Diabetes Clinical Trials

A pragmatic electronic health record (EHR) based randomized controlled trial to evaluate the utility of providing Ultromics EchoGo analysis results and recommendations for HF risk prevention therapies using an EHR embedded clinical decision support tool. Read Less

The objective of this study is to pilot a multifaceted, optimized intervention for metabolic syndrome (MetS) in emergency department patients to establish feasibility. Participants (n=20) will be randomized to intervention or control (usual care). The composite intervention will include an educational video outlining the adverse effects of MetS and the benefit of walking, a written exercise prescription with a defined goal of walking 150 minutes per week, a Fitbit accelerometer device, resources for healthy eating practices, periodic text message reminders, and an urgent referral to primary care and our health system's Healthy Me clinic for follow-up visit. Investigators hypothesize that this approach will change patient understanding and motivation to increase physical activity and healthy eating habits. Read Less

Metabolic dysfunction-associated steatotic liver disease (MASLD) is the most common chronic liver disease globally. While weight loss through lifestyle modification is the standard treatment, most patients regain weight limiting ultimate improvement in liver disease. On the other end of the spectrum, bariatric surgery has shown promise in the treatment of MASLD/metabolic dysfunction-associated steatohepatitis (MASH) due to its efficacy in inducing weight loss. Nevertheless, its adoption has been hindered by the perceived invasiveness of surgery. Over the past decade, endoscopic sleeve gastroplasty (ESG) has gained recognition as a promising minimally-invasive approach to weight loss. The procedure involves utilizing a Food and Drug Administration (FDA)-authorized endoscopic suturing device to reduce the gastric volume by 70%. Studies reveal that ESG is associated with approximately 18.2% weight loss at one year after the procedure, with sustained results for at least 10 years. Nevertheless, the effect of ESG on MASH remains unknown. In this study, the investigators will compare ESG + lifestyle modification versus lifestyle modification alone in treating histologic MASH. The study will randomize patients to one of two different treatment options: ESG + lifestyle modification or lifestyle modification alone. Read Less

The aim of this study is to determine if suvorexant can help treat the severity of insomnia in midlife women who are pre-diabetic. Read Less

Hypoglycemic complications are a major impediment to the maintenance of healthy glucose levels in persons with diabetes. The investigators recently completed a clinical pilot and feasibility study (GLIMPSE, NCT02690168), which identified a novel biomarker, glial acetate metabolism, that appears to predict the susceptibility to hypoglycemia. By providing an assay to predict hypoglycemic events and therefore diabetic complications, the development of this biomarker could significantly improve the treatment of persons with diabetes. The goal of this study is to determine the efficacy of our biomarker for predicting susceptibility to insulin-induced hypoglycemia. In order to accomplish this goal the investigatiors will pair our 13C magnetic resonance spectroscopy procedure to assess glial acetate metabolism, developed in the GLIMPSE study, with a hyperinsulinemic-hypoglycemic clamp procedure, developed in the HYPOCLAMP study (NCT03839511). The two procedures will be separated by a three day interval. The investigators will then correlate the participants' rates of glial acetate metabolism with their neuroendocrine responses to the hypoglycemic clamp. This proof of concept study will test the hypothesis that glial acetate metabolism is inversely proportional to the neuroendocrine response to hypoglycemia, that is, as glial acetate metabolism increases the neuroendocrine response will decrease. Read Less

The pilot study of Project BADGE will focus on emergency department (ED) patients with diabetes, which has significant disparities in prevalence and mortality for underserved populations. The objective is to determine the effect of a text-based resource referral platform with diabetes educational materials on patient diabetes knowledge, diabetes distress, diabetes self-care activities, and acceptability and feasibility of the intervention. Read Less

The goal of the study to understand the effects of weight loss and improvements in diabetes following bariatric surgery on brain function and thinking. This study will also examine whether non-invasive transcutaneous vagal nerve stimulation (tVNS) intervention initiated 30 days post-surgery improves brain function and thinking. The study does NOT cover any costs associated with bariatric surgery. Read Less

This study investigates the feasibility, acceptability, and preliminary efficacy of enCompass Humana, a social support intervention for caregivers of patients with cancer and diabetes. The enCompass program aims to improve support for these caregivers through a randomized feasibility study of a pilot-tested coaching and navigation program. Caregiver services and system-level support are essential, but successful interventions for cancer caregivers are rarely standardized or systematically disseminated. Consequently, many programs do not reach the most underserved caregivers. Challenges to implementation include substantial clinical staff involvement, lack of dissemination and implementation information, and failure to tailor interventions to rural contexts. Despite the lack of standardized supportive interventions, national reports and legislative efforts increasingly recognize the need to support caregivers. Caregivers reported unmet needs in all domains of social support, including instrumental help (e.g., in-home help, housekeeping), logistical and coordination support (e.g., food delivery, accompanying patients to appointments), information about illness and progression, emotional support, self-care guidance, and financial assistance (e.g., parking costs, lost wages). Caregivers show high interest in services but cited uncertainty and lack of strategies for accessing resources. Many are unaware of existing services. Interviews with oncology clinicians and healthcare administrators revealed similar findings: resources exist, but there is no system to match them with caregivers' needs. Preliminary data suggest the intervention improves caregiver coping self-efficacy and reduces anxiety and depression in patients. With input from stakeholders, including caregivers, patients, family caregiving experts, and clinical care experts, the study team adapted the CARING application into enCompass to mitigate structural barriers and normalize support-seeking. The long-term goal is to adapt this psychosocial support program to increase self-efficacy, support-seeking, and reduce loneliness among caregivers. It is hypothesized that enCompass will build self-efficacy and coping skills, serving caregivers throughout the patient's illness and complications. Read Less

The objective of this study is to conduct a multisite trial evaluating the impact of adding an audio recording of clinic visits (AUDIO) to usual care in older adults with multimorbidity, including diabetes, compared to After Visit Summary (AVS) alone (Usual Care; UC). Read Less

This is a prospective, multi-center, two-arm, randomized trial to quantify the performance of the EchoMark®/EchoSure® System for AVF diagnostic ultrasound when used under a protocol of biweekly use for assessing fistula maturation and reducing time to Clinical Maturation. Read Less

The investigators would like to see if the combination of TENS and controlled heat in a boot increases blood flow to the foot more than baseline or heat alone in people with and without diabetes. This may help people with diabetes and a diabetic wound that will not heal. Read Less

The intervention in this trial is intraocular islet transplantation. A single dose of 1000 - 3000 Islet Equivalents (IEQ)/kg recipient body weight (BW) will be infused into the anterior chamber of the eye through a self-sealing incision in the peripheral cornea. The procedure is projected to take approximately 20-30 minutes. Subject will remain flat on their back for 1 - 3 hours after islet infusion to maximize adhesion of the islets to the iris. Read Less