A qualitative study exploring partner involvement in the management of gestational diabetes mellitus: The experiences of women and partners.

AIMS: The aims of the study were to explore the experiences of women with gestational diabetes mellitus (GDM) and their partners and examine the factors influencing partner involvement in GDM management, seeking to inform a targeted couple-based intervention. DESIGN: A descriptive qualitative study. METHODS: We conducted semi-structured interviews with 14 women with GDM and their partners. Participants were recruited through convenience sampling from a tertiary hospital in Xi'an, China. Data were analysed using thematic analysis. RESULTS: Three themes and 12 subthemes were identified. Theme I: Women's expectations of their partner's involvement in GDM management-practical support and emotional support. Theme II: Partner involvement in GDM management-constructive involvement, unhelpful involvement with good intentions and insufficient involvement. Theme III: Factors that influence partner involvement in GDM-knowledge of GDM, GDM risk perception, health consciousness, attitudes towards the treatment plan, couple communication regarding GDM management, family roles and appraisal of GDM management responsibility. CONCLUSION: Women desired practical and emotional support from partners. The types of partner involvement in GDM management varied. Some partners provided constructive support, while some partners' involvement was limited, non-existent or actively unhelpful. By combining these results with the factors influencing partner involvement, our findings may help healthcare professionals develop strategies to involve partners in GDM care and enhance women's ability to manage GDM. IMPLICATIONS FOR THE PROFESSION AND PATIENT CARE: Partner involvement in GDM care may help them understand and better attend to women's needs, thus improving their experience and potential outcomes. This study highlights novel factors that need to be considered in developing couple-based interventions for this population. REPORTING METHOD: The reporting follows the COREQ checklist. PATIENT OR PUBLIC CONTRIBUTION: Some patients were involved in data interpretation. There is no public contribution.

Prevalence and associated factors of sexual dysfunction in premenopausal women with type 1 diabetes: A systematic review and meta-analysis.

BACKGROUND: Sexual dysfunction (SD) in women with diabetes is a multifaceted complication driven by hormonal, neuropathic and psychosocial factors. It has been reported that the prevalence of SD is higher in women with type 1 diabetes compared to both women with type 2 diabetes and women without diabetes. However, prevalence estimates of SD in women with type 1 diabetes are variable, due to the heterogeneity of the conducted studies and the various confounding factors that are associated with SD. AIM: This review aimed to estimate the prevalence of SD in premenopausal women with type 1 diabetes compared to women without diabetes; consider current methods for measuring SD; and identify factors associated with SD in women with type 1 diabetes. METHOD: A systematic review of the literature was conducted. Four electronic databases (Embase, MEDLINE, CINAHL, PsycINFO) were searched between 15 March and 29 April 2022, the search was updated on 4 February 2023 to identify studies that assessed SD in women with type 1 diabetes. FINDINGS: The search yielded in 1104 articles; of these, 180 were assessed for eligibility. A meta-analysis of eight eligible studies revealed that the odds of experiencing SD is three times higher in women with type 1 diabetes compared to women without diabetes (OR = 3.8 95%CI 1.8-8.0, p < 0.001). The most commonly used measure of SD was the female sexual function index (FSFI); in three studies, this was combined with the female sexual distress scale (FSDS). Factors that have shown significant association with SD are depression, anxiety and duration of diabetes. CONCLUSION: This review has shown that SD is a significant issue for women with type 1 diabetes. These findings should encourage diabetes professionals and policymakers to give more attention to female SD (FSD) by incorporating it into care pathways and clinical guidelines.

'No one ever asks about something that actually is relevant to my life': A qualitative study of diabetes and diabetes care experiences of young women with type 2 diabetes during their reproductive years.

AIM: To understand the health needs, experiences, and views of women with type 2 diabetes in relation to diabetes, reproductive health experiences, and general wellbeing. METHOD: A qualitative study using semi-structured interviews. Thirty-six women with type 2 diabetes (median age 37 years; age ranges 20-45 years; median diabetes duration 4.5 years), recruited through social media and charities in the UK (n = 23) and Turkey (n = 13). Video interviews (n = 28) were audio recorded and transcribed verbatim. Email interviews (n = 8) and transcribed video interviews were analysed using Framework Analysis. RESULTS: Two overarching themes were identified: (1) Perception of self and identity, (2) type 2 diabetes care is not orientated to women's needs. These themes highlight that living with type 2 diabetes was negatively perceived by the women in terms of their self-identity and reproductive health. Women reported that the diabetes care provided was often not appropriate or relevant to their health needs, and neglected issues of relevance to them. The women voiced ideas for enhancing current care to reflect their health needs, in particular the need for more emotional and peer-based support. CONCLUSION: Living with type 2 diabetes may negatively impact how women view themselves and how they relate to the roles they identify with such as, as a partner, mother, colleague. Current healthcare systems are not orientated to the specific needs of younger women with type 2 diabetes with limited opportunities to target their diabetes care around their health and wellbeing concerns and interests.

