Standardising personalised diabetes care across European health settings: A person-centred outcome set agreed in a multinational Delphi study.

OBJECTIVE: Standardised person-reported outcomes (PRO) data can contextualise clinical outcomes enabling precision diabetes monitoring and care. Comprehensive outcome sets can guide this process, but their implementation in routine diabetes care has remained challenging and unsuccessful at international level. We aimed to address this by developing a person-centred outcome set for Type 1 and Type 2 diabetes, using a methodology with prospects for increased implementability and sustainability in international health settings. METHODS: We used a three-round questionnaire-based Delphi study to reach consensus on the outcome set. We invited key stakeholders from 19 countries via purposive snowball sampling, namely people with diabetes (N = 94), healthcare professionals (N = 65), industry (N = 22) and health authorities (N = 3), to vote on the relevance and measurement frequency of 64 previously identified clinical and person-reported outcomes. Subsequent consensus meetings concluded the study. RESULTS: The list of preliminary outcomes was shortlisted via the consensus process to 46 outcomes (27 clinical outcomes and 19 PROs). Two main collection times were recommended: (1) linked to a medical visit (e.g. diabetes-specific well-being, symptoms and psychological health) and (2) annually (e.g. clinical data, general well-being and diabetes self management-related outcomes). CONCLUSIONS: PROs are often considered in a non-standardised way in routine diabetes care. We propose a person-centred outcome set for diabetes, specifically considering psychosocial and behavioural aspects, which was agreed by four international key stakeholder groups. It guides standardised collection of meaningful outcomes at scale, supporting individual and population level healthcare decision making. It will be implemented and tested in Europe as part of the H2O project.

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.

Effectiveness of interventions for improving physical activity level in working-age people (aged 18-60 years) with type 2 diabetes: a systematic review and meta-analysis.

BACKGROUND: The increasing prevalence of type 2 diabetes in working-age people imposes a substantial societal burden. Although physical activity is crucial for diabetes management, limited evidence exists to inform optimal strategies for promoting physical activity in this population. We aimed to determine and compare the effectiveness of interventions for increasing physical activity level in working-age people with diabetes. METHODS: In this systematic review and meta-analysis, we searched Web of Science, the Cochrane Library, Medline, Embase, PsycINFO, ClinicalTrials.gov, and ICTRP for papers published between Jan 1, 1931, and June 30, 2022, in English. Search terms included "physical activity", "diabetes", and "randomised controlled trial". We included trials reporting the effects of interventions on physical activity level (objectively or subjectively measured) in people with type 2 diabetes aged 18-60 years. Two independent reviewers conducted summary data extraction and quality assessment. We used pairwise random-effects, frequentist network meta-analyses, and meta-regression to obtain pooled effects. Heterogeneity was evaluated using I2 statistic. The risk of bias and certainty of evidence were assessed using the Cochrane risk-of-bias 2 tool and the Grading of Recommendations Assessment, Development, and Evaluation. This study is registered with PROSPERO (CRD42022323165). FINDINGS: We identified 52 trials (6257 participants) from 21 countries (32 Asia, ten North America, eight Europe, one Australia, one Africa). The overall risk of bias was classified as "some concerns" for included studies. Four types of interventions (structured exercise training, physical activity education, psychological intervention, physical activity education plus psychological intervention) were identified. Compared with control groups, the interventions showed significant effects in objectively measured (standardised mean difference 0·77, 95% CI 0·27-1·27, low certainty), subjectively measured (0·88, 0·40-1·35, very low certainty), and overall physical activity (0·82, 0·48-1·16, moderate certainty). Physical activity education exerted large effect in overall physical activity compared with control groups. Psychological intervention exerted large effects in overall physical activity compared with other interventions. Heterogeneity was high (I2=96-97%). Intervention setting (p=0·04) and facilitator (p=0·03) showed effects on heterogeneity. INTERPRETATION: Psychologically modelled education might be the most beneficial way of promoting physical activity. Intervention setting and facilitator type should be considered when designing interventions for improving physical activity level in working-age people with type 2 diabetes. Limitations of this review include restriction to the English language and considerable heterogeneity between studies. FUNDING: King's-China Scholarship Council PhD Scholarship (202108440151).

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.

Essential steps in primary care management of older people with Type 2 diabetes: an executive summary on behalf of the European geriatric medicine society (EuGMS) and the European diabetes working party for older people (EDWPOP) collaboration.

