The effects of diabetes self-management programs on clinical and patient reported outcomes in older adults: a systematic review and meta-analysis.

Objectives: With diabetes self-management continuing to become more complex for older adults, self-management programs have been shown to support this population in meeting their multifaceted medical needs. Building on our previous systematic review and meta-analysis, we aimed to update the literature on the effectiveness of diabetes self-management programs and investigate the impact of specific self-management interventions on clinical and patient-reported outcomes. Methods: We updated our literature search in the following databases: Medline, EMBASE, PsychINFO, CINAHL and Cochrane Database of Randomized Controlled Trials from November 2013 to July 2023 for studies that may fit our inclusion criteria. Two independent reviewers screened and extracted data from the included group of studies. Results: A total of 17 studies with 21 comparison arms met the inclusion criteria, totalling 5976 older adults (3510 individuals randomized to self-management programming and 2466 to usual care). The pooled effectiveness of diabetes self-management programs in older adults on glycemic control (hemoglobin A1C) was a reduction of -0.32 (95% CI -0.44, -0.19). Specifically, the most effective approach on glycemic control (A1C) was the use of feedback (-0.52%; 95% CI -0.68, -0.36). Overall, self-management programs improved behaviour change outcomes, with feedback interventions being most effective (standardized mean difference [SMD] 0.91; 95% CI 0.39, 1.43). The effect of self-management programs on body mass index, weight and lipids were statistically and clinically significant. Conclusions: The evidence for diabetes self-management programs for older adults demonstrates a small but clinically meaningful reduction in A1C, improvement in patient-reported outcomes (behaviour, self-efficacy, knowledge), and other clinical outcomes (BMI, weight and lipids). The specific strategy used in diabetes self-management programs for older adults should be considered to achieve optimal results on outcomes.

Partnered Recruitment: Engaging Individuals With Lived Experience in the Recruitment of Co-Design Participants.

BACKGROUND: Young adults with type 1 diabetes (T1D) face complex health challenges, including a heightened risk for distress. To counter this distress, there is a need to develop accessible, acceptable comprehensive care solutions that integrate diabetes and mental health care to enhance self-efficacy and counter mental health challenges in this population. OBJECTIVE: To describe the engagement of individuals with lived experience of T1D and mental health challenges in the development of a recruitment strategy to support the co-design of an innovative integrated care programme. RESULTS: Seven individuals with lived experience formed a Partner Advisory Council (PAC) to recruit young adults (18-29 years old) living with T1D, their friends or family and health researchers and professionals in co-design interviews (n = 19) and co-design events (n = 12). The PAC played a key role in developing a comprehensive recruitment strategy, overcoming traditional barriers and stigmas in the design of an integrated model of care. CONCLUSION: Assuming the presence of mental health challenges in young adults living with T1D during recruitment had far-reaching impacts on the development of a whole-person and integrated diabetes and mental health care solution. The efficient recruitment of this sample provided invaluable insights into the nuanced challenges experienced by young adults with T1D, the individual skills developed in response to their mental health challenges and the ways that this understanding can shape future programming to support mental health, quality of life and well-being. The ongoing involvement of the PAC as co-researchers underscores the enduring impact of patient engagement in developing integrated care solutions. PATIENT OR PUBLIC CONTRIBUTION: The co-design of the TECC-T1D3 model was enriched by the invaluable contributions of individuals with lived experience. This included the engagement of a diverse PAC in the recruitment of participants in co-design interviews and co-design events. PAC members actively participated in research decision-making with their insights informing a robust recruitment strategy. Beyond recruitment, PAC members continue to serve as co-researchers, shaping ongoing research and actively contributing to the TECC-T1D3 project. Six PAC members are co-authors on this manuscript.

A Scoping Review of the Relationship Between Maternal BMI and Offspring Incidence of Respiratory Infection: Where Do We Go From Here?

