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Diabetes clinical trials at UCSD
18 in progress, 8 open to new patients

  • A Safety and Efficacy Study of Relamorelin in Diabetic Gastroparesis

    open to eligible people ages 18 years and up

    This study will evaluate the safety and efficacy of Relamorelin compared to placebo in patients with diabetic gastroparesis. Patients will report daily severity scores of their diabetic gastroparesis symptoms.

    La Jolla, California and other locations

  • A Safety, Tolerability, and Efficacy Study of VC-02™ Combination Product in Subjects With Type 1 Diabetes Mellitus and Hypoglycemia Unawareness

    open to eligible people ages 18-65

    The purpose of this trial is to test if VC-02™ combination product can be implanted subcutaneously in subjects with Type 1 Diabetes and Hypoglycemia Unawareness and maintained safely for up to two years. It will also test if VC-02 is an effective treatment for these subjects.

    San Diego, California and other locations

  • Dulce Digital-Me: An Adaptive mHealth Intervention for Underserved Hispanics With Diabetes

    open to eligible people ages 18 years and up

    This study will compare Dulce Digital (i.e., the investigators' proven-effective combination of "one-size-fits-all" educational text messages and nurse monitoring of patient-transmitted blood glucose values) and Dulce Digital-Me (DD-Me), an adaptive/dynamic mHealth (mobile health) intervention that is tailored to individuals' needs and behavioral progress, in improving diabetes clinical control, adherence, and patient-provider communication in Hispanics - an at-risk, understudied population that experiences disparities in diabetes prevalence and outcomes. These striking disparities in the growing and aging US Hispanic population have taxed the US healthcare system, while significantly reducing quantity and quality of life for millions of individuals. By offering an innovative, scalable, and sustainable approach that seamlessly integrates several mHealth technologies into existing primary care team processes to improve the health of Hispanics (and eventually, other at-risk, underserved groups), DD-Me has strong potential to significantly impact public health.

    La Jolla, California and other locations

  • Fit for Two: Incorporating Wearable Trackers Into Clinical Care for Pregnant Women With Diabetes (FFT)

    open to eligible females ages 18 years and up

    This study will investigate the feasibility of an intervention to increase physical activity in pregnant women with diabetes by incorporating a brief in-person counseling session and Fitbit activity trackers into routine clinical care

    La Jolla, California

  • Measuring Sweat Glucose of Patients With Diabetes

    open to eligible people ages 18-60

    This pilot clinical trial will explore the accuracy and acceptability of a non-invasive, wearable glucose sensor in patients living with DM. This study will compare needleless glucose sensor readings from sweat with glucometer measurements from patients with any type of diabetes at fasting, and after a meal.

    San Diego, California and other locations

  • Multiple Dose Study to Evaluate the Efficacy, Safety and Pharmacodynamics of REMD-477 in Subjects With Type 1 Diabetes Mellitus

    open to eligible people ages 18-65

    This is a randomized, placebo-controlled, double-blind study to evaluate the efficacy, safety, and pharmacodynamics (PD) of multiple doses of REMD-477 in subjects who have Type 1 diabetes and are currently receiving insulin treatment. This study will determine whether REMD-477 can decrease daily insulin requirements and improve glycemic control after 12 weeks of treatment in subjects diagnosed with Type 1 diabetes with fasting C-peptide < 0.2 ng/mL at Screening. The study will be conducted at multiple sites in the United States. Approximately 75 subjects with type 1 diabetes on stable doses of insulin will be randomized in a 1:1:1 fashion into one of three treatment groups.

    San Diego, California and other locations

  • Primary Care-Based Physical Activity for Diabetic Latinas

    open to eligible people ages 18-70

    The goal of this proposal is to test the efficacy of a primary care-delivered, print-based physical activity intervention for Latinas with type II diabetes. The investigators will test the efficacy of this intervention by randomizing 80 Latinas with type II diabetes recruited through UCSD Health System primary care to either the adapted web-based physical activity intervention or standard of care, and assessing physical activity gains at six and 12 months. The ultimate goal is to develop a print-based physical activity intervention for diabetic Latinas that could be widely disseminated through primary care.

    La Jolla, California

  • The Effects of Type 1 Diabetes Mellitus and Increased Weight on Gut Microbiome and Urine Metabolome Profiles in Children

    open to eligible people ages 7-17

    This study employs a cross-sectional design to profile the gut microbiome and urine metabolome in overweight/obese children with type 1 diabetes (T1D).

    San Diego, California

  • A Safety and Efficacy Study of Relamorelin in Diabetic Gastroparesis Study 04

    Sorry, not currently recruiting here

    A 52-week study to compare the efficacy of relamorelin with that of placebo in participants with diabetic gastroparesis (DG) with respect to the core signs and symptoms of diabetic gastroparesis.

    La Jolla, California and other locations

  • Glucagon Infusion in T1D Patients With Recurrent Severe Hypoglycemia: Effects on Counter-Regulatory Responses

    Sorry, not currently recruiting here

    This is a prospective, randomized, controlled, double-blind, parallel 4-group trial with the primary analysis after 4 weeks of treatment with continuous subcutaneous glucagon infusion (CSGI) or placebo. After a 1-week qualification on continuous glucose monitoring (CGM), subjects will have their baseline hypoglycemia counter-regulatory response hormones quantified using a step-wise hypoglycemia induction procedure. Subjects meeting eligibility requirements will be randomized to 1 of 4 treatment groups, 2 glucagon, 2 placebo. Subjects will receive blinded study drug for 4 weeks, and they will be followed for an additional 26 weeks post-treatment. Subjects' counter-regulatory hormone response will be measured at baseline, the end of treatment (4 weeks), and 13 and 26 weeks after treatment ends.

