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NCT06896045
Type 1 diabetes (T1D) affects around 200,000 people in France. The only treatment is insulin, administered either by multiple injections, by pump alone or, more recently, by automated insulin delivery systems (AIDs), which have resulted in a very significant improvement in glycaemic control and quality of life. These closed-loop (CL) devices are capable of effectively regulating the conventional factors associated with glycaemic disturbance, namely dietary intake and physical activity. However, they do not account of stress, which some subjects with T1D perceive as a major disrupter of their blood sugar levels. One of the reasons for this is undoubtedly that stress, unlike diet or physical activity, cannot be anticipated. Since stress is difficult to predict, it is also more difficult to study. Its onset, intensity, duration and progression are linked to the subject's experience, psychological state and environment. Not all patients respond to stress triggers in the same way. Some patients appear to be more reactive than others to these agents, particularly when they are exposed to them chronically or repeatedly, in an anxiety-provoking environment. This is known as chronic psychosocial stress, and it is this type of stress that seems to be most closely associated with glycaemic disturbance in subjects with T1D, most often in the form of hyperglycaemia and, more rarely, hypoglycaemia. However, there are no solid epidemiological or experimental data to support these observations. The study we propose is a prospective multicentre clinical trial in 125 subjects with T1D treated with insulin pumps or multi-injections at 14 French university centres. Our aim is to evaluate the relationship between interstitial glucose levels measured by CGM and perceived stress, assessed 4 times a day, away from mealtimes in order to avoid the impact of dietary glycaemia, using a "stressometer". This stressometer is an application designed by CERITD that can be downloaded to the patient's smartphone and consists of an electronic visual analogue scale (VAS) on which the level of stress felt is evaluated quantitatively (continuous value between 0 and 10).
NCT07493122
This is a first-in-human (FIH) study designed to assess the safety, tolerability, and pharmacokinetic (PK) profile of IMC-S118AI in single-ascending dose (SAD) and multiple-ascending dose (MAD) regimens. This study will potentially also explore the effects of multiple-dosing regimens on preservation of beta-cell function in Stage 3 Type 1 diabetes.
NCT07048795
This is a non-interventional, longitudinal, prospective, multicenter, post market-registration and national study conducted in France. The study is conducted among participants with type 1 diabetes (T1D) using the mylife CamAPS FX hybrid closed-loop insulin delivery system combined with the DEXCOM G6 Continuous Glucose Monitoring (CGM) sensor (the System). The main objective of the study is to evaluate, under real-life conditions, the impact of the System on glycemic control in participants with T1D after one year of use. Secondary objectives include assessing participant-reported outcomes, such as quality-of-life, treatment satisfaction, fear of hypoglycemia, and sleep quality, describing complications related to the system, the rate of hybrid closed-loop usage over one year, and analyzing system usage parameters (e.g., Boost/Ease-Off mode use, insulin-to-carbohydrate ratios, alarms). The study will involve approximately 125 participants (including 100 adults and 25 minors) across 20 centers in France. Endocrinologists / diabetes specialists will monitor participants over the 12-month period after they start using the system and collect data at the three data collection time points.
NCT07374705
People with diabetes are at increased risk of developing dementia, including Alzheimer's disease and vascular dementia. In addition, persons with diabetes have more pronounced age-related brain atrophy and cognitive difficulties compared to people without diabetes. The mechanisms behind the effects on the brain of diabetes are still unclear. New research suggests that the brains of some people with diabetes do not respond normally to insulin signals, a condition known as brain insulin resistance (BIR). To date, there have been no large clinical studies investigating BIR and its impact on brain health, but several smaller studies suggest that BIR may be a cause of cognitive decline and impaired brain health in people with diabetes. Another mechanism that may contribute to impaired brain health in people with diabetes is damage to the blood vessels in the brain. Damage to blood vessels is a well-known complication of diabetes, but how it affects the brain is not fully described. In this project, we will investigate the relationship between BIR and brain blood vessel dysfunction and its relationship to cognition and brain function. This is done by examining patients with type 1 diabetes (T1D), type 2 diabetes (T2D) and healthy controls. The participants will undergo MRI brain scans to assess the impact of BIR on the brain physiology and to evaluate brain blood vessel health. Participants will undergo comprehensive assessments of their cognitive abilities and thorough health examination.
