Lower Extremity Amputation Rates in People With Diabetes Mellitus: A Retrospective Population Based Cohort Study in Zwolle Region, The Netherlands.

OBJECTIVE: Lower extremity amputations are a major complication of diabetes mellitus (DM). In a previous Dutch study, the incident rate of major amputations was 89.2 per 100 000 person years. The primary aim of this study was to describe the lower extremity amputation rates in people with DM in the Zwolle region, where preventive and curative footcare is organised according to the guidelines of the International Working Group of the Diabetic Foot (IWGDF). The secondary aim was to evaluate outcomes and underlying characteristics of these people. METHODS: This was a retrospective regional population based cohort study. Data from all people with DM treated in primary and secondary care, living in the region Zwolle were collected. All amputations in the period 2017 to 2019 were analysed. Comparisons were made between those with and without an amputation. RESULTS: In the analysis 5 915 people with DM were included, with a mean age of 67.8 (IQR 57.9, 75.9) years. Of those people, 47% were women and the median HbA1c was 53 (IQR 47, 62) mmol/mol. Over the three year study period 68 amputations were performed in 59 people: 46 minor, 22 major. This translated into an average annual crude amputation incidence rate of non-traumatic major and minor amputations of 41.5 and 86.9 per 100 000 person years among people with diabetes. Compared with those not undergoing amputations, those who underwent an amputation were more often men, older, mainly had T2DM, were treated in secondary care, had higher diastolic blood pressure, worse diabetic footcare profile, longer DM duration and higher HbA1c. At the end of the follow up, 111 people died: 96 (1.6%) without and 15 (25.4%) with amputations (p < .001). CONCLUSIONS: This retrospective study provides detailed insight into the rate of amputations in Dutch people with diabetes in the region Zwolle. Compared with previous Dutch estimates, these data suggest a considerable decrease in the major amputation incidence rate.

Adherence to insulin pump treatment declines with increasing age in adolescents with type 1 diabetes mellitus.

AIM: This study assessed the impact of illness perceptions, emotional responses to the disease and its management, and patient characteristics on the adherence to optimal insulin pump management in adolescents with type 1 diabetes mellitus. METHODS: From May to December 2013 and May 2015 to September 2016, we investigated 90 adolescents (50% boys), 12-18 years with type 1 diabetes. We analysed the association of optimal adherence to insulin pump therapy to age, gender, diabetes duration, results of questionnaires relating to fear and problems of self-testing, illness perceptions, emotional distress and family conflicts. Optimal adherence was defined as bolusing insulin on average ≥2.5/3 main meals/d. RESULTS: Adolescents with suboptimal adherence were on average 1.8 years older (95% Confidence Interval 1.09-2.50 years, P < .001) than those with optimal adherence. After adjustment for age, no other patient or parent factors were related to optimal adherence. CONCLUSION: Adherence to insulin pump self-management in adolescents with type 1 diabetes declined with increasing age, illustrating the challenges of transition of self-management from parents to the adolescent patient themselves.

Correction to: Mealtime insulin bolus adherence and glycemic control in adolescents on insulin pump therapy.

The Abstract section and the in the Results sections of the original version of this article, unfortunately, contained errors. The correct data are now shown in this article.

Mealtime insulin bolus adherence and glycemic control in adolescents on insulin pump therapy.

