Clinical Research Directory

Screening For Social Determinants Of Health In Routine Diabetes Care

Social determinants of health (SDOH) exert a powerful influence on the everyday management of type 1 diabetes (T1D) and short and long term outcomes of T1D. Experts agree that identifying and addressing negative social determinants of health (SDOH) may help accomplish numerous T1D care goals and promote health equity in treatment. However, fundamental research gaps in achieving these goals remain, including optimal screening and management processes for identification of negative social determinants of health (SDOH) , and how to develop robust partnerships with community-based organizations (CBOs) that address social determinants of health (SDOH) with high potential for sustainability and scalability. This project will generate new knowledge regarding how to implement a social work-led social determinants of health (SDOH) screening and referral program designed to aid families of youth with T1D who face several vulnerabilities, including food insecurity. The team will implement a single arm, pragmatic clinical trial with contemporaneous, non- randomized controls; whereby all families with a child enrolled in the California Children's Services (CCS) program (which provides specialized medical care for low-income families of youth with a qualifying chronic medical condition) will receive access to a novel social work-led social determinants of health (SDOH) screening and referral program. Outcomes will be compared against youth with T1D who are also seen in our Westwood Pediatric Endocrinology clinic but who are not enrolled in the CCS program and will not receive access to the social determinants of health (SDOH) intervention. The study team has established partnerships with several community-based organizations (CBOs) across Los Angeles County that provide social services, including food-related services, to receive referrals for CCS families who screen positive for having a social need. The study team will assess the feasibility and acceptability of this screening and referral protocol among families, CBOs, and providers (Aim 1) by measuring key implementation outcomes (comprehensive documentation of social determinants of health (SDOH) screening, result, and referral in the patients' medical record) and acceptability outcomes (self-reported satisfaction with the program by families and barriers and facilitators by CBOs and providers). The team will additionally estimate the effect of this intervention (Aim 2) by measuring changes (pre/post intervention) in families reported social needs, diabetes-related quality of life, and in the child's glycemic control (measured by HbA1c). Results from this work can provide a roadmap for sustainable and scalable social determinants of health (SDOH) interventions with potential to improve outcomes for youth with T1D in an equity-informed manner.

Repurposing Colchicine for Reduction of Residual Inflammatory Risk in Type 1 Diabetes

The aim of this clinical trial is to evaluate if colchicine in addition to standard of care improves markers of inflammation and cardiovascular disease in persons with type 1 diabetes. Participants will be assigned to either 0,5 mg colchicine daily or placebo in a 1:1 ratio for 26 weeks with the possibility of an additional 26 week extension of the intervention period. After the treatment period, there will a 5-year follow-up on all available outcome measures via electronic patient records for those who took part in the extension.

BEAD-T1D: Building the Evidence to Address Disengagement in Type 1 Diabetes

Youth with public insurance underutilize diabetes care, particularly diabetes technology which is associated with improvement in diabetes-specific outcomes. Thus, we urgently need studies to understand and increase diabetes technology utilization. This proposed research will (1) improve representation of youth in the literature, (2) address the gap in knowledge of barriers and promoters in youth, and (3) identify and address factors associated with diabetes technology uptake and utilization.

Diabetes Management Among Women Using an AID System: a Mixed Method Study

Automated insulin delivery (AID) systems substantially improve diabetes management in people with type 1 diabetes but do not account for menstrual cycle related changes in insulin sensitivity. As a result, many menstruating individuals rely on manual adjustments, such as entering fake carbohydrates, modifying insulin settings, or changing basal rates, to maintain glycemic control. This study aims to systematically characterize these manual adjustment strategies, estimate how frequently they are used across the menstrual cycle, and explore their perceived burden, effectiveness, and implications for the development of future AID algorithms that better address menstrual cycle related insulin variability.

SAFety and Efficacy of Human Anti-thymocyte ImmunoGlobUlin SAB-142 ARresting Progression of Type 1 Diabetes

This is a Phase 2b, investigator- and participant-blinded, placebo-controlled, parallel-arm study to evaluate the efficacy, safety and tolerability of SAB 142 in patients with Stage 3 New Onset of Type 1 Diabetes (NOT1D).

ENCRT-103-hPI: Evaluation of an Immune-protected ENCRT-103-hPI Containing Primary Human Islets in Adults With Type 1 Diabetes, With and Without Standard-of-care Portal Vein Islet Infusion.

