Active clinical trials for "Diabetes Mellitus, Type 1"

This is a phase 1 study to demonstrate pharmacokinetic and pharmacodynamic similarity between HEC-Glargine and US-Lantus® using the euglycemic clamp technique in healthy male adult volunteers.

An artificial pancreas (AP) is a control system for automatic insulin delivery. The investigators have implemented a missed meal bolus detection algorithm for use within an AP control system. The robust R-AP system used in this protocol has been designed to handle a variety of real-world scenarios that are critical to a high-risk patient population. The investigators will test how well the new algorithm handles missed or inaccurate meal announcements. This type of algorithm may significantly improve glucose control over the standard model predictive control (MPC) closed-loop algorithm without these new algorithm features for patients with type 1 diabetes.

To compare the glycemic control in children with type 1 diabetes using insulin Glargine and regular insulin as basal bolus therapy versus Neutral Protamine Hagedorn insulin (NPH) and regular insulin.

Type 1 diabetes mellitus (T1DM) is a chronic, autoimmune condition that involves the progressive destruction of pancreatic β-cells, eventually resulting in the loss of insulin production and secretion. Hence, an effective treatment for T1DM should focus on controlling anti-β-cell autoimmunity, combined with regeneration of lost pancreatic β-cell populations, with minimal risk to the patient. This is a phase I and II clinical trial for treatment of patient with confirmed diagnosis of T1DM for at least 12 months prior to enrolment in this trial. This study aims to determine the combined effects of autologous stem cell transplantation and immunomodulation, on regeneration of lost β-cells and halting the immune attack on the pancreatic β-cells, respectively.

This is a double-blind, randomised, controlled, two period crossover phase Ib trial using an individualized standard meal with a fixed nutrient ratio in subjects with type 1 diabetes mellitus to investigate postprandial blood glucose control with BioChaperone insulin lispro compared to Humalog®. The assessments will be conducted before and after a period of multiple daily dose administrations for 14 days. The meal tolerance test will be performed on day 1-3 and on day 14 of each period. Furthermore the study aims at investigating Post-prandial glucose (PPG) profiles with BioChaperone insulin lispro and Humalog® when injected at various injection meal intervals (-15min, 0 minutes, +15 minutes). Each subject will be randomised to a sequence of two treatments, either BioChaperone insulin lispro-Humalog® or Humalog®-Biochaperone insulin lispro, and three different sequences of injection-meal intervals. A blinded to patient continuous monitoring of glucose (CGM) will be performed during the 14 day treatment periods.

This trial is conducted in Europe. The aim of this trial is to compare pharmacodynamic (the effect of the investigated drug on the body) and pharmacokinetic (the exposure of the trial drug in the body) properties of insulin degludec and insulin glargine 300 U/mL at steady-state conditions in subjects with type 1 diabetes mellitus.

The incidence of type 1 diabetes (T1D) in young children (age <6 years) is rising. Disease management guidelines offered by the ADA and other diabetes care organizations place a high burden of responsibility onto these children's parents and caregivers to check blood sugar, administer insulin, and monitor diet and physical activity to maintain tight glycemic control. Unfortunately, this occurs at a vulnerable time in life when children's behavior is unpredictable, their T1D is difficult to control, parenting stress is elevated, and caregivers are strained by normal child caretaking routines. T1D education and support tends to be highly concentrated at diagnosis/during the inpatient stay, and requires rapid knowledge and skill acquisition on the part of parents. Not all families respond equally well to this teaching model, and many need more guided practice, problem-solving assistance, and behavioral supports than can be offered in a one-size-fits-all patient education approach. Our research will attempt to better meet the needs of individual families through a clinical behavioral stepped care intervention for T1D in parents of young children by using real-time glycemic control and [parental depression indices] to intensify management support when indicated. Primary caregivers of young children (<6 years) newly diagnosed with T1D will be randomized to either a 3-step stepped care (treatment) or usual care (comparison) condition. Stepped care components include: T1D management support delivered by trained lay parent consultants (Step 1), T1D parenting strategies and mealtime behavior management delivered by bachelor's level behavioral assistants (Step 2), and individualized diabetes education/management planning with a certified diabetes nurse educator and [consultation with a diabetes team clinical psychologist] (Step 3). Biomedical and psychosocial measurements (including A1c, depressive symptoms, mealtime behavior, parenting stress, quality of life) will occur at baseline and 3-month intervals for up to 15 months post-diagnosis. The results of this work will ultimately lead to a more practical approach to T1D education and management that can be translated more easily into a variety of clinical practice settings to support young children's T1D management.

The purpose of this study is to demonstrate the safety and feasibility of a decision support system aimed at reducing glucose variability in T1DM patient using an insulin pump.

This study will test the hypothesis that a BAC (blood alcohol content) of 0.1% will not significantly alter the anti-hypoglycemic effect of mico-dose glucagon in individuals with type 1 diabetes.

Islet transplantation is a relatively new procedure used in people with difficult to control Type 1 diabetes. Insulin producing cells (islets) are isolated from a pancreas donated by the next of kin of a person who is brain dead. After the cells are prepared, the islets are transplanted into the recipient's liver and produce insulin. Patients who receive an islet transplant take medication that suppresses their immune system and prevent rejection of the islet tissue. The investigators have also learned that there is general inflammation at the time of the transplant that is not fully controlled with our standard medications. The investigators believe this inflammation may cause some islet cell death around the time of transplant. Due to this islet death around the time of transplant, most recipients need 2 or 3 separate transplant procedures. The investigators are studying the use of Alpha-1 Antitrypsin (AAT) in islet transplant to decrease the amount of cell death caused by general inflammation. In this study, the investigators hope to decrease the need for more than one transplant procedure by controlling inflammation, before and after transplant, with Alpha-1 Antitrypsin (Aralast NP). Alpha-1 Antitrypsin is a protein made in healthy humans that helps to prevent tissue damage during times of inflammation. Alpha-1 Antitrypsin is obtained from healthy plasma donors. There have been studies in Islet Transplant in monkeys using this medication and it has shown to protect the islets from inflammation. This study involves using Alpha-1 Antitrypsin in addition to our current Standard of Care medications used in Islet Transplant.