Clinical Research Directory

The T1DWATCH Study: a Screening for Type 1 Diabetes Autoantibodies in Children for Early Detection and Intervention.

This study aims to identify early-stage type 1 diabetes (T1D) in children aged 2-6 and 8-10 years through autoantibody (Ab) screening, genetic and immunological analyses, and to evaluate the effectiveness of educational interventions, as well as the feasibility and acceptability of their implementation. It is a prospective cohort study involving 2,169 children attending primary healthcare centres in the Barcelonès area. Eligible participants will be those engaged in routine paediatric preventive programe with parental informed consent. The screening process consists of three visits: Visit 1: Capillary blood collection for 3 T1D related Ab (3-screen ELISA). Visit 2: Confirmation of positive results through a new venous blood sample to determine single T1D related Ab and metabolic tests (fasting glucose, HbA1c, C-peptide), HLA, imme cell study. Visit 3: Risk stratification based on Ab presence: Group A (negative), Group B (one positive Ab, at risk of T1D), and Group C (two positive Ab, diagnosed at stage 1 or 2). Immunological and metabolic changes will be monitored, and screening effectiveness will be assessed in terms of sensitivity, specificity, and false positive/negative rates. The association between HLA genotype and Ab positivity will be analysed using logistic regression. A cost-effectiveness analysis will be conducted alongside a qualitative evaluation of parents' and stakeholders' perceptions regarding the screening process.This study will provide evidence to optimise early T1D detection and its implementation in primary care.

Hemoglobin Levels and Resolution Time of Diabetic Ketoacidosis in Pediatric Patients

This retrospective observational cohort study aims to evaluate the association between hemoglobin levels and the time to resolution of diabetic ketoacidosis (DKA) in pediatric patients. The primary hypothesis is that children with anemia experience a longer duration of DKA and prolonged hospitalization compared with non-anemic children. All eligible patients aged 1-18 years who were diagnosed with DKA between 01.01.2013 and 01.01.2025 at a tertiary pediatric center will be included. Clinical, laboratory, and treatment data will be collected from electronic medical records.

Effects of LP-LDL® on Lipid Metabolism, Glycemic Control, Inflammatory Markers, and Cognitive Function in Individuals With Prediabetes and Diabetes Mellitus

This randomized, double-blind, placebo-controlled clinical trial investigates the effects of the probiotic LP-LDL® (Lactobacillus plantarum ECGC 13110402) on lipid metabolism, glycemic control, inflammatory biomarkers, and cognitive function in adults with prediabetes, type 1 diabetes, or type 2 diabetes who also exhibit elevated cholesterol or triglyceride levels. A total of 210 participants will be enrolled across three parallel sub-studies: * Type 1 diabetes (n = 76) * Type 2 diabetes (n = 54) * Prediabetes (n = 80) Participants will be randomized 1:1 to receive LP-LDL® or matching placebo once daily for 12 weeks, followed by a 4-week washout period. Study assessments include fasting blood tests (lipids, glucose, HbA1c, liver enzymes, inflammatory markers), cognitive testing (ACE-III), blood pressure, anthropometry, and stool measurements (microbiome, bile acids, fecal fat). Exploratory analyses include bile acid metabolism, microbiome profiling (16S rRNA), and gene expression of cholesterol transporters ABCG5/ABCG8. The study aims to determine whether LP-LDL® can improve cardiometabolic profiles and cognitive outcomes in these populations, and to clarify the mechanistic pathways underlying metabolic dysfunction, inflammation, and gut-brain communication.

Automated Insulin Delivery Versus Usual Insulin Treatment Modality Before and During Pregnancy in Women With Type 1 Diabetes

A national multi-center open-label randomized controlled trial that investigates whether the use of the automated insulin delivery system CamAPS FX initiated during pregnancy planning or in early pregnancy improves maternal time in glycemic targets and fetal growth in women with type 1 diabetes compared to usual insulin treatment modality combined with Continuous Glucose Monitoring.

