Fermo

Researchers are evaluating how well once-weekly insulin icodec maintains blood sugar levels compared to daily basal insulin injections in adults with type 2 diabetes. The study focuses on people who need to start basal insulin treatment after using other glucose-lowering medications. This phase 4 trial aims to assess insulin icodecs effectiveness in real-world clinical practice over about 13 months. Participants will be randomly assigned to receive either weekly subcutaneous injections of insulin icodec or daily subcutaneous injections of basal insulin analogues such as insulin glargine, detemir, or degludec. The study compares these two insulin regimens as part of standard type 2 diabetes care. Treatment continues during the 52-week period to monitor blood sugar control and treatment satisfaction. Throughout the study, participants will undergo assessments including measuring changes in glycated hemoglobin HbA1c from baseline to week 52. They will also complete questionnaires on treatment adherence, satisfaction, and burden, and researchers will track severe hypoglycemia episodes and insulin doses. The trial spans about 13 months, providing thorough monitoring of treatment impact and safety in daily clinical use.

Researchers are evaluating blood biomarkers related to Alzheimers Disease and neuro-injury to understand their association with cognitive and functional decline, mortality, and hospital readmission in older hospitalized patients. This multicenter, prospective observational study aims to validate a prognostic algorithm developed from a prior retrospective analysis of biomarkers in a cohort of 700 geriatric patients. The study integrates clinical, laboratory, and biomarker data to assess these relationships in a real-world population. The study involves three groups of hospitalized patients those with acute neurological disorders such as stroke or delirium, those with major neurocognitive disorder dementia, and those hospitalized for non-neurological diseases without dementia. Blood samples will be collected at baseline to measure amyloid -42, tau proteins, neuro-injury markers, neuroinflammation markers, and astrocyte activation. The research will observe participants over 12 months to record mortality and hospital readmission rates. Participants will undergo comprehensive geriatric assessments and evaluations of cognitive function and frailty at the start of the study. Blood biomarker levels will be analyzed alongside clinical data to explore their association with outcomes. The primary outcomes include all-cause mortality and number of hospital readmissions within 12 months of enrollment. This observational study does not involve treatment interventions but focuses on monitoring and data collection to improve understanding of disease progression and risks in elderly hospitalized patients.

Researchers are evaluating a mobile health m-health solution designed to support self-management skills in adults with Type 2 Diabetes Mellitus T2DM living in the Marche region of Italy. This randomized clinical trial compares the use of the personalized m-health tool integrated with the Electronic Patient Record EPR against usual diabetes care, focusing on changes in glycated hemoglobin HbA1c levels over an 18-month period. The study aims to enhance patients abilities to manage their condition through technology combined with healthcare collaboration. Participants are randomly assigned to one of two groups the treated group receives regular care plus access to the m-health solution, while the control group continues with standard care alone. The m-health solution includes mobile apps for tracking health data such as blood sugar, lifestyle habits, and diet, receiving alerts and motivational messages, communicating with healthcare professionals, and accessing educational materials. Healthcare providers will monitor patient data through an integrated platform and communicate as needed. The intervention begins at diabetic centers and continues at participants homes. Participants will undergo evaluations at the start and at 6, 12, and 18 months, including clinical assessments, questionnaires, and data collected from the m-health solution. Researchers will assess changes in diabetes severity, medication adherence, lifestyle habits, self-efficacy, quality of life, and the usability and satisfaction with the m-health tool. There are no additional visits or lab tests beyond usual care. The study includes cost-effectiveness analysis and gathers participant feedback to understand their experience with the intervention.

Parkinsons disease is a common cause of disability in older adults, characterized by motor problems including balance issues that do not improve with standard dopaminergic treatments. This research aims to explore new rehabilitation methods using robotic devices to enhance gait and reduce fall risk in elderly patients with Parkinsons disease. The study is a single-blinded randomized controlled trial involving 195 patients, designed to assess the effectiveness of these innovative approaches. Participants will be randomly assigned to one of three groups a control group receiving traditional rehabilitation therapy, a group using the Tymo system robotic device combined with traditional therapy, or a group using the Walker View robotic treadmill alongside traditional therapy. Each participant will complete 10 treatment sessions over 5 weeks, with two sessions per week. The control group will receive 50 minutes of traditional therapy per session, while the robotic groups will receive 30 minutes of traditional therapy plus 20 minutes with their assigned robotic device. Throughout the study, patients will be evaluated at the start, after treatment, and during follow-ups at 6 months, 1 year, and 2 years to monitor outcomes such as fall risk, gait performance, and fear of falling. Assessments include task-oriented exercises using robotic platforms and traditional therapy, with long-term monitoring to understand sustained effects. This approach supports understanding how robotic rehabilitation may influence motor function and safety in elderly Parkinsons patients over time.

Researchers are evaluating a program designed to improve the abilities and well-being of older adults with mild cognitive impairment MCI by engaging them in innovative activities inspired by the Montessori method within rural farming environments. This approach aims to involve both individuals and their families in a personalized therapeutic journey that promotes cognitive and motor skills while supporting a healthy lifestyle. The study is led by the Istituto Nazionale di Ricovero e Cura per Anziani and focuses on enhancing intrinsic capacities in elderly participants. The intervention includes a nine-month program of social activities conducted three days a week, each lasting five hours. These activities incorporate horticulture, pet therapy, occupational therapy, sensory and food laboratories, physical exercise, and continuous social engagement across generations. All activities take place in a rural setting chosen for its educational features and agricultural multifunctionality, offering participants a rich, stimulating environment. Participants will be assessed at the start and after nine months to measure changes in positive and negative emotions. Throughout the study, researchers will monitor cognitive and physical responses to the activities, including adherence and engagement with the program. The total participation involves regular involvement in these activities and assessments over the nine-month period, aiming to understand how these interventions impact mood and cognitive function in people with MCI.