Introduction: Pregnancy complications, including high maternal BMI, are associated with altered early development and child health outcomes. A growing body of work links the prenatal environment, specifically maternal BMI, with respiratory infections in offspring. In this rapid review, the authors review the literature supporting the hypothesis that high maternal BMI during pregnancy is associated with childhood respiratory infection incidence. Methods: The authors employed systematic search criteria in known databases-EMBASE, EMCARE, MEDLINE, CINAHL, and PsychINFO-searching from inception to January 2023. Included were primary research studies that involved (1) human pregnancy, (2) pregravid or gestational overweight or obesity, and (3) childhood respiratory infection with or without hospitalization. Results: Only 7 population-based cohort studies met the criteria, investigating maternal BMI as an exposure and childhood respiratory infection as an outcome (age 6 months to 18 years). Therefore, the authors conducted a qualitative analysis, and outcomes were reported. The authors found that >85% of the albeit few published studies support the hypothesis that maternal BMI may have independent and profound consequences on respiratory infection risk across childhood. Discussion: This area of research needs large-scale, well-controlled studies to better understand the relationship between maternal BMI and childhood respiratory infection. Possible resources such as cohort catalogs and combined databases are discussed. These findings add to the growing evidence that early environmental factors influence lifelong respiratory health. By incorporating a life course approach to infectious disease risk, policy makers can put this research to work and target health vulnerabilities before they arise.

Perceptions of diabetes distress during pregnancy in women with type 1 and type 2 diabetes: a qualitative interpretive description study.

BACKGROUND: Diabetes distress is commonly seen in adults with pre-existing diabetes and is associated with worsened glycemic management and self-management practices. While a majority of women report increased stress during pregnancy, it is unknown how women with type 1 or type 2 diabetes experience diabetes distress during this unique and transitional time. PURPOSE: This study aimed to understand the experiences and perceptions of diabetes distress in women with pre-existing diabetes during pregnancy. METHODS: A qualitative study using an interpretive description approach was conducted. In-depth, one to one interviewing was used to capture rich descriptions of the pregnancy experience. Nested, stratified, and theoretical sampling was used to recruit 18 participants with type 1 and type 2 diabetes from the quantitative strand of this mixed methods study. Constant comparative analysis was used to inductively analyze the data and develop themes. FINDINGS: Four themes, each with several subthemes, emerged under the main finding of "Diabetes Distress": 1) Worry for Baby's Health - "What's this going to do to the baby?"' 2) Feeling Overwhelmed with Diabetes Management-"It just seemed unattainable"; 3) Living with Diabetes - "There's no way out" and 4) Cycle of Diabetes Distress. CONCLUSIONS: The findings from this study identify the sources and experiences of diabetes distress during pregnancy in women with pre-existing diabetes. Diabetes distress often presents as cyclical and multifaceted during pregnancy, with elements of fear for the unborn baby, difficulties with diabetes management, and having negative lived experiences of diabetes. Further work is needed to develop appropriate screening tools for pregnancy and interventions to mitigate diabetes distress. Diabetes educators are well-positioned provide emotional support and person-centred self-management education to individuals with diabetes.

Demystifying diabetes health coaching: A scoping review unveiling the 'who' and 'where' of health coaching for adults with type 2 diabetes.

Type 2 diabetes (T2D) is a complex chronic condition that requires ongoing self-management. Diabetes health coaching interventions provide personalized healthcare programming to address physical and psychosocial aspects of diabetes self-management. AIMS: This scoping review aims to explore the contexts and settings of diabetes health coaching interventions for adults with T2D, using the RE-AIM framework. METHODS: A search was completed in MEDLINE, PsycINFO, Emcare, Embase and Cochrane. Included citations described adults with exclusively T2D who had received a health coaching intervention. Citations were excluded if they focused on any other types of diabetes or diabetes prevention. RESULTS: A total of 3418 records were identified through database and manual searches, with 29 citations selected for data extraction. Most health coaching interventions were delivered by health professionals, many employed lay health workers and a few included peer coaches. While many health coaching interventions were delivered remotely, in-person intervention settings were distributed among primary care, community health settings and non-healthcare sites. CONCLUSION: The findings of this review suggest that diabetes health coaching may be implemented by a variety of providers in different settings. Further research is required to standardize training and implementation of health coaching and evaluate its long-term effectiveness.

The Examination and Exploration of Diabetes Distress in Pre-existing Diabetes in Pregnancy: A Mixed-methods Study.

OBJECTIVES: Diabetes distress (DD) has been understudied in the pregnancy population. Pregnancy is known to be a complex, highly stressful time for women with diabetes because of medical risks and the high burden of diabetes management. Our aim in this study was to explain and understand DD in women with pre-existing diabetes in pregnancy. METHODS: An explanatory, sequential mixed-methods study was undertaken. The first strand consisted of a cross-sectional study of 76 women with type 1 and type 2 diabetes. A nested sampling approach was used to re-recruit 18 women back into the second strand for qualitative interviews using an interpretive description approach. RESULTS: DD was measured by the validated Problem Area in Diabetes (PAID) scale. A PAID score of ≥40 was positive for distress. DD prevalence was 22.4% in the cross-sectional cohort and the average PAID score was 27.75 (standard deviation 16.08). In the qualitative strand, women with a range of PAID scores (10.0 to 60.0) were sampled for interviews. The majority of these participants described themes of DD in their interviews. Of the 15 women who described DD thematically, only 6 had positive PAID scores. CONCLUSIONS: Integration of the mixed-methods data underscores important meta-inferences about DD in pregnancy, namely that DD was present to a greater degree than the PAID tool is sensitive to. DD was present qualitatively in most of the qualitative sample, despite interviewing women with a range of PAID scores. Future research on a pregnancy-specific DD scale is needed.

