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Type 1 Diabetes clinical trials

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NCT ID: NCT01074801 Completed - Type 1 Diabetes Clinical Trials

Closing the Loop for 36 Hours in Adolescents With Type 1 Diabetes

Start date: March 2010
Phase: Phase 2
Study type: Interventional

High variability of blood sugar levels and high incidence of night-time hypoglycaemia (low blood sugar) in young people with type 1 diabetes (T1D) make achieving the treatment goals in this population extremely challenging. Our ongoing research focuses on the development of a closed-loop glucose control in children and adolescents with T1D. The three components of the closed-loop system are a continuous glucose monitor, an insulin pump, and a computer-based algorithm. The studies performed thus far evaluated the efficacy and safety of overnight closed-loop glucose control. The results showed that overnight closed-loop improved control of blood glucose and prevented nocturnal hypoglycaemia, as compared to the conventional insulin pump therapy. The next objective is to evaluate the efficacy and safety of closed-loop insulin delivery over a prolonged time period, including the daytime, when normal living activities occur. This will pave the way for a more comprehensive use of closed loop systems to control glucose levels in T1D. The present study adopts an open-label, randomised, 2-period cross-over design whereby the safety and efficacy of closed-loop insulin therapy will be compared with the conventional insulin pump therapy in 12 adolescents with T1D. Participants aged 12 to 18 years will be randomised for two 36 hour studies in a clinical research facility, during which glucose levels will be controlled by either the computer-based closed-loop algorithm (intervention arm) or by conventional insulin pump therapy (control arm). During both studies participants will perform normal daily activities, i.e. playing, reading, snacking and physical activity. On both occasions, the Actiheart, a combined heart rate and movement sensor will be used to accurately quantify each subject's individual physical activity energy expenditure during the 36 hour study period and for 36 hours of free living during weekday.

NCT ID: NCT01068951 Completed - Type 1 Diabetes Clinical Trials

Treatment of Patients With Newly Onset of Type 1 Diabetes With Mesenchymal Stem Cells

Start date: June 2010
Phase: N/A
Study type: Interventional

The main hypothesis of the investigators study is that the development of autoimmune diabetes may be halted att diagnosis by the immune modulatory properties of mesenchymal stem cells.

NCT ID: NCT01055951 Completed - Type 1 Diabetes Clinical Trials

Feasibility Study of the Solo™ Insulin Pump

Start date: May 2009
Phase: Phase 1
Study type: Interventional

The purpose of this study is to assess the safety and usability of the Solo™ insulin MicroPump in subjects with type 1 diabetes who are pump users.

NCT ID: NCT01053078 Completed - Type 1 Diabetes Clinical Trials

Naltrexone and Hypoglycemia in Type 1 Diabetes

Naltrexone
Start date: October 2009
Phase: Phase 1/Phase 2
Study type: Interventional

Low blood sugar is also called hypoglycemia. Usually, it is mild and can be treated quickly and easily by eating or drinking a small amount of a sugar-rich food. If low blood sugar is left untreated, it can get worse and cause confusion, clumsiness or fainting. Severe hypoglycemia can lead to seizures, coma, and even death. Some people with diabetes do not have early warning signs of low blood sugar. This condition is called hypoglycemia unawareness. It happens when the body stops reacting to low blood sugar levels and the person does not realize that they need to treat their hypoglycemia. This can lead to more severe and dangerous hypoglycemia. The purpose of this early study is to see if a drug called naltrexone should be studied more in people with Type I diabetes and hypoglycemia unawareness. This study will show whether naltrexone could reduce hypoglycemia unawareness. The study will also show, by using magnetic resonance imaging (also called MRI), whether naltrexone changes the way blood flows in the brain when a person is experiencing hypoglycemia.