We present an executive summary of a guideline for management of type 2 diabetes mellitus in primary care written by the European Geriatric Medicine Society, the European Diabetes Working Party for Older People with contributions from primary care practitioners and participation of a patient's advocate. This consensus document relies where possible on evidence-based recommendations and expert opinions in the fields where evidences are lacking. The full text includes 4 parts: a general strategy based on comprehensive assessment to enhance quality and individualised care plan, treatments decision guidance, management of complications, and care in case of special conditions. Screening for frailty and cognitive impairment is recommended as well as a comprehensive assessment all health conditions are concerned, including end of life situations. The full text is available online at the following address: essential_steps_inprimary_care_in_older_people_with_diabetes_-_EuGMS-EDWPOP___3_.pdf.

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.

Lipohypertrophy and Insulin: An Update From the Diabetes Technology Society.

Lipohypertrophy is a common skin complication associated with insulin-treated diabetes. The impact of lipohypertrophy as a contributing factor to suboptimal glycemic control, glucose variability, and hypoglycemia is often under-recognized by health care professionals. In a recent Webinar on April 26, 2023, Diabetes Technology Society asked international experts to provide updates on the latest knowledge related to lipohypertrophy for practicing clinicians and educators, researchers, and industries involved in insulin delivery. A recording of the Webinar is freely available on the Diabetes Technology Society Web site (https://www.diabetestechnology.org/).

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.

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.

'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.

Knowledge of young people living with type 1 diabetes and their caregivers about its management.

AIMS AND OBJECTIVE: We sought to investigate knowledge and skills of type 1 diabetes (T1D) management among young people living with the disease and their caregivers. Our aim is to provide baseline evidence to inform T1D self-management education for young people living with the disease and their caregivers. BACKGROUND: Both local and international guidelines recommend ongoing T1D self-management education for people living with the disease. This is because T1D often develops among young people who rarely have the competencies to adequately manage their condition. However, the extent to which young people living with T1D and their caregivers can self-manage this chronic disease in a low-resource country like Ghana is unknown. METHODS: Using a phenomenological study design, semi-structured interviews were conducted with 28 young people living with type 1 diabetes, 12 caregivers and 6 healthcare providers in southern Ghana. Data were collected at homes, hospitals and support group centres of participants via face-to-face interviews, photovoice and video-conferencing. The data were analysed thematically using QSR NVivo 11. RESULTS: The young people living with T1D and their caregivers demonstrated knowledge and skills in the self-monitoring of blood glucose, and the treatment of hyperglycaemia. Areas of more marginal or lack of knowledge were concerning carbohydrate counting, severe hypoglycaemia and the management of intercurrent illnesses. Young persons living with T1D and their caregivers received their management information from healthcare and non-healthcare providers. Access to diabetes self-management education influenced T1D management knowledge and practices. CONCLUSION: Young people living with type 1 diabetes and their caregivers possessed limited scope of knowledge on type 1 diabetes self-management. Multiple sources of T1D knowledge were found, some of which may not be helpful to patients. The knowledge gaps identified compromises transitional independence and self-management capacity. RELEVANCE TO CLINICAL PRACTICE: It is important for clinicians and organizations that provide T1D education to provide diabetes self-management education also on managing hypoglycaemia, carbohydrate counting and managing T1D during intercurrent life events among young people living with T1D. NO PATIENT OR PUBLIC CONTRIBUTION: Patients and their caregivers were interviewed as research participants. They did not conceptualize, analyse, interpret or prepare the manuscript.

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.

Glycaemic variability and progression of chronic kidney disease in people with diabetes and comorbid kidney disease: Retrospective cohort study.