This study will evaluate the safety and performance of ENCRT-103-hPI, which is a cargo of primary islets inside Encellin's ENC-103-CED. The 103 offers a soft pillow-like encasing to contain and protect the cells from the immune system. The product is implanted in the upper arm or abdomen and is approximately the size of a quarter. Eligibility is open to both patients on a standard of care islet infusion wait list, as well as those who are not. Participation in this trial does not preclude future Encellin trial participation. The study duration is 4.5months and requires keeping the implant for 4 months, as well as adhering to a standard of care schedule of follow ups during the implant period.

Effect of a Structured Educational Intervention Through Mobile App on Hemoglobin A1c (HbA1c), Self-Efficacy and Self- Care in Adolescent With Type 1 Diabetes (T1DM)

This study aims to evaluate the effectiveness of a mobile health (mHealth) educational intervention for adolescents with Type 1 Diabetes Mellitus (T1DM). Adolescents often face challenges in maintaining optimal blood glucose control and performing regular self-care. In this study, participants will receive structured diabetes education through a mobile application designed to improve their knowledge, self-efficacy (SE), and self-management skills. The impact of the intervention will be assessed by measuring changes in HbA1c levels, diabetes self-efficacy, and self-care (SC)behaviors over time. These findings may help determine whether mobile app-based education can support better diabetes management among adolescents.

Adaptive Biobehavioral Control (ABC) in a Closed-Loop System

This study is intended to test a Web-based Information Tool (WIT) software providing additional information regarding time in range, GMI, hypo- and hyperglycemia risks, variability tracker, daily glycemic profiles, and potential changes of insulin pump parameters, to users of a commercially available Closed-Loop Control (CLC) System (Control-IQ Technology).

Behavioural Problems and Cognition in Children With Hypoglycemia Unawareness in Type-1 Diabetes Mellitus

The study is designed to explore if a multi-pronged intervention strategy comprising of Psychological Interventions, Dietary Modifications, Targeted therapy and Counselling on Parental Attitude would bring about favorable changes in behavior and cognition in children with Hypoglycemia Unawareness.

Butyrate or Intensive Lifestyle Modification in Type 1 Diabetes and Metabolic Dysfunction-Associated Steatotic Liver Disease

Background: Metabolic dysfunction-associated steatotic liver disease (MASLD) is highly prevalent in individuals with type 1 diabetes (T1D) and is associated with increased cardiovascular and metabolic risk. However, evidence regarding effective therapeutic strategies for MASLD in T1D remains scarce. Lifestyle modification has shown benefits in obesity and type 2 diabetes, whereas butyrate, a microbiota-derived short-chain fatty acid, has emerged as a potential therapeutic approach because of its anti-inflammatory and metabolic effects. This study aims to evaluate the efficacy of intensive lifestyle modification, butyrate supplementation, or their combination on hepatic steatosis in individuals with T1D and MASLD. Methods: BEAM-T1D is a factorial, randomized, 6-month, parallel-group, placebo-controlled clinical trial conducted at the Regional University Hospital of Malaga. A total of 200 adults with T1D and MASLD will be randomized (1:1:1:1) to receive: (1) standard lifestyle recommendations plus placebo; (2) intensive lifestyle modification plus placebo; (3) standard lifestyle recommendations plus butyrate; or (4) intensive lifestyle modification plus butyrate. Intensive lifestyle modification includes a hypocaloric Mediterranean diet and promotion of physical activity. Participants randomized to butyrate will receive 2.25 g/day of microencapsulated sodium butyrate. The primary endpoint will be the change in controlled attenuation parameter (CAP) measured by transient elastography (FibroScan®). Secondary outcomes include changes in liver fat content, insulin resistance, metabolic control, body composition, inflammatory markers, gut microbiota composition, and short-chain fatty acid concentrations. Results: Participant recruitment is expected to begin in October 2025. The study will evaluate the independent and combined effects of butyrate supplementation and intensive lifestyle modification on hepatic steatosis and metabolic outcomes in individuals with T1D and MASLD. Conclusion: The BEAM-T1D study will provide novel evidence regarding the potential role of butyrate and intensive lifestyle modification in the management of MASLD in T1D. If effective, these interventions could represent feasible and scalable therapeutic strategies for a population with limited evidence-based treatment options.

