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.

Characterization of data-driven clusters in diabetes-free adults and their utility for risk stratification of type 2 diabetes.

BACKGROUND: The prevention of type 2 diabetes is challenging due to the variable effects of risk factors at an individual level. Data-driven methods could be useful to detect more homogeneous groups based on risk factor variability. The aim of this study was to derive characteristic phenotypes using cluster analysis of common risk factors and to assess their utility to stratify the risk of type 2 diabetes. METHODS: Data on 7317 diabetes-free adults from Sweden were used in the main analysis and on 2332 diabetes-free adults from Mexico for external validation. Clusters were based on sex, family history of diabetes, educational attainment, fasting blood glucose and insulin levels, estimated insulin resistance and ß-cell function, systolic and diastolic blood pressure, and BMI. The risk of type 2 diabetes was assessed using Cox proportional hazards models. The predictive accuracy and long-term stability of the clusters were then compared to different definitions of prediabetes. RESULTS: Six risk phenotypes were identified independently in both cohorts: very low-risk (VLR), low-risk low ß-cell function (LRLB), low-risk high ß-cell function (LRHB), high-risk high blood pressure (HRHBP), high-risk ß-cell failure (HRBF), and high-risk insulin-resistant (HRIR). Compared to the LRHB cluster, the VLR and LRLB clusters showed a lower risk, while the HRHBP, HRBF, and HRIR clusters showed a higher risk of developing type 2 diabetes. The high-risk clusters, as a group, had a better predictive accuracy than prediabetes and adequate stability after 20 years. CONCLUSIONS: Phenotypes derived using cluster analysis were useful in stratifying the risk of type 2 diabetes among diabetes-free adults in two independent cohorts. These results could be used to develop more precise public health interventions.

International comparison of glycaemic control in people with type 1 diabetes: an update and extension.

AIMS: To update and extend a previous cross-sectional international comparison of glycaemic control in people with type 1 diabetes. METHODS: Data were obtained for 520,392 children and adults with type 1 diabetes from 17 population and five clinic-based data sources in countries or regions between 2016 and 2020. Median HbA1c (IQR) and proportions of individuals with HbA1c < 58 mmol/mol (<7.5%), 58-74 mmol/mol (7.5-8.9%) and ≥75 mmol/mol (≥9.0%) were compared between populations for individuals aged <15, 15-24 and ≥25 years. Logistic regression was used to estimate the odds ratio (OR) of HbA1c < 58 mmol/mol (<7.5%) relative to ≥58 mmol/mol (≥7.5%), stratified and adjusted for sex, age and data source. Where possible, changes in the proportion of individuals in each HbA1c category compared to previous estimates were calculated. RESULTS: Median HbA1c varied from 55 to 79 mmol/mol (7.2 to 9.4%) across data sources and age groups so a pooled estimate was deemed inappropriate. OR (95% CI) for HbA1c < 58 mmol/mol (<7.5%) were 0.91 (0.90-0.92) for women compared to men, 1.68 (1.65-1.71) for people aged <15 years and 0.81 (0.79-0.82) aged15-24 years compared to those aged ≥25 years. Differences between populations persisted after adjusting for sex, age and data source. In general, compared to our previous analysis, the proportion of people with an HbA1c  < 58 mmol/l (<7.5%) increased and proportions of people with HbA1c ≥ 75 mmol/mol (≥9.0%) decreased. CONCLUSIONS: Glycaemic control of type 1 diabetes continues to vary substantially between age groups and data sources. While some improvement over time has been observed, glycaemic control remains sub-optimal for most people with Type 1 diabetes.

A collaborative comparison of international pediatric diabetes registries.