Pre-pregnancy health of women with pre-existing diabetes or previous gestational diabetes: Analysis of pregnancy risk factors and behavioural data from a digital tool.

AIMS: To examine health behaviours and risk factors in women with pre-existing diabetes or previous gestational diabetes mellitus who are planning pregnancy. METHODS: Health behaviour, risk factor and demographic data obtained from a digital pregnancy planning advisory tool (Tommy's charity UK) were analysed. Descriptive statistical analysis was performed, stratified by diabetes type. RESULTS: Data from 84,359 women, including 668 with type 1 diabetes, 707 with type 2 diabetes and 1785 with previous gestational diabetes obtained over a 12-month period (September 2019-September 2020) were analysed. 65%, 95%CI (61,68%) of women with type 2 diabetes and 46%, 95%CI (43,48%) with previous gestational diabetes were obese (BMI ≥30 kg/m2 ), compared with 26%, 95%CI (26,26%) without diabetes. Use of folic acid supplements was low; 41%, 95%CI (40,41%) of women without diabetes and 42%, 95%CI (40,45%) with previous gestational diabetes reported taking folic acid (any dose) while 47%, 95%CI (43.50%) women with type 1 diabetes and 44%, 95%CI (40,47%) women with type 2 diabetes respectively reported taking the recommended dose (5 mg). More women with type 1 diabetes and type 2 diabetes reported smoking (20%, 95%CI [17,23%] and 23%, 95%CI [20,26%] respectively) and taking illicit/recreational drugs (7%, 95%CI [6,10%] and 9%, 95% CI [7,11%]) compared to women without diabetes (smoking 17%, 95% CI [16,17%], drug use 5%, 95%CI [5,5%]). Alcohol consumption, low levels of physical activity and of fruit and vegetable intake were also evident. CONCLUSIONS: This study highlights the potential of online pregnancy planning advisory tools to reach high-risk women and emphasises the need to improve pre-pregnancy care for women with pre-existing diabetes and previous gestational diabetes, many of whom are actively seeking advice. It is also the first to describe pre-pregnancy health behaviours in women with previous gestational diabetes.

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.

The perceived effects of COVID-19 while living with a chronic illness.

INTRODUCTION: A diagnosis of chronic illness posed a serious threat to people during the recent COVID-19 pandemic. People with chronic illnesses were faced with increased mortality and reduced access to healthcare. Self-care is the process of maintaining health and managing a chronic illness. Nurses working in specialist services provide healthcare education to people with chronic illnesses. Access to these nurses was decreased during periods of the COVID-19 virus escalation due to the reconfiguration of services and redeployment of nurses. The purpose of the research was to learn from the experiences of people with a chronic illnesses in self-care behaviors and accessing altered healthcare services to inform future practices. DESIGN: A population survey design. METHODS: A mixed methods survey was designed, combining validated questionnaires and scales with open-ended questions. A convenience sample was utilized via using social media platforms. Data analysis included descriptive and inferential statistics. Content analysis was used to analyze open-ended responses. RESULTS: There were 147 responses, with approximately half reporting no changes in face-to-face healthcare contact, 41% reporting decreased contacts and 12% increased contacts. Non-face-to-face contacts were reduced by almost 9%, did not change by almost 60%, while 33% indicated an increase. Participants reported mixed perceptions in contact with healthcare providers during restrictions. In the Patient Assessment of Chronic Illness Care and the Self-Care of Chronic Illness scales, participants scored statistically lower scores than in previous studies. Participants indicated that public health restrictions negatively impacted their confidence, created challenges with re-engaging and that access to care was more difficult. CONCLUSION: This research highlights the importance of providing continued support to people with chronic illness irrespective of other challenges to healthcare services. A structured approach to virtual self-care education is required. CLINICAL RELEVANCE: This research concluded that the experience of access to one healthcare professional as opposed to diverse multidisciplinary input was similar for a number of chronic illnesses groups of people during the COVID-19 pandemic. There was an altered dynamic of virtual contacts with healthcare providers and a lack of confidence interpreting what monitoring was required by people with a chronic illnesses due to a lack of preparedness for virtual healthcare delivery.