NCT ID: NCT01042301 Completed - Type 1 Diabetes Clinical Trials

Profiling of Original Cellular and Humoral Biomarkers of Type 1 Diabetes

Lymphoscreen
Start date: September 2007
Phase: N/A
Study type: Interventional

The "Lymphoscreen" study aims to characterize precisely (phenotypes/cytokines/functions) CD8+ T cell responses in type 1 Diabetes to identify biomarkers of the disease. Such markers are needed for refine type 1 Diabetes diagnosis/prognostic, and to design new therapeutic approaches targeting autoreactive CD8+ T cells. An original approach using DNA immunization of humanized mice allowed us to identify relevant CD8 epitopes derived from GAD65 and IA-2 beta cell autoantigens. The aims are: (i) identifying exhaustively epitopes recognized by autoreactive CD8+ T lymphocytes in type 1 Diabetes and following islet or pancreas graft in humans; (ii) identifying pathogenic CD8+ T cell patterns or profiles related to type 1 Diabetes pathogenesis and evolution; (iii) correlating CD8+ autoreactive T cell responses and autoantibody responses to new cellular (such as CD4+ T cells or peripheral cell miRNA) or humoral markers of the disease (such as serum miRNA).

NCT ID: NCT00998699 Completed - Type 1 Diabetes Clinical Trials

Study of the Effects of XOMA 052 on Insulin Production in Subjects With Well Controlled Type 1 Diabetes

Start date: February 2010
Phase: Phase 2
Study type: Interventional

The study hypothesis is that XOMA 052 may inhibit beta-cell destruction and enhance beta-cell regeneration. The purpose of this study is to assess the effects of XOMA 052 on beta-cell function and insulin production.

NCT ID: NCT00989898 Completed - Type 1 Diabetes Clinical Trials

Automated Overnight Closed-loop Glucose Control in Young People With Type 1 Diabetes

APCam05
Start date: February 2009
Phase: N/A
Study type: Interventional

Children and adolescents with type 1 diabetes need regular insulin injections or continuous insulin delivery with an insulin pump in order to keep blood sugar levels normal. The investigators know that keeping blood sugars in the normal range can prevent long term diabetes complications involving the eyes, kidneys and heart. However, achieving treatment goals can be very difficult as the tighter the investigators try to control blood glucose levels, the greater the risk for the young person to develop symptoms and signs of low glucose levels (hypoglycaemia). This is a particular problem at night. One solution is to develop a system whereby the amount of insulin injected is very closely matched to the blood sugar levels on a continuous basis. In a closed loop system, for example, a continuous glucose sensor communicates with a computer algorithm which drives an insulin pump. The investigators have been developing such a system in Cambridge over the last year with funding from the Juvenile Diabetes Research Foundation. The investigators have found that this system is very effective at preventing hypoglycaemia in young people with diabetes. Until now the information from the sensor has been entered manually into the computer and the pump settings have also been changed manually. The investigators now need to move onto the next step which is to fully automate the system. The studies will be done in a clinical research facility. The investigators will study the young people on two nights in order to find out if the closed loop system started early in the evening is as effective as when it is started later before sleep. 12 young people will be recruited from diabetes clinics in the East Anglia region. The studies will provide further important information concerning the safety, efficacy and utility of closed loop systems.

NCT ID: NCT00978796 Completed - Type 1 Diabetes Clinical Trials

Assessing Glucose Effects of Sitagliptin (Januvia) in Adult Patients With Type 1 Diabetes

Start date: September 2009
Phase: Phase 4
Study type: Interventional

The 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.

NCT ID: NCT00977808 Completed - Type 1 Diabetes Clinical Trials

Pilot Study of Closed-Loop Glucose Control in People With Type 1 Diabetes (BPK004)

Start date: May 2008
Phase: N/A
Study type: Interventional

This 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: 1. Suggest adequate insulin delivery for blood glucose control in steady state (overnight); 2. 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.

NCT ID: NCT00974051 Completed - Type 1 Diabetes Clinical Trials

Use of Terbutaline or a Reduction in Basal Insulin in the Prevention of Nocturnal Hypoglycemia

Start date: March 2008
Phase: N/A
Study type: Interventional

The investigators hypothesize that the use of an oral dose of Terbutaline or a 20% basal reduction will be able to prevent nocturnal hypoglycemia after an afternoon exercise session. This is a randomized three period cross-over study including treatment with Terbutaline, a 20% basal reduction for six hours, or no treatment (control).