Understanding Newcomer Challenges and Opportunities to Accessing Nature and Greenspace in Riverdale, Hamilton, Ontario: A Neighborhood-Centered Photovoice Study.

BACKGROUND: Access to and engagement with greenspace is related to improved health benefits. We sought to collaborate with community members as partners in research and co-creators in knowledge to better understand which components within a newcomer-dense community help or hinder individual and community efforts to access greenspace and nature-based activities. METHODS: We used photovoice methodology to engage with local residents in focus groups, photowalks, and photo-elicitation interviews. Themes were developed using direct content analysis. RESULTS: A total of 39 participants (ages 11-70 years; median years in Canada of 3.25 years) were engaged in this program of research. From the analysis, we developed four themes: (a) peace and beauty; (b) memories of home; (c) safety and cleanliness; and (d) welcoming strengthened and new opportunities. Participants associated nature with peace, citing it as "under-rated" but "vital" to the neighborhood. Via photographs and stories, participants also shared a multitude of safety concerns that prevent their access to green/outdoor spaces for healthy active living programs or activities (e.g., woodchip-covered playgrounds, ample amounts of garbage littering the park and school grounds, lack of timely ice removal on sidewalks, limited safe biking paths, and unsafe motor vehicle practices at the crosswalks surrounding local parks). CONCLUSION: To translate the key ideas and themes into an informed discussion with policy and decision-makers, we held an in-person exhibition and guided tour where community members, the lead photovoice researcher, and SCORE! principal investigator shared information about each theme in the form of a pseudo-narrative peppered with prepared discussion questions.

Technology-Enabled Collaborative Care for Type-2 Diabetes and Mental Health (TECC-D): Findings From a Mixed Methods Feasibility Trial of a Responsive Co-Designed Virtual Health Coaching Intervention.

Introduction: Type-2 diabetes (T2D) is a complex chronic condition associated with a lower quality of life due to disease specific distress. While there is growing support for personalized diabetes programs, care for mental health challenges is often fragmented and limited by access to psychiatry, and integration of care. The use of communication technology to improve team based collaborative care to bridge these gaps is promising but untested. Methods: We conducted an explanatory sequential mixed methods study to assess the feasibility and acceptability of the co-designed Technology-Enabled Collaborative Care for Diabetes and Mental Health (TECC-D) program. Participants included adults aged ≥18 years who had a clinical diagnosis of T2D, and self-reported mental health concerns. Results: 31 participants completed the 8-week virtual TECC-D program. Findings indicate that the program is feasible and acceptable and indicate that there is a role for virtual diabetes and mental health care. Discussion: The TECC-D program, designed through an iterative co-design process and supported by innovative, responsive adaptations led to good uptake and satisfaction. Conclusion: The TECC-D model is a feasible and scalable care solution that empowers individuals living with T2D and mental health concerns to take an active role in their care.

The effectiveness of sodium-glucose co-transporter 2 inhibitors on cardiorenal outcomes: an updated systematic review and meta-analysis.

