Developing and Testing a Self-Compassion Tool Kit to Improve the Care of Individuals With Type 2 Diabetes
NCT06398093 · Type 2 Diabetes, Diabetes Distress
RecruitingThere is a high prevalence of anxiety and depression in patients with Type 2 Diabetes (T2D). While past studies demonstrate the potential therapeutic effect of mindfulness-based interventions in patients with T2D, little is understood about the mode of delivery or quantity of the intervention necessary to experience benefits. This project aims to develop and implement a self-compassion tool kit based on the principles of mindfulness and meditation to better understand how self-compassion works to affect psychological health and wellbeing in patients with T2D. The investigators will study the impact of a self-compassion tool kit - including mindfulness meditation, exercise, journaling and sleep parameters - on T2D. Enhancing emotional well-being could complement current T2D treatments to facilitate improved quality of life.
PhaseNA
TypeInterventional
Age18 Years
WhereSan Diego, California, United States
SponsorUniversity of California, San Diego
▾Tap for detailsClick for full details — eligibility, all locations, contacts Efficacy of mHealth Apps for Health in a Low-income, Type II Diabetic, Hispanic Population
NCT05279729 · Diabetes Mellitus, Type 2, Obesity
RecruitingThe purpose of this study is to determine the effectiveness of mobile health applications in improving health outcomes and the subsequent benefit of improving type II diabetes outcomes in a low socioeconomic Hispanic population. This study will involve a 6-month long commitment where participants will be expected to weigh themselves every morning, at the same time, and check their blood glucose readings daily before and after meals for at least three meals in the day.
PhaseNA
TypeInterventional
Age18 Years – 64 Years
WhereSan Diego, California, United States
SponsorSan Diego State University
▾Tap for detailsClick for full details — eligibility, all locations, contacts Implementing Food Referrals for Equity and Sustained Health
NCT06661538 · Food Insecurity
RecruitingFood insecurity (FI) disproportionately affects those who have been historically marginalized and significantly contributes to poor health outcomes. In children, FI is associated with lower psychosocial functioning and academic achievement. It also contributes to the development of adverse health outcomes such as obesity, type 2 diabetes mellitus (T2DM), cardiovascular disease (CVD), and Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD). Improving the diet quality of children (e.g., decreasing fat intake, increasing fruits and vegetables (FV) and fiber intake) has been associated with lower fasting serum glucose, insulin, LDL cholesterol, non-HDL cholesterol, and reduced risk of CVD later in life. Increasing awareness and access to programs that promote food equity by providing affordable healthy produce is a promising way to improve health outcomes and empower patients and communities to achieve better health and well-being. The goal of this proposal is to refine and optimize implementation strategies that connect families to community-based food security nutrition support programs through health care systems or medical clinics. The investigators will develop a multi-disciplinary, cross-sector collaboration to optimize current processes and workflows that integrate food security nutrition support programs into the healthcare system. The investigators will also work to develop a closed-loop communication system between the healthcare and healthy food access systems to support greater patient autonomy and self-efficacy to obtain, prepare, and consume healthy foods.
PhasePhase 2
TypeInterventional
Age5 Years
WhereLa Jolla, California, United States + 1 more
SponsorUniversity of California, San Diego
▾Tap for detailsClick for full details — eligibility, all locations, contacts EASi-PROTKT™ - A Study to Test Vicadrostat (BI 690517) Taken Together With Empagliflozin in People With Type 2 Diabetes, High Blood Pressure, and Cardiovascular Disease
NCT07064473 · Diabetes Mellitus, Type 2, Hypertension, Cardiovascular Diseases
RecruitingThis study is open to adults with type 2 diabetes, high blood pressure, and cardiovascular disease. People can join the study if they have these conditions and do not have a history of heart failure. The purpose of this study is to find out if a medicine called vicadrostat, when taken with empagliflozin, helps reduce cardiovascular risk in people with these conditions. The study will compare this combination to a placebo version of vicadrostat with empagliflozin. Participants are put into 2 groups randomly, which means by chance. One group takes vicadrostat and empagliflozin tablets, and the other group takes placebo tablets with empagliflozin. Placebo tablets look like vicadrostat tablets but do not contain any medicine. Participants take a tablet once per day for 2 and a half years and up to 4 years and 3 months. All participants also continue their medication for type 2 diabetes, high blood pressure, and cardiovascular disease. Participants have an equal chance of receiving the study medicine or placebo. Participants are in the study for up to 4 years and 3 months. During this time, they visit the study site regularly. During these visits, doctors collect information about participants' health and take blood samples. The doctors document when participants experience cardiovascular events. The doctors also regularly check participants' health and take note of any unwanted effects.
PhasePhase 3
TypeInterventional
Age18 Years
WhereAnniston, Alabama, United States + 1150 more
SponsorBoehringer Ingelheim
▾Tap for detailsClick for full details — eligibility, all locations, contacts More Fresh Fruit and Vegetable Prescription Program for Families With Type 2 Diabetes Mellitus
NCT05138432 · Type 2 Diabetes
RecruitingRady Children's Hospital San Diego (RCHSD), UCSD Division of Child and Community Health and the Center for Community Health, and Northgate Gonzalez (NG) Markets will collaborate to create a Produce Prescription Program (Fruit and Vegetable Prescription Program) to be implemented in the RCHSD Diabetes Clinic. We will provide families on Medi-Cal who have a child with T2DM with a fruit and vegetable prescription (FVRx) which will enhance their ability to purchase GusNIP-eligible fresh fruits and vegetables (FV). These prescriptions will be delivered in the form of an electronic voucher that can be filled at any NG Markets throughout San Diego and Riverside counties. The goal of this program is to increase the purchase and consumption of fresh fruits and vegetables, decrease food insecurity, and improve metabolic outcomes for children with type 2 diabetes mellitus (T2DM).