BACKGROUND: An estimated 1.1 million children and adolescents aged under 20 years have type 1 diabetes worldwide. Principal investigators from seven well-established longitudinal pediatric diabetes registries and the SWEET initiative have come together to provide an international collaborative perspective and comparison of the registries. WORK FLOW: Information and data including registry characteristics, pediatric participant clinical characteristics, data availability and data completeness from the Australasian Diabetes Data Network (ADDN), Danish Registry of Childhood and Adolescent Diabetes (DanDiabKids), Diabetes prospective follow-up registry (DPV), Norwegian Childhood Diabetes Registry (NCDR), National Paediatric Diabetes Audit (NPDA), Swedish Childhood Diabetes Registry (Swediabkids), T1D Exchange Quality Improvement Collaborative (T1DX-QI), and the SWEET initiative was extracted up until 31 December 2020. REGISTRY OBJECTIVES AND OUTCOMES: The seven diabetes registries and the SWEET initiative collectively show data of more than 900 centers and around 100,000 pediatric patients, the majority with type 1 diabetes. All share the common objectives of monitoring treatment and longitudinal outcomes, promoting quality improvement and equality in diabetes care and enabling clinical research. All generate regular benchmark reports. Main differences were observed in the definition of the pediatric population, the inclusion of adults, documentation of CGM metrics and collection of raw data files as well as linkage to other data sources. The open benchmarking and access to regularly updated data may prove to be the most important contribution from registries. This study describes aspects of the registries to enable future collaborations and to encourage the development of new registries where they do not exist.

Effect of flash glucose monitoring in adults with type 1 diabetes: a nationwide, longitudinal observational study of 14,372 flash users compared with 7691 glucose sensor naive controls.

AIMS/HYPOTHESIS: The aim of this work was to evaluate changes in glycaemic control (HbA1c) and rates of severe hypoglycaemia over a 2 year period after initiation of flash glucose monitoring (FM) in type 1 diabetes. METHODS: Using data from the Swedish National Diabetes Registry, 14,372 adults with type 1 diabetes with a new registration of FM during 2016-2017 and with continued FM for two consecutive years thereafter, and 7691 control individuals using conventional self-monitoring of blood glucose (SMBG) during the same observation period, were included in a cohort study. Propensity sores and inverse probability of treatment weighting (IPTW) were used to balance FM users with SMBG users. Changes in HbA1c and events of severe hypoglycaemia were compared. RESULTS: After the start of FM, the difference in IPTW change in HbA1c was slightly greater in FM users compared with the control group during the follow-up period, with an estimated mean absolute difference of -1.2 mmol/mol (-0.11%) (95% CI -1.64 [-0.15], -0.75 [-0.07]; p < 0.0001) after 15-24 months. The change in HbA1c was greatest in those with baseline HbA1c ≥70 mmol/mol (8.5%), with the estimated mean absolute difference being -2.5 mmol/mol (-0.23%) (95% CI -3.84 [-0.35], -1.18 [-0.11]; p = 0.0002) 15-24 months post index. The change was also significant in the subgroups with initial HbA1c ≤52 mmol/mol (6.9%) and 53-69 mmol/mol (7.0-8.5%). Risk of severe hypoglycaemic episodes was reduced by 21% for FM users compared with control individuals using SMBG (OR 0.79 [95% CI 0.69, 0.91]; p = 0.0014)]. CONCLUSIONS/INTERPRETATION: In this large cohort, the use of FM was associated with a small and sustained improvement in HbA1c, most evident in those with higher baseline HbA1c levels. In addition, FM users experienced lower rates of severe hypoglycaemic events compared with control individuals using SMBG for self-management of glucose control.

Comparison between data-driven clusters and models based on clinical features to predict outcomes in type 2 diabetes: nationwide observational study.

