Aim: The aim of this study is to estimate the causally attributable one-year healthcare costs for individuals getting a type 2 diabetes diagnosis compared to a matched sample and show the incurred costs of medication and in primary and secondary healthcare.
Methods: Causal estimation using a difference-in-differences design to estimate the one-year health care costs attributable to type 2 diabetes. Danish registry data consisting of the entire population in years 2016-2019. Newly diagnosed individuals with type 2 diabetes in 2018 were identified using a validated method. Sociodemographic and historical health data were used to identify a matched control group. Individuals were followed for two years before and one year after the date of diagnosis using. Three cost components were analysed: medication and primary and secondary healthcare costs.
Results: A total of 18,133 individuals were diagnosed with type 2 diabetes in 2018 and matched successfully 1:1 to a control group. The total attributable one-year cost of type 2 diabetes was EUR 1316. The main cost component was hospital care (EUR 1004) and primary care (EUR 167). The total attributable cost of incident diabetes in Denmark in 2018 was approx. EUR 24 million.
Conclusions: The majority of the first year health care cost of incident diabetes is incurred at the hospital level followed by primary care and medication. Our yearly cost estimate per newly diagnosed is considerably lower than estimates from the US and Australia.
{"title":"Attributable one-year healthcare cost of incident type 2 diabetes: A population-wide difference-in-differences study in Denmark.","authors":"Eskild Klausen Fredslund, Annelli Sandbæk, Thim Prætorius","doi":"10.1111/dme.15455","DOIUrl":"https://doi.org/10.1111/dme.15455","url":null,"abstract":"<p><strong>Aim: </strong>The aim of this study is to estimate the causally attributable one-year healthcare costs for individuals getting a type 2 diabetes diagnosis compared to a matched sample and show the incurred costs of medication and in primary and secondary healthcare.</p><p><strong>Methods: </strong>Causal estimation using a difference-in-differences design to estimate the one-year health care costs attributable to type 2 diabetes. Danish registry data consisting of the entire population in years 2016-2019. Newly diagnosed individuals with type 2 diabetes in 2018 were identified using a validated method. Sociodemographic and historical health data were used to identify a matched control group. Individuals were followed for two years before and one year after the date of diagnosis using. Three cost components were analysed: medication and primary and secondary healthcare costs.</p><p><strong>Results: </strong>A total of 18,133 individuals were diagnosed with type 2 diabetes in 2018 and matched successfully 1:1 to a control group. The total attributable one-year cost of type 2 diabetes was EUR 1316. The main cost component was hospital care (EUR 1004) and primary care (EUR 167). The total attributable cost of incident diabetes in Denmark in 2018 was approx. EUR 24 million.</p><p><strong>Conclusions: </strong>The majority of the first year health care cost of incident diabetes is incurred at the hospital level followed by primary care and medication. Our yearly cost estimate per newly diagnosed is considerably lower than estimates from the US and Australia.</p>","PeriodicalId":11251,"journal":{"name":"Diabetic Medicine","volume":" ","pages":"e15455"},"PeriodicalIF":3.2,"publicationDate":"2024-10-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142460384","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Lawrence Fisher, Susan Guzman, William Polonsky, Danielle Hessler
Aims
Diabetes distress (DD) refers to the emotional and behavioural challenges associated with managing this demanding chronic disease over time. DD is alarmingly common and it has a significant impact on self-management behaviours and clinical outcomes. Thus, there is growing recognition that DD is a pressing problem that deserves careful attention in clinical care. Translating the application of validated DD assessment and intervention protocols from the research to the clinical setting, however, presents challenges that require a reconsideration of some common assumptions about what DD is, how prevalent it is, how it presents itself clinically, how it might best be assessed and by whom.
Methods
We employed data from six large-scale studies using five common DD measures. Using these data, we review and challenge several common assumptions about DD.
Results
These data suggest that, because of its relative ubiquity, DD should not be viewed as a ‘co-morbidity’ or ‘complication’ of diabetes and it should not be seen as a mental health/illness ‘condition’. Furthermore, we argue that DD assessment should: (1) be accepted as a standard part of comprehensive diabetes care, (2) occur regularly using broad rather than brief screening measures and (3) be addressed directly by diabetes clinicians, rather than exclusively by behavioural specialists.
Conclusions
The results form the basis of a series of suggestions to enhance the translation, adoption and implementation of DD knowledge derived from the research setting directly into the real world of clinical care.
