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Type 1 Diabetes clinical trials

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NCT ID: NCT01785667 Completed - Type 1 Diabetes Clinical Trials

Incidence of Retinopathy and Associated Risk Factors in Children and Young Adults With Type 1 Diabetes in Denmark

DCPD1987
Start date: January 2011
Phase: N/A
Study type: Observational [Patient Registry]

The objective of this study is to clarify the current diabetic status, including development of complications, in a nationwide cohort of type 1 diabetics, who were last examined together in a large study in 1995. These youngsters were originally participating in a nationwide study of children with type 1 diabetes in Denmark back in 1986. The investigators will try to establish risk factors for developing diabetic retinopathy. The investigators will have emphasis on retinal vessel geometry and the possibilities for early detection of reversible retinal changes, and prediction of other vascular complications.

NCT ID: NCT01782261 Completed - Type 1 Diabetes Clinical Trials

Incretin Effect on the Immunological Phenotype

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

Assessment of the effect of incretin based therapies (Liraglutide and Saxagliptin) on immune cells in healthy subjects and patients with type 1 diabetes

NCT ID: NCT01773707 Completed - Type 1 Diabetes Clinical Trials

CTLA4-Ig (Abatacept)for Prevention of Abnormal Glucose Tolerance and Diabetes in Relatives At -Risk for Type 1

Start date: March 2013
Phase: Phase 2
Study type: Interventional

The study is a 2-arm, multicenter, 1:1 randomized, placebo controlled clinical trial. All subjects will receive close monitoring for development of AGT or T1DM. Subjects will receive Abatacept or placebo and close monitoring for development of AGT or T1DM. To assess the safety, efficacy, and mode of action of Abatacept to prevent AGT and T1DM. The primary objective is to determine whether intervention with Abatacept will prevent or delay the development of AGT in at-risk autoantibody positive non-diabetic relatives of patients with T1DM. Secondary outcomes include: the effect of Abatacept on the incidence of T1DM; analyses of C-peptide and other measures from the OGTT; safety and tolerability; and mechanistic outcomes.

NCT ID: NCT01773668 Completed - Type 2 Diabetes Clinical Trials

Feasibility Study - Integrated Sensor and Infusion Set. Trial III

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

The purpose of this study is to collect performance data on the Integrated sensor and infusion set during 3 days of use and demonstrate performance adequacy of the integrated sensor and infusion set with glucose sensing and insulin delivery functionalities. The hypothesis of this study is that having the infusion of insulin in close proximity to the sensor does not interfere with the sensor accuracy. This study focuses on high bolus patients. A high bolus is defined as 12 units or more.

NCT ID: NCT01755416 Completed - Type 1 Diabetes Clinical Trials

Liraglutide Versus Insulin Mono-therapy in the Closed Loop Setting

Start date: January 2013
Phase: Phase 2
Study type: Interventional

Hypothesis: In type 1 diabetes mellitus, in the setting of a closed loop glucose control system: adjunctive therapy with Liraglutide will afford better post-prandial glycemic excursions than insulin mono-therapy. Specific Aim: To determine if post-prandial glucose excursions are lowered with the addition of Liraglutide compared to insulin mono-therapy. Study Design: This is a randomized open labeled crossover design trial comparing adjuvant Liraglutide and insulin Vs. insulin mono-therapy using the ePID closed-loop system for insulin delivery.

NCT ID: NCT01754337 Completed - Type 1 Diabetes Clinical Trials

Closed-loop Control of Glucose Levels (Artificial Pancreas) for 24 Hours in Adults and Adolescents With Type 1 Diabetes

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

Closed-loop strategy is composed of three components: glucose sensor to read glucose levels, insulin pump to infuse insulin and a dosing mathematical algorithm to decide on the required insulin dosages based on the sensor's readings. A dual-hormone closed-loop system would regulate glucose levels through the infusion of two hormone: insulin and glucagon. The main objective of this project is to compare the efficacy of single-hormone closed-loop strategy, dual-hormone closed-loop strategy and pump therapy to regulate glucose levels in a 24-hours in-patient study with standardized conditions in adults and adolescents with type 1 diabetes. The investigators hypothesized that dual-hormone closed-loop strategy is more effective in regulating glucose levels in adults and adolescents with type 1 diabetes compared to single-hormone closed-loop strategy, which in turn is more effective than the conventional pump therapy.

NCT ID: NCT01754181 Completed - Type 1 Diabetes Clinical Trials

Initial Testing of the Diabeloop Algorithm in T1D Patients on Pump Therapy Over the Prandial Period and Physical Activity.

DiabeloopWP6-0
Start date: March 2013
Phase: Phase 3
Study type: Interventional

The main objective is to assess if the Diabeloop algorithm provides better glycemic control than a "manual" usual algorithm of patients with type 1 diabetes treated by insulin pump during meals, and during activity qualified "moderate" to "severe" by the patients. The study will be conducted in 18 patients. The investigation centers are: CHSF (for Diabeloop algorithm test during activity), CHU of Grenoble and CHU of Toulouse (for Diabeloop algorithm test during meals.

NCT ID: NCT01753362 Completed - Type 1 Diabetes Clinical Trials

Liraglutide In Overweight Patients With Type 1 Diabetes

Start date: December 2012
Phase: Phase 3
Study type: Interventional

The purpose of this study is to examine the effects of liraglutide (a drug used to treat type 2 diabetes) on glucose (sugar) control over the 26 week study period when used in addition to insulin.

NCT ID: NCT01747967 Completed - Type 1 Diabetes Clinical Trials

Immune Biomarkers of Residual Beta-cell Mass in Type 1 Diabetes

IMMADIAB
Start date: November 15, 2011
Phase: N/A
Study type: Interventional

There is currently no imaging technique allowing to directly visualize and measure pancreatic beta-cell mass. Consequently, the best parameter to estimate this mass is the insulin (and its C-peptide byproduct) that residual beta cells are able to produce. This insulin secretion is measured during a meal test, before and at different times after drinking a standardized quantity of nutrients. However, this test is cumbersome (lasting 3 h, with blood samples taken every 30 minutes) and it holds poor sensitivity, probably insufficient to detect very few residual beta cells. Nevertheless, these few residual cells can improve glycemic control and can be instrumental for the clinical efficacy of immune and/or regenerative therapies. We hypothesize that residual beta cells may not only represent the remaining insulin secretory capacity, but also the antigenic load capable of stimulating beta-cell-reactive T lymphocytes. The disappearance of these T lymphocytes from circulating blood over time may thus be correlated with beta-cell loss. Measuring beta-cell-reactive T-cell responses may therefore provide simple and sensitive immune surrogate markers of residual insulin secretion. Other surrogate markers may be obtained by measuring urinary C peptide or residual secretion of the counter-regulatory hormone glucagon. The main objectives of this study are: 1. To evaluate the correlation between beta-cell-reactive T-cell responses and residual insulin secretion. 2. To evaluate the correlation between the residual insulin secretion measured by serum C peptide and by urinary C peptide. 3. To evaluate the correlation between the residual insulin and glucagon secretion.

NCT ID: NCT01745549 Completed - Type 2 Diabetes Clinical Trials

Efficacy, Safety and Satisfaction of the New Pen Needle 33 Gauge x 4 mm.

AGO01
Start date: December 2012
Phase: N/A
Study type: Interventional

During the last years, even more little needles are used for the injection of sub cutaneous insulin, for the diabetes therapy. The aim of this study is to evaluate the non inferiority of a new needle, smaller than another needle, in terms of hematic levels od fructosamine, an indicator of glycemic control.