NCT07376850
The TANGO study is a 12-month study involving 120 children and adolescents with Type 1 Diabetes (T1D) across the Czech Republic, Israel, and Poland who use automated insulin delivery (AID) systems. Currently, the global standard for diabetes management is "Time in Range" (TIR), which aims to keep blood sugar levels between 70-180 mg/dL. However, newer technologies like AID systems may now allow for a tighter, more physiological goal called "Time in Normal Glycemia" (TING), which targets a range of 70-140 mg/dL. This study will randomly assign participants to follow either the standard TIR target or the tighter TING target to see if the narrower range improves overall blood sugar control and HbA1c without increasing the risk of hypoglycemia, family stress, or daily treatment burden. By comparing these two approaches, researchers hope to determine if clinical guidelines should be updated to reflect a more precise glucose target for children and adolescents worldwide
NCT06688331
The main purpose of the study is to check: * Can therapy with a preparation of regulatory cells (Tregs lymphocytes) and/or an anti-CD20 antibody preparation (rituximab) be successfully used in children with pre-diabetes to treat or delay type 1 diabetes? * Is therapy with a preparation of regulatory cells (Tregs lymphocytes) and/or a preparation of antiCD20 antibodies (rituximab) safe for children with pre-diabetes, and what side effects may be associated with it? The study will include patients at high risk for type 1 diabetes whose laboratory tests have confirmed preserved normal/high insulin production. First (part 1 of the study), tests will be performed to determine the risk of the disease (determination of autoantibodies that characterize the autoimmune background). In order to confirm the effectiveness of the therapy, not all patients will receive the study treatment. The study will be a so-called blinded randomized trial. This means that in this trial, all participants will undergo the same study procedures, but the participant will be randomly assigned to one of four (4) groups that will receive different treatment regimens before entering the study. The participant will be randomly assigned to one of four groups: * Group I will receive a preparation of regulatory cells (Tregs lymphocytes) along with a preparation of antiCD20 antibodies, * Group II will receive a preparation of regulatory cells (Tregs lymphocytes) together with an inert substance (placebo) * Group III will receive a preparation of antiCD20 antibodies along with a sham treatment (inert substance) * Group IV will receive an agent containing an inert substance and sham treatment. Approximately 150 patients aged 6-16 who are at risk of developing type 1 diabetes will be enrolled in the study, which will last up to 96 months. Each enrolled participant will remain in the study for up to five years.
NCT07258758
The overall objective for this project is to evaluate the effects of a person-centred education intervention to promote a healthy, sustainable Nordic diet compared with the current practice of providing short dietary information on health outcomes of adults with Type 1 diabetes. The study will measure the intervention's impact on blood glucose levels, blood lipids, blood pressure, and adherence to a sustainable and healthy Nordic diet. The main question the trial aims to answer is: Does a person-centred nutritional education have an impact on glucose time in range for adults with Type 1 diabetes, compared with short dietary information? The participants will: * Attend either a person-centred nutrition education (intervention) or receive short dietary information (control group). * Wear their sensor for continuous glucose monitoring (CGM) throughout the trial. * Visit the clinic for data collection (blood samples and clinical checks) at the start and end of the trial. * Keep a four-day food diary, fill out a food frequency questionnaire (FFQ) and estimate their food enjoyment at the start and end of the trial.
NCT06894784
The goal of this clinical trial is to learn if Empagliflozin and Semaglutide, individually and combined, added to Automated Insulin Delivery (AID) works to improve time-in-range in adults living with Type 1 Diabetes. It will also evaluate the safety of Empagliflozin and Semaglutide in this context. The primary hypothesis of this study is : \- The combination therapy of semaglutide and empagliflozin will increase time-in-range compared to placebo when added to AID therapy. The secondary hypotheses are : * The combination therapy of semaglutide and empagliflozin will increase time-in-range compared to semaglutide alone when added to AID therapy. * The combination of semaglutide and empagliflozin will increase time-in-range compared to empagliflozin alone when added to AID therapy. In this study, the research team will compare Empagliflozin and Semaglutide to a placebo (a look-alike substance that contains no drug) to see if they improve time-in-range. This study has four groups: Group 1: semaglutide injection + empagliflozin tablet. Group 2: semaglutide injection + placebo tablet. Group 3: placebo injection + empagliflozin tablet. Group 4: placebo injection + placebo tablet. This is a 2x2 factorial crossover study. This means that all participants will undergo both injection intervention (placebo and semaglutide) arms. Within each injection arm, participants will take both tablets (placebo and empagliflozin). By the end of the study, every participant will have taken part in each study group.