Poor self-management contributes to insufficient glycemic control in adolescents with type 1 diabetes (T1DM). We assessed the effects on glycemic control of adherence to self-measurement of blood glucose (SMBG) and insulin boluses in 90 adolescents with T1DM on insulin pump therapy over a 2-month period. We compared the number of insulin boluses and SMBGs around main meals to the "gold standard" of optimal diabetes management (SMBGs and a bolus before each main meal and SMBG before bedtime). The mean (95% CI) HbA1c levels were 2.9(1.7 to 4.0) mmol/mol lower for every additional insulin bolus and 3.1(1.6 to 4.5) mmol/mol lower for every additional SMBG. Patients performing SMBG and bolusing around each main meal had considerably lower HbA1c levels than those unable to do (95% CI for difference 4.3 to 10.4 mmol/mol and 11.5 to 20.1 mmol/mol respectively). For each additional mealtime bolus/day, the odds ratio of achieving target HbA1c levels of <58 mmol/mol was 6.73 (95% CI 2.94-15.38), after adjustment for gender, age, diabetes duration, and affective responses to SMBG in a multiple logistic regression model.Conclusion: Glycemic control in adolescents with T1DM on insulin pump therapy is strongly dependent on adherence to insulin boluses around mealtimes. What is Known: • In mixed groups of children and adolescents, insulin bolus frequency and self-monitoring of blood glucose (SMBG) frequency were determinants of HbA1c levels. • Adherence to insulin boluses and SMBG is particularly challenging in adolescents. What is New: • In adolescents on insulin pump therapy, each additional insulin bolus, particularly around mealtime, was significantly associated with approximately 3 mmol/mol lower HbA1c levels. • This beneficial effect of mealtime bolusing was strongest for the evening meal.

Gender differences in the evaluation of care for patients with type 2 diabetes: a cross-sectional study (ZODIAC-52).

BACKGROUND: Little is known about the association between patient-related factors and patients' evaluation of care. Aim was to investigate which patient-related factors are associated with patients' evaluation of care in men and women with type 2 diabetes (T2D) in primary care. METHODS: This cross-sectional study included 1102 patients with T2D from 52 general practices. We measured patients' evaluation with the EUROPEP questionnaire and collected demographic, clinical and psychological data from questionnaires and health records. Stepwise linear regression analyses were used. RESULTS: The location where the questionnaire was completed (at home or at the general practice) was associated with all outcomes in men and women. Next to this, in men, explanatory factors for the care provider EUROPEP subscale were use of insulin, having some problems with T2D self-care and coffee consumption (R2 8.4%); coffee consumption was associated with the general practice subscale (R2 4.0%). In women, well-being, quality of life, following a general diet, and use of oral glucose-lowering drugs were associated with the care provider subscale (R2 16.8%). For the general practice subscale, well-being and age were explanatory factors (R2 9.4%). CONCLUSIONS: Only a few factors were found to be associated with patients' evaluation of care for men and women with T2D. Taken together, these factors explained only a small part of the variance of the EUROPEP scores. This explained variance was largely attributable to the location where the questionnaire was completed. We therefore advise to be aware of the possible consequences of filing-out questionnaires about patients' evaluation of care at the general practice. TRIAL REGISTRATION: NCT01570140 (Clinicaltrials.gov). Registered 29 March 2012.

Within-class differences in cancer risk for sulfonylurea treatments in patients with type 2 diabetes (ZODIAC-55) - a study protocol.

BACKGROUND: Patients with type 2 diabetes (T2D) are at increased risk for developing cancer. As approximately 8% of the world's population is living with T2D, even a slight increase in cancer risk could result in an enormous impact on the number of persons developing cancer. In addition, several glucose lowering drug classes for treating patients with T2D have been associated with a difference in risk of cancer overall, and especially for obesity related cancers. In what way and to what degree cancer risk is modified by the use of different sulfonylureas (SU) is unclear. The primary aim of this study will be to evaluate within-class SU differences in obesity related cancer risk. Secondary aims will be to investigate within-class SU differences in risk for all cancers combined and site-specific cancers separately (i.e. breast, colorectal, prostate, bladder and lung cancer) and to account for duration-response relationships between individual SU use and cancer risk. METHODS: Patients will be selected from a Dutch primary care cohort of patients with T2D linked with the Dutch Cancer Registration (ZODIAC-NCR). Within this cohort study annually collected clinical data (e.g. blood pressure, weight, HbA1c) and nationwide data on cancer incidence are available. Time-dependent cox proportional hazard analyses will be performed to evaluate SU cancer risk, adjusted for potential confounders. DISCUSSION: This study will be the first prospective cohort study investigating within-class SU differences in cancer risk and could contribute to improved decision making regarding the individual drugs within the class of SUs, and possibly improve quality of life and result in an increased cost-effectiveness of healthcare in patients with T2D. TRIAL REGISTRATION: Nederlands Trialregister ( NTR6166 ), 6 Jan 2017.

