Effects of the Proactive interdisciplinary self-management (PRISMA) program on self-reported and clinical outcomes in type 2 diabetes: a pragmatic randomized controlled trial.

BACKGROUND: Diabetes self-management education can be helpful for patients with type 2 diabetes in managing their condition. We aimed to study the effects of the group-based PRoactive Interdisciplinary Self-MAnagement (PRISMA) training program on self-reported and clinical outcomes in patients with type 2 diabetes treated in general practice. METHODS: Persons aged 18 years or older diagnosed with type 2 diabetes and treated in primary care were included. In a randomized controlled trial design (1:1), patients were followed for 6 months with an extension phase of 6 months. Block randomization was used. The patients with type 2 diabetes received either PRISMA in addition to usual care or usual care only. All patients completed a range of validated questionnaires (including knowledge, skills, and confidence for self-management [PAM], diabetes self-care behavior [SDSCA], health-related quality of life [EQ-5D], and emotional well-being [WHO-5]). In addition, clinical outcomes (HbA1c, body mass index, systolic blood pressure, and cholesterol levels) were collected during the routine diabetes checkups. RESULTS: Of the total sample (n = 193), 60.1% were men. The mean age was 69.9 years (SD = 9.1). No significant differences were found on self-reported outcomes between the groups at 0, 6, and 12 months. The clinical outcomes were not reported due to a large number of missing values. CONCLUSION: PRISMA did not improve self-reported outcomes in patients with type 2 diabetes treated in primary care. It was not possible to make a statement about the clinical effects. TRIAL REGISTRATION: date: 16/07/2014, number: NL4550 (https://www.trialregister.nl/trial/4550).

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.

Thyroid Disease and Type 1 Diabetes in Dutch Children: A Nationwide Study (Young Dudes-3).

OBJECTIVE: To investigate the prevalence of overt thyroid disease in children in The Netherlands with and without type 1 diabetes mellitus (T1DM). STUDY DESIGN: Nationwide, retrospective cohort study in The Netherlands. Using the national registry of both healthcare reimbursement and pharmaceutical care, data of all Dutch children (aged 0-14 years) with a diagnosis of T1DM, or a diagnosis of hypothyroidism or hyperthyroidism in the period 2009-2011. RESULTS: The prevalence of thyroid disease was 0.15% in children without T1DM, and 3.43% in children with T1DM (rate ratio 23.59; 95% CI 19.92-27.93; P < .001). Both hyperthyroidism and hypothyroidism were 24 times more likely in children with T1DM than in those without. Thyroid disease was more common in girls than in boys, both in children with T1DM (rate ratio of girls vs boys 3.07; 95% CI 2.10-4.49) and in children without T1DM (rate ratio 1.59; 95% CI 1.49-1.69). This sex difference was more pronounced for hypothyroidism than for hyperthyroidism. CONCLUSIONS: Children with T1DM in The Netherlands are 24 times more likely to develop thyroid disease than their peers without diabetes. Girls with T1DM were more prone to thyroid disease, particularly hypothyroidism.

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.

Is orthostatic hypotension related to falling? A meta-analysis of individual patient data of prospective observational studies.

Background: orthostatic hypotension (OH) is one out of many risk factors believed to contribute to an increased fall risk in elderly subjects but it is unclear whether an independent association between OH and falling exists. Objectives: to perform an individual patient data (IPD) meta-analysis of prospective observational studies investigating the relationship between OH and falling. Design: MEDLINE, EMBASE, the Cochrane Library and the abstracts of annual meetings of selected hypertension societies were searched. Both one-stage (analysing all IPD from all studies simultaneously) and two-stage (analysing IPD per study, and then pooling the results) methods were used, and both logistic and cox regression analyses were performed. The study protocol was published on PROSPERO (2015:CRD42015019178). Results: from 34 selected abstracts, 6 studies were included. IPD were provided in 1,022 patients from 3 cohorts and were included in the IPD meta-analysis. The one-stage meta-analysis showed a significant relationship between OH and time to first fall incident (hazard ratio (HR) 1.52 (95% Confidence Interval (CI) 1.23-1.88)). No significant relationship between OH and falling was found in the one-stage logistic regression analysis and the two-stage logistic and cox regression analyses. Conclusions: this IPD meta-analysis of prospective observational studies showed a clear and significant relationship between OH and time to first fall incident. Although the ORs of falling was not significantly different for patients with and without OH, a the cox regression analyses reporting HRs and including time to incident provided more clinically relevant information in present meta-analysis.

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.

