Clinical Research Directory

Mediterranean Diet and Oxidative Stress in Type 1 Diabetes (MEDOX-T1D)

Achieving optimal glycemic control in type 1 diabetes requires a holistic approach that includes individualized medical nutrition therapy in addition to appropriate insulin therapy. When diabetes is poorly managed, metabolic control is impaired. Hyperglycemic events increase oxidative stress in the body and can lead to complications. The aim of this study is to examine the effect of a 12-week Mediterranean diet on oxidative stress markers in children with type 1 diabetes who do not meet the metabolic target (HbA1c \> 7%) and whose adherence to the Mediterranean diet is "poor" and "needs improvement". The study, planned between March 2026 and March 2027, will be conducted with girls aged 10-18 years with type 1 diabetes who are followed up at the Department of Pediatric Endocrinology, Istanbul Faculty of Medicine, Istanbul University. In the first phase, participants were divided into groups based on their HbA1c levels: those with HbA1c ≤ 7 met the metabolic target (Group A); Those with HbA1c \> 7 will be divided into two groups: those not meeting the metabolic target (Group B). In the second stage, the intervention group will be determined according to the results of the KIDMED, the pediatric Mediterranean diet adherence scale. Those in Group B who did not meet the metabolic targets and those with "poor" and "need improvement" KIDMED results will form the intervention group (Group C). Adolescents in Group C will receive a 12-week Mediterranean diet intervention. Information will be collected from participants using questionnaires, scales, and experimental methods. This includes completing the 'Personal Information Form', 'Biochemical Parameters Form', '3-Day Nutrition Questionnaire', 'KIDMED scale', and 'Sensor Data Form'. The obtained data will be analyzed both individually and before-and-after using SPSS 26. The findings are expected to show improvement in OS markers in the intervention group. Improvement in glycemic control markers is also predicted. A decrease in HbA1c levels, a reduction in blood sugar fluctuations, and an increase in the duration of staying within the target range are expected. This study is expected to contribute to the literature by revealing the effects of the Mediterranean diet on oxidative stress and metabolic control parameters in type 1 diabetes. It is anticipated that the findings will support the potential role of dietary approaches with antioxidant properties not only in glycemic control but also in oxidative stress levels and long-term complication risks.

Creating Linked Inpatient CGM for Kids

Continuous glucose monitors (CGMs) are currently used in the inpatient setting at many hospitals for the care of patients with diabetes and for clinical research studies. This includes Boston Children's Hospital, however, the CGM data is not accessible to clinical or research teams in real-time. CGMs measure and display a patient's glucose level every 5 minutes and provide alerts for predicted or actual low or high glucose levels. The CGM data is currently only accessible on bedside handheld receivers or a mobile device app, neither of which sync with the hospital EMR or other hospital databases. This observational study tests a companion mobile Android device app that wirelessly receives real-time outputs from the Dexcom G7 CGM app and transmits the data to a centralized hospital database. That database in turn feeds into an internal BCH web dashboard which allows live data viewing and integration into future clinical decision support tools. The investigators are testing the hypothesis that the companion mobile app can accurately and efficiently transmit CGM data to a hospital database. Data will be analyzed for accuracy and efficiency by comparing CGM readings captured by the companion app to CGM readings documented in the formal Dexcom database. Accuracy (difference between CGM readings from both sources) and efficiency (number of CGM readings captured) will be assessed. The findings will be generalizable to using the companion app in future research studies.

To Evaluate the Change in Glucose Parameters in Adult Patients With Type 1 or Type 2 Diabetes From Europe Using the iCan o3 CGM System for 60 Days Period

This study is a post-market, prospective, interventional, multicenter clinical trial designed to evaluate the impact of the iCan O3 Continuous Glucose Monitoring (CGM) System on glycemic control in adults with Type 1 (T1D) or Type 2 Diabetes (T2D). Coordinated by Prof. Dr. Christophe De Block at Universitair Ziekenhuis Antwerpen (UZA), Belgium, and sponsored by Changsha Sinocare Inc., the study aims to assess changes in glucometric parameters over 60 days. The primary objective is to demonstrate an improvement in Time in Range (TIR) compared to baseline, measured during an initial 15-day blinded period using self-monitored blood glucose (SMBG) assessed by the iCan O3 CGM System. Secondary objectives include evaluating the system's efficacy, safety, and usability and patient-reported outcomes such as treatment satisfaction and diabetes management impact. The study will enroll 70 patients aged 18-75 with HbA1c \>7.5%, stable treatment regimens, and smartphone proficiency while excluding individuals with recent diabetes-related hospitalizations, severe comorbidities, or conflicting trial participation. The study timeline spans from February 2025 to September 2025, with patients undergoing a 15-day blinded period followed by a 45-day unblinded period where real-time CGM data is accessible. Key endpoints include improvements in TIR, Time Below Range (TBR), Time Above Range (TAR), mean glucose levels, glucose variability, and patient-reported outcomes and safety metrics such as device deficiencies and adverse events. Risks, including skin irritation and delayed glucose readings, will be mitigated through patient training and safety protocols. Anticipated benefits include improved glycemic control, reduced reliance on fingerstick testing, and enhanced quality of life. Data will be collected from CGM metrics, questionnaires, and adverse event logs, with statistical analysis comparing baseline and post-intervention outcomes. The study adheres to ethical standards and EU MDR 2017/745 regulations, aiming to validate the iCan O3 CGM System's clinical utility in real-world diabetes management.

CGM Adherence Compared to Finger-stick Glucose Monitoring in Pregnancies With Type 2 Pregestational Diabetes

The purpose of this study is to compare patient adherence to blood sugar monitoring during pregnancy using two different measurement methods in pregnancies complicated by pregestational type 2 diabetes (T2DM). Pregnant patients with T2DM are at risk of having larger babies, babies with low sugar levels in the first 24 hours of life, higher rates of cesarean delivery, stillbirth (death of baby inside the womb), and hypertensive or high blood pressure disorders of pregnancy, such as preeclampsia. Prior studies have shown that treating high blood sugars in pregnancy with medications can reduce these risks. To determine the amount of medication needed, recording of blood sugar levels is necessary. This trial aims to determine whether continuous blood sugar monitors have improved patient recording of blood sugar levels over finger stick blood sugar measurements. Patients involved in the study will be assigned to either: 1. Fingerstick glucose monitoring (FSG) 2. Continuous glucose monitoring (CGM) Patients will be randomize in a 1:1 ratio. FSG Group: blood sugar is tested four times daily - once fasting and two hours after every meal (post-prandial). Blood will be tested using a glucometer, and values will be recorded in a blood sugar log from the time of enrollment to the time of delivery. CGM Group: A CGM sensor will be placed on the patient's arm for blood sugar collection every 3-5 minutes. This data is sent to a phone application from the time of enrollment to the time of delivery. These sensors will need to be replaced every 14 days. Percent adherence will be recorded from the time you were randomized to a study group until delivery.