NCT06365255
The EPISTRESS2 study is a one-off cross-sectional epidemiological survey, carried out via an online form in patients with type 1 diabetes followed up by participating investigating centres. In type 1 diabetes (T1DM), studies on stress and its impact on glycaemia have led to ambiguous results, mainly because there are no solid epidemiological or experimental data in the literature. The aim of this study was to assess the impact of perceived stress on blood glucose levels in a population of subjects with T1DM at 10 national centres.
NCT05029271
The purpose of this study is to evaluate the user experience of InPen™ with InPen™ Diabetes Management App and Guardian 4 system in adult patients with type 1 diabetes for the design of a future pivotal study.
NCT04587297
a food collection will be performed in this study with type 1 diabetic patients trained to carbohydrate counting, to collect data on the meals consumed daily and their quantities for a period of 1 month.
NCT03433677
The purpose of this study is to evaluate the compatibility and safety of LY900014 and insulin lispro with an external continuous subcutaneous insulin infusion system in adult participants with type 1 diabetes.
NCT01565824
The aim is to investigate whether the implementation of a web-based support to women with type 1 diabetes during pregnancy and early motherhood can improve well-being and self management of diabetes. Type 1 diabetes is associated with increased medical risks and increased psychosocial pressure in relation to childbearing. There is need for extended support from both health care professionals and peers. Web-based interventions can improve personal capacity and self-management in people with long- term illnesses but are not evaluated in childbearing women with type 1 diabetes. A web site prototype for full-size browsers and mobile devices has been developed through a participatory design by multidisciplinary researchers, health care professionals, experienced mothers with type 1 diabetes and web designers. In a randomised control study the developed web site offering information, communication with health care professionals, person-centred self-care diaries and online social community of included women, is provided to the intervention group in early pregnancy at admission to specialised antenatal clinics at six hospitals in Sweden. A control group will receive standard care (usual care). Total n = 160. Primary outcomes are Well-Being Questionnaire and Diabetes Empowerment Scale. The intervention offers proactive solutions for strengthening patients' decision making of diabetes in daily life during pregnancy and early motherhood, and is expected to increase their wellbeing, personal capacity and knowledge of diabetes.
NCT01501032
The purpose of this feasibility study is to evaluate the MDLAP (MD-Logic Artificial Pancreas system)automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes. The study will include 3 inpatient admissions (12-24 hr), which will include overnight sleep, over-bolus meal, under-bolus meal and exercise.
NCT00925977
A randomized, crossover, open study in order to compare treatment satisfaction with insulin Glargine plus insulin Apidra Vs NPH insulin plus insulin Apidra in newly diagnosed children and adolescents with type 1 diabetes. The study will include two consecutive periods: 2 weeks run in period and 24 weeks intervention period, divided into two separate treatment periods of 12 weeks. According to randomization, each patient will be treated consecutively with both treatment arms: 12 weeks with insulin Glargine and than 12 weeks with NPH insulin or 12 weeks with insulin NPH ad than 12 weeks with insulin Glargine. Patients will complete DTSQ (Diabetes Treatment Satisfaction Questionnaire) at months 0, 12 and 24 weeks, before and at the end of each study arm.
NCT00417131
Islets of Langerhans intended for clinical transplantation are labelled with a radioactive tracer. The tracer is retained in viable cells of the transplant. At infusion (transplantation) of the islets into the portal vein the tracer can be followed for two hours with positron emission tomography (PET). Imaging and calculations can give estimates of the proportion of surveying islets and the rate of early destruction. Also the distribution of the islets into the liver can be viewed.