AIMS/HYPOTHESIS: Research using data-driven cluster analysis has proposed five novel subgroups of diabetes based on six measured variables in individuals with newly diagnosed diabetes. Our aim was (1) to validate the existence of differing clusters within type 2 diabetes, and (2) to compare the cluster method with an alternative strategy based on traditional methods to predict diabetes outcomes. METHODS: We used data from the Swedish National Diabetes Register and included 114,231 individuals with newly diagnosed type 2 diabetes. k-means clustering was used to identify clusters based on nine continuous variables (age at diagnosis, HbA1c, BMI, systolic and diastolic BP, LDL- and HDL-cholesterol, triacylglycerol and eGFR). The elbow method was used to determine the optimal number of clusters and Cox regression models were used to evaluate mortality risk and risk of CVD events. The prediction models were compared using concordance statistics. RESULTS: The elbow plot, with values of k ranging from 1 to 10, showed a smooth curve without any clear cut-off points, making the optimal value of k unclear. The appearance of the plot was very similar to the elbow plot made from a simulated dataset consisting only of one cluster. In prediction models for mortality, concordance was 0.63 (95% CI 0.63, 0.64) for two clusters, 0.66 (95% CI 0.65, 0.66) for four clusters, 0.77 (95% CI 0.76, 0.77) for the ordinary Cox model and 0.78 (95% CI 0.77, 0.78) for the Cox model with smoothing splines. In prediction models for CVD events, the concordance was 0.64 (95% CI 0.63, 0.65) for two clusters, 0.66 (95% CI 0.65, 0.67) for four clusters, 0.77 (95% CI 0.77, 0.78) for the ordinary Cox model and 0.78 (95% CI 0.77, 0.78) for the Cox model with splines for all variables. CONCLUSIONS/INTERPRETATION: This nationwide observational study found no evidence supporting the existence of a specific number of distinct clusters within type 2 diabetes. The results from this study suggest that a prediction model approach using simple clinical features to predict risk of diabetes complications would be more useful than a cluster sub-stratification.

Risk for developing perianal abscess in type 1 and type 2 diabetes and the impact of poor glycemic control.

PURPOSE: The primary aim of this study was to see whether perianal abscess rate differs between patients with type 1 and type 2 diabetes. A secondary aim was to determine whether poor glycemic control increases the risk for perianal abscess. METHODS: Data from the Swedish National Diabetes Registry and the Swedish National Patient Registry between January 2008 and June 2015 were matched. The risk for anal abscess was evaluated in univariate and multivariate analyses with type of diabetes, HbA1c level, BMI, and various diabetes complications as independent factors. RESULTS: Patients with type 1 diabetes had a lower rate of perianal abscess than patients with type 2 diabetes when adjusted for HbA1c, sex, and age (OR 0.65; 95% CI 0.57-0.73). The risk for perianal abscess increased with higher HbA1c. Incidence of perianal abscess was also elevated in diabetes patients with complications related to poor glycemic control such as ketoacidosis and coma (OR 2.63; 95% CI 2.06-3.35), gastroparesis, and polyneuropathy (OR 1.81; 95% CI 1.41-2.32). CONCLUSIONS: The prevalence of perianal abscess was higher among patients with type 2 diabetes than those with type 1, suggesting that metabolic derangement may be more important than autoimmune factors. Poor glycemic control was associated with higher risk for perianal abscess.

Patients' and Health Care Professionals' Perceptions of the Potential of Using the Digital Diabetes Questionnaire to Prepare for Diabetes Care Meetings: Qualitative Focus Group Interview Study.

BACKGROUND: In effective diabetes management, it is important that providers and health care systems prioritize the delivery of patient-centered care and that they are respectful of and responsive to individual patient preferences and barriers. OBJECTIVE: The objective of the study was to conduct focus group interviews to capture patients' and health care professionals' perceptions and attitudes regarding digital technology and to explore how the digital Diabetes Questionnaire can be used to support patient participation in diabetes care, as a basis for an implementation study. METHODS: A qualitative study was conducted with six focus group discussions with diabetes specialist nurses and medical doctors (n=29) and four focus group discussions with individuals with diabetes (n=23). A semistructured focus group interview guide was developed, including probing questions. The data were transcribed verbatim, and qualitative content analysis was performed using an inductive approach. RESULTS: Two main categories were revealed by the qualitative analysis: perceptions of digital technology and the digital questionnaire in diabetes management and care and perceptions of participation in diabetes care. An overarching theme that emerged from the focus group interviews was patients' and professionals' involvement in diabetes care using digital tools. CONCLUSIONS: The analysis identified important factors to consider when introducing the digital Diabetes Questionnaire in clinical use. Both professionals and patients need support and training in the practical implementation of the digital questionnaire, as well as the opportunity to provide feedback on the questionnaire answers.

Health-related quality of life and glycaemic control among adults with type 1 and type 2 diabetes - a nationwide cross-sectional study.