MyDiaMate For Remission Of Diabetes Distress In Type 1 Diabetes (MyREMEDY)

In the MyREMEDY study the investigators research whether the MyDiaMate self-help application is effective in strengthening the mental health of adults with type 1 diabetes in comparison with care as usual. The MyREMEDY study takes place in four countries: The Netherlands, United Kingdom, Spain, and Germany.

CNP-103 in Adolescent and Adult Subjects Ages 12-35 With Recently Diagnosed (Within 6 Months) Stage 3 Type 1 Diabetes (T1D)

This study is a Phase 1b/2a First-in-Human (FIH) clinical trial to assess the safety, tolerability, pharmacodynamics (PD), and efficacy of multiple ascending doses of CNP-103. The approximately 393-days study consists of a Screening Period (28 days), Treatment Period (90 days), and Post-Dose Evaluations (275 days).

Omnipod-5 A French Prospective Multicentric Study in Real World (Optimal-B)

The purpose of this postmarket clinical investigation is to evaluate the levels of glycemic control, quality of life, and satisfaction, as well as the patient experience, and acute diabetes complication rates provided by the Omnipod 5 Automated Insulin Delivery System (referred to as the Omnipod 5 System) in a real-world setting.

French Prospective Multicentric Study in Real World

The purpose of this postmarket clinical investigation is to evaluate the levels of glycemic control, quality of life, and satisfaction, as well as the patient experience, and acute diabetes complication rates provided by the Omnipod 5 Automated Insulin Delivery System (referred to as the Omnipod 5 System) in a real-world setting.

ACCESS 2: AI for pediatriC diabetiC Eye examS Study 2

The purpose of this study is to determine if use of a nonmydriatic fundus camera using autonomous artificial intelligence software at the point of care increases the proportion of underserved youth with diabetes screened for diabetic retinopathy, and to determine the diagnostic accuracy of the autonomous AI system in detecting diabetic retinopathy from retinal images of youth with diabetes.

Post Market Registry for the Omnipod 5 System in Children and Adults With Type 1 Diabetes

This is a decentralized observational clinical registry to collect real-world evidence related to the safety and effectiveness of the Omnipod 5 system in children and adults with Type 1 Diabetes.

Effect of Omega-3 Fatty Acids on Eye Blood Vessels in Type 1 Diabetes

This double-blind, placebo-controlled randomized clinical trial evaluates the effects of omega-3 fatty acid supplementation on retinal vascular structure and function in children and adolescents with type 1 diabetes. The study compares omega-3 supplementation with placebo to assess changes in retinal microvascular parameters, retinal blood flow, visual function, and systemic biomarkers over time, as well as the safety and tolerability of supplementation during the study period.

Safety and Efficacy of Adjunct Therapies in Adults With Type 1 Diabetes: Multicenter, Registry Study

This will be a multicenter registry-based study to evaluate safety and efficacy of GLP-1RA and SGLTi therapies in adjunct to insulin in adults with type 1 diabetes (T1D) over 1 year. This study will enroll participants who have been prescribed adjunct therapy as part of usual care.

Transdisciplinary Care for Young Adults With Type 1 Diabetes

The incidence of type 1 diabetes (T1D) is increasing globally with the most substantial increases occurring in the youngest age groups. A growing number of youths with T1D must therefore transition their healthcare from pediatric to adult T1D care settings as they approach young adulthood. This healthcare transition introduces many challenges because it coincides with a developmental period that is fraught with social, financial, residential, school/work and other changes/demands. Thus, it is not surprising that young adults (YA) with T1D are at risk for suboptimal glycemic levels, the development of diabetes-related complications, and psychosocial issues such as depression, anxiety, and disordered eating. Yet, few evidence-based interventions to assist YA with T1D with this complex healthcare transition exist. In this study, we are testing the feasibility, acceptability, and initial efficacy of a novel transdisciplinary model of care (Transdisciplinary Care for Transition; TCT) in which a diabetes nurse educator, psychologist, and transition navigator (case manager) co-deliver transitional care. TCT addresses the psychological and systems barriers to transition and aims to improve outcomes via better assessment of YA needs and resources, better cross-discipline and YA-provider communication, and better collaboration with YA to resolve problems that cross pediatric and adult healthcare settings. We will recruit 80 YA with T1D during their final visit in pediatric T1D specialty care to participate in a pilot randomized controlled trial during which we will randomize YA to a standard care control group (SCC) or to receive three TCT visits during the 6 months post discharge from pediatric T1D care. In SCC, participants will transition to adult T1D care as usual per their clinic's standard transition procedures. All study procedures can be completed remotely. This includes enrollment, study evaluations, and TCT visits for those randomized to TCT. Thus, we are recruiting individuals from across the United States. Aim 1: Examine the feasibility, acceptability, and fidelity of TCT in YA with T1D. Aim 2: Examine the preliminary efficacy of TCT versus SCC on YA HbA1c, transition readiness and success, and continuity of care and explore for an effect on diabetes distress and acute care utilization.