BACKGROUND: The 2022 Canadian Cardiovascular Society (CCS) cardiorenal guideline provided clinical recommendations on sodium-glucose co-transport 2 inhibitors (SGLT2i) and glucagon-like peptide-1 receptor agonists (GLP-1RA) use. Since then, additional trials of relevance for SGLT2i have been published. This update re-evaluates the clinical recommendations for using SGLTi and their indirect comparison with existing evidence on GLP-1RA as compared to the standard of care to reduce cardiorenal morbidity and mortality. METHODS: We updated our existing search and screening of the literature from September 2021 to April 2023 for randomized controlled trials of SGLT2i and GLP-1RA with placebo control. We conducted risk of bias assessment, data extraction and updated our meta-analysis of studies with similar interventions and components. The certainty of the evidence was determined using GRADE. RESULTS: Evidence from three new trials and additional results from an updated existing trial on SGLT2i met our inclusion criteria after an updated search. Across all the included studies, the total sample size was 151,023 adults, with 90,943 in SGLT2i trials and 60,080 in GLP-1 RA trials. The mean age ranged from 59.9 to 68.4 years. Compared with standard care, the use of SGLT2i and GLP-1 RA showed significant reductions in the outcomes of cardiovascular (CV) mortality (14% & 13%), any-cause mortality (12% & 12%), major adverse CV events (MACE) (11% & 14%), heart failure (HF) hospitalization (30% & 9%), CV death or HF hospitalization (23% & 11%), and kidney composite outcome (32% & 22%). In participants with T2D, both classes demonstrated significant cardiorenal protection. But, only GLP-1RA showed a reduction in non-fatal stroke (16%) and only SGLT2i showed a reduction in HF hospitalization (30%) in this population of people living with T2D. CONCLUSIONS: This updated and comprehensive meta-analysis substantiates and strengthens the clinical recommendations of the CCS cardiorenal guidelines.

Peer Support for Type 2 Diabetes Management in Low- and Middle-Income Countries (LMICs): A Scoping Review.

Background: Although there is evidence of peer support in high-income countries, the use of peer support as an intervention for cardiometabolic disease management, including type 2 diabetes (T2DM), in low- and middle-income countries (LMICs), is unclear. Methods: A scoping review methodology was used to search the databases MEDLINE, Embase, Emcare, PsycINFO, LILACS, CDSR, and CENTRAL. Results: Twenty-eight studies were included in this scoping review. Of these, 67% were developed in Asia, 22% in Africa, and 11% in the Americas. The definition of peer support varied; however, peer support offered a social and emotional dimension to help individuals cope with negative emotions and barriers while promoting disease management. Conclusions: Findings from this scopingreview highlight a lack of consistency in defining peer support as a component of CMD management in LMICs. A clear definition of peer support and ongoing program evaluation is recommended for future research.

Precision prognostics for cardiovascular disease in Type 2 diabetes: a systematic review and meta-analysis.

BACKGROUND: Precision medicine has the potential to improve cardiovascular disease (CVD) risk prediction in individuals with Type 2 diabetes (T2D). METHODS: We conducted a systematic review and meta-analysis of longitudinal studies to identify potentially novel prognostic factors that may improve CVD risk prediction in T2D. Out of 9380 studies identified, 416 studies met inclusion criteria. Outcomes were reported for 321 biomarker studies, 48 genetic marker studies, and 47 risk score/model studies. RESULTS: Out of all evaluated biomarkers, only 13 showed improvement in prediction performance. Results of pooled meta-analyses, non-pooled analyses, and assessments of improvement in prediction performance and risk of bias, yielded the highest predictive utility for N-terminal pro b-type natriuretic peptide (NT-proBNP) (high-evidence), troponin-T (TnT) (moderate-evidence), triglyceride-glucose (TyG) index (moderate-evidence), Genetic Risk Score for Coronary Heart Disease (GRS-CHD) (moderate-evidence); moderate predictive utility for coronary computed tomography angiography (low-evidence), single-photon emission computed tomography (low-evidence), pulse wave velocity (moderate-evidence); and low predictive utility for C-reactive protein (moderate-evidence), coronary artery calcium score (low-evidence), galectin-3 (low-evidence), troponin-I (low-evidence), carotid plaque (low-evidence), and growth differentiation factor-15 (low-evidence). Risk scores showed modest discrimination, with lower performance in populations different from the original development cohort. CONCLUSIONS: Despite high interest in this topic, very few studies conducted rigorous analyses to demonstrate incremental predictive utility beyond established CVD risk factors for T2D. The most promising markers identified were NT-proBNP, TnT, TyG and GRS-CHD, with the highest strength of evidence for NT-proBNP. Further research is needed to determine their clinical utility in risk stratification and management of CVD in T2D.

People living with type 2 diabetes (T2D) are more likely to develop problems with their heart or blood circulation, known as cardiovascular disease (CVD), than people who do not have T2D. However, it can be difficult to predict which people with T2D are most likely to develop CVD. This is because current approaches, such as blood tests, do not identify all people with T2D who are at an increased risk of CVD. In this study we reviewed published papers that investigated the differences between people with T2D who experienced CVD compared to those who did not. We found some indicators that could potentially be used to determine which people with T2D are most likely to develop CVD. More studies are needed to determine how useful these are. However, they could potentially be used to enable clinicians to provide targeted advice and treatment to those people with T2D at most risk of developing CVD.

