Continuous glucose monitoring during diabetic pregnancy (GlucoMOMS): A multicentre randomized controlled trial.

AIM: Diabetes is associated with a high risk of adverse pregnancy outcomes. Optimal glycaemic control is fundamental and is traditionally monitored with self-measured glucose profiles and periodic HbA1c measurements. We investigated the effectiveness of additional use of retrospective continuous glucose monitoring (CGM) in diabetic pregnancies. MATERIAL AND METHODS: We performed a nationwide multicentre, open label, randomized, controlled trial to study pregnant women with type 1 or type 2 diabetes who were undergoing insulin therapy at gestational age < 16 weeks, or women who were undergoing insulin treatment for gestational diabetes at gestational age < 30 weeks. Women were randomly allocated (1:1) to intermittent use of retrospective CGM or to standard treatment. Glycaemic control was assessed by CGM for 5-7 days every 6 weeks in the CGM group, while self-monitoring of blood glucose and HbA1c measurements were applied in both groups. Primary outcome was macrosomia, defined as birth weight above the 90th percentile. Secondary outcomes were glycaemic control and maternal and neonatal complications. RESULTS: Between July 2011 and September 2015, we randomized 300 pregnant women with type 1 (n = 109), type 2 (n = 82) or with gestational (n = 109) diabetes to either CGM (n = 147) or standard treatment (n = 153). The incidence of macrosomia was 31.0% in the CGM group and 28.4% in the standard treatment group (relative risk [RR], 1.06; 95% CI, 0.83-1.37). HbA1c levels were similar between treatment groups. CONCLUSIONS: In diabetic pregnancy, use of intermittent retrospective CGM did not reduce the risk of macrosomia. CGM provides detailed information concerning glycaemic fluctuations but, as a treatment strategy, does not translate into improved pregnancy outcome.

Introduction of the DiaGene study: clinical characteristics, pathophysiology and determinants of vascular complications of type 2 diabetes.

BACKGROUND: Type 2 diabetes is a major healthcare problem. Glucose-, lipid-, and blood pressure-lowering strategies decrease the risk of micro- and macrovascular complications. However, a substantial residual risk remains. To unravel the etiology of type 2 diabetes and its complications, large-scale, well-phenotyped studies with prospective follow-up are needed. This is the goal of the DiaGene study. In this manuscript, we describe the design and baseline characteristics of the study. METHODS: The DiaGene study is a multi-centre, prospective, extensively phenotyped type 2 diabetes cohort study with concurrent inclusion of diabetes-free individuals at baseline as controls in the city of Eindhoven, The Netherlands. We collected anthropometry, laboratory measurements, DNA material, and detailed information on medication usage, family history, lifestyle and past medical history. Furthermore, we assessed the prevalence and incidence of retinopathy, nephropathy, neuropathy, and diabetic feet in cases. Using logistic regression models, we analyzed the association of 11 well known genetic risk variants with type 2 diabetes in our study. RESULTS: In total, 1886 patients with type 2 diabetes and 854 controls were included. Cases had worse anthropometric and metabolic profiles than controls. Patients in outpatient clinics had higher prevalence of macrovascular (41.9% vs. 34.8%; P = 0.002) and microvascular disease (63.8% vs. 20.7%) compared to patients from primary care. With the exception of the genetic variant in KCNJ11, all type 2 diabetes susceptibility variants had higher allele frequencies in subjects with type 2 diabetes than in controls. CONCLUSIONS: In our study population, considerable rates of macrovascular and microvascular complications are present despite treatment. These prevalence rates are comparable to other type 2 diabetes populations. While planning genomics, we describe that 11 well-known type 2 diabetes genetic risk variants (in TCF7L2, PPARG-P12A, KCNJ11, FTO, IGF2BP2, DUSP9, CENTD2, THADA, HHEX, CDKAL1, KCNQ1) showed similar associations compared to literature. This study is well-suited for multiple omics analyses to further elucidate disease pathophysiology. Our overall goal is to increase the understanding of the underlying mechanisms of type 2 diabetes and its complications for developing new prediction, prevention, and treatment strategies.

Mindfulness-based cognitive therapy for people with diabetes and emotional problems: long-term follow-up findings from the DiaMind randomized controlled trial.

