Determinants of excessive weight gain after the initiation of insulin therapy in type 2 diabetes mellitus:Retrospective inception cohort study (ZODIAC 60)

AIMS: To explore determinants of excessive weight gain after initiation of insulin therapy in type 2 diabetes mellitus (T2DM), in particular variables identified in the pre-insulin phase.METHODS: We performed a retrospective observational intervention cohort study, by means of a new user design/ inception cohort concerning n = 5086 patients. We studied determinants of excessive weight gain (5 kg or more) in the first year after initiation of insulin therapy, using both visualization and logistic regression analysis with subsequent receiver operation characteristic (ROC) analyses. Potential determinants pre-, at- and post-insulin initiation were included.RESULTS: One out of 10 patients (10.0%) gained 5 kg weight or more. The earliest determinants of excessive weight gain were weight change (inversely) and HbA1c change in the two years prior to insulin therapy (p &lt; 0.001). Patients that lost weight parallel with HbA1c rise in the two-years pre-insulin, showed the most pronounced weight gain. Of these patients, roughly one out of five (20.3%) gained 5 kg weight or more.CONCLUSIONS: Clinicians and patients should be alert for excessive weight gain after initiation of insulin, in the case of weight loss prior to insulin therapy initiation, particularly with increasing and prolonged high HbA1c at (and after) insulin initiation.</p

Course of body weight before and after the initiation of insulin therapy in type 2 diabetes mellitus:Retrospective inception cohort study (ZODIAC 58)

Aims: The aim of this study was to explore the effect of insulin treatment initiation on weight by taking weight change prior to initiation into account. Materials and methods: We performed an observational retrospective inception cohort study, concerning Dutch primary care. We identified all patients that initiated insulin treatment (n = 7967) and individually matched patients with a reference patient (n = 5213 pairs). We obtained estimated mean weight changes in the five years prior to five years post insulin therapy. We applied linear regression analysis on weight change in the first year after insulin therapy (T0 to T+1), with matched group as primary determinant adjusted for pre-insulin weight change and additional covariates. Results: Estimated mean weight increased in the five consecutive years prior to insulin therapy (-0.23 kg in year T-5 to T-4, 0.01 kg in year T-4 to T-3, 0.07 kg in year T-3 to T-2, 0.24 kg in year T-2 to T-1, and 0.46 kg in year T-1 to T0) and continued to increase in the first year after, that is T0 to T+1, at a slightly lower rate (0.31 ± 3.9 kg). Pre-insulin weight change had the highest explained variance and was inversely and independently associated with weight change (p < .001). Starting insulin was associated with weight increase, independent of pre-insulin weight change (β-adjusted 1.228, p < .001). Stratification revealed that despite having a more or less similar baseline BMI, patients with substantial weight increase showed higher estimated mean BMI's followed by weight loss pre-insulin. In matched references, estimated mean weight changes were negative in all years concerning the study period, indicating consistent weight loss. Conclusions: Initiation of insulin therapy was independently associated with weight increase; however, overall effect on weight was small and subject to substantial variation. Pre-insulin weight change is identified as a relatively strong inverse determinant of weight change after insulin initiation

Improved well-being and decreased disease burden after 1-year use of flash glucose monitoring (FLARE-NL4)

Introduction: The FreeStyle Libre is a flash glucose monitoring (FSL-FGM) system. Compared with finger-prick based self-monitoring of blood glucose, FSL-FGM may provide benefits in terms of improved glycemic control and decreased disease burden. Methods: Prospective nationwide registry. Participants with diabetes mellitus (DM) used the FSL-FGM system for a period of 12 months. End points included changes in HbA1c, hypoglycemia, health-related quality of life (12-Item Short Form Health Surveyv2 (SF-12v2) and 3-level version of EuroQol 5D (EQ-5D-3L)), a specifically developed patient-reported outcome measures (PROMs) questionnaire, diabetes-related hospital admission rate and work absenteeism. Measurements were performed at baseline, and after 6 months and 12 months. Results: 1365 persons (55% male) were included. Mean age was 46 (16) years, 77% of participants had type 1 DM, 16% type 2 DM and 7% other forms. HbA1c decreased from 64 (95%CI 63 to 65) mmol/mol to 60 (95%CI 60 to 61) mmol/mol with a difference of -4 (95% CI -6 to 3) mmol/mol. Persons with a baseline HbA1c >70 mmol/mol had the most profound HbA1c decrease: -9 (95% CI -12 to to 5) mmol/mol. EQ-5D tariff (0.03 (95%CI 0.01 to 0.05)), EQ-VAS (4.4 (95%CI 2.1 to 6.7)) and SF-12v2 mental component score (3.3 (95%CI 2.1 to 4.4)) improved. For most, PROMs improved. Work absenteeism rate (/6 months) and diabetes-related hospital admission rate (/year) decreased significantly, from 18.5% to 7.7% and 13.7% to 2.3%, respectively. Conclusions: Real world data demonstrate that use of FSL-FGM results in improved well-being and decreased disease burden, as well as improvement of glycemic control