BACKGROUND: Health-related quality of life and glycaemic control are some of the central outcomes in clinical diabetes care and research. The purpose of this study was to describe the health-related quality of life and assess its association with glycaemic control in adults with type 1 and type 2 diabetes in a nationwide setting. METHODS: In this cross-sectional survey, people with type 1 (n = 2479) and type 2 diabetes (n = 2469) were selected at random without replacement from the Swedish National Diabetes Register. Eligibility criteria were being aged 18-80 years with at least one registered test of glycated haemoglobin (HbA1c) the last 12 months. The generic 36-item Short Form version 2 (SF-36v2) was answered by 1373 (55.4%) people with type 1 diabetes and 1353 (54.8%) with type 2 diabetes. RESULTS: Correlation analyses showed weak correlations between scores on the SF-36v2 and glycaemic control for both diabetes types. After the participants were divided into three groups based on their levels of HbA1c, multivariate regression analyses adjusted for demographics, other risk factors and diabetes complications showed that among participants with type 1 diabetes, the high-risk group (≥70 mmol/mol/8.6%) had statistically significantly lower means in five out of eight domains of the SF-36v2 and the mental component summary measure, as compared with the well-controlled group (< 52 mmol/mol/6.9%). Among the participants with type 2 diabetes, the high-risk group had the lowest statistically significantly means in seven domains and both summary measures. CONCLUSIONS: Among people with type 1 and type 2 diabetes, adults with high-risk HbA1c levels have lower levels of health-related quality of life in most but not all domains of the SF-36v2. This finding was not explained by demographics, other risk factors, or diabetes complications. The weak individual-level correlations between HRQOL scores and levels of glycaemic control argues for the need to not focus exclusively on either HbA1c levels or HRQOL scores but rather on both because both are important parts of a complex, life-long, challenging condition.

Refill adherence and persistence to lipid-lowering medicines in patients with type 2 diabetes: A nation-wide register-based study.

PURPOSE: This study aimed to describe and compare refill adherence and persistence to lipid-lowering medicines in patients with type 2 diabetes by previous cardiovascular disease (CVD). METHODS: We followed 97 595 patients (58% men; 23% with previous CVD) who were 18 years of age or older when initiating lipid-lowering medicines in 2007-2010 until first fill of multi-dose dispensed medicines, death, or 3 years. Using personal identity numbers, we linked individuals' data from the Swedish Prescribed Drug Register, the Swedish National Diabetes Register, the National Patient Register, the Cause of Death Register, and the Longitudinal Integration Database for Health Insurance and Labour Market Studies. We assessed refill adherence using the medication possession ratio (MPR) and the maximum gap method, and measured persistence from initiation to discontinuation of treatment or until 3 years after initiation. We analyzed differences in refill adherence and persistence by previous CVD in multiple regression models, adjusted for socioeconomic status, concurrent medicines, and clinical characteristics. RESULTS: The mean age of the study population was 64 years, 80% were born in Sweden, and 56% filled prescriptions for diabetes medicines. Mean MPR was 71%, 39% were adherent according to the maximum gap method, and mean persistence was 758 days. Patients with previous CVD showed higher MPR (3%) and lower risk for discontinuing treatment (12%) compared with patients without previous CVD (P < 0.0001). CONCLUSIONS: Patients with previous CVD were more likely to be adherent to treatment and had lower risk for discontinuation compared with patients without previous CVD.

Risk factors for atrial fibrillation in type 2 diabetes: report from the Swedish National Diabetes Register (NDR).