The impact of the COVID-19 pandemic on people with diabetes and diabetes services: A pan-European survey of diabetes specialist nurses undertaken by the Foundation of European Nurses in Diabetes survey consortium.

AIM: To describe diabetes nurses' perspectives on the impact of the COVID-19 pandemic on people with diabetes and diabetes services across Europe. METHODS: An online survey developed using a rapid Delphi method. The survey was translated into 17 different languages and disseminated electronically in 27 countries via national diabetes nurse networks. RESULTS: Survey responses from 1829 diabetes nurses were included in the analysis. The responses indicated that 28% (n = 504) and 48% (n = 873) of diabetes nurses felt the COVID-19 pandemic had impacted 'a lot' on the physical and psychological risks of people with diabetes, respectively. The following clinical problems were identified as having increased 'a lot': anxiety 82% (n = 1486); diabetes distress 65% (n = 1189); depression 49% (n = 893); acute hyperglycaemia 39% (n = 710) and foot complications 18% (n = 323). Forty-seven percent (n = 771) of respondents identified that the level of care provided to people with diabetes had declined either extremely or quite severely. Self-management support, diabetes education and psychological support were rated by diabetes nurse respondents as having declined extremely or quite severely during the COVID-19 pandemic by 31% (n = 499), 63% (n = 1,027) and 34% (n = 551), respectively. CONCLUSION: The findings show that diabetes nurses across Europe have seen significant increases in both physical and psychological problems in their patient populations during COVID-19. The data also show that clinical diabetes services have been significantly disrupted. As the COVID-19 situation continues, we need to adapt care systems with some urgency to minimise the impact of the pandemic on the diabetes population.

The impact of online self-management interventions on midlife adults with type 2 diabetes: a systematic review.

BACKGROUND: Online self-management education programmes are now recommended for people with type 2 diabetes to improve self-management capacities. There is limited evidence to determine whether such programmes improve the health outcomes for midlife adults with diabetes. AIMS: The purpose of this systematic review was to assess the impact of online self-management interventions with digital consulting on glycated haemoglobin (HbA1c), total cholesterol, blood pressure, diabetes distress, self-efficacy, and depression in midlife adults. METHODS: A systematic review was undertaken searching Medline, Embase and CINAHL. Studies were appraised using the Cochrane Collaboration's tool. RESULTS: Eight studies were included. Online interventions resulted in the improvement of HbA1c (pooled mean difference on HbA1c: -0.35%, 95% CI (-0.52, -0.18), P<0.001). A narrative synthesis was conducted for all secondary outcomes. No conclusions could be drawn on the impact of these outcomes. CONCLUSION: Online interventions improve HbA1c. Further research is needed for secondary outcomes.

Interventions to increase the uptake of postpartum diabetes screening among women with previous gestational diabetes: a systematic review and Bayesian network meta-analysis.