OBJECTIVE: The DiaMind trial showed beneficial immediate effects of mindfulness-based cognitive therapy (MBCT) on emotional distress, but not on diabetes distress and HbA1c. The aim of the present report was to examine if the effects would be sustained after six month follow-up. METHODS: In the DiaMind trial, 139 outpatients with diabetes (type-I or type-II) and a lowered level of emotional well-being were randomized into MBCT (n=70) or a waiting list with treatment as usual (TAU: n=69). Primary outcomes were perceived stress, anxiety and depressive symptoms, and diabetes distress. Secondary outcomes were, among others, health status, and glycemic control (HbA1c). RESULTS: Compared to TAU, MBCT showed sustained reductions at follow-up in perceived stress (p<.001, d=.76), anxiety (p<.001, assessed by HADS d=.83; assessed by POMS d=.92), and HADS depressive symptoms (p=.004, d=.51), but not POMS depressive symptoms when using Bonferroni correction for multiple testing (p=.016, d=.48). No significant between-group effect was found on diabetes distress and HbA1c. CONCLUSION: This study showed sustained benefits of MBCT six months after the intervention on emotional distress in people with diabetes and a lowered level of emotional well-being. TRIAL REGISTRATION: Dutch Trial Register NTR2145, http://www.trialregister.nl.

The effects of a mindfulness-based intervention on emotional distress, quality of life, and HbA(1c) in outpatients with diabetes (DiaMind): a randomized controlled trial.

OBJECTIVE: Emotional distress is common in outpatients with diabetes, affecting ∼20-40% of the patients. The aim of this study was to determine the effectiveness of group therapy with Mindfulness-Based Cognitive Therapy (MBCT), relative to usual care, for patients with diabetes with regard to reducing emotional distress and improving health-related quality of life and glycemic control. RESEARCH DESIGN AND METHODS: In the present randomized controlled trial, 139 outpatients with diabetes (type 1 or type 2) and low levels of emotional well-being were randomized to MBCT (n = 70) or a waiting list group (n = 69). Primary outcomes were perceived stress (Perceived Stress Scale), anxiety and depressive symptoms (Hospital Anxiety and Depression Scale), mood (Profiles of Mood States), and diabetes-specific distress (Problem Areas In Diabetes). Secondary outcomes were health-related quality of life (12-Item Short-Form Health Survey), and glycemic control (HbA(1c)). Assessments were conducted at baseline and at 4 and 8 weeks of follow-up. RESULTS: Compared with control, MBCT was more effective in reducing stress (P < 0.001, Cohen d = 0.70), depressive symptoms (P = 0.006, d = 0.59), and anxiety (P = 0.019, d = 0.44). In addition, MBCT was more effective in improving quality of life (mental: P = 0.003, d = 0.55; physical: P = 0.032, d = 0.40). We found no significant effect on HbA(1c) or diabetes-specific distress, although patients with elevated diabetes distress in the MBCT group tended to show a decrease in diabetes distress (P = 0.07, d = 0.70) compared with the control group. CONCLUSIONS: Compared with usual care, MBCT resulted in a reduction of emotional distress and an increase in health-related quality of life in diabetic patients who had lower levels of emotional well-being.

The fracture and osteoporosis clinic: 1-year results and 3-month compliance.

INTRODUCTION: A Fracture and Osteoporosis (F&O) clinic started in two major general hospitals in the South of the Netherlands on April 1st 2004. Its objectives were to perform easy and complete assessment of female and male patients aged 50 years and over, initially treated for a low-energy trauma fracture, and to evaluate its effectiveness for early diagnosis and treatment of osteoporosis. METHODS: All eligible patients were selected from the digital X-ray system of the Emergency Department. DXA-scans and, if indicated, spinal radiographs were made. If osteoporosis was diagnosed, the F&O nurse explained the treatment strategy. Treatment advice was sent to the general practitioner (GP), who prescribed medication and provided further support. After 3 months, all osteoporosis patients received a compliance and side effects follow-up questionnaire. RESULTS: Up to June 1st 2005, 1058 patients followed the diagnostic procedure; 584 patients did not. Three times more women (804) than men (254) suffered a fracture. Osteoporosis occurred 10% more often in women. Overall, 37.1% had osteoporosis, based on DXA-scan only, and 39.6% when spinal radiographs were added. Spinal radiographs of the thoracic and or lumbar spine were made in 166 patients, radiographs of the thorax in 114 patients. Overall, fractures of the wrist were most common, with fractures of the hand occurring most frequently in men (20.0%). All fracture sites, except foot and clavicula, were associated with a higher frequency of osteoporosis than in the Dutch population. The response rate to the 3-month compliance questionnaire was 73% increasing to 96% after telephone contact. 86% visited their GP; 11% did not because they already received anti-osteoporotic medication prior to the fracture. Bisphosphonates were prescribed to 84% and discontinued by 7%. 13% reported side effects of bisphosphonates. Only half of the patients received the recommended calcium supplementation. CONCLUSIONS: The F&O clinic with its digital X-ray system facilitated easy, complete identification of fracture patients and early treatment of osteoporosis, which was frequently diagnosed. Self-reported compliance was high.