{"title":"Bringing the assessment and treatment of diabetes distress into the real world of clinical care: Time for a shift in perspective","authors":"Lawrence Fisher, Susan Guzman, William Polonsky, Danielle Hessler","doi":"10.1111/dme.15446","DOIUrl":"10.1111/dme.15446","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Aims</h3>\u0000 \u0000 <p>Diabetes distress (DD) refers to the emotional and behavioural challenges associated with managing this demanding chronic disease over time. DD is alarmingly common and it has a significant impact on self-management behaviours and clinical outcomes. Thus, there is growing recognition that DD is a pressing problem that deserves careful attention in clinical care. Translating the application of validated DD assessment and intervention protocols from the research to the clinical setting, however, presents challenges that require a reconsideration of some common assumptions about what DD is, how prevalent it is, how it presents itself clinically, how it might best be assessed and by whom.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>We employed data from six large-scale studies using five common DD measures. Using these data, we review and challenge several common assumptions about DD.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>These data suggest that, because of its relative ubiquity, DD should not be viewed as a ‘co-morbidity’ or ‘complication’ of diabetes and it should not be seen as a mental health/illness ‘condition’. Furthermore, we argue that DD assessment should: (1) be accepted as a standard part of comprehensive diabetes care, (2) occur regularly using broad rather than brief screening measures and (3) be addressed directly by diabetes clinicians, rather than exclusively by behavioural specialists.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusions</h3>\u0000 \u0000 <p>The results form the basis of a series of suggestions to enhance the translation, adoption and implementation of DD knowledge derived from the research setting directly into the real world of clinical care.</p>\u0000 </section>\u0000 </div>","PeriodicalId":11251,"journal":{"name":"Diabetic Medicine","volume":"41 12","pages":""},"PeriodicalIF":3.2,"publicationDate":"2024-10-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142406230","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Roland H. Stimson, Mark W. J. Strachan, Anna R. Dover, Rohana J. Wright, Shareen Forbes, Gayle McRobert, Fraser W. Gibb
<p>Despite substantial advances in diabetes care over the previous decade, only a minority of people with type 1 diabetes achieve an HbA1c <53 mmol/mol.<span><sup>1</sup></span> Automated insulin delivery (AID) systems have consistently demonstrated efficacy in reducing HbA1c.<span><sup>2</sup></span> Omnipod 5 (Insulet Corp) is a tubeless AID system which was launched in the United Kingdom in 2023. Here, we report the first 1-year CGM, HbA1c and weight outcomes in people using Omnipod 5, under routine clinical care, in the United Kingdom.</p><p>This was a prospective, observational assessment based in a single Scottish centre which provides diabetes care for approximately 5000 adults with type 1 diabetes. As a service evaluation of routinely collected data, this project did not require ethical approval. We included all adults who transitioned from Omnipod DASH (standalone CSII) to Omnipod 5 (hybrid closed loop with Dexcom G6 CGM) between June and August 2023. Data were obtained from the electronic health record (SCI-Diabetes), LibreView, Dexcom Clarity and Glooko.</p><p>Paired CGM data were available in 45/50 (90 days prior to Omnipod 5 and 90 days after 1 year of use) and paired HbA1c data were available in 41/50 (measured at a median 200 days [202–336] after OP5 commencement). CGM metrics reported are consistent with those described in the international consensus document.<span><sup>3</sup></span> Paired weight data were available in 28/50 (median 308 days after OP5 commencement [244–370]). Results are presented as median (IQR). Paired data were compared with Wilcoxon signed rank tests and correlations were assessed by Spearman correlation coefficient. <i>p</i> <0.05 were considered statistically significant. Statistical analyses were performed using R Studio.</p><p>Median age was 42 years (IQR: 30–53), duration of diabetes was 24 years (13–34) and 64% were female. Baseline HbA1c was 69 mmol/mol (61–75) and 22% had an HbA1c <58 mmol/mol. Thirty-eight per cent had BMI >30 kg/m<sup>2</sup>. Fifty-nine per cent were predominantly using the lowest glucose target (6.1 mM) at the end of follow-up and median time in auto mode was 94% (91–99).</p><p>In those with paired HbA1c data, median baseline HbA1c was 70 mmol/mol (63–76) and fell to 58 mmol/mol (52–63) during Omnipod 5 use (<i>p</i> < 0.001). Data summarising CGM changes are presented in the figure (Figure 1), including a change in TIR from 42% (33–58) to 60% (53–68, <i>p</i> < 0.001). GMI fell from 66 mmol/mol (57–70) to 58 mmol/mol (54–62, <i>p</i> < 0.001) and coefficient of variation for glucose fell from 37% (34–42) to 34% (32–38, <i>p</i> = 0.009). Change in TIR at 1 year was strongly negatively correlated with baseline TIR (<i>R</i> −0.581, <i>p</i> < 0.001). Percentage of insulin delivered as bolus was negatively correlated with increase in TIR (<i>R</i> −0.518, <i>p</i> < 0.001). Age, sex and socio-economic deprivation were not associated with TIR response to