Remedy to Diabetes Distress (R2D2): A Scalable Screen to Treat Program for School-age Families

This R01 is in response to RFA-DK-19-021, Treating Diabetes Distress to Improve Glycemic Outcomes in Type 1 Diabetes. The objective is to test the feasibility and acceptability of a novel, practical, and potentially scalable screen to treat program for diabetes distress in families of school-age children with T1D (called Remedy to Diabetes Distress \[R2D2\]) and to test the initial efficacy of R2D2 to reduce diabetes distress to improve children's glycemic control.

Competition Induced Hyperglycemia in Athletes With Type 1 Diabetes

Design and methods 12 athletes with T1D and 12 healthy athletes are included in a prospective experimental randomized, cross-over study. Athletes are provided with a Dexcom G6 CGM to measure glucose excursions before, during and after exercise and a Holter ECG-E-patch to measure HRV. Psychological stress levels are assessed from Competitive State Anxiety Inventory-2. The athletes are studied on two occasions: Day 1: 5K running competition and Day 2: 5K high intensity training session (running) in the athletes' regular training environment. Endpoints Primary endpoints: Change in plasma glucose from start of exercise to end of exercise during competition compared to training. Secondary endpoints: Hormonal response (cortisol, adrenalin, noradrenaline). Changes in heart rate and HRV before, during and after exercise. CGM-glucose and plasma glucose discrepancies.

Repeat BCG Vaccinations for the Treatment of New Onset Type 1 Diabetes in Children Age 8-<18 Years

The purpose of this study is to investigate if repeat bacillus Calmette-Guérin (BCG) vaccinations can confer a beneficial immune and metabolic effect in new onset pediatric Type 1 diabetes.

M1no-Study - Early Identification of Infants With High Type 1 Diabetes Risk for Participation in Primary Prevention Trials

The goal of this observational study is to identify newborns at increased genetic risk of developing type 1 diabetes-specific beta-cell autoantibodies in order to determine eligibility for participation in primary prevention randomized controlled trials aimed at preventing beta-cell autoimmunity.

Think-Find-Solve Activities for Insulin Self-Management in Type 1 Diabetes

Children with type 1 diabetes require lifelong insulin therapy. However, improper management of insulin therapy may lead to serious, potentially life-threatening complications. The aim of this study is to examine the effect of an activity book developed for insulin therapy on insulin self-management among children with type 1 diabetes and their parents. The study is designed as a cluster randomized controlled experimental trial at the center level, including pre-test, 1- month, and 3-month follow-up measurements. The study will be initiated after obtaining ethical approval and institutional permissions. The sample will consist of children aged 8-12 years with type 1 diabetes and their parents. The study will be conducted in two different hospitals in Istanbul; using cluster randomization, one hospital will be assigned to the intervention group and the other to the control group. Prior to the main study, a pilot study will be conducted with 15 participants in each group, and the sample size will be calculated using G\*Power based on the pilot data. Data will be collected using the "Descriptive Information Form for Children with Diabetes" and the "Insulin Treatment Self-Management Scale (ITSMS) - Child (8-18 years) and Parent Forms." The "Find-Solve-Learn Insulin Self-Management Activity Book" will be applied to the children in the intervention group. The children will be monitored to complete the activity book at least twice a month for three months, and feedback will be obtained from their families regarding the process. The data collection process will include pre-test, 1-month, and 3-month follow-up measurements. The obtained data will be analyzed using appropriate statistical methods.