PhaseNA
TypeInterventional
Age18 Years
WhereSan Diego, California, United States
SponsorUniversity of California, San Diego
▾Tap for detailsClick for full details — eligibility, all locations, contacts Efficacy of Using Mobile Health Applications for Health
NCT05589155 · Diabetes Mellitus, Type 2, Obesity
RecruitingThe purpose of this study is to determine the effectiveness of mobile health applications in improving health outcomes and type II diabetes outcomes in type 2 diabetics. This study will involve a 6-month long commitment where participants will be expected to weigh themselves every morning, at the same time, and check their blood glucose readings daily before and after meals for at least three meals in the day.
PhaseNA
TypeInterventional
Age18 Years – 64 Years
WhereSan Diego, California, United States
SponsorSan Diego State University
▾Tap for detailsClick for full details — eligibility, all locations, contacts THC Effects on Glucose in Type 2 Diabetes
NCT05322213 · Type 2 Diabetes
RecruitingThis study will examine the effects THC has on Glucose Metabolism and Endothelial Functioning in participants with Type 2 Diabetes. The participants will complete blood tests and tests to measure energy expenditure, CVD risks, and glucose metabolism. These tests will be performed prior to start of treatment and again after 2-weeks of treatment with the THC or placebo.
PhasePhase 1
TypeInterventional
Age21 Years – 70 Years
WhereLa Jolla, California, United States
SponsorUniversity of California, San Diego
▾Tap for detailsClick for full details — eligibility, all locations, contacts GATEWAY: Safety Evaluation of the MiniMed™ NMX8-AID System in Children and Adults Living With Diabetes
NCT07228117 · Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus
RecruitingThe purpose of this study is to check that a new insulin pump, called NMX8, is safe when used with a continuous glucose monitoring sensor called Disposable Sensor 5 in people with diabetes. The study will include people with Type 1 diabetes who are 7-85 years old and people with Type 2 diabetes who are 18-85 years old. Patients will use their current therapy while also wearing the DS5 for up to 40 days. During this time, they will complete a meal and exercise log. Patients will then be put into one of three groups by a computer by chance and given the NMX8 pump to use for 90 days. During this time, patients will either bolus or not bolus for meals and continue to complete a meal and exercise log depending on the group they are in. Once their part in the study is over, if patients like the pump and want to keep using it, they may be able to join a Continued Access Period to keep using the NMX8 pump.
PhaseNA
TypeInterventional
Age7 Years – 85 Years
WhereLittle Rock, Arkansas, United States + 32 more
SponsorMedtronic MiniMed, Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Randomized Comparison of Stage-Based Care Versus Risk Factor-Based Care for Prevention of Cardiovascular Events
NCT06112418 · Diabetes Mellitus, Type 2, PreDiabetes, Metabolic Syndrome
RecruitingTRANSFORM is a prospective, randomized, open blinded endpoint (PROBE), event-driven, pragmatic trial in patients who are at increased risk for atherosclerotic cardiovascular (CV) disease but with no known symptomatic CV disease. The trial tests the hypothesis that a Cleerly Coronary Artery Disease (CAD) Staging System-based care strategy reduces CV events compared with risk factor-based care.
PhaseNA
TypeInterventional
Age55 Years
WhereChandler, Arizona, United States + 122 more
SponsorCleerly, Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts CGM for Management of Type 2 Diabetes in Pregnancy
NCT06628453 · Type 2 Diabetes Mellitus (T2DM), Pregnancy
RecruitingThe goal of this clinical trial is to learn if continuous glucose monitoring works better than self-monitoring of blood glucose (fingersticks) to treat type 2 diabetes in pregnancy. It will also learn about all risk factors (biologic, personal, social) for maternal and infant complications in type 2 diabetes pregnancies. The main questions it aims to answer are: 1. Does continuous glucose monitoring improve infant outcomes compared to self-monitoring of blood glucose? 2. Does continuous glucose monitoring improve maternal diabetes control and other maternal outcomes compared to self-monitoring of blood glucose? 3. What other factors increase the risk of maternal and infant complications? Participants will: 1. Use continuous glucose monitoring or self-monitoring of blood glucose to monitor blood sugar control from enrollment until delivery 2. Have blood drawn at enrollment, 24 weeks, 34 weeks and delivery to measure hemoglobin A1c levels and store blood for future analysis 3. Complete surveys about social support, environmental stressors, diabetes distress and glucose monitoring satisfaction at research visits 4. Have umbilical cord blood collected at delivery for analysis
PhaseNA
TypeInterventional
Age18 Years – 50 Years
WhereBirmingham, Alabama, United States + 6 more
SponsorUniversity of Alabama at Birmingham
▾Tap for detailsClick for full details — eligibility, all locations, contacts