{"title":"Outcomes after 1 year in adults using Omnipod 5: Real-world data from a UK diabetes centre","authors":"Roland H. Stimson, Mark W. J. Strachan, Anna R. Dover, Rohana J. Wright, Shareen Forbes, Gayle McRobert, Fraser W. Gibb","doi":"10.1111/dme.15453","DOIUrl":"10.1111/dme.15453","url":null,"abstract":"<p>Despite substantial advances in diabetes care over the previous decade, only a minority of people with type 1 diabetes achieve an HbA1c <53 mmol/mol.<span><sup>1</sup></span> Automated insulin delivery (AID) systems have consistently demonstrated efficacy in reducing HbA1c.<span><sup>2</sup></span> Omnipod 5 (Insulet Corp) is a tubeless AID system which was launched in the United Kingdom in 2023. Here, we report the first 1-year CGM, HbA1c and weight outcomes in people using Omnipod 5, under routine clinical care, in the United Kingdom.</p><p>This was a prospective, observational assessment based in a single Scottish centre which provides diabetes care for approximately 5000 adults with type 1 diabetes. As a service evaluation of routinely collected data, this project did not require ethical approval. We included all adults who transitioned from Omnipod DASH (standalone CSII) to Omnipod 5 (hybrid closed loop with Dexcom G6 CGM) between June and August 2023. Data were obtained from the electronic health record (SCI-Diabetes), LibreView, Dexcom Clarity and Glooko.</p><p>Paired CGM data were available in 45/50 (90 days prior to Omnipod 5 and 90 days after 1 year of use) and paired HbA1c data were available in 41/50 (measured at a median 200 days [202–336] after OP5 commencement). CGM metrics reported are consistent with those described in the international consensus document.<span><sup>3</sup></span> Paired weight data were available in 28/50 (median 308 days after OP5 commencement [244–370]). Results are presented as median (IQR). Paired data were compared with Wilcoxon signed rank tests and correlations were assessed by Spearman correlation coefficient. <i>p</i> <0.05 were considered statistically significant. Statistical analyses were performed using R Studio.</p><p>Median age was 42 years (IQR: 30–53), duration of diabetes was 24 years (13–34) and 64% were female. Baseline HbA1c was 69 mmol/mol (61–75) and 22% had an HbA1c <58 mmol/mol. Thirty-eight per cent had BMI >30 kg/m<sup>2</sup>. Fifty-nine per cent were predominantly using the lowest glucose target (6.1 mM) at the end of follow-up and median time in auto mode was 94% (91–99).</p><p>In those with paired HbA1c data, median baseline HbA1c was 70 mmol/mol (63–76) and fell to 58 mmol/mol (52–63) during Omnipod 5 use (<i>p</i> < 0.001). Data summarising CGM changes are presented in the figure (Figure 1), including a change in TIR from 42% (33–58) to 60% (53–68, <i>p</i> < 0.001). GMI fell from 66 mmol/mol (57–70) to 58 mmol/mol (54–62, <i>p</i> < 0.001) and coefficient of variation for glucose fell from 37% (34–42) to 34% (32–38, <i>p</i> = 0.009). Change in TIR at 1 year was strongly negatively correlated with baseline TIR (<i>R</i> −0.581, <i>p</i> < 0.001). Percentage of insulin delivered as bolus was negatively correlated with increase in TIR (<i>R</i> −0.518, <i>p</i> < 0.001). Age, sex and socio-economic deprivation were not associated with TIR response to ","PeriodicalId":11251,"journal":{"name":"Diabetic Medicine","volume":"41 12","pages":""},"PeriodicalIF":3.2,"publicationDate":"2024-10-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1111/dme.15453","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142406231","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Jessica Y. Wong, Sara E. Styles, Esko J. Wiltshire, Martin I. de Bock, Alisa Boucsein, Octavia J. Palmer, Benjamin J. Wheeler
Aim
To understand experiences of using second-generation advanced hybrid closed-loop (AHCL) therapy in adolescents and young adults with chronically elevated glucose levels who were previously using multiple daily injections (MDI) therapy.
Method
Semi-structured interviews with participants aged 13–25 years, on AHCL therapy for 3 months as part of a single-arm prospective study. Key inclusions: HbA1c ≥69 mmol/mol (8.5%); diabetes duration ≥1 year; and using MDI therapy prior to the study. Qualitative content analysis was used to identify themes and subthemes.
Results
Interviews were conducted among 14 participants with mean age 19.4 ± 4.3 years and mean baseline HbA1c 90 ± 25 mmol/mol (10.4 ± 4.5%). Three themes were identified: (1) substantially improved glucose levels improved perceptions of overall health; (2) features of AHCL aid in adoption and ongoing self-management; and (3) burden of care was reduced through automation of insulin delivery. Overall, there were positive impacts on physical, mental and social well-being. Participants were willing to overlook minor frustrations with AHCL because of the vast benefits that they had experienced. Four participants reported transient pseudo-hypoglycaemia: symptoms of hypoglycaemia when objectively measured glucose was in the clinically recommended range (3.9–10 mmol/L, 70–180 mg/dL).
Conclusion
Transition to AHCL therapy positively impacted diabetes management in adolescents and youth with chronically elevated glucose levels. It appears to create a window of opportunity in which youth may re-engage with diabetes management. Pseudo-hypoglycaemia can occur during the transition to AHCL. This could be a barrier to AHCL uptake and is likely to require individualised support.
