Fermo

Researchers are evaluating how well the approved weekly injectable insulin icodec controls blood sugar levels compared to daily injectable basal insulins in adults with type 2 diabetes. This Phase 4 study focuses on people who need to start basal insulin treatment and have had type 2 diabetes for at least 180 days. The goal is to understand the effectiveness of once-weekly insulin icodec against standard daily basal insulins in real-world clinical practice over about 13 months. Participants will receive either insulin icodec once a week or one of the daily basal insulin analogues, such as insulin glargine, insulin detemir, or insulin degludec. Both treatments are given by subcutaneous injection. The choice between weekly or daily insulin is based on current treatment standards for type 2 diabetes. The study lasts approximately 52 weeks, during which participants maintain their assigned insulin regimen. During the study, researchers will monitor changes in participants' blood sugar control using the glycated hemoglobin (HbA1c) test from the start until week 52. Participants will have their HbA1c measured within 90 days before starting the treatment. Safety and any reactions to the insulin will also be tracked. The study aims to assess how well the weekly insulin icodec works compared to daily basal insulins in managing blood sugar over a year.

The BAD-GER study is a multicenter, prospective observational research designed to validate a biomarker algorithm that predicts mortality and hospital readmission in older adults. This algorithm is based on a retrospective analysis of Alzheimer Disease and neurodegeneration biomarkers from a cohort of 700 previously hospitalized geriatric patients. The study focuses on blood biomarkers related to Alzheimer Disease, neuro-injury, and neuroinflammation to understand their association with cognitive and functional decline, as well as mortality risks. Participants in the study will have blood samples collected at the start to measure levels of specific biomarkers including amyloid 2 (A2), total and phosphorylated tau protein, neurofilament light chain, CXCL8, CXCL12, and glial fibrillary acidic protein. The study integrates these biomarker data with clinical information, routine lab tests, and immunophenotyping to create a minimal dataset for analysis. The study includes three groups of hospitalized patients based on neurological and dementia status. During the study, researchers will assess participants' functional and cognitive status, track mortality, and monitor hospital readmission over a 12-month period from enrollment. The primary outcomes measured are all-cause mortality and the number of hospital readmissions within this timeframe. The study aims to provide insights into how these biomarkers relate to health outcomes in older hospitalized patients with various neurological conditions or dementia.

Researchers are evaluating the impact of a mobile health (m-health) solution on improving the self-management skills of adults with Type 2 Diabetes Mellitus (T2DM) living in the Marche region of Italy. This randomized clinical trial compares the personalized m-health solution, integrated with patients' Electronic Patient Records (EPR), to usual care. The main goal is to assess changes in glycated haemoglobin (HbA1c) levels from the start of the intervention through 18 months, along with other health-related factors like medication adherence, lifestyle habits, self-efficacy, and quality of life. Participants in the treated group will receive training and personalized setup of the m-health solution, which includes mobile applications for tracking health data, receiving alerts and motivational messages, communicating with healthcare professionals, and accessing educational materials. Healthcare providers at Diabetes Centres (CADs) will monitor patient data via a dedicated EPR interface and maintain communication as needed. The intervention begins at the CADs and continues at participants' homes, with follow-up evaluations at 6, 12, and 18 months. Throughout the study, participants will complete self-administered questionnaires and clinical assessments during routine physician visits. Data will be collected from the m-health solution, clinical evaluations, and focus groups to evaluate usability, patient experience, and cost-effectiveness. Importantly, no extra visits or laboratory tests beyond usual care are required. The total observation period spans 18 months from baseline to final follow-up.

Parkinson's disease is a common cause of disability in older adults, marked by motor problems and balance difficulties that do not improve with standard medication. This study aims to explore new rehabilitation methods using robotic devices to improve walking and reduce fall risk in elderly patients with Parkinson's disease. The research includes a long-term follow-up to evaluate the lasting effects of these treatments over two years. Participants will be randomly assigned to one of three groups: a control group receiving only traditional physical therapy, a group combining traditional therapy with 20 minutes of robotic training using the Tymo system (a platform that assesses and helps posture), or a group combining traditional therapy with 20 minutes on the Walker View robotic treadmill equipped with sensors and a 3D camera. Each participant will undergo a total of 10 sessions over five weeks, with two sessions per week. Throughout the study, patients will be assessed before treatment, at the end of treatment, and at 6, 12, and 24 months after treatment ends. Researchers will measure differences in fall risk among the groups and monitor patients' progress using clinical scales and evaluations. The study includes careful monitoring of therapy effects and long-term outcomes to better understand how robotic rehabilitation may benefit elderly individuals with Parkinson's disease.

Researchers are exploring ways to improve the natural abilities of older adults with mild cognitive impairment by using innovative activities inspired by the Montessori approach in rural agricultural settings. The study focuses on involving these individuals and their families in a personalized therapeutic program that encourages cognitive and motor skill development through engaging experiences. Participants will take part in a nine-month program featuring social activities such as horticulture, pet therapy, occupational therapy, sensory labs, and physical exercise. These activities will be held three days a week, each lasting five hours, promoting continuous interaction across different generations and supporting a healthy lifestyle. Throughout the study, participants will be assessed for changes in their positive and negative emotions at the start and after nine months. Researchers will monitor cognitive and motor skills, lifestyle habits, and social engagement. The goal is to understand how these activities impact overall well-being and intrinsic capacity in older adults with mild cognitive impairment.