AIMS/HYPOTHESIS: Atrial fibrillation (AF) is more frequent in patients with diabetes than in the general population. However, characteristics contributing to AF risk in diabetes remain speculative. METHODS: Observational study of 83,162 patients with type 2 diabetes, aged 30-79 years, with no baseline AF, 17% had history of cardiovascular disease (CVD) and 3.3% history of congestive heart failure (CHF), followed up for development of AF during mean 6.8 years from 2005-2007 to 2012. A subgroup of 67,780 patients without history of CVD or CHF was also analysed. RESULTS: Using Cox regression, cardiovascular risk factors associated with risk for AF were updated mean BMI (HR 1.31 per 5 kg/m(2)) or obesity (HR 1.51), updated mean systolic BP (SBP; HR 1.13 per 10 mmHg) or hypertension (HR 1.71), and cumulative microalbuminuria (HR 1.21), p < 0.001 for all analyses. Male sex, increasing age and height were also significant predictors. HRs were 1.76 for a history of CHF and 2.56 for in-study CHF, while 1.32 for history of CVD and 1.38 for in-study CHD (p < 0.001). Among patients without history of CVD or CHF, significant predictors were similarly BMI, SBP, and cumulative microalbuminuria and CHF. The risk of AF differed in the subgroups achieving or not achieving a target BP < 140/85 mmHg. The HRs for AF were (per 10 mmHg increase) 0.88 and 1.24, respectively. CONCLUSIONS/INTERPRETATION: The modifiable risk factors high BP, high BMI and albuminuria were strongly associated with AF in type 2 diabetes. CVD, advancing age and height were also associated with AF in type 2 diabetes.

Prevalence and risk factors for diabetic retinopathy at diagnosis of type 2 diabetes: an observational study of 77 681 patients from the Swedish National Diabetes Registry.

INTRODUCTION: To assess the prevalence of diabetic retinopathy (DR) in persons with newly diagnosed type 2 diabetes (T2D) to understand the potential need for intensified screening for early detection of T2D. RESEARCH DESIGN AND METHODS: Individuals from the Swedish National Diabetes Registry with a retinal photo <2 years after diagnosis of T2D were included. The proportion of patients with retinopathy (simplex or worse) was assessed. Patient characteristics and risk factors at diagnosis were analyzed in relation to DR with logistic regression. RESULTS: In total, 77 681 individuals with newly diagnosed T2D, mean age 62.6 years, 41.1% females were included. Of these, 13 329 (17.2%) had DR.DR was more common in older persons (adjusted OR 1.03 per 10-year increase, 95% CI 1.01 to 1.05) and men compared with women, OR 1.10 (1.05 to 1.14). Other variables associated with DR were OR (95% CI): lower education 1.08 (1.02 to 1.14); previous stroke 1.18 (1.07 to 1.30); chronic kidney disease 1.29 (1.07 to 1.56); treatment with acetylsalicylic acid 1.14 (1.07 to 1.21); ACE inhibitors 1.12 (1.05 to 1.19); and alpha blockers 1.41 (1.15 to 1.73). DR was more common in individuals born in Asia (OR 1.16, 95% CI 1.08 to 1.25) and European countries other than those born in Sweden (OR 1.11, 95% CI 1.05 to 1.18). CONCLUSIONS: Intensified focus on screening of T2D may be needed in Sweden in clinical practice since nearly one-fifth of persons have retinopathy at diagnosis of T2D. The prevalence of DR was higher in men, birthplace outside of Sweden, and those with a history of stroke, kidney disease, and hypertension.

Associations Between HbA1c and Glucose Time in Range Using Continuous Glucose Monitoring in Type 1 Diabetes: Cross-Sectional Population-Based Study.

INTRODUCTION: Continuous glucose monitoring (CGM) introduces novel indicators of glycemic control. METHODS: This cross-sectional study, based on the Swedish National Diabetes Register, examines 27,980 adults with type 1 diabetes. It explores the relationships between HbA1c (glycated hemoglobin) and various CGM-derived metrics, including TIR (time in range, representing the percentage of time within the range of 4-10 mmol/l for 2 weeks), TAR (time above range), TBR (time below range), mean glucose, standard deviation (SD), and coefficient of variation (CV). Pearson correlation coefficients and linear regression models were utilized for estimation. RESULTS: The analysis included 46% women, 30% on insulin pump, 7% with previous coronary heart disease and 64% with retinopathy. Mean ± SD values were age 48 ± 18 years, diabetes duration 25 ± 16 years, HbA1c 58.8 ± 12.8 mmol/mol, TIR 58.8 ± 19.0%, TAR 36.3 ± 20.0%, TBR 4.7 ± 5.4%, mean sensor glucose 9.2 ± 2.0 mmol/l, SD 3.3 ± 1.0 mmol/l, and CV 36 ± 7%. The overall association between HbA1c and TIR was - 0.71 (Pearson's r), with R2 0.51 in crude linear regression and 0.57 in an adjusted model. R2 values between HbA1c and CGM mean glucose were 0.605 (unadjusted) 0.619 (adjusted) and TAR (unadjusted 0.554 and fully adjusted 0.568, respectively), while fully adjusted R2 values were 0.458, 0.175 and 0.101 between HbA1c and CGM SD, CGM CV and TBR, respectively. CONCLUSIONS: This descriptive study demonstrates that the degree of association between HbA1c and new and readily available CGM-derived metrics, i.e., time in range (TIR), time above range (TAR), and CGM mean glucose, is robust in assessing the management of individuals with type 1 diabetes in clinical settings. Metrics from CGM that pertain to variability and hypoglycemia exhibit only weak correlations with HbA1c.