    San Diego, California and other locations

  • Medical Optimization of Management of Type 2 Diabetes Complicating Pregnancy (MOMPOD)

    Sorry, not currently recruiting here

    Purpose: The objective of this proposal is to study the safety and efficacy of metformin added to insulin for treatment of type 2 diabetes mellitus (T2DM) among pregnant women. Participants: 1200 pregnant women with type 2 diabetes complicating pregnancy from 10 U.S. clinical centers Procedures (methods): Pregnant women with T2DM between 10 weeks and 20 weeks 6 days and a singleton fetus will be randomized to insulin/placebo versus insulin/metformin. Primary outcome is composite adverse neonatal outcome (clinically relevant hypoglycemia, birth trauma, hyperbilirubinemia, stillbirth/neonatal death). Study visits monthly at clinical visits; blood draw at 24-30 weeks. Maternal and infant outcomes will be chart abstracted.

    San Diego, California and other locations

  • Studying the Effectiveness of Non-Invasive Glucose Sensors in Patients With Diabetes: The SENSOR Study

    Sorry, currently not accepting new patients, but might later

    The overall goal for this pilot clinical trial is to explore the accuracy and acceptability of a non-invasive, wearable glucose sensor in patients living with DM. This study will compare needleless glucose sensor readings with glucometer measurements from patients with type 1 or type 2 diabetes (T1DM or T2DM), under varying conditions.

    San Diego, California

  • A Safety and Efficacy Study of Relamorelin in Diabetic Gastroparesis Study 03

    Sorry, accepting new patients by invitation only

    A 46-week study to compare the efficacy of relamorelin with that of placebo in participants with diabetic gastroparesis (DG). At the end of the 40-week Treatment Period, participants will either continue on relamorelin or placebo for 6 additional weeks.

    La Jolla, California and other locations

  • A Safety, Tolerability, and Efficacy Study of VC-01™ Combination Product in Subjects With Type I Diabetes Mellitus

    Sorry, in progress, not accepting new patients

    The purpose of this trial is to test if VC-01™ combination product can be implanted subcutaneously in subjects with Type 1 Diabetes and maintained safely for two years. It will also test if VC-01 is an effective treatment for subjects with Type 1 Diabetes.

    San Diego, California and other locations

  • A Study to Evaluate the Effect of Long-term Treatment With BELVIQ (Lorcaserin HCl) on the Incidence of Major Adverse Cardiovascular Events and Conversion to Type 2 Diabetes Mellitus in Obese and Overweight Subjects With Cardiovascular Disease or Multiple Cardiovascular Risk Factors

    Sorry, in progress, not accepting new patients

    This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study in overweight and obese subjects with CV disease and/or multiple CV risk factors.

    San Diego, California and other locations

  • Epidemiology of Diabetes Interventions and Complications (EDIC)

    Sorry, in progress, not accepting new patients

    OBJECTIVE— The Diabetes Control and Complications Trial (DCCT) demonstrated the powerful impact of glycemic control on the early manifestations of microvascular complications. Contemporary prospective data on the evolution of macrovascular and late micro vascular complications of type 1 diabetes are limited. The Epidemiology of Diabetes Interventions and Complications (EDIC) study is a multicenter, longitudinal, observational study designed to use the well-characterized DCCT cohort of 1,400 patients to determine the long-term effects of prior separation of glycemic levels on micro- and macrovascular outcomes. EDIC is in its 13th year of followup. The study is expecting to last until 2016. RESEARCH DESIGN AND METHODS— Using a standardized annual history and physical examination, 28 EDIC clinical centers that were DCCT clinics will follow the EDIC cohort for 10 years. Annual evaluation also includes resting electro c a rdiogram, Doppler ultrasound measurements of ankle/arm blood pressure, and screening for nephropathy. At regular intervals, a timed 4-h urine is collected, lipid pro files are obtained, and stereoscopic fundus photographs are taken. In addition, dual B-mode Doppler ultrasound scans of the common and internal carotid arteries will be perf o rmed at years 1 and 6 and at study end.

    San Diego, California and other locations

  • Metabolomic Profiling in Adolescents With Obesity and Diabetes

    Sorry, in progress, not accepting new patients

    The purpose of this study is to identify unique metabolite signatures associated with the development of Type 2 diabetes and diabetic kidney disease in children. We have a sub-study, with the purpose to validate the presence of a genetic marker (DENND1A) in the urine of adolescent females with polycystic ovarian syndrome.

    San Diego, California

  • Unidas Por la Vida: A Healthy Lifestyle Intervention for High-risk Latina Dyads

    Sorry, accepting new patients by invitation only

    Mexican American women have significantly elevated rates of obesity and type 2 diabetes. The proposed study tests a novel intervention that capitalizes on an existing important family dyad (mothers and their adult daughters) to foster clinically significant and long-lasting health behavior change. If found to effective, this intervention strategy has great potential to address health disparities in this, and other, at-risk populations.