Active clinical trials for "Diabetes Mellitus, Type 1"

Diabetes distress has been identified as one of the largest contributors to the racial disparity in glycemic control that disproportionately burdens Black patients ages 18-30 years with type 1 diabetes (T1D). In order to combat this issue, this study assesses the feasibility of the culturally tailored intervention T1DES and evaluates the effect of the T1DES intervention on diabetes outcomes in a pilot randomized clinical trial among Black young adults with T1D.

The purpose of this research study is to evaluate a transition preparation program designed for adolescents and young adults (AYAs) with type 1 diabetes (T1D). This transition program will support AYAs as they prepare to transition from pediatric to adult endocrinology medical care and will also include a caregiver. Results from this study will inform clinical recommendations regarding self-management best practices for AYAs with T1D prior to transitioning to adult medical care.

Type 1 diabetes mellitus (DM) is an autoimmune disease characterized by absolute insulin deficiency, defined as insulin-dependent diabetes mellitus and develops due to autoimmune damage of beta cells in the pancreas. Approximately 425 million people worldwide are diabetic patients, 5% to 10% of whom are T1DM. In the majority of type 1 DM prevention studies, the main aim is to stop beta cell destruction. Primary prevention studies aim to prevent or alter exposure to environmental stimuli before autoimmunity is developed. Secondary prevention studies address interventions in the autoimmune processes that cause betacell destruction. Tertiary prevention studies include interventions to stop or reverse beta-cell destruction after clinical diagnosis of type 1 DM. Despite all technological advances, type1DM has not shown a permanent improvement in metabolic control over the last 5 years. Breast milk provides protection against Type 1 DM through the prevention of diabetogenic infections, delaying exposure to diet antigens including cow's milk, and the ability to produce healthy intestinal microbiota. Xiao et al. (2018) published in Nature, investigated the effect of human milk oligosaccharides on non-obese diabetic rats, where it was found that it improved intestinal flora and insulitis scores and brought the blood glucose level closer to the optimum level. This study is expected to fill the gap in the literature about dose-dependent efficacy and placebo of breastmilk oligosaccharides in diabetic humans. This project will investigate 1) the possible contribution of 2-FL oligosaccharides to the disease's metabolic control 2) their effects on beta-cell preservation in the pancreas 3)their effects on intestinal microbiota 4) whether there is a doseresponse relationship as compared to placebo among type 1 diabetic children. This project is designed as a double-blind randomized placebo-controlled experiment lasting for 36 months. The proposed research population consists of 111 children aged 4-16-year-old who were diagnosed with Type 1 DM at the Department of Pediatric Endocrinology of Ege University. The sample size was calculated as 111 with an effect size of 0.33, an error of 0.05 and a power of 80% using the F-test group (for a numerical variable such as blood glucose) for 3 groups. It is planned that the two intervention arms consist of 37 volunteers and the placebo group of 37 volunteers. In the research, 1.5 g/day of human milk oligosaccharides will be supplemented in the first intervention group and 3 g/day for the second intervention group. The placebo group will receive maltodextrin as a placebo at a dose with no effect on metabolic control. Patients included in the study will be provided human milk oligosaccharides for 3 months and will be under follow-up for 12 months. All variables, mainly C-peptide, HbA1c, immunoglobulins, lymphocytes and faecal analysis will be examined. The project aims to ameliorate the microbiota profile, optimize C-peptide levels, reduce exogenous insulin dependence through the provision of 2-FL from human milk oligosaccharides and develop a more applicable, acceptable and an innovative method in the metabolic control of the disease. It is believed that the psychosocial and economic burdens of the disease will be reduced by increasing the metabolic control of the disease.

Iatrogenic hypoglycemia is still considered to be the number one barrier to effective glycemic control in patients with type 1 diabetes (T1D). In a previous study, it was observed in people without diabetes that fasting can be detrimental to the hormonal and hepatic responses to insulin-induced hypoglycemia. In the experiments described herein, the impact fasting has on hypoglycemic counterregulation in people with T1D will be determined.