Periodontitis in patients with diabetes and its association with diabetes-related complications. A register-based cohort study.

OBJECTIVE: To evaluate the association between type 1 diabetes (T1D)/type 2 diabetes (T2D) and periodontitis and assess the influence of periodontitis on diabetes-related complications. DESIGN: Observational study; longitudinal analysis of register data. SETTING: Swedish primary care centres, hospitals and dental clinics reporting to nationwide healthcare registers (2010-2020). PARTICIPANTS: 28 801 individuals with T1D (13 022 women; mean age 42 years) and 57 839 individuals without diabetes (non-T1D; 26 271 women; mean age 43 years). 251 645 individuals with T2D (110 627 women; mean age 61 years) and 539 805 individuals without diabetes (non-T2D; 235 533 women; mean age 60 years). Diabetes and non-diabetes groups were matched for age, gender and county of residence. MAIN OUTCOME MEASURES: Prevalent periodontitis, diabetes-related complications (retinopathy, albuminuria, stroke and ischaemic heart disease) and mortality. RESULTS: Periodontitis was more common among T2D (22%) than non-T2D (17%). Differences were larger in younger age groups (adjusted RR at age 30-39 years 1.92; 95% CI 1.81 to 2.03) and exacerbated by poor glycaemic control. Periodontitis prevalence was 13% in T1D and 11% in non-T1D; only the subgroup with poor glycaemic control was at higher risk for periodontitis. Periodontitis was associated with a higher incidence of retinopathy (T1D: HR 1.08, 95% CI 1.02 to 1.14; T2D: HR 1.08, 95% CI 1.06 to 1.10) and albuminuria (T1D: HR 1.14, 95% CI 1.06 to 1.23; T2D: HR 1.09, 95% CI 1.07 to 1.11). Periodontitis was not associated with a higher risk for stroke, cardiovascular disease or higher mortality in T1D/T2D. CONCLUSIONS: The association between T2D and periodontitis was strong and exacerbated by poor glycaemic control. For T1D, the association to periodontitis was limited to subgroups with poor glycaemic control. Periodontitis contributed to an increased risk for retinopathy and albuminuria in T1D and T2D.

First year national Swedish paediatric Hba1c data are at the level of several intervention studies: Results from a Swedish nationwide diabetes register study.

AIMS/HYPOTHESIS: To study the progression of HbA1c after diagnosis of type 1 diabetes in children and adolescents during 2010-2019 with emphasis on HbA1c nadir 3-6 months after onset. METHODS: Partial funding was secured for this study. The Swedish paediatric diabetes quality register SWEDIABKIDS has >95 % coverage of type 1 diabetes up to 18 years. A mixed model for repeated measurements was used to estimate differences in HbA1c between onset year periods. RESULTS: We followed 6,891 patients over two years from onset (48,292 HbA1c values). We found a gradual decrease in mean HbA1c 24 months after onset from 56.0 mmol/mol (7.28 %) in 2010/11 to 50.5 mmol/mol (6.77 %) in 2018/19, which is at the level of several recent intervention studies. The initial drop in HbA1c from onset until 3 and 6 months has become more pronounced in recent years. There was a significant positive correlation between HbA1c at 3 and 6 months with 12, 18 and 24 months. Percentage of severe hypoglycaemic coma was higher (5.1 % vs 3.4 %; p = 0.023) in 2010/2011 than 2018/2019, but the absolute risk of ketoacidosis was essentially unchanged, (1.5 % to 0.8 %, p = 0.110) CONCLUSIONS/INTERPRETATION: There was a continuous decrease in HbA1c over the study period 2010-2019, which coincides in time with an increased use of diabetes technology and lowering the HbA1c target to 48 mmol/mol (6.5 %). The decrease in 2-year HbA1c was preceded by a lower HbA1c nadir, which may set the trajectories for coming HbA1c and be a modifiable factor for a long-term improvement in metabolic control.

