Saint Cyr Sur Loire

Researchers are evaluating the EkiYou V2 Digital Therapy in adults with type 1, type 2, or pancreatic diabetes who use multiple daily insulin injections. This multicenter randomized controlled trial involves 154 adults treated with basal-bolus insulin regimens and continuous glucose monitors (CGM). The study aims to compare EkiYou V2 with standard care for insulin dose management and to assess participant satisfaction, user experience, and quality of life. Participants will be randomly assigned to two groups. One group will use the EkiYou V2 mobile application from the start for six months. The other group will continue standard care for the first three months and then receive EkiYou V2 for the last three months. The device helps estimate daily bolus and basal insulin doses and adjusts insulin parameters weekly, including basal insulin dose, insulin-to-carb ratios, and correction factors. It also provides carbohydrate counting with a large food database, bolus calculation based on meals, physical activity, and blood glucose, bolus correction advice, insulin reminders, and automatic titration. Participants will attend three visits over six months, including at study start. Researchers will monitor glucose data via CGM devices and collect quality of life and satisfaction data through electronic questionnaires. The main outcome measured is the change in the percentage of time blood glucose levels are in the target range (70-180 mg/dL) after three months compared to baseline. Safety and adherence will be tracked throughout the study period.

Researchers are evaluating the Omnipod 5 Automated Insulin Delivery System in people with type 1 diabetes aged 2 years and older in France. This study aims to gather real-world data on blood sugar control, quality of life, patient satisfaction, and rates of acute diabetes complications over a 12-month period following the start of automated insulin delivery with the Omnipod 5 system. Participants will use the Omnipod 5 system, a tubeless insulin pump designed to deliver insulin automatically when paired with compatible Dexcom continuous glucose monitors (G6 or G7). The study follows patients who have been prescribed a commercial version of this system and have not used it before. The system is intended to help manage diabetes by maintaining blood sugar levels within a target range. During the 12 months, participants will be monitored in a non-interventional way to observe their glycemic control and device usage in everyday life. Researchers will assess changes in the percentage of time blood sugar stays within the target range of 70 to 180 mg/dL, quality of life, satisfaction, and safety. Data will be collected through questionnaires and regular follow-up, with participants needing to understand and respond to study information and surveys in French.

Cardiogenic shock is a serious condition where the heart cannot pump enough blood, leading to organ damage and high risk of death. This research evaluates whether adjusting the mean arterial pressure (MAP) target based on central venous pressure (CVP) can improve organ function and survival compared to using a standard MAP target. The study focuses on adults with cardiogenic shock, aiming to find better blood pressure management strategies to protect organs and enhance patient outcomes. Participants are randomly assigned to one of two groups. One group receives personalized blood pressure management, targeting a MAP adjusted by adding CVP to a base range of 65 to 75 mmHg, not exceeding 90 mmHg. CVP is measured using a catheter in the superior vena cava. After 48 hours, if tissue perfusion improves, the MAP target may be lowered to 65-70 mmHg. The other group follows standard care with a MAP target of 65-70 mmHg according to current guidelines. During the study, researchers monitor participants for outcomes including death, use of mechanical heart support, and severe kidney failure at 7 and 28 days after randomization. Assessments include measuring blood pressure, CVP, and organ function. Participants’ safety and health status are regularly checked throughout the study period to evaluate the impact of personalized MAP management on survival and organ protection.

This research aims to evaluate the ongoing safety, performance, and patient quality of life related to the Control-IQ system in managing type 1 diabetes. It is a post-market surveillance study assessing the device in all approved populations over a 12-month period. The study focuses on the rate of severe metabolic complications like diabetic ketoacidosis (DKA) and severe hypoglycemia, as well as patient satisfaction and real-world use of the system. Participants will use the t:slim X2 insulin pump equipped with Control-IQ technology along with a Dexcom G6 or G7 continuous glucose monitor. After starting use of the system, participants will be followed for 12 months to monitor their glycemic control, device usage, and quality of life. The study collects data on device performance and patient experiences during this time. During the study, participants will be monitored for safety through the tracking of severe hypoglycemia and diabetic ketoacidosis events over 12 months. Researchers will also assess glycemic outcomes and gather patient-reported feedback on satisfaction, trust, usability, and quality of life improvements. Participants are expected to complete questionnaires and allow access to clinical data, including recent HbA1c results, to support these assessments.