Search

Introduction: As continuous intraperitoneal insulin infusion (CIPII) results in a more physiologic action of insulin than subcutaneous (SC) insulin administration, we hypothesized that CIPII would result in less glycemic variability (GV) than SC insulin therapy among type 1 diabetes mellitus (T1DM) patients. Materials and Methods: Data from 5-day blind continuous glucose monitoring (CGM) measurements performed during a 26-week, prospective, observational case-control study were analyzed. The coefficient of variation (CV) was the primary measure of GV. In addition, the SD of the mean glucose level, mean of daily differences, and mean amplitude of glycemic excursions were calculated. Results: In total, 176 patients (36% male; mean age, 49 [SD 13] years; median diabetes duration, 24 [interquartile range, 17, 35] years; glycated hemoglobin level, 63 [10] mmol/mmol), of which 37 used CIPII and 139 SC insulin therapy, were analyzed. CGM data were available for 169 patients at baseline (CIPII, n=35; SC, n=134) and for 164 patients at 26 weeks (CIPII, n=35; SC, n=129). After adjustment for baseline differences, the CV was 4.9% (95% confidence interval, 1.0, 8.8) lower with CIPII- compared with SC-treated patients, irrespective of the use of multiple daily injections or continuous SC insulin infusion. There were no differences in other indices of GV between groups. Conclusions: Despite higher blood glucose, the CV was slightly lower with CIPII compared with SC insulin therapy in T1DM patients, and other measures of GV were identical. Future studies are needed to confirm these findings and investigate whether this results in prevention of hypoglycemia and even perhaps (less) microvascular complications. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Objective: Our aim was to investigate whether trends in quality of diabetes care differ between sexes in the Netherlands from 1998 till 2013. Research Design and Methods: In this prospective observational cohort study quality of care was measured using process and outcome measures in patients with type 2 diabetes in primary care. Trend and absolute differences between sexes were investigated for patients <75 years. Subgroup analyses were performed in patients ≥75 years. 10-year mortality risk was assessed with the Globorisk risk equation in patients without cardiovascular diseases <75 years. Results: The number of patients increased from 2,644 in 1998 to 62,230 in 2013. In 1998, 51% of the men and 60% of the women <75 years had an HbA1c >53 mmol/mol; this decreased to approximately 29% in both sexes in 2013. Patients having a systolic blood pressure >140 mmHg decreased from 70% to 42%, and from 80% to 40% in men and women <75 years, respectively. In patients ≥75 years it decreased from 72% to 50% in men and 85% to 56% in women. Obesity increased in both sexes, whereas smoking in men and women declined in patients <75 years (men: 34% to 22%; women: 22% to 18%). The number of patients with a mortality risk >20% over 10 years decreased from 15% to 3% in men and from 18% to 3% in women. Conclusions: Quality of diabetes care has improved considerably in the period 1998–2013 in both sexes. Possibly relevant trend differences between sexes were observed for HbA1c, systolic blood pressure, BMI and smoking. The predicted mortality risk decreased over time in both sexes. Except for BMI in both age groups and systolic blood pressure in patients ≥75 years, no evident poorer risk factor control in women compared to men was found at the end of the study period. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Background: Previous studies have shown that many within-class differences exist between sulfonylureas (SUs), however, whether differences exist regarding the time it takes between initiating an SU and the need to intensify treatment with insulin is unclear. The aim of this study was investigate the relationships between the three frequently used sulphonylureas, prescribed as dual therapy next to metformin, and the time needed to treatment intensification with either insulin or oral triple therapy in patients with type 2 diabetes mellitus. Methods: Zwolle Outpatient Diabetes project Integrating Available Care (ZODIAC) is a prospective observational cohort study set in primary care in the Netherlands. Annually collected data on diabetes medication and clinical variables within ZODIAC are used to evaluate the primary outcome, time to insulin and secondary outcome, time to either insulin or triple oral therapy. For statistical analysis a time-dependent cox proportional hazard model was used. Results: 3507 patients were included in the analysis, with a mean age of 61 (SD 11.4) and a median HbA1c of 6.8% [IQR 6.4–7.4] (50.8 mmol/mol [IQR 46.4–57.4]).The hazard ratio (HR) for the primary endpoint was 1.10 (95% CI 0.78–1.54) for metformin/glimepiride and 0.93 (95% CI 0.67–1.30) for metformin/tolbutamide with metformin/gliclazide as reference group. The HR for the secondary outcome was 1.04 (95% CI 0.78–1.40) and 0.85 (95% CI 0.64–1.13), respectively. Conclusion: In this large Dutch primary care cohort, new users of neither gliclazide, glimepiride nor tolbutamide as dual therapy with metformin, resulted in differences in the time needed for further treatment intensification. [ABSTRACT FROM AUTHOR]