Two-year use of flash glucose monitoring is associated with sustained improvement of glycemic control and quality of life (FLARE-NL-6)

INTRODUCTION: The FreeStyle Libre (FSL) is a flash glucose monitoring (FGM) system. The Flash Monitor Register in the Netherlands (FLARE-NL-4) study previously demonstrated the positive effects of FSL-FGM use during 1 year on glycemic control, quality of life and disease burden among persons with diabetes mellitus (DM). The present follow-up study assesses the effects of FSL-FGM after 2 years. RESEARCH DESIGN AND METHODS: Patients included in the FLARE-NL-4 study who continued FSL-FGM during the 1-year study period were invited to participate (n=687). Data were collected using questionnaires (the 12-Item Short Form Health Survey version 2 (SF-12(v2)) and the EuroQol 5-Dimension 3-Level (EQ-5D-3L) for quality of life), including self-reported hemoglobin A1c (HbA1c). RESULTS: A total of 342 patients agreed to participate: mean age 48.0 (±15.6) years, 52% men and 79.5% with type 1 DM. HbA1c decreased from 60.7 (95% CI 59.1 to 62.3) mmol/mol before use of FSL-FGM to 57.3 (95% CI 55.8 to 58.8) mmol/mol after 1 year and 57.8 (95% CI 56.0 to 59.5) mmol/mol after 2 years. At the end of the 2-year follow-up period, 260 (76%) persons were still using the FSL-FGM and 82 (24%) had stopped. The main reason for stopping FSL-FGM was financial constraints (55%). Concerning the whole 2-year period, there was a significant decrease in HbA1c among persons who continued use of FSL-FGM (−3.5 mmol/mol, 95% CI −6.4 to –0.7), while HbA1c was unaltered compared with baseline among persons who stopped FSL-FGM (−2.4 mmol/mol, 95% CI −7.5 to 2.7): difference between groups 2.2 (95% CI −1.3 to 5.8) mmol/mol. After 2 years, persons who continued use of FSL-FGM had higher SF-12 mental component score and higher EQ-5D Dutch tariff score and felt less often anxious or depressed compared with persons who discontinued FSL-FGM. CONCLUSIONS: Although the considerable number of non-responders limits generalizability, this study suggests that persons who continue to use FSL-FGM for 2 years may experience sustained improvement in glycemic control and quality of life

Quantitative analysis of orthopedic metal artefact reduction in 64-slice computed tomography scans in large head metal-on-metal total hip replacement, a phantom study

Purpose: Quantification of the effect of O-MAR on decreasing metal artefacts caused by large head metal on metal total hip arthroplasty (MoM THA) in a dedicated phantom setup of the hip. Background: Pathological reactions of the hip capsule on Computed tomography (CT) can be difficult to diagnose due to different metal artefacts. The O-MAR algorithm deploys an iterative loop where the metal sinogram is identified, extracted, and subsequently serves as a mask to correct the measured sinogram. Main goal of this study is to quantify the ability of the O-MAR technique to correct deviation in medullary bone attenuation caused by streak artefacts from the large-head MoM THA embedded in a phantom. Secondary goal is to evaluate the influence of O-MAR on CNR. Methods: The phantom was designed as a Perspex box (PMMA) containing water and a supplementary MOM THA surrounded by Perspex columns comprising calibrated calcium pellets. Each column contains 200 mg of hydroxyapatite/calcium carbonate to simulate healthy bone tissue. Scans were obtained with and without a MoM THA at different dose levels. Different reconstructions were made with filter A, iDose(4) level 5 and with and without O-MAR. The scans without the prosthesis were used as the baseline. Information about the attenuation in Hounsfield units, image noise in standard deviation within the ROI's were extracted and the CNR was calculated. Results: Pellet L0 and R0 (proximal of the MoM THA) were defined as reference, lacking any disturbance by metal artefacts; L5, L6 and L8 were respectively visually categorized as 'light' 'medium' and 'heavy disturbance'. Significant improvements in attenuation deviation caused by metal artefact were 43, 68 and 32 %, for respectively pellet L5, L6 and L8 (p <0.001). Significant CNR improvements were present for L5 and L6 and were respectively 72 and 52 % (p <0.001). O-MAR showed no improvement on CNR for L8. Conclusion: This phantom study significantly increases image quality by the use of O-MAR in the presence of metal artefacts by significantly reducing metal artefacts subsequently and increasing CNR on a 64 slice CT system in light and medium disturbance of the imag

Performance of the Eversense versus the Free Style Libre Flash glucose monitor during exercise and normal daily activities in subjects with type 1 diabetes mellitus

