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.

Researchers are studying a communication intervention designed to reduce financial toxicity for patients with cancer. This intervention aims to support cancer care providers in discussing treatment costs more effectively alongside the existing DISCO app for patients. The study involves oncology care providers from Wayne State University and Karmanos Cancer Institute who treat patients at specific clinics. The study will include 20 oncology providers such as medical oncologists, nurses, social workers, and advanced practice providers. Participants will complete a baseline survey and attend two individual meetings. The first meeting focuses on developing the DISCO Provider intervention by gathering feedback on content, organization, and implementation. The second meeting pilots the intervention to assess acceptability, usability, and usefulness for training providers in cost discussions. Participants will provide feedback through audio-recorded interviews, which will be transcribed and analyzed. Researchers will measure the intervention's acceptability, usability, and usefulness immediately after the pilot test. The study monitors how providers respond to training for discussing treatment costs and gathers suggestions for improvement. Total participation includes surveys and two meetings with investigators.

Researchers are evaluating the efficacy and safety of BGM0504 compared to semaglutide in people with type 2 diabetes who are already taking metformin and/or 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.

Researchers are studying the safety, tolerability, and effects of ALN-4324 in overweight to obese adults. The study has two parts: one in healthy volunteers and another in adults with type 2 diabetes mellitus (T2DM). It aims to understand how the drug behaves in the body and its impact on blood sugar control and other health measures. Participants in the first part receive a single dose of ALN-4324 or a placebo, given as an injection under the skin. In the second part, adults with T2DM receive multiple doses of ALN-4324 or placebo, also by injection. The study uses a randomized, double-blind design, meaning participants are randomly assigned to groups and neither they nor the researchers know who receives the drug or placebo during the trial. During the study, participants will be monitored for side effects and how their bodies process the drug. Blood tests will measure drug levels and effects on blood sugar control, including hemoglobin A1c and glucose tolerance. The study lasts up to 12 months, with assessments at various times depending on the part. Safety and how well participants tolerate the drug are the main outcomes being measured.

Researchers are studying the effects of a single dose of ALN-4324 on whole-body insulin sensitivity in adults with Type 2 Diabetes Mellitus (T2DM). This phase 2, randomized, double-blind, placebo-controlled trial aims to assess how well ALN-4324 works compared to a placebo in improving insulin sensitivity, which is important for managing blood sugar in T2DM patients. Participants will receive either one subcutaneous injection of ALN-4324 or a matching placebo. The study is designed with two groups, and each participant only receives a single dose. The trial includes a follow-up period lasting up to 9 months to monitor effects and safety. During the study, participants will be evaluated through various assessments including changes in insulin sensitivity measured by the M-value and M/I ratio, endogenous glucose production, and Hemoglobin A1c levels. Researchers will also track the frequency of adverse events for safety. These measurements will be taken from baseline and followed for up to 6 months, with some safety monitoring extending to 9 months after dosing.

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 focuses on adults with type 2 diabetes mellitus (T2DM) to evaluate how screening for diabetes distress and related interventions affect patients. Diabetes distress, which is the stress and worry related to managing diabetes, is common and linked to poorer self-care and health outcomes. The study aims to improve diabetes care for diverse populations, especially in community health centers that care for many racial and ethnic minorities. Participants will be involved in one of two study groups. One group will receive detailed training on the ARISE program, a structured approach to screen for diabetes distress and address it using personalized strategies and referrals. The other group will receive a brief training on a general diabetes distress screening model. The study compares these approaches through a cluster randomized controlled trial involving community health centers. Throughout the 12 months of the study, researchers will monitor blood sugar control (A1C levels), diabetes distress scores, cholesterol, blood pressure, body mass index, depression and anxiety screenings, and the number of referrals made. The study includes regular assessments and tracks changes over time to understand the impact of these screening and intervention strategies on patient health and emotional well-being.

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 L'Aquila. 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.