OBJECTIVE: This study aimed to summarize the current interventions aimed at improving postpartum diabetes screening attendance and to compare their effectiveness. DATA SOURCES: Literature searches were conducted in the Web of Science, Embase, Cochrane Library, CINAHL, and PubMed from inception to March 20, 2023. STUDY ELIGIBILITY CRITERIA: Quantitative studies involving an intervention to increase postpartum diabetes screening attendance among women with gestational diabetes mellitus were included. METHODS: The Joanna Briggs Institute checklists were used for the quality appraisal of the included studies. A Bayesian network meta-analysis was performed to synthesize the comparative effectiveness of the relevant interventions aimed at improving postpartum diabetes screening rates. RESULTS: A total of 40 studies were included in this review with pooled data from 17,123 women. Studies included randomized controlled trials (n=11, including 3 US-based studies and 8 non-US-based studies) and nonrandomised studies (n=29, including 13 US-based studies and 16 non-US-based studies). Of the 14 studies that reported screening outcomes, 11 detected early type 2 diabetes at a rate ranging from 2.0% to 23.0%. The types of interventions identified included reminders (eg, postal letters, emails, and phone messages), educational interventions, screening methods and delivery, policy changes, antenatal groups, and multimodal interventions. Based on the network meta-analysis from randomized controlled trials, antenatal group intervention, which refers to antenatal patient education delivered in groups (1 US-based study), had the highest probability to be the most effective intervention (odds ratio, 10; 95% confidence interval, 1.6-77.0), followed by one-to-one educational intervention with written educational materials or counselling (odds ratio, 6.9; 95% confidence interval, 3.6-16.0). The results from nonrandomized studies indicated that flexible screening methods and delivery (2 US-based studies) had the greatest impact on screening uptake (odds ratio, 3.9; 95% confidence interval, 1.8-10.0), followed by educational interventions (1 US-based study and 2 non-US-based studies) with antenatal patient education and written educational materials (odds ratio, 3.4; 95% confidence interval, 1.9-6.3) and antenatal groups (odds ratio, 3.3; 95% confidence interval, 1.7-6.7). CONCLUSION: The presented evidence suggests that antenatal patient education delivered in groups and offering more flexible screening methods were associated with the greatest increase in attendance. The multimodal interventions and reminders could still be important if they were more theoretically grounded and were more integrated into the healthcare system.

The effects of a couple-based gestational diabetes mellitus intervention on self-management and pregnancy outcomes: A randomised controlled trial.

AIMS: To estimate the effectiveness of the Couples Coping with Gestational Diabetes Mellitus (GDM) Programme on GDM self-management and pregnancy outcomes. METHODS: A randomised controlled trial among pregnant women with suboptimal GDM self-management and their partners was undertaken. Couples recruited from three hospitals in China were randomly allocated to either intervention (n = 70) or control (n = 70) conditions. Couples in the intervention group underwent the couple-based intervention (GDM education, shared illness appraisals, initiation of collaborative action and consolidation of collaborative action). Women in the control group received individual GDM education. Data were analysed using the independent samples t-test, chi-square test, and generalised estimating equations. RESULTS: GDM knowledge for the women and their partners and GDM self-management significantly improved in both the intervention and control groups, with stronger improvement in the intervention group. Women in the intervention group gained significantly less weight than those in the control group (11.2 kg ± 2.8 kg vs 13.1 kg ± 2.6 kg, p = 0.008). Infant birth weights were significantly lower in the intervention group (3.2 kg ± 0.3 kg vs 3.4 kg ± 0.4 kg, p = 0.008). There were no significant differences in other pregnancy outcomes. CONCLUSIONS: The Couples Coping with GDM Programme was associated with improvements in GDM knowledge of women and their partners and in women's self-management, and with lower gestational weight gain and infant birth weight.

Which diabetes specific patient reported outcomes should be measured in routine care? A systematic review to inform a core outcome set for adults with Type 1 and 2 diabetes mellitus: The European Health Outcomes Observatory (H2O) programme.

OBJECTIVES: The objective was to identify candidate patient reported outcomes with potential to inform individual patient care and service development for inclusion in a digital outcome set to be collected in routine care, as part of an international project to enhance care outcomes for people with diabetes. METHODS: PubMed, COSMIN and COMET databases were searched. Published studies were included if they recommended patient reported outcomes that were clinically useful and/or important to people with diabetes. To aid selection decisions, recommended outcomes were considered in terms of the evidence endorsing them and their importance to people with diabetes. RESULTS: Twenty-seven studies recommending 53 diabetes specific outcomes, and patient reported outcome measures, were included. The outcomes reflected the experience of living with diabetes (e.g. psychological well-being, symptom experience, health beliefs and stigma) and behaviours (e.g. self-management). Diabetes distress and self-management behaviours were most endorsed by the evidence. CONCLUSIONS: The review provides a comprehensive list of candidate outcomes endorsed by international evidence and informed by existing outcome sets, and suggestions for measures. PRACTICE IMPLICATIONS: The review offers evidence to guide clinical application. Integrated measurement of these outcomes in care settings holds enormous potential to improve provision of care and outcomes in diabetes.

Experiences and needs of Saudi mothers when a child or adolescent is diagnosed with type 1 diabetes mellitus: a qualitative study.