High-sensitive troponin T is associated with all-cause and cardiovascular mortality in stable outpatients with type 2 diabetes (ZODIAC-37).

BACKGROUND: We aimed to investigate whether high-sensitive cardiac troponin T (hs-cTnT) is associated with all-cause and cardiovascular mortality in stable type 2 diabetes (T2D) outpatients treated in primary care. METHODS: Cardiac troponin T was measured with a high-sensitive assay at baseline in patients with T2D participating in the observational ZODIAC study. Cox proportional hazards models were used to investigate the relationship between hs-cTnT and mortality with adjustment for selected confounders. Risk prediction capabilities of hs-cTnT were assessed with Harrell C statistics. RESULTS: Complete baseline data were available for 1,133 patients. During median follow-up of 11 (7-14) years, 513 (45%) patients died, of which 218 (42%) died of cardiovascular causes. Of the patients with undetectable hs-cTnT levels (<3 ng/L), only 23% died, compared with 58% with low detectable levels (3-14 ng/L) and 84% with raised levels (≥14 ng/L). Natural log hs-cTnT was significantly associated with all-cause mortality (hazard ratio 1.30, 95% CI 1.19-1.42) and cardiovascular mortality (hazard ratio 1.33, 95% CI 1.15-1.53), independent of potential confounders. The Harrell C statistic for the crude model of hs-cTnT was 0.72 (95% CI 0.70-0.75) for all-cause mortality and 0.74 (95% CI 0.71-0.77) for cardiovascular mortality. CONCLUSIONS: Higher levels of hs-cTnT are associated with mortality in stable outpatients with T2D. The high crude Harrell C values and the excellent prognosis of patients with undetectable levels illustrate the strength of hs-cTnT as a potential marker for mortality.

Addition of sulphonylurea to metformin does not relevantly change body weight: a prospective observational cohort study (ZODIAC-39).

AIM: To investigate changes in body weight trajectories after the addition of individual sulphonylureas (SUs) to metformin in patients with type 2 diabetes. MATERIALS AND METHODS: We conducted a retrospective observational cohort study, in a primary care setting in the Netherlands. Patients aged ≥18 years with type 2 diabetes who were included in the ZODIAC cohort between 1998 and 2012 and who received metformin monotherapy at inclusion (n = 29 195), and had used metformin as monotherapy for at least 1 year before receiving dual therapy through the addition of an SU for at least 1 year were eligible for inclusion. The primary outcome was within-drug yearly change in body weight after receiving add-on therapy with individual SUs during 5 years of follow-up. The secondary outcome was within-drug yearly change in glycated haemoglobin (HbA1c). Annual changes in weight and HbA1c were estimated with linear mixed models, adjusted for age, gender and diabetes duration. RESULTS: A total of 2958 patients were included. No significant weight changes were observed within and between any of the individual SUs after treatment intensification (p = 0.24). In addition, no significant difference in weight between the add-on therapy combinations was observed (p = 0.26). The average HbA1c the year before intensification was 7.2% (55 mmol/mol) and dropped below 7.0% (53 mmol/mol) the year after. CONCLUSIONS: In patients with type 2 diabetes treated in primary care, strict glycaemic control can be maintained with SUs used as add-on therapy to metformin, without the offset of relevant weight changes.

Alanine aminotransferase and mortality in patients with type 2 diabetes (ZODIAC-38).