Patient Experiences after Open Trigger Finger Release in Patients with Type 1 and Type 2 Diabetes-A Retrospective Study Using Patient-reported Outcome Measures.

Trigger finger is overrepresented among patients with diabetes mellitus (DM). Whether DM affects the outcome after open trigger finger release (OTFR) in patients with DM is not known. Our aim was thus to explore outcomes after OTFR in patients with type 1 (T1D) and type 2 DM (T2D). Methods: Data included patient-reported outcome measures (PROMs) from all OTFRs performed between 2010 and 2020 registered in the Swedish national registry for hand surgery in individuals over 18 years cross-linked with the Swedish National Diabetes Register (NDR). PROMs included QuickDASH and HQ8, a questionnaire designed for national registry for hand surgery, preoperative and at 3 and 12 months postoperative. HQ8 included pain on load, pain on motion without load, and stiffness. Outcome was calculated using linear-mixed models and presented as means adjusted for age and stratified by sex. Results: In total, 6242 OTFRs were included, whereof 496 had T1D (332, 67% women) and 869 had T2D (451, 52% women). Women with T1D reported more symptoms of stiffness (P < 0.001), and women with T2D reported more pain on load (P < 0.05), motion without load (P < 0.01), and worse overall result at 3 months. At 12 months, however, no differences were found in any of the HQ-8 PROMs among men or women. Women with T2D had slightly higher QuickDASH scores at 3 and 12 months. Conclusion: Patients with T1D and T2D can expect the same results after OTFR as individuals without DM, although the improvement might take longer especially among women with T2D.

Real-world study of flash glucose monitoring among adults with type 2 diabetes within the Swedish National Diabetes Register.

BACKGROUND: The Swedish National Diabetes Register (NDR) initiated registration of the FreeStyle Libre® system and other continuous glucose monitoring (CGM) systems in June 2016. We investigated change in HbA1c for people with type 2 diabetes (T2DM) using FreeStyle Libre in Sweden. METHODS: We included adults with T2DM, registered in the NDR after January 1, 2014, and an index date for first use of FreeStyle Libre of June 2016 or later. Methodology was a before/after comparison of HbA1c within 6 months before the index date versus HbA1c around 6 and 12 months after the index date. RESULTS: 711 adults with T2DM using FreeStyle Libre had HbA1c measurements within the study period. Mean HbA1c was significantly reduced at 6 months (-0.50%-unit) and at 12 months (-0.52%-unit) in this group. Degree of change was negatively correlated to baseline HbA1c. Reductions in HbA1c were observed in incident users of FreeStyle Libre with T2DM who were truly naïve to CGM or had unknown prior experience of CGM, and aged 25-74 years. CONCLUSIONS: This real-world study on the Swedish NDR shows that people with T2DM using FreeStyle Libre system for 6 and 12 months significantly reduced their HbA1c.

Risk trajectories of complications in over one thousand newly diagnosed individuals with type 2 diabetes.