AIM: To explore the experiences of Saudi mothers with children or adolescents who have Type 1 diabetes mellitus at time of diagnosis. BACKGROUND: The Kingdom of Saudi Arabia (KSA) has one of the highest incidence rates of Type 1 diabetes mellitus in children and adolescents in the world. Few studies have considered the most appropriate methods of support for parents in the KSA and none report the experiences of Saudi mothers. DESIGN: Phenomenological inquiry. METHOD: Qualitative interviews were conducted with 11 Saudi mothers and data were analysed following Giorgi's 5-step method. RESULTS: The lived experiences of Saudi mothers coalesced around three overarching themes and eight subthemes: 1. In the dark (mother's instinct, challenges of diagnosis phase, cultural reflections); 2. Empowerment (methods of support, mother's health and wellbeing); 3. Coping and acceptance (stigma and cultural perceptions, coping strategies, transformation and adaptation). CONCLUSIONS: Effective interventions delivered in other countries to support mothers may be effective in the KSA. However, the central role that Saudi mothers play in the management of their child's condition, and the place of Islam in Saudi society, indicate the need for customized methods of support that take into account psychosociocultural needs of both mother and child.

The Impact of Type 2 Diabetes on Women's Health and Well-being During Their Reproductive Years: A Mixed-methods Systematic Review.

BACKGROUND: The incidence of Type 2 Diabetes (T2DM) among younger women now accounts for 40% of females with T2DM. Women of reproductive age with T2DM have additional health considerations and their needs may differ from older populations. OBJECTIVES: The aims were (1) to identify the health issues encountered by women aged 16-45 years living with T2DM; (2) to determine the modifiable risk factors associated with living with diabetes; (3) to specify ideas for interventions to meet age and gender-specific diabetes-related healthcare needs. METHODS: A systematic search was performed in the following databases; MEDLINE, PsycINFO, EMBASE, CINAHL, Web of Science, and Maternity and Infant Care. Databases were searched without time and study design limits. The Mixed Methods Appraisal Tool was used to assess the methodological quality of included studies. Data were narratively synthesised due to mixed methods evidence included. RESULTS: A total of 32 papers were included in the review from which six domains were identified from the synthesis: (1) diabetes related modifiable risk factors: blood glucose, cardiovascular risk, neuropathy/nephropathy/retinopathy, diabetes self-management barriers (2) reproductive health: diabetes care before pregnancy, pre-pregnancy care barriers and expectations of women, contraceptive use (3) psychosocial wellbeing: depression symptoms and diabetes distress, perception of T2DM, emotional concerns about pregnancy (4) sexual function; (5) menopause; (6) sociocultural factors: social support, cultural norms. CONCLUSION: This review highlighted specific health issues affecting women of reproductive age with T2DM and which represent an important focus for health services research and health care delivery. Future research needs to address identified health domains to improve women's health and well-being living with T2DM.

The gestational diabetes future diabetes prevention study (GODDESS): A partially randomised feasibility controlled trial.

OBJECTIVES: To assess the feasibility of an ante- and post-natal lifestyle intervention for women with gestational diabetes mellitus (GDM) to reduce type 2 diabetes risk. DESIGN: A partially randomised patient preference feasibility trial. SETTING: Diabetes antenatal clinics in two inner-London hospitals, UK. PARTICIPANTS: Pregnant women ≥18 years with a GDM diagnosis and pre-pregnancy body mass index of ≥25kg/m2. INTERVENTION: Participants in the intervention group were offered four motivational interview-based sessions (two antenatally and two postnatally, at 3 and 6 months postpartum), a WhatsApp support group, a FitBit and electronic self-help resources. OUTCOME MEASURES: Recruitment; retention; intervention dose received; data completion; adaptions; proportion achieving ≥5% weight loss; weight change, blood glucose; blood pressure; diet, physical activity, breastfeeding and depression. Clinical outcomes were measured at baseline and 6 months postpartum. RESULTS: 50 participants were recruited from 155 eligible women (32% recruitment rate). Thirty-four were recruited to the intervention group (23 following randomisation (RI-group) and 11 based on preference (PI-group)); and 16 to the control group (13 randomised (RC-group) and 3 preference (PC-group)). Attrition was 44% (n = 22/50). Forty-six percent (n = 6) of the intervention group (25% (n = 2) of the RI-group and 80% (n = 4) of the PI-group) achieved ≥5% weight loss compared to 8% (n = 1) in the control group (95% confidence interval (CI) -0.69 to 0.07). Mean weight change was -2.1kg±9.0 in the intervention group (0kg±5.4 in the RI-group and -5.4kg±13.0 in the PI-group) compared to +4.4kg±4.9 in the control group (RC +4.4kg ±5.3 and PC +4.7kg ±3.1, 95% CI -12.4 to 0.2). CONCLUSIONS: Recruitment was feasible, but strategies to improve retention are needed. The findings suggest the intervention can support women with GDM to lose weight. The observed weight loss was primarily in women who preferred the intervention. Therefore, future trials may need to adopt a preference design and consider factors associated with preference. TRIAL REGISTRATION: Trial registration: ISRCTN52675820 https://www.isrctn.com/ISRCTN52675820?q=ISRCTN52675820&filters=&sort=&offset=1&totalResults=1&page=1&pageSize=10&searchType=basic-search.