{"title":"Experiences of adolescents and young adults with type 1 diabetes and chronically elevated glucose levels following the transition from multiple daily injections to advanced hybrid closed-loop: A qualitative study","authors":"Jessica Y. Wong, Sara E. Styles, Esko J. Wiltshire, Martin I. de Bock, Alisa Boucsein, Octavia J. Palmer, Benjamin J. Wheeler","doi":"10.1111/dme.15449","DOIUrl":"10.1111/dme.15449","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Aim</h3>\u0000 \u0000 <p>To understand experiences of using second-generation advanced hybrid closed-loop (AHCL) therapy in adolescents and young adults with chronically elevated glucose levels who were previously using multiple daily injections (MDI) therapy.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Method</h3>\u0000 \u0000 <p>Semi-structured interviews with participants aged 13–25 years, on AHCL therapy for 3 months as part of a single-arm prospective study. Key inclusions: HbA1c ≥69 mmol/mol (8.5%); diabetes duration ≥1 year; and using MDI therapy prior to the study. Qualitative content analysis was used to identify themes and subthemes.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>Interviews were conducted among 14 participants with mean age 19.4 ± 4.3 years and mean baseline HbA1c 90 ± 25 mmol/mol (10.4 ± 4.5%). Three themes were identified: (1) substantially improved glucose levels improved perceptions of overall health; (2) features of AHCL aid in adoption and ongoing self-management; and (3) burden of care was reduced through automation of insulin delivery. Overall, there were positive impacts on physical, mental and social well-being. Participants were willing to overlook minor frustrations with AHCL because of the vast benefits that they had experienced. Four participants reported transient pseudo-hypoglycaemia: symptoms of hypoglycaemia when objectively measured glucose was in the clinically recommended range (3.9–10 mmol/L, 70–180 mg/dL).</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusion</h3>\u0000 \u0000 <p>Transition to AHCL therapy positively impacted diabetes management in adolescents and youth with chronically elevated glucose levels. It appears to create a window of opportunity in which youth may re-engage with diabetes management. Pseudo-hypoglycaemia can occur during the transition to AHCL. This could be a barrier to AHCL uptake and is likely to require individualised support.</p>\u0000 </section>\u0000 </div>","PeriodicalId":11251,"journal":{"name":"Diabetic Medicine","volume":"42 1","pages":""},"PeriodicalIF":3.2,"publicationDate":"2024-10-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142388834","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Sarah Manallack, Edith E. Holloway, Frans Pouwer, Jane Speight, Elizabeth Holmes-Truscott
Aims
To examine associations between weight self-stigma and healthy diet or physical activity, and potential moderating effects of self-esteem, diabetes self-efficacy, and diabetes social support, among adults with type 2 diabetes.
Methods
Diabetes MILES-2 data were used, an Australian cross-sectional online survey. Participants with type 2 diabetes who considered themselves overweight, and reported concern about weight management (N = 726; 48% insulin-treated), completed the Weight Self-Stigma Questionnaire (WSSQ; total score and subscales: self-devaluation, fear of enacted stigma), measures of diabetes self-care (diet, exercise), and hypothesised psychosocial moderators (self-esteem, diabetes self-efficacy, and diabetes social support). Adjusted linear regression tested associations and interaction effects, separately by insulin treatment status.
Results
Greater weight self-stigma (WSSQ total) was associated with less optimal dietary self-care (both groups: β = −0.3), and with a lower level of exercise (non-insulin only: β = −0.2; all p < 0.001). All hypothesised moderators were negatively associated with weight self-stigma (range r = −0.2 to r = −0.5). Positive associations were identified between the hypothesised moderators and self-care behaviours (strongest between diet and diabetes self-efficacy, r = > 0.5). No significant interaction effects were observed.
Conclusions
This study provides novel evidence of negative associations between weight self-stigma and self-care behaviours among adults with type 2 diabetes. Weight self-stigma is a demonstrated barrier to self-care behaviours in type 2 diabetes cohorts. Acknowledgement and strategies to address weight self-stigma are needed in clinical care and health programmes.
{"title":"Associations between weight self-stigma and healthy diet and physical activity among adults with type 2 diabetes: Cross-sectional results from the second Diabetes MILES – Australia (MILES-2) study","authors":"Sarah Manallack, Edith E. Holloway, Frans Pouwer, Jane Speight, Elizabeth Holmes-Truscott","doi":"10.1111/dme.15440","DOIUrl":"10.1111/dme.15440","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Aims</h3>\u0000 \u0000 <p>To examine associations between weight self-stigma and healthy diet or physical activity, and potential moderating effects of self-esteem, diabetes self-efficacy, and diabetes social support, among adults with type 2 diabetes.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>Diabetes MILES-2 data were used, an Australian cross-sectional online survey. Participants with type 2 diabetes who considered themselves overweight, and reported concern about weight management (<i>N</i> = 726; 48% insulin-treated), completed the Weight Self-Stigma Questionnaire (WSSQ; total score and subscales: self-devaluation, fear of enacted stigma), measures of diabetes self-care (diet, exercise), and hypothesised psychosocial moderators (self-esteem, diabetes self-efficacy, and diabetes social support). Adjusted linear regression tested associations and interaction effects, separately by insulin treatment status.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>Greater weight self-stigma (WSSQ total) was associated with less optimal dietary self-care (both groups: <i>β</i> = −0.3), and with a lower level of exercise (non-insulin only: <i>β</i> = −0.2; all <i>p</i> < 0.001). All hypothesised moderators were negatively associated with weight self-stigma (range <i>r</i> = −0.2 to <i>r</i> = −0.5). Positive associations were identified between the hypothesised moderators and self-care behaviours (strongest between diet and diabetes self-efficacy, <i>r</i> = > 0.5). No significant interaction effects were observed.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusions</h3>\u0000 \u0000 <p>This study provides novel evidence of negative associations between weight self-stigma and self-care behaviours among adults with type 2 diabetes. Weight self-stigma is a demonstrated barrier to self-care behaviours in type 2 diabetes cohorts. Acknowledgement and strategies to address weight self-stigma are needed in clinical care and health programmes.</p>\u0000 </section>\u0000 </div>","PeriodicalId":11251,"journal":{"name":"Diabetic Medicine","volume":"42 1","pages":""},"PeriodicalIF":3.2,"publicationDate":"2024-09-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11635584/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142343477","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Theresa C. Mohr, Maartje de Wit, Jiska Embaye, Dominic Ehrmann, Norbert Hermanns, Gina Lehmann, María Teresa Anarte Ortiz, Laura Torreblanca Murillo, Kirsty Winkley, Alexandra Famiglietti, Frans Pouwer, Frank J. Snoek
Aims
Diabetes distress is common among people with type 1 diabetes (T1D), negatively affecting quality of life, self management, and diabetes outcomes. E-health-based interventions could be an effective and low-cost way to improve the psychological care for people with T1D experiencing diabetes distress. The MyREMEDY study aims to test the effectiveness of the online unguided self-help intervention MyDiaMate in decreasing diabetes distress in adults with T1D. MyDiaMate is based on Cognitive Behavioural Therapy and consists of eight modules, each focusing on a different aspect of living with T1D that is often experienced as burdensome (e.g. hypoglycaemia, fatigue).
