Cost-Effectiveness

This research aims to explore how PhytoRx Families, an innovative produce prescription program, can impact nutrition, health, and healthcare use among families in rural North Carolina facing food insecurity. The study focuses on adults and school-aged children, addressing barriers like limited access to affordable healthy food in lower-resourced rural communities. Participants include 30 adult-child pairs with children aged 8 to 14 years. Healthcare providers at local clinics will refer eligible families who screen positive for food insecurity. The program provides fresh produce boxes and nutrition education over a 16-week period, aiming to improve fruit and vegetable intake and related health outcomes. During the study, participants will complete dietary recalls and health assessments at the start and end of the 16 weeks. Researchers will measure fruit and vegetable intake, diet quality, food security, blood pressure, HbA1C, body mass index, and various nutrition-related behaviors. The study will also track healthcare usage and evaluate changes over the intervention period.

Researchers are evaluating QX1206 in an open-label phase 1b trial involving adults with Type 2 Diabetes Mellitus T2DM and Non-Alcoholic Fatty Liver Disease NAFLD. The study aims to determine the recommended dose for future studies and examine the preliminary effects of QX1206 on blood sugar control and other metabolic factors. Participants will take QX1206 orally before bedtime. The trial will last up to 12 weeks, during which laboratory tests and measurements will be taken before the first dose and throughout the study to monitor effects and safety. The study focuses on finding the best dose and assessing changes in blood sugar and insulin resistance. During the study, participants will undergo regular assessments including blood tests for hemoglobin A1c, fasting glucose, insulin levels, and insulin resistance. Researchers will track the recommended phase 2 dose from day 1 through week 12. Patients must comply with study procedures and attend all visits. The total participation period is up to 12 weeks.

This research aims to evaluate the safety and effectiveness of a pulsed electric field ablation system in adults aged 18 to 70 with type 2 diabetes mellitus who have suboptimal blood sugar control despite medication or lifestyle changes. The study focuses on patients with glycated hemoglobin levels between 7.5% and 10.5% who have been diagnosed with type 2 diabetes for at least six months. Participants will receive treatment with the pulsed electric field ablation system and be observed over a period of up to 12 months. The study measures changes in HbA1c levels at multiple points after treatment1 month, 3 months, 6 months, and 12 monthsas well as average fasting blood glucose, weight, and the need for additional hypoglycemic medication when HbA1c exceeds 8.5%. Safety is monitored through the recording of adverse events, device performance, and instrument evaluations during the procedure. During the study, participants will attend scheduled visits for assessments including blood tests to track HbA1c and fasting glucose, weight measurements, and monitoring of medication use. The main outcome is the change in HbA1c levels six months after treatment, with additional follow-up up to 12 months to observe ongoing effects and safety. Participants must comply with visit schedules, lifestyle restrictions, and avoid blood donation during the trial.

Researchers are evaluating the efficacy and safety of BGM0504 compared to semaglutide in people with type 2 diabetes who are already taking metformin andor sulfonylureas. This phase 3 trial is conducted in China and sponsored by BrightGene Bio-Medical Technology Co., Ltd. The goal is to see how well these treatments control blood sugar levels and manage the condition. Participants receive one of three treatments 5 mg or 10 mg of BGM0504, or 1 mg of semaglutide. All drugs are given as weekly injections under the skin. The trial includes a 32-week period to measure blood sugar changes, followed by further assessments up to 52 weeks to evaluate body weight, blood sugar control, and fasting glucose levels. During the study, participants will have regular visits for blood tests to measure hemoglobin A1c and fasting glucose, along with weight checks. Researchers will monitor safety and treatment effects throughout the study. The total participation time can last up to 52 weeks, with ongoing evaluations to understand how the treatments work over time.

Researchers are evaluating the effects of BGM0504 in Chinese patients with type 2 diabetes who have poor blood sugar control managed only by diet and exercise. This phase III clinical trial aims to assess the benefits and safety of BGM0504 injections over 32 weeks compared to a placebo, with extended monitoring for up to 52 weeks to evaluate longer-term effects. Participants receive weekly subcutaneous injections of either 5 mg or 10 mg of BGM0504, or a placebo, in a randomized and double-blind manner. The study includes a main treatment period of 32 weeks, during which the primary outcome of blood sugar control measured by hemoglobin A1c is evaluated, followed by continued treatment and assessment up to 52 weeks for additional safety and efficacy measures. During the trial, participants will undergo regular assessments including blood tests to measure hemoglobin A1c, fasting glucose, and body weight. These evaluations occur at specified intervals to monitor changes from baseline. Safety and treatment adherence will also be closely followed throughout the study period, which lasts up to 52 weeks for each participant.

