A Study for Patients With Type 1 Diabetes
Diabetes MellitusType 1Comparison of blood glucose levels in patients with Type 1 diabetes when they take a new basal insulin analog and when they take insulin glargine
Assess the Efficacy of the Low Glucose Suspend (LGS) Feature in the MiniMed Paradigm® X54 System...
Type 1 Diabetes MellitusThe purpose of this study is to assess the efficacy of the Low Glucose Suspend (LGS) feature in reducing hypoglycemia with the MiniMed Paradigm® X54 System with hypoglycemic induction from exercise. The study will consist of a total of 50 subjects, age 16 through 60 years with Type 1 Diabetes Mellitus.
A Trial Evaluating the Effect of NN1250 at Steady State Conditions in Subjects With Type 1 Diabetes...
DiabetesDiabetes Mellitus1 moreThis trial was conducted in Europe. The aim of this clinical trial was to evaluate the effect on the blood glucose-lowering effect of NN1250 (insulin degludec) in subjects with type 1 diabetes.
Assessing Glucose Effects of Sitagliptin (Januvia) in Adult Patients With Type 1 Diabetes
Type 1 DiabetesThe purpose of this study is to determine the effects of sitagliptin on glucose variability both after meals and overnight in adult patients with type 1 diabetes.
Pilot Study of Closed-Loop Glucose Control in People With Type 1 Diabetes (BPK004)
Type 1 DiabetesThis study plans to link two existing technologies, the insulin pump and the continuous glucose monitor (CGM), to essentially develop an artificial pancreas, i.e., closed-loop. This will be done using two continuous glucose monitors (CGMs), a computer containing an investigational control algorithm that uses glucose information from the CGM to recommend insulin dosing, and an insulin pump. The purpose of this study is to test the ability of continuous glucose monitors together with an insulin pump and a mathematical formula to control blood sugar levels of people with type 1 diabetes. The Closed-Loop control algorithm will: Suggest adequate insulin delivery for blood glucose control in steady state (overnight); Cover adequately with an insulin bolus the pre-set carbohydrate content of a breakfast. If successful, this study will conceptually prove the feasibility of automated model-predictive closed-loop glucose control in T1DM.
Trial of Otelixizumab for Adolescents and Adults With Newly Diagnosed Type 1 Diabetes Mellitus (Autoimmune):...
Diabetes MellitusType 1DEFEND-2 is a Phase 3 confirmatory study for the Phase 3 DEFEND-1 study. The study objective is to find out if an 8-day series of otelixizumab infusions leads to greater improvement in insulin secretion as compared with placebo. Insulin secretion will be assessed using mixed meal-stimulated C-peptide. Subjects will be assigned to receive either otelixizumab or placebo at a ratio of 2:1 (2/3 otelixizumab, 1/3 placebo). These study agents will be administered as an addition to insulin, diet, and other standard of care treatments.
Relative Bioavailability and Activity of Different Formulations of Insulin Glargine and Lixisenatide...
Type 1 Diabetes MellitusPrimary Objective: to assess the relative bioavailability of a single dose of insulin glargine (Lantus) and lixisenatide given subcutaneously as on-site mix versus separate and simultaneous injections of each drug Secondary Objectives: to compare the activity of a single dose of insulin glargine and lixisenatide given subcutaneously as on-site mix versus separate and simultaneous injections of each drug to assess the safety and tolerability of insulin glargine and lixisenatide given subcutaneously as on-site mix
Safety and Effectiveness of Low Molecular Weight Sulfated Dextran in Islet Transplantation
Diabetes MellitusType IType 1 diabetes is an autoimmune disease in which the insulin-producing pancreatic beta cells are destroyed, resulting in poor blood sugar control. The purpose of this study is to assess the safety and effectiveness of low molecular weight sulfated dextran (LMW-SD) on post-transplant islet function in people with type 1 diabetes who have responded to intensive insulin therapy.
Long Term Safety Trial to Compare Insulin Treatment With Preprandial Inhaled Human Insulin to s.c....
DiabetesDiabetes Mellitus1 moreThis trial is conducted in Oceania. The aim of this trial is to compare the safety of using pulmonary inhaled human insulin to s.c. insulin aspart both combined with NPH insulin in subjects with type 1 diabetes.
Cord Blood Plus Vitamin D and Omega 3s in T1D
Type 1 DiabetesIn this pilot study the investigators are trying to see if a single intravenous infusion of autologous (self) cord blood cells followed by 1 year of daily vitamin D and omega 3 fatty acid supplementation can preserve beta cell function (prolong "honeymoon") in children with type 1 diabetes. All subjects will continue to use insulin therapy as needed to maintain the best possible glucose control. 15 Subjects will be randomized such that 2 of every 3 (10 total) will receive cord blood plus vitamin D and Omega 3 while 1 of 3 (5 total) will serve as controls and will not receive cord blood, vitamin D, or Omega 3 supplementation. The study will involve 5 visits over 1 year to the University of Florida This study is a follow-up to our initial study of cord blood infusion alone in which 23 children received autologous cord blood. The initial study was 100% safe but additional studies like the one described above are needed to determine how to improve cord blood based therapy.