Methods
The effectiveness of MyDiaMate will be tested through a randomised-controlled trial across four European countries (the Netherlands, Germany, Spain and the United Kingdom). Six hundred and sixty adults (N = 165 per country) with T1D will be recruited and randomised with a balance of 2:1 into the intervention and care as usual groups. Intervention group members receive access to MyDiaMate for 6 months, care as usual group members receive access after 3 months for 3 months. Participants fill in questionnaires at 0 (baseline), 3 (effectiveness) and 6 months (follow-up). Primary outcome is diabetes distress at 3 months. Secondary outcomes are emotional well-being, psychological self-efficacy in relation to diabetes, social engagement, fatigue, and glycaemic outcomes. Moreover, logdata of MyDiaMate use is passively collected. Linear mixed model analyses will be used to test the effectiveness of MyDiaMate along with identifying which user subgroup benefits most from MyDiaMate use.
{"title":"Effectiveness of the MyDiaMate application in reducing diabetes distress in adults with type 1 diabetes: Study protocol of the multi-national, randomised-controlled MyREMEDY trial","authors":"Theresa C. Mohr, Maartje de Wit, Jiska Embaye, Dominic Ehrmann, Norbert Hermanns, Gina Lehmann, María Teresa Anarte Ortiz, Laura Torreblanca Murillo, Kirsty Winkley, Alexandra Famiglietti, Frans Pouwer, Frank J. Snoek","doi":"10.1111/dme.15442","DOIUrl":"10.1111/dme.15442","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Aims</h3>\u0000 \u0000 <p>Diabetes distress is common among people with type 1 diabetes (T1D), negatively affecting quality of life, self management, and diabetes outcomes. E-health-based interventions could be an effective and low-cost way to improve the psychological care for people with T1D experiencing diabetes distress. The MyREMEDY study aims to test the effectiveness of the online unguided self-help intervention MyDiaMate in decreasing diabetes distress in adults with T1D. MyDiaMate is based on Cognitive Behavioural Therapy and consists of eight modules, each focusing on a different aspect of living with T1D that is often experienced as burdensome (e.g. hypoglycaemia, fatigue).</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>The effectiveness of MyDiaMate will be tested through a randomised-controlled trial across four European countries (the Netherlands, Germany, Spain and the United Kingdom). Six hundred and sixty adults (<i>N</i> = 165 per country) with T1D will be recruited and randomised with a balance of 2:1 into the intervention and care as usual groups. Intervention group members receive access to MyDiaMate for 6 months, care as usual group members receive access after 3 months for 3 months. Participants fill in questionnaires at 0 (baseline), 3 (effectiveness) and 6 months (follow-up). Primary outcome is diabetes distress at 3 months. Secondary outcomes are emotional well-being, psychological self-efficacy in relation to diabetes, social engagement, fatigue, and glycaemic outcomes. Moreover, logdata of MyDiaMate use is passively collected. Linear mixed model analyses will be used to test the effectiveness of MyDiaMate along with identifying which user subgroup benefits most from MyDiaMate use.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Trial Registration</h3>\u0000 \u0000 <p>Clinicaltrials.gov NCT06308549.</p>\u0000 </section>\u0000 </div>","PeriodicalId":11251,"journal":{"name":"Diabetic Medicine","volume":"42 1","pages":""},"PeriodicalIF":3.2,"publicationDate":"2024-09-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11635550/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142343478","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Shaghayegh Khanmohammadi, Amirhossein Habibzadeh, A. B. M. Kamrul-Hasan, Art Schuermans, Mohammad Shafi Kuchay
Aims
While randomized controlled trials data on the long-term effect of glucose-lowering drugs (GLDs) on liver-related outcomes are lacking, population-based studies have evaluated the associations of GLDs with liver-related outcomes in individuals with type 2 diabetes (T2D). we aimed to conduct a systematic review of population-based studies evaluating the effects of GLDs on liver-related outcomes in people with T2D.