INTRODUCTION: Combined data suggest a bimodal association of alanine aminotransferase (ALT) with mortality in the general population. Little is known about the association of ALT with mortality in patients with type 2 diabetes. We therefore investigated the association of ALT with all-cause, cardiovascular and noncardiovascular mortality in patients with type 2 diabetes. DESIGN: A prospective study was performed in patients with type 2 diabetes, treated in primary care, participating in the Zwolle Outpatient Diabetes project Integrating Available Care (ZODIAC) study. Cox regression analyses were performed to determine the associations of log2 -transformed baseline ALT with all-cause, cardiovascular and noncardiovascular mortality. RESULTS: In 1187 patients with type 2 diabetes (67 ± 12 years, 45% female), ALT levels were 11 (8-16) U/L. During median follow-up for 11.1 (6.1-14.0) years, 553 (47%) patients died, with 238 (20%) attributable to cardiovascular causes. Overall, ALT was inversely associated with all-cause mortality (hazard ratio [HR] 0.81; 95% confidence interval [CI] 0.72-0.92), independently of potential confounders. This was less attributable to cardiovascular mortality (HR 0.87; 95% CI 0.72-1.05), than to noncardiovascular mortality (HR 0.77; 95% CI 0.65-0.90). Despite the overall inverse association of ALT with mortality, it appeared that a bimodal association with all-cause mortality was present with increasing risk for levels of ALT above normal (P = 0.003). DISCUSSION: In patients with type 2 diabetes, low levels of ALT are associated with an increased risk of all-cause mortality, in particular noncardiovascular mortality, compared to normal levels of ALT, while risk again starts to increase when levels are above normal.

The relationship between N-terminal prosomatostatin, all-cause and cardiovascular mortality in patients with type 2 diabetes mellitus (ZODIAC-35).

BACKGROUND: The hormone somatostatin inhibits growth hormone release from the pituitary gland and is theoretically linked to diabetes and diabetes related complications. This study aimed to investigate the relationship between levels of the stable somatostatin precursor, N-terminal prosomatostatin (NT-proSST), with mortality in type 2 diabetes (T2DM) patients. METHODS: In 1,326 T2DM outpatients, participating in this ZODIAC prospective cohort study, Cox proportional hazards models were used to investigate the independent relationship between plasma NT-proSST concentrations with all-cause and cardiovascular mortality. RESULTS: Median concentration of NT-proSST was 592 [IQR 450-783] pmol/L. During follow-up for 6 [3-10] years, 413 (31%) patients died, of which 176 deaths (43%) were attributable to cardiovascular causes. The age and sex adjusted hazard ratios (HRs) for all-cause and cardiovascular mortality were 1.48 (95%CI 1.14 - 1.93) and 2.21 (95%CI 1.49 - 3.28). However, after further adjustment for cardiovascular risk factors there was no independent association of log NT-proSST with mortality, which was almost entirely attributable to adjustment for serum creatinine. There were no significant differences in Harrell's C statistics to predict mortality for the models with and without NT-proSST: both 0.79 (95%CI 0.77 - 0.82) and 0.81 (95%CI 0.77 - 0.84). CONCLUSIONS: NT-proSST is unsuitable as a biomarker for cardiovascular and all-cause mortality in stable outpatients with T2DM.

The incidence of type 1 diabetes is still increasing in the Netherlands, but has stabilised in children under five (Young DUDEs-1).

AIM: This study described the incidence and prevalence of type 1 diabetes in children in the Netherlands in 2010-2011 and to compare these results with earlier studies. METHODS: This was a retrospective nationwide cohort study of Dutch children aged 14 years or younger. Patients were identified using health insurance reimbursement registries for hospital care and invoices for insulin. In the Netherlands, all children with diabetes are treated by hospital-based paediatricians and health care for all Dutch citizens is covered by law. RESULTS: The incidence of type 1 diabetes almost doubled between 1978-1980 and 2010-2011, from 11.1 to 21.4 per 100 000. In the youngest age group, who were under 5 years, the incidence rate doubled between 1996 and 1999 and remained stable after that. There were no relevant incidence differences between the sexes. The overall prevalence of type 1 diabetes in the Netherlands during 2009-2011 was 143.6 (95% confidence interval 141.1-146.2) per 100 000 children and was similar for boys and girls. CONCLUSION: The incidence of type 1 diabetes in children in the Netherlands almost doubled between 1978-1980 and 2010-2011, but the incidence in children under 5 years appeared to stabilise between 1996 and 1999. There were no statistical differences between the sexes.

Validation of the howRu and howRwe questionnaires at the individual patient level.