Diagnosis and Prediction of CKD Progression by Assessment of Urinary Peptides.

Progressive CKD is generally detected at a late stage by a sustained decline in eGFR and/or the presence of significant albuminuria. With the aim of early and improved risk stratification of patients with CKD, we studied urinary peptides in a large cross-sectional multicenter cohort of 1990 individuals, including 522 with follow-up data, using proteome analysis. We validated that a previously established multipeptide urinary biomarker classifier performed significantly better in detecting and predicting progression of CKD than the current clinical standard, urinary albumin. The classifier was also more sensitive for identifying patients with rapidly progressing CKD. Compared with the combination of baseline eGFR and albuminuria (area under the curve [AUC]=0.758), the addition of the multipeptide biomarker classifier significantly improved CKD risk prediction (AUC=0.831) as assessed by the net reclassification index (0.303±-0.065; P<0.001) and integrated discrimination improvement (0.058±0.014; P<0.001). Correlation of individual urinary peptides with CKD stage and progression showed that the peptides that associated with CKD, irrespective of CKD stage or CKD progression, were either fragments of the major circulating proteins, suggesting failure of the glomerular filtration barrier sieving properties, or different collagen fragments, suggesting accumulation of intrarenal extracellular matrix. Furthermore, protein fragments associated with progression of CKD originated mostly from proteins related to inflammation and tissue repair. Results of this study suggest that urinary proteome analysis might significantly improve the current state of the art of CKD detection and outcome prediction and that identification of the urinary peptides allows insight into various ongoing pathophysiologic processes in CKD.

Validity of an Accelerometer-Based Activity Monitor System for Measuring Physical Activity in Frail Older Adults.

This study aimed to investigate the validity of the accelerometer-based DynaPort system to detect physical activity in frail, older subjects. Eighteen home-dwelling subjects (Groningen Frailty Indicator [GFI] score ≥ 4, ≥ 75 years) were included. Activities in their home environment were simultaneously observed by two researchers and measured with the DynaPort system during six consecutive hours. Primary outcome measures were the sensitivity and specificity of the DynaPort for locomotion (90% considered as sufficient agreement). Other outcome measures were overall agreement, and sensitivity and specificity for other activities. Sensitivity and specificity for locomotion were 83.3% and 100.0%, respectively. Overall agreement was 74.6%. Sensitivity was sufficient for sitting (94.4%), but not for lying and standing (59.2% and 69.6%, respectively). Specificity was sufficient for lying and standing (100.0% and 93.3%, respectively), but not for sitting (80.7%). In conclusion, the DynaPort system is not a valid method for assessing physical activity in frail, older subjects.

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.

Skin autofluorescence is associated with 5-year mortality and cardiovascular events in patients with peripheral artery disease.

OBJECTIVE: Advanced glycation end products play a pivotal role in atherosclerosis. Recently, we showed that tissue advanced glycation end products deposition, noninvasively assessed by skin autofluorescence (SAF), is increased in patients with peripheral artery disease. The aim of the present study was to establish whether SAF is associated with all-cause mortality and with fatal or nonfatal major adverse cardiovascular events (MACE) in patients with peripheral artery disease. APPROACH AND RESULTS: We performed a single-center prospective cohort study of 252 patients with peripheral artery disease (mean age, 66±11 years), recruited from the outpatient clinic (October 2007 to June 2008) who were followed until June 2013. SAF was measured with the AGE Reader. The primary end point was all-cause mortality, and the secondary end point was fatal or nonfatal MACE, defined as cardiovascular death and nonfatal myocardial infarction or stroke. During a median follow-up of 5.1 (interquartile range, 5.0-5.3) years, 62 (25%) patients died. Fatal or nonfatal MACE occurred in 62 (25%) patients. A higher SAF was associated with increased risk for all-cause mortality (hazard ratio per unit increase, 2.01; 95% confidence interval, 1.40-2.88; P=0.0002) and fatal or nonfatal MACE (hazard ratio, 1.82; 95% confidence interval, 1.28-2.60; P=0.001), also after adjustment for cardiovascular risk factors and the use of lipid-lowering drugs (hazard ratio, 1.63; 95% confidence interval, 1.13-2.34; P=0.009 and hazard ratio, 1.50; 95% confidence interval, 1.04-2.17; P=0.03, for all-cause mortality and fatal and nonfatal MACE, respectively). CONCLUSIONS: SAF as a measure of advanced glycation end products deposition is independently associated with all-cause mortality and fatal or nonfatal MACE in patients with peripheral artery disease after a 5-year follow-up.

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.

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.