Methods
PubMed, Web of Science, and Embase databases were systematically searched for population-based studies testing the associations of GLDs with liver-related outcomes in individuals with T2D and no liver disease other than non-alcoholic fatty liver disease (NAFLD) from inception to 23 February 2024. GLDs included SGLT2is, TZDs, insulin, GLP-1 RAs and dipeptidyl peptidase-4 inhibitors (DPP4Is).
Results
Ten cohort studies, comprising 1,274,641 participants, met the inclusion criteria. The median follow-up period ranged from 8.9 to 76 months. Of all the GLDs under investigation, SGLT2is were associated with the strongest reduction in NAFLD incidence, cirrhosis, and composite liver-related events compared to other medications. TZDs were associated with a reduced risk of developing NAFLD and cirrhosis but were not significantly associated with a lower incidence of hepatocellular carcinoma. GLP-1 RAs demonstrated a significant association with reduced liver-related mortality.
Conclusions
Observational data from population-based studies suggest that GLDs such as SGLT2is are associated with beneficial long-term liver-related outcomes in T2D patients with NAFLD. Additional studies, including randomized controlled trials with long-term follow-up, are needed to confirm these findings.
{"title":"Glucose-lowering drugs and liver-related outcomes among individuals with type 2 diabetes: A systematic review of longitudinal population-based studies","authors":"Shaghayegh Khanmohammadi, Amirhossein Habibzadeh, A. B. M. Kamrul-Hasan, Art Schuermans, Mohammad Shafi Kuchay","doi":"10.1111/dme.15437","DOIUrl":"10.1111/dme.15437","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Aims</h3>\u0000 \u0000 <p>While randomized controlled trials data on the long-term effect of glucose-lowering drugs (GLDs) on liver-related outcomes are lacking, population-based studies have evaluated the associations of GLDs with liver-related outcomes in individuals with type 2 diabetes (T2D). we aimed to conduct a systematic review of population-based studies evaluating the effects of GLDs on liver-related outcomes in people with T2D.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>PubMed, Web of Science, and Embase databases were systematically searched for population-based studies testing the associations of GLDs with liver-related outcomes in individuals with T2D and no liver disease other than non-alcoholic fatty liver disease (NAFLD) from inception to 23 February 2024. GLDs included SGLT2is, TZDs, insulin, GLP-1 RAs and dipeptidyl peptidase-4 inhibitors (DPP4Is).</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>Ten cohort studies, comprising 1,274,641 participants, met the inclusion criteria. The median follow-up period ranged from 8.9 to 76 months. Of all the GLDs under investigation, SGLT2is were associated with the strongest reduction in NAFLD incidence, cirrhosis, and composite liver-related events compared to other medications. TZDs were associated with a reduced risk of developing NAFLD and cirrhosis but were not significantly associated with a lower incidence of hepatocellular carcinoma. GLP-1 RAs demonstrated a significant association with reduced liver-related mortality.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusions</h3>\u0000 \u0000 <p>Observational data from population-based studies suggest that GLDs such as SGLT2is are associated with beneficial long-term liver-related outcomes in T2D patients with NAFLD. Additional studies, including randomized controlled trials with long-term follow-up, are needed to confirm these findings.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Registration Number</h3>\u0000 \u0000 <p>PROSPERO CRD442024536872.</p>\u0000 </section>\u0000 </div>","PeriodicalId":11251,"journal":{"name":"Diabetic Medicine","volume":"41 11","pages":""},"PeriodicalIF":3.2,"publicationDate":"2024-09-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142343480","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Johan Røikjer, Matilde Monteiro-Soares, Daina Walton, Elisabetta Iacopi, Jarmila Jirkovska, Michael Edmonds, Anna Trocha, William Jeffocate, Sicco Bus, the Diabetic Foot Study Group (DFSG) prevention of the first ulcer research group
Aim
A diabetes-related foot ulcer (DFU) is a major risk factor for lower-extremity amputation (LEA). To help clinicians predict the risk of LEA in people with DFU, the Diabetic Foot Risk Assessment (DIAFORA) system was developed but has never been externally validated.
Methods
In this study, 317 people presenting with a new DFU were included. At baseline, participants were grouped into three groups based on their DIAFORA score: low-risk (<15), medium-risk (15–25), and high-risk (>25). Participants were followed until healing, LEA, death, or at least 3 months. Discriminative accuracy was evaluated using sensitivity, specificity, likelihood ratios (LRs) and the area under the curve (AUC).
Results
All 317 participants completed at least 3 months of follow-up for a median duration of 146 days, during which 12.6% underwent minor amputation and 2.5% major amputation. People in the low- and medium-risk categories had major amputation rates of 0.9% and 2.1%, respectively, and negative LR of major LEA of 0.10 and 0.38, respectively, while the people in the high-risk category had an amputation rate of 25.0% and a positive LR of 12.9. The DIAFORA risk groups had a sensitivity of 75.0% and a specificity of 65.7%, with a corresponding AUC of 0.78 (95% CI 0.68–0.87) for the prediction of major LEA.
