity of sex. This narrative review provides an overview of the problem of sexual dysfunction in women with diabetes, current methods of assessing sexual dysfunction in women, pharmacological and non-pharmacological interventions to treat it and an example of how psychological support for women with diabetes who experience sexual dysfunction can be integrated into a diabetes service. There are still significant gaps in our knowledge of how best to support women with diabetes and sexual dysfunction. However, raising awareness of the problem may help women with diabetes and healthcare professionals to discuss it as part of diabetes clinical consultations.