The goal of this clinical trial is to compare the effect of low carbohydrate diet versus Mediterranean diet on blood sugar values in adolescents with type 1 diabetes. The main question aims to answer whether a low carbohydrate diet is as effective as the Mediterranean diet for better glycaemic control in type 1 adolescents. The investigators are also aiming to check whether low carbohydrate diet is safe and does not elevate cholesterol blood levels and whether the diet is adherable among youth with type 1 diabetes. Participants with type 1 diabetes wearing a continuous glucose monitor and that will sign an informed consent will be randomly selected for 2 groups. One group will get the Mediterranean diet program and the other will get the low carbohydrate diet program, both for a duration of six months. Each participant will attend a cooking workshop at the beginning of the study. Blood work and stool samples will be taken at the beginning and 3 times through the study periodd. Each participant will attend meetings with the dietician thorough the period of the study.

Evolving technology and clinical innovation have led to dramatic changes in the management of type 1 diabetes (T1D). These changes have led to a need to collect a growing number of details from families during their visits. As a result, much of the physician-patient visit is spent transferring information instead of focusing on diabetes care, contributing to increased time pressures in clinic and unmet needs for patients. In response to this reality, the investigators have developed a tool that allows families to input their diabetes-related information into their physicians' electronic health record (EHR) documentation tool before their clinic visit, using a questionnaire administered via CHEO's secure patient portal (MyChart®). The investigators will evaluate the impact of an integrated electronic patient questionnaire, on quality of care (patient-reported), diabetes control and clinic efficiency. The investigators hope that our study will determine whether having families input clinical data prior to a visit is an effective strategy to improve the quality of diabetes care. The investigators believe that the findings will be of interest to all those studying the value of incorporating patient-entered data both within diabetes care and beyond.

Moving into the era of electronic communication, it changes the way we shall engage our children and adolescents. According to data of the Census and Statistics Department of Hong Kong releases in 2019, more than 80% and up to 99.4% of those aged 10-14 years, and aged 15-24 years respectively had a mobile phone device. A recent survey carried by Kebede et al. (2019) had shown that using diabetes apps was positively associated with self-care behavior in type 1 and type 2 diabetes mellitus (DM). A systematic review carried in Spain by Quevedo Rodríguez et al. (2018) had found most of the available smartphone apps lacked quality certification and very few provide scientific references on their content. In Hong Kong, there is currently no Chinese smartphone application targeting for the pediatric type 1 population, therefore, most of the education is based on face-to-face or telephone communication with the diabetic nurse and endocrinologists in limited encounters. For families or patients with limited command of English language, apart from one adult oriented DM information smartphone application, the chance of having on-hand mobile device support is truly limited. In light of this context, we shall first design an evidence-based locally tailored Chinese smartphone application for pediatric type 1 DM and then evaluate its effectiveness in improving management of type 1 DM in a robust manner. The main research question for this project is whether a self-help smartphone application in local Chinese language, tailored to include local clinical practice, culture and food spectrum, can improve diabetes control and psychological wellbeing in patients with type 1 diabetes mellitus aged 6-18 years. Eligible participants will be randomized to either using the smartphone application (on top of standard diabetic care) or continue standard diabetic care. The study aims to compare the difference between the two groups for their diabetic control and the psychological wellbeing.

The objective of this study is to test the early effects and implementation of an enhanced community health worker (CHW) model (T1D-CATCH) that encourages and supports diabetes technology use in young adults from underrepresented minority groups (YA-URMs) with type 1 diabetes (T1D). The investigators will conduct a 9-month randomized controlled trial in which YA-URMs will be randomized toT1D-CATCH or usual care. The investigators will recruit from adult and pediatric endocrinology and primary care practices in a large safety-net health system in the Bronx, New York. Our specific aims are to 1) evaluate T1D-CATCH effects on technology initiation and continued use over 6 months and 2) evaluate T1D-CATCH implementation using Proctor's Taxonomy of Implementation Outcomes: feasibility, adoption, fidelity, and cost.

Food forms an integral part of diabetes management. As children mature into young adults, they must learn to adopt lifestyle behaviours critical for optimal diabetes care. The development of food preparation and cooking skills at a young age may help to facilitate healthy food choices in children and provide a solid foundation for young adulthood. Food skills workshops are effective interventions that have been shown to improve food literacy and healthy eating in the general pediatric population. However, food skills programs have not been adequately evaluated in children with type 1 diabetes. Further, virtual programs are not well assessed, which can increase the accessibility of food education during the pandemic and in the future.

This study aims to identify the unmet psychoeducational needs of parents of children 8-12 years of age using insulin pump and CGM for pediatric T1D management and to leverage that information to develop an innovative app-based psychoeducational intervention to optimize use of these technologies and improve T1D outcomes.