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Type 1 Diabetes clinical trials

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NCT ID: NCT01739829 Completed - Type 1 Diabetes Clinical Trials

Open-label Investigation of the Safety and Effectiveness of DIABECELL® in Patients With Type 1 Diabetes Mellitus

Start date: August 2011
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to establish the safety and efficacy of xenotransplantation of DIABECELL® in patients with established type 1 diabetes mellitus

NCT ID: NCT01736930 Completed - Type 1 Diabetes Clinical Trials

An Outpatient Pump Shutoff Pilot Feasibility and Safety Study

PSO1
Start date: January 2012
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate an overnight system that will turn off the insulin pump automatically if the system predicts that a low blood sugar is likely. The study system includes a combination continuous glucose monitor (CGM)/ insulin pump made by Medtronic MiniMed, Inc and a regular laptop computer that runs a computer program that predicts low blood sugar. It works by (1) measuring the glucose levels under the skin with a continuous glucose monitor, (2) using a computer program on a laptop to predict what will happen to the glucose level over the next 35-55 minutes, and (3) turning off the insulin pump when the computer program predicts that low blood sugar will occur. We have tested this system overnight in the hospital and are ready to test the system in the home environment to learn more about how well it will work and to make sure that the blood sugar does not go too high when the pump shuts off. This study has several phases and will take about a month or a little more for a patient to complete. Patients will use the study system for about 5 days at home to show that the patient is able to use it correctly. After that, the patient will be asked to use the study system each night for an additional 3-4 weeks. During this time, the system will be active for two-thirds of the nights and not active for one-third of the nights. When the system is active and predicts that your blood sugar will become low, the insulin pump will shut off for up to 2 hours. The study will include 2 clinical centers in the United States.

NCT ID: NCT01736228 Completed - Type 1 Diabetes Clinical Trials

Open-label Investigation of the Safety and Efficacy of DIABECELL in Patients With Type 1 Diabetes Mellitus

Start date: November 2012
Phase: Phase 2
Study type: Interventional

The purpose of this study is to establish the efficacy and safety of xenotransplantation of DIABECELL [immunoprotected (alginate-encapsulated) porcine islets] in patients with established type 1 diabetes mellitus

NCT ID: NCT01726829 Completed - Type 1 Diabetes Clinical Trials

Overnight Type 1 Diabetes Control Under MD-Logic Closed Loop System at the Patient's Home

Start date: November 2012
Phase: N/A
Study type: Interventional

This is a randomized prospective single blind trial to evaluate blood glucose control overnight under closed-loop insulin delivery with MD-Logic Artificial Pancreas (MDLAP) system in patients with type 1 diabetes, being conducted in: Tel Aviv, Israel, Ljubljana, Slovenia and Hannover, Germany; In this study,75 eligible patients will be enrolled.Each subject will participate in four consecutive over nights under closed-loop with MDLAP, and four additional over nights under regular sensor augmented pump therapy at home with a washout period of 10 ± 3 days between arms.

NCT ID: NCT01724190 Completed - Type 1 Diabetes Clinical Trials

Effect of Vitamin D on the Honeymoon Period in Children and Adolescents With Type 1 Diabetes

Start date: November 2012
Phase: N/A
Study type: Interventional

The purpose of this study is to determine if supplementation with Vitamin D in children and adolescents with newly diagnosed type 1 diabetes increases the number of patients who enter the honeymoon period.

NCT ID: NCT01722682 Completed - Type 1 Diabetes Clinical Trials

Bone Marrow vs Liver as Site for Islet Transplantation

IsletBOM2
Start date: June 2012
Phase: Phase 1/Phase 2
Study type: Interventional

The goal of this study is to evaluate safety and efficacy of bone marrow (BM) as site for pancreatic islet transplantationin humans. Our hypothesis is that BM represents a better site than liver (currently the location of choice for this procedure) thanks to its potential capacity to favor islet engraftment. To address our hypothesis we propose herein a randomized phase II trial to compare BM and liver as sites for islet transplantation in T1D patients.