Type 1 Diabetes in Ontario Schools: Policy and Practice.

OBJECTIVES: Type 1 diabetes (T1D) is a challenging chronic condition. Young children with T1D require daily support to manage their condition while at school. In 2018, Ontario established a provincial policy to ensure safe and equitable school participation for children with diabetes. Despite this, children and parents describe very different school experiences. In this qualitative study we describe the interpretation and implementation of school board policy related to the care of children with T1D from the perspective of school educators (principals/teachers). METHODS: Policy documents were reviewed employing a qualitative descriptive research design using directed qualitative content analysis. Semistructured interviews were conducted with 13 teachers and principals from 10 publicly funded elementary schools across the Hamilton and Toronto District School Boards in 2021. RESULTS: There are major differences in how policies regarding T1D are being implemented in schools. This includes how school staff are educated about T1D, and how they interpret and act on blood glucose information. Although educators often play an active role in supporting children, many face barriers, including competing priorities, fear, lack of information, and lack of support. Facilitators include effective communication/collaboration, actionable information, time, and a diabetes "champion." In some instances, access to nursing support could help to resolve barriers or create care gaps. CONCLUSIONS: School board policy provides high-level guidance on how to support children with T1D in school, but gaps remain. We provide specific recommendations regarding policy, staff education/training, roles and responsibilities, and future research.

Supporting self-management in women with pre-existing diabetes in pregnancy: a mixed-methods sequential comparative case study.

INTRODUCTION: Maternal glycemia is associated with pregnancy outcomes. Thus, supporting the self-management experiences and preferences of pregnant women with type 1 and type 2 diabetes is crucial to optimize glucose control and perinatal outcomes. RESEARCH DESIGN AND METHODS: This paper describes the mixed methods integration of a sequential comparative case study. The objectives are threefold, as we integrated the quantitative and qualitative data within the overall mixed methods design: (1) to determine the predictors of glycemic control during pregnancy; (2) to understand the experience and diabetes self-management support needs during pregnancy among women with pre-existing diabetes; (3) to assess how self-management and support experiences helpe to explain glycemic control among women with pre-existing diabetes in pregnancy. The purpose of the mixing was to integrate the quantitative and qualitative data to develop rich descriptive cases of how diabetes self-management and support experiences and preferences in women with type 1 and type 2 diabetes during pregnancy help explain glucose control. A narrative approach was used to weave together the statistics and themes and the quantitative results were integrated visually alongside the qualitative themes to display the data integration. RESULTS: The quantitative results found that women achieved "at target" glucose control (mean A1C of the cohort by the third visit: 6.36% [95% Confidence Interval 6.11%, 6.60%]). The qualitative findings revealed that feelings of fear resulted in an isolating and mentally exhausting pregnancy. The quantitative data also indicated that women reported high levels of self-efficacy that increased throughout pregnancy. Qualitative data revealed that women who had worked hard to optimize glycemia during pregnancy were confident in their self-management. However, they lacked support from their healthcare team, particularly around self-management of diabetes during labour and delivery. CONCLUSIONS: The achievement of optimal glycemia during pregnancy was motivated by fear of pregnancy complications and came at a cost to women's mental health. Mental health support, allowing women autonomy, and the provision of peer support may improve the experience of diabetes self-management during pregnancy. Future work should focus on developing, evaluating and implementing interventions that support these preferences.

What are effective strategies to respond to the psychological impacts of working on the frontlines of a public health emergency?

Background: The COVID-19 pandemic has disrupted the healthcare and public health sectors. The impact of working on the frontlines as a healthcare or public health professional has been well documented. Healthcare organizations must support the psychological and mental health of those responding to future public health emergencies. Objective: This systematic review aims to identify effective interventions to support healthcare workers' mental health and wellbeing during and following a public health emergency. Methods: Eight scientific databases were searched from inception to 1 November 2022. Studies that described strategies to address the psychological impacts experienced by those responding to a public health emergency (i.e., a pandemic, epidemic, natural disaster, or mass casualty event) were eligible for inclusion. No limitations were placed based on study design, language, publication status, or publication date. Two reviewers independently screened studies, extracted data, and assessed methodological quality using the Joanna Briggs Institute critical appraisal tools. Discrepancies were resolved through discussion and a third reviewer when needed. Results were synthesized narratively due to the heterogeneity of populations and interventions. Outcomes were displayed graphically using harvest plots. Results: A total of 20,018 records were screened, with 36 unique studies included in the review, 15 randomized controlled trials, and 21 quasi-experimental studies. Results indicate that psychotherapy, psychoeducation, and mind-body interventions may reduce symptoms of anxiety, burnout, depression, and Post Traumatic Stress Disorder, with the lowest risk of bias found among psychotherapy interventions. Psychoeducation appears most promising to increase resilience, with mind-body interventions having the most substantial evidence for increases in quality of life. Few organizational interventions were identified, with highly heterogeneous components. Conclusion: Promoting healthcare workers' mental health is essential at an individual and health system level. This review identifies several promising practices that could be used to support healthcare workers at risk of adverse mental health outcomes as they respond to future public health emergencies.Systematic review registration: https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=203810, identifier #CRD42020203810 (PROSPERO).