Conclusion
The DIAFORA score is a useful tool for risk stratification of people presenting with a newly occurred DFU, with the external validation presenting results similar to those presented in the original study. The DIAFORA score may guide clinicians towards more individualized DFU treatment regimens.
{"title":"External validation of the DIAFORA system to predict lower-extremity amputations in a prospective Danish cohort","authors":"Johan Røikjer, Matilde Monteiro-Soares, Daina Walton, Elisabetta Iacopi, Jarmila Jirkovska, Michael Edmonds, Anna Trocha, William Jeffocate, Sicco Bus, the Diabetic Foot Study Group (DFSG) prevention of the first ulcer research group","doi":"10.1111/dme.15443","DOIUrl":"10.1111/dme.15443","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Aim</h3>\u0000 \u0000 <p>A diabetes-related foot ulcer (DFU) is a major risk factor for lower-extremity amputation (LEA). To help clinicians predict the risk of LEA in people with DFU, the Diabetic Foot Risk Assessment (DIAFORA) system was developed but has never been externally validated.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>In this study, 317 people presenting with a new DFU were included. At baseline, participants were grouped into three groups based on their DIAFORA score: low-risk (<15), medium-risk (15–25), and high-risk (>25). Participants were followed until healing, LEA, death, or at least 3 months. Discriminative accuracy was evaluated using sensitivity, specificity, likelihood ratios (LRs) and the area under the curve (AUC).</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>All 317 participants completed at least 3 months of follow-up for a median duration of 146 days, during which 12.6% underwent minor amputation and 2.5% major amputation. People in the low- and medium-risk categories had major amputation rates of 0.9% and 2.1%, respectively, and negative LR of major LEA of 0.10 and 0.38, respectively, while the people in the high-risk category had an amputation rate of 25.0% and a positive LR of 12.9. The DIAFORA risk groups had a sensitivity of 75.0% and a specificity of 65.7%, with a corresponding AUC of 0.78 (95% CI 0.68–0.87) for the prediction of major LEA.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusion</h3>\u0000 \u0000 <p>The DIAFORA score is a useful tool for risk stratification of people presenting with a newly occurred DFU, with the external validation presenting results similar to those presented in the original study. The DIAFORA score may guide clinicians towards more individualized DFU treatment regimens.</p>\u0000 </section>\u0000 </div>","PeriodicalId":11251,"journal":{"name":"Diabetic Medicine","volume":"42 1","pages":""},"PeriodicalIF":3.2,"publicationDate":"2024-09-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11635586/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142343479","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Christopher A. Muir, William Kuang, Kavitha Muthiah, Jerry R. Greenfield, Lisa M. Raven
Aims
Early post-transplant hyperglycaemia (EPTH) and post-transplant diabetes mellitus (PTDM) are common following solid organ transplantation and may be associated with adverse outcomes. We studied the prevalence of EPTH and cumulative 5-year prevalence of PTDM in a modern cohort of heart transplant recipients who were free from diabetes at baseline as well as the association of EPTH, PTDM and pre-transplant T2DM with adverse transplant-related outcomes.
Methods
Retrospective cohort study of heart transplant recipients followed for 5 years at a single centre in Sydney, Australia.
Results
A total of 141 patients were included, of whom 25 had pre-existing type 2 diabetes mellitus (T2DM) and 116 were free from diabetes at baseline. In patients without pre-existing T2DM, 88 of 116 (76%) experienced EPTH, which was associated with higher rates of acute rejection and hospitalizations, and lower 5-year survival. PTDM developed in 45 of 116 (39%) patients, all of whom had experienced EPTH. Both PTDM and pre-existing T2DM were associated with increased rates of graft rejection and hospitalization, and greater than three-fold increased likelihood of death compared to patients that remained free from diabetes.
Conclusion
EPTH and PTDM are highly prevalent following cardiac transplantation. EPTH develops within days of transplant and is strongly associated with progression to PTDM. Pre-existing T2DM, PTDM and EPTH are associated with greater hospitalization, increased episodes of rejection and worse 5-year survival compared to patients who remained free from diabetes during follow-up.