AIM: To investigate the association between glycaemic variability and the development of End-Stage-Kidney-Disease (ESKD) among individuals with diabetes and chronic kidney disease. METHODS: A cohort study using UK electronic primary care health records from the Clinical Practice Research Datalink. Glycaemic variability was assessed using a variability score and intra-individual coefficient of variation (CV) of HbA1c. We calculated sub-distribution hazard ratios (sHR) for developing ESKD using competing risk regression analysis. RESULTS: There were 37,222 eligible participants (45.5 % male), with a mean age of 76.4 years (SD ± 9.2), and a mean baseline eGFR 40.7 (±10.7) ml/min/1.73 m2. There were 5,086 incidents of ESKD in the follow-up period. The adjusted sHR (95 %CI) for each variability score group, were as follows: 21-40, 1.38 (1.27-1.50); 41-60, 1.54 (1.41-1.68); 61-80, 1.61 (1.45-1.79); and 81-100, 1.42 (1.19-1.68), compared with the group (score 0-20) with least variability. The adjusted sHR for CV were as follows: 6.7-9.9, 1.29 (1.15-1.45); 10.0-13.9, 1.55 (1.39-1.74); 14.0-20.1, 1.79 (1.60-2.01) and ≥20.2, 2.10 (1.88-2.34) compared to reference group 0-6.6. CONCLUSIONS: Glycaemic variability was strongly associated with the development of ESKD in people with diabetes and CKD.

A Mobile Phone App for the Prevention of Type 2 Diabetes in Malaysian Women With Gestational Diabetes Mellitus: Protocol for a Feasibility Randomized Controlled Trial.

BACKGROUND: Over 50% of women with a history of gestational diabetes mellitus (GDM) will develop type 2 diabetes (T2D) in later life. Asian women experience a disproportionate risk of both GDM and T2D compared to women from other ethnic backgrounds. Lifestyle interventions and behavior change can delay or even prevent the onset of T2D. We have developed a digitalized diabetes prevention intervention for the prevention of T2D in Malaysian women with GDM. OBJECTIVE: The protocol describes a randomized controlled trial (RCT) to test the feasibility of undertaking a definitive trial of a diabetes prevention intervention, including a smartphone app and group support. Secondary aims are to summarize anthropometric, biomedical, psychological, and lifestyle outcomes overall and by allocation group, and to undertake a process evaluation. METHODS: This is a two-arm parallel feasibility RCT. A total of 60 Malaysian women with GDM will be randomized in the antenatal period to receive the intervention or standard care until 12 months post partum. The intervention is a diabetes prevention intervention delivered via a smartphone app developed based on the Information-Motivation-Behavioral Skills model of behavior change and group support using motivational interviewing. The intervention provides women with tailored information and support to encourage weight loss through adapted dietary intake and physical activity. Women in the control arm will receive standard care. The Malaysian Ministry of Health's Medical Research and Ethics Committee has approved the trial (NMRR-21-1667-60212). RESULTS: Recruitment and enrollment began in February 2022. Future outcomes will be published in peer-reviewed health-related research journals and presented at national, regional, or state professional meetings and conferences. This publication is based on protocol version 2, January 19, 2022. CONCLUSIONS: To our knowledge, this will be the first study in Malaysia that aims to determine the feasibility of a digital intervention in T2D prevention among women with GDM. Findings from this feasibility study will inform the design of a full-scale RCT in the future. TRIAL REGISTRATION: ClinicalTrials.gov NCT05204706; https://clinicaltrials.gov/ct2/show/NCT05204706. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/37288.

Psychologically informed oral health interventions in pregnancy and type 2 diabetes: a scoping review protocol.

INTRODUCTION: Periodontal health is becoming a recognised component in managing gestational diabetes. Gestational diabetes is characterised as raised blood glucose levels first discovered in pregnancy and managed similarly to type 2 diabetes. Currently, the standard intervention for gestational diabetes in the UK entails dietary modifications and physical activity interventions. However, considering the literature discussed in this review, it is argued that oral health advice and support should also become an integrated part of gestational diabetes management. OBJECTIVE: The objective of this scoping review is to map out psychologically informed oral health interventions in pregnancy and type 2 diabetes. This will inform the development of a new behavioural intervention to promote oral health-related behaviours in women with gestational diabetes. As no literature exists on oral health interventions in gestational diabetes, it was deemed appropriate to synthesise the evidence on oral health interventions designed for pregnant women and individuals with type 2 diabetes. METHODOLOGY: The scoping review will be conducted using the Joanna Briggs Institute's methodology for scoping reviews. Studies including pregnant women and individuals with type 2 diabetes over 18 years of age will be included. Only studies including a psychologically informed oral health intervention will be considered. The authors will consider experimental and quasi-experimental research designs. The Ovid Interface including EMBASE, Medline, Global Health, APA PsychInfo, Health Management Information, Maternity, Infant Care Database and the Cochrane Library will be used as information sources. The planned searches will commence on the week of the 25 July 2022. Only articles in Danish and English will be considered. The study selection will follow the Preferred Reporting Items for Scoping Reviews process. The data will be presented using narrative synthesis. ETHICS AND DISSEMINATION: No ethical approval is needed for this review. The results will be published in a relevant scientific journal.