This research aims to evaluate the effect of a single dose of ALN-4324 on whole-body insulin sensitivity in adults with Type 2 Diabetes Mellitus T2DM. The study is a randomized, double-blind, placebo-controlled Phase 2 trial focusing on patients aged 18 to 65 years with T2DM, investigating how ALN-4324 may influence insulin function compared to placebo. Participants will receive a single subcutaneous dose of either ALN-4324 or a placebo. The study uses a parallel assignment model with triple masking to compare the effects of the investigational drug and placebo. The primary treatment period extends up to 3 months, with additional monitoring extending up to 9 months to assess safety and secondary outcomes. During the study, participants will undergo assessments including measurements of insulin sensitivity M-value, glucose production, and hemoglobin A1c levels at baseline and throughout follow-up visits up to 6 or 9 months. Researchers will track adverse events and changes in metabolic markers to understand treatment effects. The total participation period spans several months, with regular visits to monitor health and study progress.

Researchers are studying enicepatide, a dual GLP-1GIP receptor agonist, to evaluate its safety and effectiveness for chronic weight management. This study focuses on adults with obesity or overweight who either have or do not have type 2 diabetes mellitus T2DM. The goal is to understand how enicepatide can support weight loss alongside diet and physical activity. Participants will be randomly assigned to receive one of three doses of enicepatide or a matching placebo. The medication is given as a weekly subcutaneous injection. All participants will follow a reduced-calorie diet and increased physical activity during the study. Treatment will continue for 52 weeks, with assessments throughout the period. During the study, participants will undergo various evaluations including body weight, waist circumference, blood glucose, insulin levels, cholesterol, blood pressure, and quality of life questionnaires. Researchers will monitor changes from baseline to week 52 and track safety through adverse event reporting. The total participation duration extends to approximately one year with regular visits for treatment and assessments.

Researchers are investigating how biological aging relates to the risk of developing type 2 diabetes mellitus T2DM, especially in people with and without metabolic dysfunction-associated steatotic liver disease MASLD. They are measuring biological age using methods like phenotypic age, Klemera-Doubal method, and homeostatic dysregulation to see how aging affects diabetes risk. This observational study evaluates these associations using various statistical models to better understand the link between aging and T2DM incidence over time. Participants are grouped based on whether they have MASLD at the start of the study or not. The study collects data from annual health check-ups, including abdominal ultrasound and metabolic indicators like body mass index, blood pressure, cholesterol levels, and blood sugar measurements. No experimental treatments are given, as this is an observational study monitoring participants over an average of three years. During the study, researchers will track the onset of type 2 diabetes by reviewing health records and metabolic data collected yearly. They will assess the incidence of T2DM and analyze how biological aging measures correspond with disease development. The primary outcome is the incidence of new T2DM cases through the study completion. Participants will be observed for about three years, with no interventions applied, allowing researchers to monitor natural disease progression and aging effects.

This research aims to evaluate the effectiveness of screening for diabetes distress DD and providing interventions for adults with type 2 diabetes mellitus T2DM. Diabetes distress is the emotional stress related to managing diabetes, which affects medication adherence, lifestyle habits, and overall quality of life. The study focuses on populations disproportionately affected by T2DM and DD, including African-Americans and Hispanics, and seeks to improve emotional health screening and support within real-world primary care settings. Participants care centers will be randomly assigned to either receive an in-depth training on the ARISE screening and intervention program or a brief training on the 7As model for diabetes distress screening. The ARISE program trains community health center staff to screen patients using validated tools to identify diabetes distress levels and their sources, then provide tailored support and referrals. The other group receives an enhanced usual care training. This pragmatic study uses a cluster randomized design to compare these approaches. During the study, participants will be regularly assessed over 12 months for outcomes including A1C levels, diabetes distress scores, cholesterol levels, blood pressure, body mass index, depression and anxiety screening results, and healthcare referrals. The study tracks these measures to understand the impact of the screening and intervention programs on diabetes management and emotional health. The total participation spans the intervention and follow-up periods to monitor changes in health and distress.

Researchers are investigating ischemic stroke cases in patients who are on oral anticoagulants due to atrial fibrillation or other cardioembolic arrhythmias. This observational study, called ASPERA, aims to understand the characteristics of these stroke cases and to evaluate the short- and long-term outcomes of different strategies used to prevent recurrent strokes. The study includes both retrospective and prospective data collection from multiple centers worldwide, coordinated by the University of LAquila. The study has two parts ASPERA-R and ASPERA-P. ASPERA-R collects retrospective data over five years, focusing on baseline demographic, clinical, and neuroimaging features of ischemic strokes in patients on oral anticoagulants. ASPERA-P enrolls patients prospectively for two years with follow-up for five years to assess risks of stroke recurrence and safety events under different secondary prevention approaches, such as continuing or changing oral anticoagulation. Participants will have their data collected at several time points, including hospital admission, discharge, and follow-ups at 90 days, 1 year, and 5 years after stroke. Assessments include clinical evaluations, neuroimaging exams, and monitoring for stroke recurrence, bleeding events, heart attacks, and mortality. The study tracks outcomes to better understand risks and to identify features linked to stroke recurrence and safety events, with total participation lasting up to seven years for prospective patients.