BACKGROUND: The howRu and howRwe are new short questionnaires which are meant to measure health-related quality of life and patient experience. However, validation at the individual patient level has not yet taken place. We aimed to investigate the validity of both questionnaires at the individual patient level. METHODS: In this prospective validation study, patients were asked to complete both questionnaires and comment on their answers in a semi-structured in-depth interview. Based on the transcribed interviews, a panel of 45 general practitioners and 45 patients filled out the questionnaires as they thought the patients had completed them. The questionnaires were considered valid instruments when a reliable and acceptable level of agreement was reached between the patient's score and the score of a review panel, defined as a concordance correlation coefficient (CCC) of ≥0.70. Bland-Altman plots were also made. RESULTS: Ninety patients were included. The CCC of the howRu total score of the review panel and patients was 0.80 (95 % CI 0.73 to 0.86). Bland-Altman plots showed a mean difference of -0.96 and the limits of agreement ranged from -2.87 to 0.95. The CCC of the howRwe total score was 0.57 (95 % CI 0.42 to 0.69). The mean difference on the Bland-Altman plots was -0.54 and the limits of agreement ranged from -3.59 to 2.52. CONCLUSIONS: The howRu seems to be a valid questionnaire for measuring health-related quality of life at the individual patient level. We do not advice to use the tested version of the howRwe questionnaire for assessing patient experience at the individual patient level. TRIAL REGISTRATION: The study was registered at clinicaltrials.gov NCT01830803 . Registration date: 5 April 2013.

Radiating low back pain in general practice: incidence, prevalence, diagnosis, and long-term clinical course of illness.

OBJECTIVE: The aim of this study was to calculate the incidence and prevalence of radiating low back pain, to explore the long-term clinical course of radiating low back pain including the influence of radiculopathy (in a subsample of the study population) and non-radiating low back pain thereon, and to describe general practitioners' (GPs') treatment strategies for radiating low back pain. DESIGN: A historic prospective cohort study. SETTING: Dutch general practice. SUBJECTS: Patients over 18 years of age with a first episode of radiating low back pain, registered by the ICPC code L86. MAIN OUTCOME MEASURES: Incidence and prevalence, clinical course of illness, initial diagnoses established by the GPs, and treatment strategies. RESULTS: Mean incidence was 9.4 and mean prevalence was 17.2 per 1000 person years. In total, 390 patients had 1193 contacts with their GPs; 50% had only one contact with their GP. Consultation rates were higher in patients with a history of non-radiating low back pain and in patients with a diagnosis of radiculopathy in the first five years. In this study's subsample of 103 patients, L86 episodes represented radiculopathy in 50% of cases. Medication was prescribed to 64% of patients, mostly NSAIDs. Some 53% of patients were referred, mainly to physiotherapists and neurologists; 9% of patients underwent surgery. CONCLUSION: Watchful waiting seems to be sufficient general practice care in most cases of radiating low back pain. Further research should be focused on clarifying the relationship between radicular radiating low back pain, non-radicular radiating low back pain, and non-radiating low back pain.

Development and validation of the Perception of Self-Monitoring of Blood Glucose Scale in insulin-treated patients with diabetes.

BACKGROUND AND PURPOSE: The Perception of Self-Monitoring of Blood Glucose (P-SMBG) scale was developed and validated to assess perceptions of self-monitoring of blood glucose (SMBG) in insulin-treated patients with diabetes. METHOD: An initial 68-item version of the P-SMBG has been evaluated by a panel of professionals and patients. A sample of 375 patients tested the revised scale. RESULTS: Factor analysis suggested a 19-item scale and a 2-factor structure, separating negatively and positively worded items. Cronbach's alpha was .84 and .72, and the intraclass correlation coefficient was .66 and .57, respectively for both factors. Item-total correlations were in the range of .23-.66. Convergent/divergent validity was confirmed for the negatively worded items. CONCLUSIONS: The final P-SMBG scale (21 items) can be used to assess positive and negative perceptions of SMBG in insulin-treated patients with diabetes.

Continuous intraperitoneal insulin infusion in type 1 diabetes: a 6-year post-trial follow-up.

