Continuous Glucose Monitoring for Women With Gestational Diabetes: a Randomized Controlled Trial
There are a few ongoing large randomized controlled trials (RCT's) on continuous glucose monitoring (CGM) in women with gestational diabetes (GDM) powered for pregnancy outcomes. However, none of these studies included women diagnosed with early GDM. The CORDELIA trial is a Belgian open-label multi-centric RCT with 17 centers in women with GDM (including both early and late GDM). Women will be randomized 1/1 to either treatment with CGM (intervention group, Freestyle Libre 3) or continue with self-monitoring of blood glucose (SMBG) with glucometer in line with normal routine (control arm). The study ends at the postpartum oral glucose tolerance test (OGTT 6-24 weeks postpartum) to screen for glucose intolerance.
Botulinum Toxin Injection in the Upper Esophageal Sphincter for Retrograde-cricopharyngeus Dysfunction: a Prospective, Double Blind, Placebo-controlled Trial
The aim of this study is to assess the effect of botulinum toxin injection into the upper esophageal sphincter in a double blind, placebo controlled study. Investigators want to assess the effect on symptoms short term (1-20 weeks after BT injection), and long term (48 weeks after BT injection). This is a prospective double-blind randomized placebo-controlled study. Questionnaires assessing symptoms will be filled out on several occasions. At 20 weeks, a reassessment of symptoms will be done, without unblinding patients or investigator. Failures (to BT or placebo, defined as no clinical improvement or improvement less than 50%) will get the chance to receive a second procedure with active treatment (BT) in open label.
Physical Activity Coaching After Surgery for Patients With Resectable Non-small Cell Lung Cancer: a Randomized Controlled Trial
The goal of this randomized controlled clinical trial is to test a 12-week physical activity telecoaching program for NSCLC patients after surgery. The main question it aims to answer is: What is the effectiveness and acceptability of a 12-week (semi)automated low-to-moderate intensity PA tele coaching program on physical activity (mean steps per day) in resectable (stage I-IIIA) NSCLC patients after lung surgery, as compared to usual care? Patients with NSCLC will be enrolled in the study from 1 month postoperatively up to 1 year postoperatively. They will be randomized in either the intervention group or the control group. Patients randomized in the intervention group will be asked to enter a 12-week physical activity telecoaching program with the aim to enhance their physical activity. The telecoaching programs consists of 4 pilars: 1. A wearable (Fitbit) to measure and give feedback on their daily step count. 2. A smartphone coaching application, installed on a smartphone and linked to the wearable, providing automated coaching by displaying an individual activity goal (expressed as daily step count) and daily and weekly feedback on the performance (steps) of the patient. 3. A one-to-one semi-structured interview with the coach discussing the importance of physical activity, motivation, self-efficacy, barriers, favourite activities, and (coping) strategies to become more active resulting in an individual action plan. 4. Phone calls by the coaches initiated in pre-defined situations (non-compliance with wearing the step counter, failure to transmit the data, failure to progress). Patients randomized in the control group will remain their usual care and will not enter the 12-week physical activity telecoaching program.