{"title":"Association of early post-transplant hyperglycaemia and diabetes mellitus on outcomes following heart transplantation","authors":"Christopher A. Muir, William Kuang, Kavitha Muthiah, Jerry R. Greenfield, Lisa M. Raven","doi":"10.1111/dme.15441","DOIUrl":"10.1111/dme.15441","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Aims</h3>\u0000 \u0000 <p>Early post-transplant hyperglycaemia (EPTH) and post-transplant diabetes mellitus (PTDM) are common following solid organ transplantation and may be associated with adverse outcomes. We studied the prevalence of EPTH and cumulative 5-year prevalence of PTDM in a modern cohort of heart transplant recipients who were free from diabetes at baseline as well as the association of EPTH, PTDM and pre-transplant T2DM with adverse transplant-related outcomes.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>Retrospective cohort study of heart transplant recipients followed for 5 years at a single centre in Sydney, Australia.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>A total of 141 patients were included, of whom 25 had pre-existing type 2 diabetes mellitus (T2DM) and 116 were free from diabetes at baseline. In patients without pre-existing T2DM, 88 of 116 (76%) experienced EPTH, which was associated with higher rates of acute rejection and hospitalizations, and lower 5-year survival. PTDM developed in 45 of 116 (39%) patients, all of whom had experienced EPTH. Both PTDM and pre-existing T2DM were associated with increased rates of graft rejection and hospitalization, and greater than three-fold increased likelihood of death compared to patients that remained free from diabetes.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusion</h3>\u0000 \u0000 <p>EPTH and PTDM are highly prevalent following cardiac transplantation. EPTH develops within days of transplant and is strongly associated with progression to PTDM. Pre-existing T2DM, PTDM and EPTH are associated with greater hospitalization, increased episodes of rejection and worse 5-year survival compared to patients who remained free from diabetes during follow-up.</p>\u0000 </section>\u0000 </div>","PeriodicalId":11251,"journal":{"name":"Diabetic Medicine","volume":"42 1","pages":""},"PeriodicalIF":3.2,"publicationDate":"2024-09-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11635589/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142343476","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Kristy Tian, Li Chang Ang, Pratik Choudhary, Jason Chon Jun Choo, Yong Mong Bee, Su-Yen Goh, Ming Ming Teh
Aim
We aim to compare the burden of Level 1 (<4 mmol/L) and Level 2 (<3 mmol/L) hypoglycaemia between type 2 diabetes (T2D) patients with and without chronic kidney disease (CKD).
Methods
T2D subjects with and without CKD (eGFR<60 mL/min/1.73 m2) were recruited from a tertiary-care hospital. Subjects wore the Freestyle Libre-Pro sensor for 2 weeks. The number of hypoglycaemic events and intra-day difference in Level 1 and 2 hypoglycaemias were compared between the cohorts.
Results
We recruited 134 subjects: 74 with CKD (44 M:30F) and 60 without CKD (36 M:24F), with no difference in HbA1c between the two cohorts (66 ± 20 vs 64 ± 16 mmol/mol, p = 0.529). The CKD cohort had increased level 1 (OR 1.73, p = 0.011), level 2 hypoglycaemias (OR 2.16, p = 0.002), and glycaemic variability than the non-CKD cohort (35.3 ± 9.5 vs 32.3 ± 6.8%). The CKD cohort had more level 2 hypoglycaemia events nocturnally compared to day at 1.9 ± 3.1 vs. 1.4 ± 2.5 events/person within the two week sensor wearing period (p = 0.022), whereas there was no significant intra-day difference in the number of such events within the non-CKD cohort.
Conclusions
The CKD cohort has a greater burden of hypoglycaemia despite being treated to similar HbA1c targets. The greater number of nocturnal events warrants safety concern. Interstitial fluid glucose targets should be incorporated into the glycaemic guidelines for T2D patients with CKD.
{"title":"High incidence of low interstitial fluid glucose among type 2 diabetes patients with chronic kidney disease (CKD) despite adhering to appropriate glycated haemoglobin targets—has time come for robust integration of interstitial fluid glucose targets into glycaemic guidelines?","authors":"Kristy Tian, Li Chang Ang, Pratik Choudhary, Jason Chon Jun Choo, Yong Mong Bee, Su-Yen Goh, Ming Ming Teh","doi":"10.1111/dme.15438","DOIUrl":"10.1111/dme.15438","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Aim</h3>\u0000 \u0000 <p>We aim to compare the burden of Level 1 (<4 mmol/L) and Level 2 (<3 mmol/L) hypoglycaemia between type 2 diabetes (T2D) patients with and without chronic kidney disease (CKD).</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>T2D subjects with and without CKD (eGFR<60 mL/min/1.73 m<sup>2</sup>) were recruited from a tertiary-care hospital. Subjects wore the Freestyle Libre-Pro sensor for 2 weeks. The number of hypoglycaemic events and intra-day difference in Level 1 and 2 hypoglycaemias were compared between the cohorts.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>We recruited 134 subjects: 74 with CKD (44 M:30F) and 60 without CKD (36 M:24F), with no difference in HbA1c between the two cohorts (66 ± 20 vs 64 ± 16 mmol/mol, <i>p</i> = 0.529). The CKD cohort had increased level 1 (OR 1.73, <i>p</i> = 0.011), level 2 hypoglycaemias (OR 2.16, <i>p</i> = 0.002), and glycaemic variability than the non-CKD cohort (35.3 ± 9.5 vs 32.3 ± 6.8%). The CKD cohort had more level 2 hypoglycaemia events nocturnally compared to day at 1.9 ± 3.1 vs. 1.4 ± 2.5 events/person within the two week sensor wearing period (<i>p</i> = 0.022), whereas there was no significant intra-day difference in the number of such events within the non-CKD cohort.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusions</h3>\u0000 \u0000 <p>The CKD cohort has a greater burden of hypoglycaemia despite being treated to similar HbA1c targets. The greater number of nocturnal events warrants safety concern. Interstitial fluid glucose targets should be incorporated into the glycaemic guidelines for T2D patients with CKD.</p>\u0000 </section>\u0000 </div>","PeriodicalId":11251,"journal":{"name":"Diabetic Medicine","volume":"42 2","pages":""},"PeriodicalIF":3.2,"publicationDate":"2024-09-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142281902","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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