NCT ID: NCT01722643 Completed - Type 1 Diabetes Clinical Trials

Incentives, Cognitive Training and Internet Therapy for Teens With Poorly Controlled Type 1 Diabetes

Start date: January 2014
Phase: N/A
Study type: Interventional

The overall goal of this project is to develop a novel family friendly intervention that will help teens with poor metabolic control of their type 1 diabetes increase and sustain daily self monitoring of blood glucose and lower HbA1c. This is important because poor metabolic control has long-term health implications. This project will provide important information regarding new effective ways to improve outcomes among teens with poorly controlled type 1 diabetes. Primary hypotheses are that the intervention, MAxIM, will: (1) help teens improve and maintain glucose control, and (2) improve decision making (improve executive function and reduce delay discounting), which will predict treatment outcome.

NCT ID: NCT01722266 Completed - Type 1 Diabetes Clinical Trials

Liraglutide in the Treatment of Type 1 Diabetes Mellitus

Start date: November 1, 2012
Phase: Phase 3
Study type: Interventional

Hypothesis 1: Treatment with Liraglutide in patients with type 1 diabetes decreases fasting, postprandial and the overall mean glucose concentrations. Aim 1.1: To compare the mean fasting, the mean weekly glucose and the standard deviation of weekly blood glucose concentrations as recorded by continuous glucose monitoring prior to and following 6 weeks and 12 weeks of treatment with 0.6, 1.2 and 1.8 mg of liraglutide daily. In addition, the time spent at glucose concentrations >150 and 200mg/dl and <70 and <40 mg/dl will also be compared. Aim 1.2: To compare the postprandial glucose concentrations following a test meal before and after 12 weeks of treatment with 0.6, 1.2 and 1.8 mg of liraglutide daily. Glucose concentrations will be measured as areas under the curve for the data obtained from the meal challenge. Aim 1.3: To compare HbA1c levels(glycated hemoglobin) before and after 12 weeks of treatment with 0.6, 1.2 and 1.8 mg of liraglutide daily Hypothesis 2: Treatment with Liraglutide in patients with type 1 diabetes decreases postprandial glucagon concentrations and increases postprandial C-peptide concentrations. Aim 2.1: To compare fasting and postprandial glucagon and C-peptide concentrations following a test meal before and after 12 weeks of treatment with 0.6, 1.2 and 1.8 mg of liraglutide daily. Hypothesis 3: Treatment with Liraglutide in patients with type 1 diabetes delays gastric emptying. Aim 3.1: To compare the gastric emptying as measured by acetaminophen absorption before and after 12 weeks of treatment with 0.6, 1.2 and 1.8 mg of liraglutide daily.

NCT ID: NCT01722240 Completed - Type 1 Diabetes Clinical Trials

Liraglutide in Type 1 Diabetes

1966
Start date: November 1, 2012
Phase: Phase 3
Study type: Interventional

The glucose lowering effects of GLP-1 agonists are well established in subjects with type 2 diabetes, however, these have not been studied prospectively in subjects with type 1 diabetes. The investigators have, therefore, designed this study to investigate the central hypothesis that in patients with type 1 diabetes, Liraglutide has a glucose lowering effect. A major secondary objective of this study is to elucidate the mechanisms responsible for its glucose lowering effects and those involved in reducing the insulin dose. The specific aims of this proposal are: Hypothesis 1: Treatment with Liraglutide in patients with type 1 diabetes decreases HbA1c, fasting, postprandial and the overall mean glucose concentrations while decreasing the dose of insulin required. Hypothesis 2: Treatment with Liraglutide in patients with type 1 diabetes decreases basal and postprandial glucagon concentrations and increases basal and postprandial C-peptide concentrations. Hypothesis 3: Treatment with Liraglutide in patients with type 1 diabetes delays gastric emptying.

NCT ID: NCT01718093 Completed - Type 1 Diabetes Clinical Trials

A Pilot Study to Assess the Glucose Lowering Effect of Metformin and Sitagliptin in Adolescents With Type 1 Diabetes

Start date: October 2012
Phase: Phase 4
Study type: Interventional

The purpose of this study is to see if the use of metformin and sitagliptin used in conjunction with insulin can improve the blood sugars of teenagers with Type 1 diabetes.