Introduction Accurate blood glucose measurements are important in persons with diabetes during normal daily activities (NDA), even more so during exercise. We aimed to investigate the performance of fluorescence sensor-based and glucose oxidase-based interstitial glucose measurement during (intensive) exercise and NDA. Research design and methods Prospective, observational study in 23 persons with type 1 diabetes when mountain biking for 6 days, followed by 6 days of NDA. Readings of the Eversense (fluorescence-based continuous glucose monitoring (CGM); subcutaneously implanted) and of the Free Style Libre (FSL; glucose oxidase-based flash glucose monitoring (FGM); transcutaneously placed) were compared with capillary glucose levels (Free Style Libre Precision NeoPro strip (FSLCstrip)). Results Mean average differences (MAD) and mean average relative differences (MARD) were significantly different when comparing exercise with NDA (reference FSLCstrip); Eversense MAD 25±19 vs 17±6 mg/dL (p<0.001); MARD 17±6 vs 13%±6% (p<0.01) and FSL MAD 32±17 vs 18±8 mg/dL (p<0.01); MARD 20±7 vs 12%±5% (p<0.001). When analyzing the data according to the Integrated Continuous Glucose Monitoring Approvals (class II-510(K) guidelines), the overall performance of interstitial glucose readings within 20% of the FSLCstrip during exercise compared with NDA was 69% vs 81% for the Eversense and 59% vs 83% for the FSL, respectively. Within 15% of the FSLCstrip was 59% vs 70% for the Eversense and 46% vs 71% for the FSL. Conclusions During exercise, both fluorescence and glucose oxidase-based interstitial glucose measurements (using Eversense and FSL sensors) were less accurate compared with measurements during NDA. Even when acknowledging the beneficial effects of CGM or FGM, users should be aware of the risk of diminished accuracy of interstitial glucose readings during (intensive) exercise

Health claims databases used for kidney research around the world

Health claims databases offer opportunities for studies on large populations of patients with kidney disease and health outcomes in a non-experimental setting. Among others, their unique features enable studies on healthcare costs or on longitudinal, epidemiological data with nationwide coverage. However, health claims databases also have several limitations. Because clinical data and information on renal function are often lacking, the identification of patients with kidney disease depends on the actual presence of diagnosis codes only. Investigating the validity of these data is therefore crucial to assess whether outcomes derived from health claims data are truly meaningful. Also, one should take into account the coverage and content of a health claims database, especially when making international comparisons. In this article, an overview is provided of international health claims databases and their main publications in the area of nephrology. The structure and contents of the Dutch health claims database will be described, as well as an initiative to use the outcomes for research and the development of the Dutch Kidney Atlas. Finally, we will discuss to what extent one might be able to identify patients with kidney disease using health claims databases, as well as their strengths and limitations

Frozen section diagnosis of borderline ovarian tumors with suspicious features of invasive cancer is a devil's dilemma for the surgeon:A systematic review and meta-analysis

Introduction Frozen section diagnoses of borderline ovarian tumors are not always straightforward and a borderline frozen section diagnosis with suspicious features of invasive carcinoma (reported as "at least borderline" or synonymous descriptions) presents us with the dilemma of whether or not to perform a full surgical staging procedure. By performing a systematic review and meta-analysis, the prevalence of straightforward borderline and "at least borderline" frozen section diagnoses, as well as proportion of patients with a final diagnosis of invasive carcinoma in these cases, were assessed and compared, as quantification of this dilemma may help us with the issue of this clinical decision. Material and methods PubMed, EMBASE and Cochrane library databases were searched and studies discussing "at least borderline" frozen section diagnoses were included in the review. Numbers of specific frozen section diagnoses and subsequent final histological diagnoses were extracted and pooled analysis was performed to compare the proportion of patients diagnosed with invasive carcinoma following borderline and "at least borderline" frozen section diagnoses, presented as risk ratio and risk difference with 95% confidence intervals (95% CI). Results Of 4940 screened records, eight studies were considered eligible for quantitative analysis. A total of 921 women was identified and 230 (25.0%) of these women were diagnosed with "at least borderline" ovarian tumor at the time of frozen section. Final histological diagnoses were reported in five studies, including 61 women with an "at least borderline" diagnosis and 290 women with a straightforward borderline frozen section diagnosis. Twenty-five of 61 women (41.0%) of the "at least borderline" group had invasive cancer at final diagnosis, compared with 28 of 290 women (9.7%) of the straightforward borderline frozen section group (risk difference -0.34, 95% CI -0.53 to -0.15; relative risk 0.25, 95% CI 0.13-0.50). Conclusions Women diagnosed with "at least borderline" frozen section diagnoses were found to have a higher chance of carcinoma upon final diagnosis when compared with women with a straightforward borderline frozen section diagnosis (41.0% vs 9.7%). Especially in the serous subtype, and after preoperative consent, full staging during initial surgery might be considered in these cases to prevent a second surgical procedure