Protocol for a feasibility study and process evaluation of a psychosocially modelled diabetes education programme for young people with type 1 diabetes: the Youth Empowerment Skills (YES) programme.

INTRODUCTION: Adolescence is a challenging period for young people with type 1 diabetes, associated with worsening glycaemia and care disengagement. Educational interventions in this period tend to focus on diabetes-specific skills, with less emphasis on the psychosocial challenges associated with diabetes experienced by young people. To address this limitation, we codesigned with young people a psychosocially modelled programme of diabetes education, named 'Youth Empowerment Skills' (YES). The programme aims to facilitate a positive adaptation to life with diabetes and engagement with diabetes care through peer-based learning, immersive simulations and support from an outreach youth worker. Here, we present a protocol for a feasibility study of the YES programme. METHODS AND ANALYSIS: The study was designed following the Medical Research Council Complex Intervention Evaluation Framework to: test the feasibility (acceptance, implementability, recruitment and completion) of the YES programme; and estimate its efficacy in relation to metabolic and psychosocial outcomes. The study will take place in diabetes centres serving socioculturally diverse populations. We will conduct a feasibility randomised controlled trial (waiting-list design) with integrated process evaluation. Fifty young people with type 1 diabetes (aged 14-19 years) will be randomly allocated to either the YES intervention or a waiting-list control. Randomisation acceptability will be assessed with provision for a preference allocation. Outcomes will be evaluated at 6 months, at which point the waiting list participants will be exposed to the YES programme with further follow-up to 12 months. A simultaneous process evaluation will use a mixed-methods approach collecting qualitative and quantitative data. Study findings will be used to optimise the intervention components, outcome measures and recruitment methods to inform a subsequent definitive trial. ETHICS AND DISSEMINATION: The protocol has ethical approval from the UK Health Research Authority (approval IRAS project ID: 279877). Findings will be disseminated in multiple formats for lay and professional audiences. PROTOCOL DATE AND VERSION: 7 April 2021, V.1.1. TRIAL REGISTRATION NUMBER: NCT04670198.

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.

An integrated pre-pregnancy care programme framework theoretically modelled from the perspectives of women with Type 2 diabetes and healthcare professionals.

BACKGROUND: Pregnancies in women with diabetes are associated with significant additional risks for the fetus, infant and mother such as, higher risk of stillbirths or congenital anomalies. Pre-pregnancy care can attenuate these risks. However, while women with Type 2 diabetes account for half of pregnancies in women with pre-existing diabetes, they are much less likely to receive pre-pregnancy care than women with Type 1 diabetes. This discrepancy may be related to the fact that most pre-pregnancy care is located in specialist diabetes centres where women with Type 1 diabetes are managed; whereas women with Type 2 diabetes are managed in primary care and reproductive care is not a routine element of diabetes care. Therefore, to improve pre-pregnancy care among women with Type 2 diabetes strategies need to be tailored to the specific needs of this group and the context of their diabetes care. OBJECTIVES: This paper seeks to inform the development of an integrated pre-pregnancy care programme by presenting strategies identified by women with Type 2 diabetes and healthcare professionals that address some of the barriers they experience in relation to pre-pregnancy care. METHODS: A qualitative study using semi-structured in-depth interviews with women of reproductive age with Type 2 diabetes (n=30) and diabetes healthcare professionals (n=22) from both primary and secondary care. Data were transcribed verbatim and analysed thematically using Framework Analysis. The identified themes were then mapped to create a theoretical intervention framework using Normalisation Process Theory and the Capabilities, Opportunity, and Motivation to perform a Behaviour model. RESULTS: Six themes were identified expressing the need for a multimodal approach for improving the uptake of pre-pregnancy care in women with Type 2 diabetes. These themes were then mapped onto the constructs of Normalisation Process Theory as follows: coherence (enhancing understanding of reproductive needs among women and healthcare professionals); cognitive participation (constructing a positive narrative for pregnancy and Type 2 diabetes); collective action (increasing the visibly of the reproductive needs of women, integrating healthcare systems and utilising supportive technologies); and reflexive monitoring (using multi-modal approaches to support systemised care). The data were also modelled to identify target behaviours for intervention detailing what needs to be done by whom, when and where. CONCLUSION: Women with Type 2 diabetes account for half of pregnancies in those with pre-existing diabetes; however, they are less likely to receive pre-pregnancy care than women with Type 1 diabetes. Pre-pregnancy care can reduce the maternal and fetal risks associated with Type 2 diabetes. This study presents strategies to improve the current low uptake of pre-pregnancy care for women with Type 2 diabetes. These strategies have been tailored to the specific needs of women and healthcare professionals and support integration within the woman's routine diabetes management.