BACKGROUND: Continuous intraperitoneal insulin infusion (CIPII) with an implantable pump is a treatment option for patients with type 1 diabetes mellitus (T1DM). Aim of the present study was to describe the long-term course of glycaemic control, complications, health related quality of life (HRQOL) and treatment satisfaction among T1DM patients treated with CIPII. METHODS: Nineteen patients that participated in a randomized cross-over trial comparing CIPII and subcutaneous (SC) therapy in 2006 were followed until 2012. Laboratory, continuous glucose monitoring, HRQOL and treatment satisfaction measurements were performed at the start of the study, the end of the SC-, the end of the CIPII treatment phase in 2006 and during CIPII therapy in 2012. Linear mixed models were used to calculate estimated values and to test differences between the moments in time. RESULTS: In 2012, more time was spent in hyperglycaemia than after the CIPII treatment phase in 2006: 37% (95% CI 29, 44) vs. 55% (95% CI 48, 63), mean difference 19.8% (95% CI 3.0, 36.6). HbA1c was 65 mmol/mol (95% CI 60, 71) at the end of the SC treatment phase in 2006, 58 mmol/mol (95% CI 53, 64) at the end of the CIPII treatment phase and 65 mmol/mol (95% CI 60, 71) in 2012, respectively (p > 0.05). In 2012, the median number of grade 2 hypoglycaemic events per week (1 (95% CI 0, 2)) was still significantly lower than during prior SC therapy (3 (95% CI 2, 4)): mean change -1.8 (95% CI -3.4, -0.4). Treatment satisfaction with CIPII was better than with SC insulin therapy and HRQOL remained stable. Pump or catheter dysfunction of the necessitated re-operation in 7 patients. No mortality was reported. CONCLUSIONS: After 6 years of CIPII treatment, glycaemic regulation is stable and the number of hypoglycaemic events decreased compared to SC insulin therapy. Treatment satisfaction with CIPII is superior to SC insulin therapy, HRQOL is stable and complications are scarce. CIPII is a safe and effective treatment option for selected patients with T1DM, also on longer term.

Design of the e-Vita diabetes mellitus study: effects and use of an interactive online care platform in patients with type 2 diabetes (e-VitaDM-1/ZODIAC-40).

UNLABELLED: Trial registration: NCT01570140. BACKGROUND: Due to ongoing rise in need for care for people with chronic diseases and lagging increase in number of care providers, alternative forms of care provision and self-management support are needed. Empowering patients through an online care platform could help to improve patients' self-management and reduce the burden on the healthcare system. METHODS: Access to laboratory results and educational modules on diabetes will be offered through a platform for subjects with type 2 diabetes mellitus treated in primary care. Differences in socio-demographic and clinical characteristics between subjects expressing interest vs. disinterest to use the platform will be explored. Platform usage will be tracked and compared. Patient satisfaction and quality of life will be measured by validated questionnaires and economic analyses will be performed. DISCUSSION: This study is designed to assess the feasibility of use of an online platform in routine primary healthcare for subjects with type 2 diabetes mellitus in the Netherlands, and to study effects of use of the platform on treatment satisfaction, quality of life and clinical parameters. Although providing access to a online platform is not a novel intervention, usage and effects have not yet been studied in this patient population.

Type 2 diabetes seems not to be a risk factor for the carpal tunnel syndrome: a case control study.

BACKGROUND: Previous studies have shown that the carpal tunnel syndrome seems to occur more frequently in patients with diabetes mellitus and might be associated with the duration of diabetes mellitus, microvascular complications and degree of glycaemic control. Primary aim was to determine if type 2 diabetes can be identified as a risk factor for carpal tunnel syndrome after adjusting for possible confounders. Furthermore, the influence of duration of diabetes mellitus, microvascular complications and glycaemic control on the development of carpal tunnel syndrome was investigated. METHODS: Retrospective, case-control study using data from electronic patient charts from the Isala (Zwolle, the Netherlands). All patients diagnosed with carpal tunnel syndrome in the period from January 2011 to July 2012 were included and compared with a control group of herniated nucleus pulposus patients. RESULTS: A total of 997 patients with carpal tunnel syndrome and 594 controls were included. Prevalence of type 2 diabetes was 11.5% in the carpal tunnel syndrome group versus 7.2% in the control group (Odds Ratio 1.67 (95% confidence interval 1.16-2.41)). In multivariate analyses adjusting for gender, age and body mass index, type 2 diabetes was not associated with carpal tunnel syndrome (OR 0.99 (95% CI 0.66-1.47)). No differences in duration of diabetes mellitus, microvascular complications or glycaemic control between groups were detected. CONCLUSION: Although type 2 diabetes was more frequently diagnosed among patients with carpal tunnel syndrome, it could not be identified as an independent risk factor.