Although the increased risk of complications of type 2 diabetes (T2D) is well known, there is still little information about the long-term development of comorbidities in relation to risk factors. The purpose of the present study was to describe the risk trajectories of T2D complications over time in an observational cohort of newly diagnosed T2D patients, as well as to evaluate the effect of common risk factors on the development of comorbidities. This national cohort study investigated individuals with T2D in the Swedish National Diabetes Register regarding prevalence of comorbidities at the time of diagnosis, and the incidence of cardiovascular disease (CVD), chronic kidney disease (CKD) and heart failure in the entire patient cohort and stratified by HbA1c levels and age at baseline. Multivariable Cox regressions were used to evaluate risk factors predicting outcomes. We included 100,878 individuals newly diagnosed with T2D between 1998 and 2012 in the study, with mean 5.5 years follow-up (max 17 years). The mean age at diagnosis was 62.6 ± SD12.5 years and 42.7% of the patients were women. Prevalent CVD was reported for 17.5% at baseline. Although the prevalence of comorbidities was generally low for individuals 50 years or younger at diagnosis, the cumulative incidence of the investigated comorbidities increased over time. Newly diagnosed CVD was the most common comorbidity. Women were shown to have a lower risk of developing comorbid conditions than men. When following the risk trajectory of comorbidities over a period of up to 15 years in individuals with type 2 diabetes, we found that all comorbidities gradually increased over time. There was no distinct time point when onset suddenly increased.

High HbA1c Levels Are Associated With Development of Trigger Finger in Type 1 and Type 2 Diabetes: An Observational Register-Based Study From Sweden.

OBJECTIVE: Trigger finger (TF) is a hand disorder causing the fingers to painfully lock in flexion. Diabetes is a known risk factor; however, whether strict glycemic control effectively lowers risk of TF is unknown. Our aim was to examine whether high HbA1c was associated with increased risk of TF among individuals with diabetes. RESEARCH DESIGN AND METHODS: The Swedish National Diabetes Register (NDR) was cross-linked with the health care register of the Region of Skåne in southern Sweden. In total, 9,682 individuals with type 1 diabetes (T1D) and 85,755 individuals with type 2 diabetes (T2D) aged ≥18 years were included from 2004 to 2019. Associations between HbA1c and TF were calculated with sex-stratified, multivariate logistic regression models with 95% CIs, with adjustment for age, duration of diabetes, BMI, and systolic blood pressure. RESULTS: In total, 486 women and 271 men with T1D and 1,143 women and 1,009 men with T2D were diagnosed with TF. Increased levels of HbA1c were associated with TF among individuals with T1D (women OR 1.26 [95% CI 1.1-1.4], P = 0.001, and men 1.4 [1.2-1.7], P < 0.001) and T2D (women 1.14 [95% CI 1.2-1.2], P < 0.001, and men 1.12 [95% CI 1.0-1.2], P = 0.003). CONCLUSIONS: Hyperglycemia increases the risk of developing TF among individuals with T1D and T2D. Optimal treatment of diabetes seems to be of importance for prevention of diabetic hand complications such as TF.

Range of Risk Factor Levels, Risk Control, and Temporal Trends for Nephropathy and End-stage Kidney Disease in Patients With Type 1 and Type 2 Diabetes.

OBJECTIVE: To investigate trends, optimal levels for cardiometabolic risk factors, and multifactorial risk control in diabetic nephropathy and end-stage kidney disease (ESKD) in patients with diabetes and matched control subjects. RESEARCH DESIGN AND METHODS: This study included 701,622 patients with diabetes from the Swedish National Diabetes Register and 2,738,137 control subjects. Trends were analyzed with standardized incidence rates. Cox regression was used to assess excess risk, optimal risk factor levels, and risk according to the number of risk factors, in diabetes. RESULTS: ESKD incidence among patients with and without diabetes initially declined until 2007 and increased thereafter, whereas diabetic nephropathy decreased throughout follow-up. In patients with diabetes, baseline values for glycated hemoglobin, systolic blood pressure (SBP), triglycerides, and BMI were associated with outcomes. Hazard ratio (HR) for ESKD for patients with type 2 diabetes who had all included risk factors at target was 1.60 (95% CI 1.49-1.71) compared with control subjects and for patients with type 1 diabetes 6.10 (95% CI 4.69-7.93). Risk for outcomes increased in a stepwise fashion for each risk factor not at target. Excess risk for ESKD in type 2 diabetes showed a HR of 2.32 (95% CI 2.30-2.35) and in type 1 diabetes 10.92 (95% CI 10.15-11.75), compared with control. CONCLUSIONS: Incidence of diabetic nephropathy has declined substantially, whereas ESKD incidence has increased. Traditional and modifiable risk factors below target levels were associated with lower risks for outcomes, particularly notable for the causal risk factors of SBP and HbA1c, with potential implications for care.