OBJECTIVE -- To investigate the effects of continuous intraperitoneal insulin infusion (CIPII) compared with subcutaneous insulin on health-related quality of life (HRQOL) and treatment satisfaction, and to perform a cost analysis in type 1 diabetes. RESEARCH DESIGN AND METHODS -- We used an open-label, prospective, cross-over, randomized, 16-month study (N = 24). HRQOL and patient satisfaction were assessed with questionnaires (the 36-item short-form health survey [SF-36], the World Health Organization-Five Well-Being Index [WHO-5], and the Diabetes Treatment Satisfaction Questionnaire [DTSQ]). Direct costs of CIPII and continuous subcutaneous insulin infusion (CSII) were compared. RESULTS -- Questionnaire scores were higher with CIPII than with subcutaneous therapy. Yearly direct pump- and procedure-associated costs for CIPII were estimated at €10,910 compared with €4,810 for CSII. CONCLUSIONS -- Apart from improving glycemic control, CIPII improved HRQOL and treatment satisfaction compared with subcutaneous insulin. Direct pump- and procedure-associated costs are considerably higher for CIPII, however. [ABSTRACT FROM AUTHOR]

Continuous intraperitoneal insulin infusion (CIPII) with an implantable pump is safe and effective in selected subjects with diabetes. Our aim was to assess surgical experience and complications with CIPII. We performed a retrospective longitudinal observational cohort study of patients that started with CIPII from 1990 to 2006. Operation free period and complication rate were compared between patients initiating CIPII before 2000 and from 2000 onwards. In 63 patients, 166 re-operations were performed during 381 patient-years. Re-operations were pump replacement due to end-of-battery life (47%), laparoscopic catheter-related procedures (29%) and other interventions (24%). Median operation free period increased from 21 to 78 months from 2000 onwards ( p = 0.039). Nineteen percent of patients developed complications. No operation-related mortality was reported. Increased experience together with technical improvements has led to an increase of the operation free period. The absence of procedure-related mortality and a low complication rate makes CIPII feasible for selected patients with diabetes. [ABSTRACT FROM AUTHOR]

As part of an ongoing cross-over trial to compare the effects of IP insulin to SC insulin in poorly controlled T1DM (HbA[sub 1c]>7.5% and/or ≥ 5 hypoglycemic events/wk), preliminary data on glycemic control, quality of life (QOL) and treatment satisfaction (TS) are reported of 20 subjects enrolled thus far. Design: a 3 month run-in phase is followed by two 6 months treatment phases. At the end of the run-in phase, subjects are randomized to receive insulin either by IP (implantable pump; MIP 2007C, Medtronic) or SC (CSII or MDI) administration. In the 2nd treatment phase, subjects cross over to the other treatment mode. Enrolment started March 2006. Mean age 43.8±11.6 years; 8M, 12F; mean diabetes duration 22.9±10.9 years; mean HbA[sub 1c] 8.6±1.2%; HbA[sub 1c]>7.5% in 16 subjects; hypoglycemic events ≥ 5/wk in 12 subjects; 18 subjects used CSII, 2 used MDI at trial enrolment. Dec 31st 2006, 19 subjects had completed the 1st half of the 1st treatment phase. One subject was lost to follow-up (IP-group). Ten subjects had completed the 1st treatment phase. Change over time was evaluated using General Linear Model procedures, adjusting for baseline values. There were no baseline differences between groups with respect to HbA[sub 1c], BMI, diabetes duration, blood pressure, QOL or TS. After 3 months, HbA[sub 1c] dropped 0.53% in the IP-group compared to the SC-group (95% CI -1.04, -0.03; p=0.04) and time spent in euglycemia increased 17.2% in the IP-group compared to the SC-group (95% CI 0.5, 33.9; p<0.05). After 6 months, TS increased 9.8 points (95% CI 2.7, 16.9; p=0.01) in the IP-group compared to the SC-group. Neither HbA[sub 1c] nor time in euglycemia nor QOL did differ significantly between groups after 6 months. Interim data suggest that IP insulin infusion improves glycemic control and increases time in euglycemia in otherwise poorly controlled T1DM. Further evaluation will determine whether these effects are sustainable. [ABSTRACT FROM AUTHOR]