Saint Cyr Sur Loire

Researchers are evaluating the EkiYou V2 Digital Therapy in adults with diabetes who use multiple daily insulin injections as part of a basal-bolus insulin regimen. This multicenter randomized controlled trial aims to compare the performance of this digital therapy with conventional insulin management methods and assess user satisfaction and quality of life. The study is sponsored by DiappyMed and follows 154 adults over a 6-month period. Participants will be randomly assigned to either receive the EkiYou V2 device at the start or continue their standard basal-bolus insulin care for three months before switching to the device for the remaining three months. The EkiYou V2 is a mobile application that supports insulin dose estimation, including basal insulin dose, insulin-to-carb ratios, and correction factors. It uses a large food database, accounts for meals, physical activity, and glucose levels, and connects to continuous glucose monitoring CGM devices. During the 6-month study, participants will attend three visits and complete electronic questionnaires to report their quality of life and satisfaction with the application. Researchers will monitor glucose control through CGM data, measuring time spent in the target glucose range and other glucose-related outcomes. Safety events and adverse effects related to the device will also be tracked throughout the trial.

Researchers are evaluating the Omnipod 5 Automated Insulin Delivery System in people with type 1 diabetes aged 2 years and older. This study aims to gather real-world data on blood sugar control, quality of life, user satisfaction, patient experience, and rates of acute diabetes complications over the course of one year. The study is a non-interventional, prospective follow-up conducted in France to understand how the device performs in everyday use. Participants will use the Omnipod 5 System paired with a Dexcom continuous glucose monitor, either the G6 or G7 model. The device delivers insulin automatically and is tubeless. Each participants involvement begins when they start using the system in automated mode and continues for approximately 12 months. This period allows researchers to observe how participants manage their diabetes with the device in a real-world setting. During the study, participants will complete questionnaires at the start, 6 months, and 12 months to assess quality of life and treatment satisfaction. Researchers will monitor glucose levels, insulin delivery patterns, and rates of hypoglycemia and diabetic ketoacidosis. Data such as time spent in target glucose ranges, lab HbA1c if available, and device usage time will be collected. The study also tracks reasons if participants stop using the system. All data will help evaluate the devices impact on diabetes management and patient experience over a year.

This research aims to evaluate personalized blood pressure management in adults experiencing cardiogenic shock, a dangerous condition where the heart cannot pump enough blood, leading to organ problems and high risk of death. The study focuses on whether adjusting mean arterial pressure MAP targets based on central venous pressure CVP can improve organ function and survival compared to standard MAP targets. Cardiogenic shock currently has a poor outlook, and finding the best blood pressure goal is critical to improving outcomes. Participants will be randomly assigned to one of two groups. One group will receive personalized MAP management where the target MAP is adjusted by adding the measured CVP to a baseline, aiming for an effective perfusion pressure of 65 mmHg, with limits set between 65 mmHg plus CVP and 90 mmHg plus CVP. After 48 hours, if tissue perfusion improves, MAP targets may be lowered. The other group will receive standard care targeting a MAP of 65 to 70 mmHg, following international guidelines. CVP is measured using a catheter placed in the superior vena cava. During the study, researchers will monitor participants for up to 28 days, checking outcomes such as mortality, use of mechanical heart support, kidney failure, and other organ functions. Assessments include vital signs, organ failure scores, blood tests, and complications like arrhythmias or bleeding. The study collects data at specific times after randomization to evaluate survival, length of hospital stay, and need for treatments like dialysis or ventilation. Overall, the study seeks to determine if personalized blood pressure targets can better protect organs and improve survival in cardiogenic shock.

This research aims to evaluate the ongoing safety, performance, and quality of life associated with using the Control-IQ system in people with type 1 diabetes. The study is a post-market surveillance, single-arm, prospective cohort design conducted in France and sponsored by Tandem Diabetes Care, Inc. It focuses on the first 12 months of real-world use of the Control-IQ system across all approved populations. Participants will use the tslim X2 insulin pump with Control-IQ technology combined with Dexcom G6 or G7 continuous glucose monitoring sensors. They will follow standard care practices while using the system continuously for 12 months. The study observes the devices safety by measuring rates of severe metabolic complications like diabetic ketoacidosis and severe hypoglycemia during this period. During the study, participants will provide data on their blood glucose levels and device use, while also completing questionnaires about their treatment satisfaction, system usability, quality of life, and fear of hypoglycemic events. Researchers will monitor glycemic control outcomes such as time in target glucose range and time spent above or below specified glucose levels. The study follows participants for one year, including tracking device usage and collecting clinical data according to usual care standards.