Clinical Research Directory

The Effect of Hedia Diabetes Assistant on TiMe-in-range in People With Type 1 Diabetes and Sub-Optimal Glycemic Control in France - A Randomised Controlled Trial.

The goal of this randomized controlled study is to assess the clinical performance and safety of Hedia Diabetes Assistant in adults with type 1 diabetes and suboptimal glycemic control in France. The main question to answer is: \- Does Hedia Diabetes Assistant improve glycemic control? Researchers will compare Hedia Diabetes Assistant in addition to standard treatment to standard treatment alone to see if Hedia Diabetes Assistant can improve glycemic control. Subjects will: * Use Hedia Diabetes Assistant in addition to their standard treatment or only use standard treatment for 6 months. * Visit the clinic once when they are included into the study and will otherwise be followed remotely. * Fill out questionnaires when they are included and after 6 months.

Continuous Glucose Monitoring for Outpatient Diabetes Management After Hospital Discharge

This study aims to improve patient awareness of the utility of continuous glucose monitoring systems in blood glucose monitoring and to improve patient satisfaction regarding diabetes care, particularly in the matter of blood glucose monitoring, at the transitions of care from the inpatient setting to the ambulatory setting.

Pediatric Insulin Plan Calculator for T1DM Management

This is a multi-centre, prospective, randomized, open-label controlled trial designed to evaluate the effectiveness of a flexible digital insulin dose calculator in children under 12 years of age with Type 1 Diabetes Mellitus (T1DM) managed with multiple daily injections (MDI). Participants will be stratified by continuous glucose monitoring (CGM) use and baseline HbA1c, and randomised to receive either standard care alone or standard care plus the insulin dose calculator tool for 6 months. The primary outcome is the change in HbA1c from baseline to 6 months. Secondary outcomes include CGM-derived glycaemic metrics (Time in Range, Time Below Range, Time Above Range, and Coefficient of Variation), total daily insulin dose (units/kg/day), healthcare provider contact frequency, and caregiver-reported usability and satisfaction. The study aims to determine whether the use of a structured digital decision-support tool improves glycaemic control and supports safer insulin dosing in paediatric patients with T1DM.

Using a Personalized Decision Support Tool to Help People With Type 1 Diabetes Manage Exercise

This study evaluates a clinician-facing decision-support toolkit designed to assist adults with type 1 diabetes in preparing for moderate-intensity exercise. The netIOB \& Exercise Toolkit (NEXT) integrates recent glucose data and insulin delivery history to provide individualized suggestions regarding exercise timing, insulin adjustments, and carbohydrate intake. Adults with type 1 diabetes will complete three supervised exercise sessions under different pre-exercise guidance approaches: (A) published consensus-based standard-of-care guidance, (B) usual personal care routines, and (C) guidance informed by the NEXT Toolkit. A healthy adult control group will complete a single supervised exercise session to provide comparative physiologic data.

Thai PainPREDICT Validation Study

Painful diabetic neuropathy (PDN) is one of the most common and disabling complications of diabetes mellitus, substantially affecting quality of life, daily functioning, and health system burden. Early identification of PDN is crucial for timely treatment, prevention of complications such as foot ulcers and amputations, and for reducing healthcare costs. However, in Thailand there are limited culturally adapted and validated tools for screening PDN. PainPREDICT is an internationally validated questionnaire designed to characterize neuropathic pain profiles, but its adaptation for Thai patients has not yet been undertaken. In parallel, the use of mobile health technologies (mHealth) has the potential to expand access to screening and monitoring of chronic conditions, particularly in resource-limited settings.