Precision Subclassification of Mental Health in Diabetes: Digital Twins for Precision Mental Health to Track Subgroups

Mental conditions and disorders (e.g. distress, depressive, anxiety, and eating disorders) are more prevalent in people with diabetes (PWD) and associated with reduced quality of life and impaired glycaemic outcomes. Evidence supports a complex network between psychosocial factors and glycaemic control that can be highly variable between persons. It is assumed that subgroups exist that show different trajectories of glycaemia and mental health. Belonging to a particular subgroup may be linked with a higher risk of developing mental health problems compared to others. This suggests that it is possible to treat individuals in different subgroups in a manner that optimizes their treatment and can improve health outcomes. Accurate characterisation can inform more individualized care. This calls for a more personalised approach considering the idiosyncrasies of different subgroups. Over 3 years, the investigators have established the basis of a precision mental health approach for diabetes using n-of-1 analyses. By utilizing combined ecological momentary assessment (EMA: repeated daily sampling of psychosocial factors in everyday life) and continuous glucose monitoring (CGM), intensive longitudinal data per person could be collected. This enables the analysis of individual associations between glycaemic parameters and psychosocial variables and identification of individual sources of diabetes distress in each person. The objective of the present study is to use of the n-of-1 approach to identify subgroups of PWD who share common characteristics in the associations between glucose and psychosocial variables. The identified subgroups shall be used to develop a digital twin for precision mental health in diabetes. The digital twin serves as representation of a real person, allowing to make simulations and predictions of the course of mental health and glycaemia. These predictions can inform diabetes care and lead to more precise, personalised treatment decisions. To achieve this, a longitudinal panel including over 1,400 PWD who continuously complete EMA and questionnaire surveys and measure glucose levels using CGM was developed. Over 1000 clinical interviews to diagnose mental disorders have been conducted to identify major mental health conditions and map mental outcomes. To identify subgroups and develop the digital twin, the sampling will be expanded aiming at a total of 1,809 PWD. Incidence and remission of mental disorders will be determined via repeated interviews. The complex networks between clinical, metabolic, and psychosocial data will be analysed using machine learning, leading to new insights with the potential to shape future guidelines. These results will be used by the digital twin to predict courses of glycaemic control and mental health, translating the individual evidence into direct treatment suggestions.

Buzzy and TickleFlex in Reducing Insulin Injection Pain and Fear

This interventional randomized controlled clinical trial aims to evaluate the effectiveness of two nonpharmacological devices, Buzzy and TickleFlex, in reducing pain and fear associated with insulin injections among children with Type 1 Diabetes Mellitus (T1DM). A total of 90 participants aged 6 to 12 years will be randomly assigned to one of three groups: Buzzy, TickleFlex, or control. The Buzzy device provides combined cold and vibration stimulation near the injection site to decrease pain perception based on the gate control theory, while the TickleFlex device is a soft, flexible attachment for insulin pens designed to minimize needle pressure and discomfort during injection. Pain and fear will be assessed immediately before and after a single insulin injection using validated instruments, including the Wong-Baker FACES Pain Rating Scale and the Children's Fear Scale (CFS), rated independently by the child, parent, and researcher. It is hypothesized that both Buzzy and TickleFlex applications will significantly reduce pain and fear compared to standard insulin injection without intervention. The study is expected to provide evidence supporting the use of nonpharmacological methods in pediatric diabetes care to improve children's comfort and treatment adherence.

Eating Disturbances in Patients With Type 1 Diabetes Initiating Insulin Therapy

The prevalence of eating disorders is particularly high among people with type 1 diabetes (T1D). These abnormalities, such as "diabulimia," are frequently responsible for poor insulin therapy management and, consequently, chronic glycemic imbalance, exposing them to an increased risk of complications. Their detection and management unfortunately remain insufficient in current practice. However, to date, no study has addressed the question of the prevalence and impact of eating disorders in this context. Our research hypotheses are therefore as follows: 1. The existence of an eating disorder is likely frequently overlooked and, therefore, not taken into account in patients with T1D initiating semi-automated insulin therapy with BF. 2. The existence of an eating disorder could impair the performance of the BF device in terms of improving glycemic control in patients with T1D initiating this treatment method. Patients clinical characteristics, glycemic monitoring parameters ad questionnaires answers will be recorded. The prevalence of eating disorders will be calculated, and the association between the presence of these abnormalities and baseline clinical characteristics and glycemic control parameters will be analyzed.

Effect of a Probiotic Supplement on Gut Microbiota and Glycemic Control in Patients With Type 1 Diabetes (PRODIAB)

This randomized, double-blind clinical trial aims to evaluate the effect of a probiotic supplement on gut microbiota composition and glycemic control in adults with type 1 diabetes mellitus. A secondary comparison will be made with a healthy control group. Participants will be assigned to receive either a probiotic or a placebo for 98 days. Stool samples and metabolic parameters will be collected at baseline and after the intervention period. The study seeks to better understand how modulation of the intestinal microbiota may influence glucose regulation in people with type 1 diabetes.