Which patient and treatment factors are related to successful cardiovascular risk score reduction in general practice? Results from a randomized controlled trial.

BACKGROUND: Cardiovascular disease is a leading cause of death. It is important to identify patient and treatment factors that are related to successful cardiovascular risk reduction in general practice. This study investigates which patient and treatment factors are related to changes in cardiovascular risk estimation, expressed as the Systematic Coronary Risk Evaluation (SCORE) 10 year risk of cardiovascular mortality. METHODS: 179 general practice patients with mild-moderately elevated cardiovascular risk followed a one-year programme which included structured lifestyle and medication treatment by practice nurses, with or without additional self-monitoring. From the patient and treatment data collected as part of the "Self-monitoring and Prevention of RIsk factors by Nurse practitioners in the region of Groningen" randomized controlled trial (SPRING-RCT), the contribution of patient and treatment factors to the change in SCORE was analysed with univariate and multivariate analyses. RESULTS: In multivariate analyses with multiple patient and treatment factors, only SCORE at baseline, and addition of or dose change in lipid lowering or antihypertensive medications over the course of the study were significantly related to change in SCORE. CONCLUSIONS: Our analyses support the targeting of treatment at individuals with a high SCORE at presentation. Lipid lowering medication was added or changed in only 12% of participants, but nevertheless was significantly related to ΔSCORE in this study population. Due to the effect of medication in this practice-based project, the possible additional effect of the home monitoring devices, especially for individuals with no indication for medication, may have been overshadowed. TRIAL REGISTRATION: trialregister.nl NTR2188.

The Value of Glycemic Control Prior to Cancer Diagnosis on All-Cause Mortality among Patients with Type 2 Diabetes in Dutch Primary Care.

BACKGROUND: Poor glycemic control prior to cancer diagnosis for patients with preexisting type 2 diabetes (T2DM) may predict a worse cancer diagnosis. We investigated the association between pre-diagnosis glycemic control and all-cause mortality in patients with T2DM who develop cancer. METHODS: This prospective cohort study linked data from three sources covering 1989 to 2019: a T2DM benchmarking database, the Netherlands Cancer Registry, and the Personal Records Database. We included patients with T2DM and incident primary breast, colorectal, or prostate cancer (stage 0-III), with target glycemic control defined according to Dutch guidelines. Analysis involved estimating the association between glycemic control and all-cause mortality with Cox proportional hazard models, accounting for individual expected survival relative to the general population and relevant disease (e.g., diabetes duration and medications) and individual (e.g., age and gender) characteristics. RESULTS: Of the 71,648 linked cases, 620 had breast cancer, 774 had colorectal cancer, and 438 had prostate cancer, with follow-up data available for 6.4 (4.2-8.4), 5.6 (2.7-7.6), and 6.3 (4.5-8.2) years, respectively. Compared with patients with pre-diagnosis glycemic control at target, the HRs and 95% confidence intervals for mortality among those with pre-diagnosis glycemic control not at target were 1.40 (1.00-1.96) for breast cancer, 1.45 (1.12-1.88) for colorectal cancer, and 1.39 (0.98-1.98) for prostate cancer. CONCLUSIONS: Among patients with T2DM in Dutch primary care, poor glycemic control before diagnosis with breast and colorectal cancer can increase mortality compared with good control. IMPACT: Glycemic control prior to cancer diagnosis is of prognostic value.