Active clinical trials for "Diabetes Mellitus, Type 1"

Type 1 diabetes is a lifelong metabolic disorder that affects 1 out of every 400-600 American children each year, with many children being diagnosed at younger and younger ages. To achieve proper diabetes control, it is necessary to conform or adhere one's behavior to a physician-prescribed diabetes self-care regimen. As such, parents of children with Type 1 diabetes must be highly involved in managing their child's disease on a daily basis, especially parents of affected children who are very young and more highly dependent upon parental caretaking. As children diagnosed with Type 1 diabetes at a very young age may be at an increased risk for the development of long-term behavioral and medical complications, more research is needed to understand and treat the leading contributors to diabetes-related parental distress and medical outcomes among this growing subgroup. Recent findings indicate that responsibility for diabetes management falls heavily on mothers. The majority of families do not receive outside child care assistance and report feeling overwhelmed. Parents report high levels of pediatric parenting stress difficulty, as well as moderate symptoms of anxiety. The current study aims to expand such preliminary findings and specifically examine the effects of a newly-developed parenting support program for parents of young children with Type 1 diabetes. The utility of the intervention will be evaluated. It is hypothesized that parents completing the parent support program will report lower levels of psychosocial distress and improved quality of life. It is hypothesized that the children of participating parents will also demonstrate improved quality of life and metabolic control.

The primary and secondary objectives of this study are: Primary: To evaluate stem-cell-mobilization in subjects with diabetic neuropathy receiving SB-509. Stem cell mobilization will be assessed by evaluating the presence of stem cells circulating in peripheral blood. Secondary: To evaluate the safety of SB-509 in subjects treated with SB-509 with diabetic neuropathy; and to compare the effect of SB-509 versus placebo on a pre-defined multi-endpoint analysis that includes visual analog scale for pain intensity (VASPI), total neuropathy score (TNS), evoked nerve conduction velocity (NCV) and quantitative sensory testing (QST)

The investigators hypothesized that the administration of Etanercept to children newly diagnosed with T1DM may be able to interdict the progression of T1DM. The aim of this study is to evaluate the feasibility and safety of Etanercept administration to pediatric patients recently diagnosed with type 1 DM.

Post-prandial hyperglycemia occurs despite meticulous carbohydrate counting and rapid acting insulin therapy. Furthermore, this occurs even in the setting of the closed loop system. Currently the algorithm used for calculating the glucose-responsive insulin delivery cannot respond in a timely fashion to the glucose absorption resulting from a meal. In diabetes, there is paradoxical immediate post-prandial hyperglucagonemia that results in immediate post-prandial hyperglycemia. Amylin deficiency and/or dysregulated GLP-1 seems to be the etiology. Pharmacologic replacement of these hormones alleviates immediate post-prandial hyperglycemia in diabetes. With this protocol, the investigators would like to optimize treatment of T1DM by physiologic replacement of hormones in addition to insulin and in the process also optimize the insulin algorithm. This is a paired, randomized, and controlled comparison of pramlintide and insulin versus exenatide and insulin Vs insulin monotherapy using the ePID closed-loop system for insulin delivery. The investigators will stratify the study subjects into the following sub-groups of 5 subjects of 22-30 years old, 4 subjects of 18-21 years old, 4 subjects of 16-18 years old. The investigators would also begin the study with the 21-25 year patient sub-group and then transition to the other sub-groups after evaluating all the safety issues. 22-30 year old ones would be considered as an adult subset, 18-21 year olds would be considered pediatric subset according to the guidelines of FDA's Center for Devices and Radiological Health (CDRH) and 16-18 year olds are considered typical pediatric population. At this time, Spanish-speaking subjects will not be recruited because Medtronic Minimed as yet does not have any literature in Spanish that may used in explaining the study to this group of patients. When in the future Medtronic is able to provide us with the appropriate Spanish literature, the investigators will at that time amend the protocol to include this group of subjects.

The main purpose of the study is to determine the effects of 16 weeks of adjunctive pramlintide or exenatide use on glycemic control in Type 1 Diabetes.

This is a randomized, placebo-controlled phase II study to investigate if a prime and boost of 20ug Diamyd® (rhGAD65 formulated in Alhydrogel®), administered subcutaneously four weeks apart, is safe and can preserve beta cell function in children and adolescents with type 1 diabetes with a diabetes duration less than 18 months at intervention.

This research project will investigate the effects of pramlintide (Symlin) given by continuous subcutaneous (under the skin) infusion throughout the day and night, along with meal doses similar to those injected during conventional pramlintide (Symlin) treatment, delivered using a second insulin pump, in subjects with inadequately controlled type I diabetes mellitus who are already using insulin pump therapy. Study participants will wear two pumps for a four month period, taking insulin in their usual manner and pramlintide (Symlin) in a similar basal/bolus fashion. Continuous glucose monitors will be worn on three occasions during the study to assess blood glucose responses to continuous pramlintide (Symlin) treatment.

Primary Outcomes: Average decrease in A1c from baseline to end of Study Phase (52 weeks) for subjects in the "722 Group" is greater than that for subjects in the "Control (MDI) Group". Secondary Outcomes: Incidence and frequency of severe hypoglycemia; Measure of glycemic variability, Area Under the Curve (AUC); Quality of Life; and Health Economic Outcomes (MRU)

The trial is conducted in Europe. This clinical pharmacology trial investigates the effect of exercise on the pharmacokinetics and pharmacodynamics of inhaled insulin in subjects with type 1 diabetes.

The goal of this study is to evaluate safety and feasibility of bone marrow (BM) as site for islet transplantation (Tx) in humans. The investigators hypothesis is that BM represents a better site than liver thanks to its potential capacity to favor islet engraftment in face of a more easiness of access and bioptic follow up.