The experiences of insulin use among older people with Type 2 diabetes mellitus: A thematic synthesis.

BACKGROUND: Type 2 diabetes mellitus is common in older people. Managing diabetes in older people can be challenging due to comorbidities and age-related disabilities, particularly in the context of insulin therapy. The purpose of this review is to explore older people's experiences of insulin use and to consider how these experiences might inform healthcare delivery. REVIEW METHODS: A systematic review with thematic synthesis was conducted and reported in accordance with the PRISMA and ENTREQ statements. MEDLINE, Embase, PsycInfo, CINAHL and Web of Science were searched from 1985 to September 2019 with subsequent updates in December 2019 and June 2022. Included studies were quality appraised, findings tabulated, and results used to inform an integrated thematic synthesis. RESULTS: Fourteen studies that reported insulin experiences with 274 patients aged 60 years and over were included; nine of the studies were qualitative and five used questionnaires surveys. Seven themes emerged that were grouped into treatment-related factors (physical impact of insulin, physical capacity to administer insulin, insulin self-management behaviours) and person-centred factors (emotional factors, social factors, daily living, and personal knowledge/beliefs). Three analytical themes to guide clinical practice were derived from the data: addressing physical capacity and ability, supporting social and emotional issues and improving interactions with healthcare professionals. CONCLUSION: The review indicates issues surrounding the technical aspects of insulin administration, side effects of treatment and reactions to insulin administration are common amongst older people. However, research evidence is limited, and there is an urgent need for empirical, participatory research with older insulin dependent adults with type 2 diabetes. IMPLICATIONS FOR PRACTICE: Healthcare professionals need to ensure that older type 2 diabetes people on insulin are actively involved in their own care, to allow their insulin regimens to be personalised and aligned with their goals and expectations. Tailored educational interventions to reduce treatment hazards and promote physical and psychological wellbeing are also needed for this population.

Study protocol on risk factors for the diagnosis of gestational diabetes mellitus in different trimesters and their relation to maternal and neonatal outcomes (GDM-RIDMAN).

INTRODUCTION: Gestational diabetes mellitus (GDM) is often associated with adverse pregnancy outcomes. However, the association of risk factors with GDM diagnosis, maternal and neonatal health outcomes is less established when compared with women without GDM. We aim to examine the diagnostic accuracy of the conventional and novel risk factors for a GDM diagnosis and their impact on maternal and neonatal health outcomes. METHODS AND ANALYSIS: This retrospective cohort and nested case-control study at six public health clinics is based on medical records and questionnaire survey of women between 2 and 12 months postpartum. The estimated required sample size is 876 complete records (292 cases, 584 control, at a ratio of 1:2). Oral glucose tolerance test results will be used to identify glucose dysregulation, and maternal and neonatal outcomes include maternal weight gain, pre-eclampsia, polyhydramnios, mode of delivery, preterm or postdate birth, complications in labour, birth weight, gestational age at birth, Apgar score, congenital anomaly, congenital hypothyroidism, neonatal death or stillbirth, hypoglycaemia and hyperbilirubinaemia. Psychosocial measures include the WHO Quality of Life: brief, mother-infant bonding (14-item Postpartum Bonding Questionnaire and 19-item Maternal Postnatal Attachment Scale), anxiety (7-item Generalised Anxiety Disorder), depression (9-item Patient Health Questionnaire) and stress (Perceived Stress Scale symptoms) questionnaires. The comparative incidences of maternal and neonatal health outcomes, the comparative prevalence of the psychosocial outcomes between women with GDM and without GDM, specificity, sensitivity, positive and negative predictive values of the risk factors, separately and combined, will be reported. All GDM risk factors and outcomes will be modelled using multivariable regression analysis and the receiver operating characteristics curve will be reported. ETHICS AND DISSEMINATION: This study was approved by the Malaysia Research and Ethics Committee, Ministry of Health Malaysia. Informed consent will be obtained from all participants. Findings will be submitted for publications in scientific journals.