Active clinical trials for "Diabetes Mellitus, Type 1"

Type 1 diabetes (T1D) is the most common endocrine disorder in children. In France, T1D prevalence is estimated to 12.2 per 100 000. Worldwide T1D incidence increased rapidly in the last decades, around 3% per year. T1D is caused by autoimmune destruction of pancreatic beta cells, leading to hyperglycaemia. T1D was recently associated an important loss in life expectancy compared with the general population. To date, the precise aetiology of T1D onset and the mechanisms involved in T1D remain unknown and no preventive treatment of T1D exists. It is now well admitted that T1D results from a combined effect of genes, environmental factors and gene-environment interactions. Several genetic factors have been reported as associated to T1D, the most important being the human leukocyte antigen class II genes. Whole genome association studies suggested more than 50 T1D other susceptibility locus, but conferring individually a modest risk to develop T1D. Longitudinal studies demonstrated that only a low fraction of genetically predisposed subjects develop T1D and all these genetic factors cannot explain the increase in prevalence of T1D in the latter half of the 20th century, suggesting the implication of environmental factors. Literature has accumulated a lot of evidence for the role of enterovirus in T1D. Several retrospective, prospective, post-mortem human studies, as well as animal studies, strongly suggest contribution of human enteroviruses to the pathogenesis of T1D. Enterovirus probably play a dual role in T1D, some enterovirus being associated with an increased risk of T1D and others with a protective effect. Interestingly, several T1D susceptibility loci are implicated in antiviral response. Epidemiologic and genetic approaches have led to new insights into T1D causation, but a collective explanation is still lacking. The project aims at (1) demonstrating the gene-enterovirus interaction effect on T1D onset and (2) characterizing the "precipitating" effect of enterovirus on T1D by a follow-up study of T1D high-risk subjects (first degree unaffected relatives with positive autoantibodies to islet antigens). A structural originality of this project is to perform a family-based study of gene-enterovirus interaction in T1D using innovative and robust methods. This project will be conducted in close collaboration between our INSERM unit, the Inter-regional network of paediatric diabetology, labelled biobanks (CBC Biotec of Hospices Civils de Lyon and CRB-LRB of Lariboisière' hospital at Paris), the Centre National de Référence des Enterovirus at Lyon and the Centre National de Génotypage at Evry. The investigators will first conduct a 3-years pilot study (2016-2019), based on a sample of 250 nuclear families ascertained through a paediatric T1D proband in four centres. Families will be ascertained during the hospitalization of the proband at the time of T1D diagnosis. The study will be then extended to whole Inter-regional network of paediatric diabetology. This research is a unique opportunity to explore further the implication of enterovirus and their interactions with genetic factors involved in T1D susceptibility and aims to target high-risk T1D subjects. This innovative project opens the door of the development of preventive therapy for T1D.

This study evaluates a new test formulation of a glucose lowering drug, insulin lispro, delivered by an insulin pump continuously under the skin. The study will be conducted in participants with type 1 diabetes mellitus to investigate how the human body processes the new test formulation and its effect on blood sugar levels when it is delivered via an insulin pump. Side effects and tolerability will be documented. The study will last about 4 to 11 weeks, including screening, lead-in and follow up. Screening is required within 28 days prior to entering the study.

This study will use a randomized, crossover design. Children aged 13-18 years who have been diagnosed with Type 1 diabetes for at least 1 year and with at least 2 Hemoglobin A1c values ≥10.0% more than 60 days apart within the past year, with the most recent HbA1c value between 10-14%, will be placed into two separate treatment groups. Group A will undergo home monitoring for 12 weeks through the use of the Vivify kit, which contains a wireless tablet with daily medication/diet/symptom questionnaires. Group B will initially continue diabetes management per standard of care, including quarterly office visits. After a period of 12 weeks, Group B will switch to the RPM protocol, while Group A will return to standard of care. Both groups will have HbA1c values checked at the 0, 3, and 6 month time periods to assess the effect of the remote monitoring protocol. Participation in the RPM protocol will involve daily completion of the Care Plan questions, as well as weekly uploads of blood glucose values using the Glooko, Inc (Mountain View, CA) application, and weekly video visits with a member of the endocrinology team that will aim to address barriers to optimal care, whether they be motivation, knowledge or other difficulties. Barriers to care will be assessed in part through the completion of knowledge and self-efficacy assessments.

GLP-1 increases skeletal and cardiac microvascular perfusion and improves insulin's microvascular responses in human subjects with T1DM, leading to improved metabolic insulin responses, endothelial function, and increased muscle oxygenation

To compare the early pharmacokinetic exposure of URAL and insulin lispro (ILisp).

The purpose of the study is to present evidence based literature and clinical data to the medical directors at Missouri Medicaid to help modify the existing policy regarding insulin pump therapy in pediatric patients with diabetes.

Physical exercise is one of the main recommendations included in clinical guidelines for people with type 1 diabetes (T1D) because it is associated with substantially lower cardiovascular and overall mortality risks. Adherence to regular physical activity is low in the T1D population due to factors like time limitations, no access to appropriate equipment at home, or economic costs. High-intensity interval training (HIIT) has been proposed as a time-efficient methodology, consisting of sessions of short duration and high intensity exercises. An easier and cheaper training alternative for HIIT is exercising with elastic bands, either in a clinic or at home. Even so, training with elastic bands in T1D in combination with the HIIT method has not been compared to aerobic training. Besides, it is necessary to understand the glycemic impact of both kinds of exercise in order to build better artificial pancreas systems able to deal with exercise automatically. The aim of the study will be to determine the impact of aerobic exercise versus high-intensity interval training (HIIT) exercise on glycemic control.

The study was carried out in a diabetic patient who was starting a new approach for treatment. Previously the patient was treated with Novo-mix insulin injection twice per day, the physician decided to change the treatment strategy to be with three doses of novo-rapid insulin injections per day plus one injection of Lantus SoloStar in dinner. For two weeks we were monitoring the blood glucose level by the FreeStyle Libre sensor. Moreover, the right statistical technique was used for data analysis.

The purpose of this study is to measure how often low blood sugars occur in people who live with both adrenal insufficiency (AI) and diabetes and need to take insulin. People who live with AI need to take steroid replacement tablets every day, for life. Two of the most common types of steroid replacement tablets are called prednisolone and hydrocortisone. Low blood sugar (hypoglycemia) is a very common side effect of taking insulin and can often be unpleasant, frightening and dangerous. People who have adrenal failure are also at risk of hypoglycaemia, although this is rare. It is not known whether taking steroids affects how often hypoglycaemia happens. The study has three aims: To measure how often low blood sugars occur at night in people who live with with both adrenal insufficiency (AI) and insulin-treated diabetes To compare how often low blood sugars occur in people taking prednisolone for their AI versus those taking hydrocortisone. To compare the patterns throughout the day for low blood sugars in those taking prednisolone versus those taking hydrocortisone. The study will compare this information with results in people who have AI without diabetes. Participants will be given continuous glucose monitoring systems (Dexcom G6 devices) which are small wearable devices that measure glucose levels throughout the day and night. They will be asked to wear a device for 30 days. Participants will not be asked to make any changes to their usual medications or their diet.

18 preschool aged children and their families will attend structured, multidisciplinary, family-centered intensive education sessions over a 3-day weekend in a residential camp setting to address the unique challenges of managing type 1 diabetes mellitus in young children. A second 'booster' session, will be conducted 6 months later.