Strengthening Community Roots: Anchoring Newcomers in Wellness and Sustainability (SCORE!): A protocol for the co-design and evaluation of a healthy active living program among a newcomer community in Canada.

BACKGROUND: The burden of childhood obesity and cardiometabolic risk factors affecting newcomer Canadians living in lower socioeconomic circumstances is a concerning public health issue. This paper describes Strengthening Community Roots: Anchoring Newcomers in Wellness and Sustainability (SCORE!), an academic-community research partnership to co-design interventions that nurture and optimize healthy activity living (HAL) among a community of children and families new to Canada in Hamilton, Ontario, Canada. METHODS/DESIGN: Our overarching program is informed by a socio-ecological model, and will co-create HAL interventions for children and families new to Canada rooted in outdoor, nature-based physical activity. We will proceed in three phases: Phase 1) synthesis of existing evidence regarding nature based HAL interventions among children and families; Phase 2) program development through four data collection activities including: i) community engagement activities to build trustful relationships and understand barriers and facilitators, including establishing a community advisory and action board, qualitative studies including a photovoice study, and co-design workshops to develop programs; ii) characterizing the demographics of the community through a household survey; iii) characterizing the built environment and HAL programs/services available in the community by developing an accessible real-time systems map; and iv) reviewing municipal policies relevant to HAL and sustainability; leading to Phase 3) implementation and evaluation of the feasibility of co-designed HAL programs. CONCLUSION: The etiology of childhood obesity and related chronic diseases is complex and multifactorial, as are intervention strategies. The SCORE! program of research brings together partners including community members, service providers, academic researchers, and organizational leaders to build a multi-component intervention that promotes the health and wellness of newcomer children and families.

Diabetes remission and relapse following an intensive metabolic intervention combining insulin glargine/lixisenatide, metformin and lifestyle approaches: Results of a randomised controlled trial.

AIM: Non-surgical options for inducing type 2 diabetes remission are limited. We examined whether remission can be achieved by combining lifestyle approaches and short-term intensive glucose-lowering therapy. METHODS: In this trial, 160 patients with type 2 diabetes on none to two diabetes medications other than insulin were randomised to (a) an intervention comprising lifestyle approaches, insulin glargine/lixisenatide and metformin, or (b) standard care. Participants with glycated haemoglobin (HbA1c) <7.3% (56 mmol/mol) at 12 weeks were asked to stop diabetes medications and were followed for an additional 52 weeks. The primary outcome was diabetes relapse defined as HbA1c ≥6.5% (48 mmol/mol) at 24 weeks or thereafter, capillary glucose ≥10 mmol/L on ≥50% of readings, or use of diabetes medications, analysed as time-to-event. Main secondary outcomes included complete or partial diabetes remission at 24, 36, 48 and 64 weeks defined as HbA1c <6.5% (48 mmol/mol) off diabetes medications since 12 weeks after randomisation. A hierarchical testing strategy was applied. RESULTS: The intervention significantly reduced the hazard of diabetes relapse by 43% (adjusted hazard ratio 0.57, 95% confidence interval 0.40-0.81; p = .002). Complete or partial diabetes remission was achieved in 30 (38.0%) intervention group participants versus 16 (19.8%) controls at 24 weeks and 25 (31.6%) versus 14 (17.3%) at 36 weeks [relative risk 1.92 (95% confidence interval 1.14-3.24) and 1.83 (1.03-3.26), respectively]. The relative risk of diabetes remission in the intervention versus control group was 1.88 (1.00-3.53) at 48 weeks and 2.05 (0.98-4.29) at 64 weeks. CONCLUSIONS: A 12-week intensive intervention comprising insulin glargine/lixisenatide, metformin and lifestyle approaches can induce remission of diabetes.