Cardiovascular Risk in Children With Chronic Conditions Study

Children living with chronic health conditions face a higher risk of developing cardiovascular diseases than their peers, largely due to the accelerated aging of the heart and blood vessels. Although experts recognize this elevated risk and recommend close monitoring and early intervention, the underlying mechanisms driving this phenomenon remain poorly understood. At present, no effective interventions specifically target its root causes. Recent research shows that both large blood vessels (such as the carotid artery) and small vessels (such as those in the retina) can display early signs of damage decades before clinically apparent heart or vascular disease emerges. This accelerated vascular aging can result from multiple factors - including disease-related processes such as persistent inflammation and metabolic disturbances, treatment-related effects such as chemotherapy or long-term steroid use, and lifestyle changes associated with chronic illness, such as reduced physical activity and altered eating habits. However, it is still unclear how these factors influence the development and progression of vascular changes in children as they grow. Importantly, these changes can be monitored through non-invasive methods, offering a unique opportunity to study at-risk patients many years before overt cardiovascular disease develops. Identifying these early changes may enable us to detect and track individuals at heightened risk well in advance of clinical disease. This study aims to deepen our understanding of the causes of increased cardiovascular risk in children with chronic conditions and to lay the groundwork for earlier, more targeted prevention strategies.

Semaglutide Treatment in Type 1 Diabetes

The goal of this clinical trial is to investigate the efficacy of semaglutide on body weight, insulin dose requirements and improvements in glucose control and safety aspects in regards to risk of hypoglycemia and diabetic ketoacidosis for patients with established Type 1 Diabetes.

Structured Education Program and Glycemic Control in Adolescents With Type 1 Diabetes

Type 1 diabetes is becoming more common in Kuwaiti and Arab adolescents. Many young people with this condition struggle to keep their blood glucose levels under control, which can lead to diabetes-related complications and affect their quality of life. The goal of this clinical trial is to evaluate the effectiveness of a structured educational program on glycemic control among Arab adolescents with type 1 diabetes aged 11 to 14 years. Participants will be randomly assigned to one of two groups. The intervention group will receive the structured education program, and the control group will continue with standard care. All participants will undergo assessments that include: * collecting demographic and diabetes management data * measuring weight and height * measuring HbA1c levels and lipid profile * filling out questionnaires on quality of life, carbohydrate and insulin dosing knowledge, physical activity * collecting dietary intake * providing AGP report Participants in the intervention group will additionally be required to: * attend the program for 4 consecutive days, one day for parents and three days for children * fill out 3-day food diary records during the program * attend a refresher course after 6 months Participants in the control group will have the opportunity to participate in the program after approximately six months.

Physical, Psychological and Socioeconomic Effects of Childhood Onset Diabetes in Sweden

The researchers study time trends of childhood-onset type 1 diabetes and its most serious complication, end-stage renal disease. They further analyse physical, psychological and socio-economic long-term effects on patients and families to identify potentially preventive factors in a population perspective. The researchers investigate the economic burden of disease and study and improve statistical methods for case-control data. The projects use a longitudinal nationwide database involving about 23 000 childhood-onset diabetes cases with maximum follow-up of 48 years and for each case 4 matched controls. The Swedish Childhood Diabetes Register is linked to a number of official, Swedish registers: the Renal register, the Cause of Death register, the National Patient register, the Prescribed Drugs register, the Cancer register and the Integrated Database for Labour Market Research. The researchers use GAM modelling for time trend analyses, standard case-control/cohort analyses, Cox regression for life table analyses, linear fixed effect probability for career development and propensity score models for confounding. The project group is multidisciplinary and involves experts in paediatrics, nephrology, epidemiology, health economics and statistics. This unique database and team continues to yield population-based new knowledge on the consequences of this increasingly common chronic childhood-onset disease.

Motivational Interviewing and WhatsApp-Based Monitoring for Metabolic Control and Self-Efficacy in Adolescents With T1DM

This clinical study aims to determine the effects of motivational interviewing and social media-based patient monitoring on metabolic control and self-efficacy in adolescents with Type 1 diabetes. Additionally, the study will assess the adolescents\' attitudes toward their disease, quality of life, and perceived levels of social support. The primary research questions are as follows: For adolescents with Type 1 diabetes who receive motivational interviewing and social media-based monitoring: How do their attitudes toward their disease compare to those in the control group? How do their perceived levels of social support compare to those in the control group? How do their self-efficacy levels compare to those in the control group? How does their quality of life compare to that of the control group? How do their HbA1c levels compare to those in the control group?