A co-design study to develop supportive interventions to improve psychological and social adaptation among adults with new-onset type 1 diabetes in Denmark and the UK.

OBJECTIVE: To develop supportive interventions for adults with new-onset type 1 diabetes (T1D) to facilitate positive adaptive strategies during their transition into a life with diabetes. DESIGN: The study used a co-design approach informed by Design Thinking to stimulate participants' reflections on their experiences of current care and generate ideas for new supportive interventions. Visual illustrations were used to depict support needs and challenges. Initial discussions of these needs and challenges were facilitated by researchers and people with diabetes in workshops. Data comprising transcribed audio recordings of the workshop discussions and materials generated during the workshops were analysed thematically. SETTINGS: Specialised diabetes centres in Denmark and the United Kingdom. PARTICIPANTS: Adults with new-onset T1D (n=24) and healthcare professionals (HCPs) (n=56) participated in six parallel workshops followed by four joint workshops with adults (n=29) and HCPs (n=24) together. RESULTS: The common solution prioritised by both adults with new-onset T1D and HCP participants was the development of an integrated model of care addressing the psychological and social elements of the diagnosis, alongside information on diabetes self-management. Participants also indicated a need to develop the organisation, provision and content of care, along with the skills HCPs need to optimally deliver that care. The co-designed interventions included three visual conversation tools that could be used flexibly in the care of adults with new-onset T1D to support physical, psychological and social adaptation to T1D. CONCLUSION: This co-design study has identified the care priorities for adults who develop T1D, along with some practical conversational tools that may help guide HCPs in attending to the disruptive experience of the diagnosis and support adults in adjusting into a life with diabetes.

The experiences of prepregnancy care for women with type 2 diabetes mellitus: a meta-synthesis.

BACKGROUND: Diabetes is one of the most common medical conditions affecting pregnancy and is associated with a number of adverse fetal, infant, and maternal outcomes. These adverse outcomes can be avoided or minimized with appropriate prepregnancy care (PPC). However, the uptake of PPC is limited in women with type 2 diabetes mellitus (T2DM). The reasons for poor uptake are multifactorial, reflecting both women's understanding of pregnancy risks, and limitations in care delivery. METHODS: A systematic literature review with meta-synthesis was undertaken to identify qualitative studies exploring experiences of PPC for women with T2DM incorporating the views of women with T2DM and health care professionals (HCPs). Identified studies included were synthesized in a meta-ethnography to develop an understanding of the elements contributing to the uptake of PPC among women with T2DM. RESULTS: The systematic review identified seven studies yielding data from 28 women with T2DM and 83 HCPs. The following six third-order constructs were identified from the synthesis: understanding PPC, emotive catalysts, beliefs about reproduction among women with T2DM, relationships and social factors, HCP behaviors and perspectives, and health care system factors. These constructs were used to develop a multifactorial model expressing the interactive issues that shape the reproductive health-seeking behaviors of women with T2DM to identify potential areas for intervention. CONCLUSION: The uptake of PPC among women with T2DM seems to be informed by their personal orientation to their reproductive needs, their interactions with HCPs, and system-level influences. Future interventions to enhance PPC uptake need to address these underlying issues.