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Type 1 Diabetes clinical trials

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NCT ID: NCT01530347 Terminated - Type 1 Diabetes Clinical Trials

Non Invasive Breath Based Acetone-meter- Easy Check

Start date: March 2012
Phase: Phase 1
Study type: Interventional

Segment 1- this segment will include two main steps: Step 1-Calibration: During this step we plan to collect paired measurements of capillary blood glucose using reference method and data generated by the non invasive study device. Samples will be obtained at specific time points during 4 hours: at fasting, and after consuming standard liquid meal at 60, 120, 180 and 240 minutes. At each time point capillary blood glucose will be measured using the invasive reference method. The paired reference and study device data will be analyzed using multivariate regression model to formulate a calibration algorithm model. This model will convert the acetone values measured by study device to blood glucose values. step 2-Validation: During this segment the second step of this segment we plan to evaluate the validity and reliability of the non-invasive breath-based glucometer compared to standard invasive reference glucometer. Results will be compared using a Clark error grid. Segment 2- During this segment we plan to collect paired measurements of capillary blood glucose beta Hydroxybutyrate using reference method and acetone values generated by the non invasive breath based study device. Samples will be obtained at specific time points during 4 hours after overnight fasting, while basal insulin will be suspended, which is accepted to produce ketosis.

NCT ID: NCT01515384 Terminated - Type 2 Diabetes Clinical Trials

A Trial of 18F-AV-133 Positron Emission Tomography (PET)

Start date: June 2010
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the safety and pancreas imaging properties of 18F-AV-133.

NCT ID: NCT01460251 Terminated - Type 1 Diabetes Clinical Trials

OPen Label Study to Evaluate Long Term Treatment Effect of DiaPep277

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

The study is an open-label extension study, offering patients who participated and completed previous studies 901 and 910 (an extension to 901) to continue treatment with DiaPep277 and clinical follow-up, for up to 3 additional years.The aim of the study is to collect safety and efficacy data of long term treatment effect of Diapep277.Only patients who completed studies 901 or 910 and still have stimulated C-peptide level equal to or above 0.2 nmol/L will be eligible for this extension study

NCT ID: NCT01398995 Terminated - Type 1 Diabetes Clinical Trials

Managing Insulin Pumps for Exercise (Study 2)

Start date: May 2011
Phase: N/A
Study type: Interventional

People with Type 1 Diabetes Mellitus (T1DM) like to take part in sport and exercise, but problems with metabolism and blood glucose control can make this difficult. Some people with T1DM administer their insulin via an insulin pump, also know as continuous subcutaneous insulin infusion (CSII) therapy, in which a background or basal level of insulin is constantly infused under the skin by a special pump, with bolus doses of insulin given to accompany food. Clinical experience suggests that this may be particularly useful for managing diabetes for exercise, but there is limited experimental evidence to support this. The aim of this research , which is divided into three parts, is to investigate the hypothesis that the physiological response to sub-maximal (moderate) exercise of a person with type 1 diabetes treated with CSII, can be made to approximate more closely to the physiological response of a healthy individual by a prior reduction of their basal insulin infusion rate. Evidence from children demonstrates that reducing the basal insulin infusion rate to 50% of normal at the beginning of exercise can reduce rates of low blood glucose (hypoglycaemia) during exercise. However, reducing the insulin infusion rate will not have an immediate effect on levels of insulin in the body, and evidence from adults suggests that the level of insulin in the bloodstream at the start of exercise is an important factor in whether hypoglycaemia develops during exercise. This suggests that reducing the basal insulin infusion rate some time before exercise may be useful. The aim of this study is to compare the effect of a basal insulin reduction on blood glucose levels between visits when this reduction is made at the start of exercise, 30 minutes before, 60 minutes before and 90 minutes before. The null hypothesis to be tested is that there is no difference between these conditions.

NCT ID: NCT01341587 Terminated - Type 2 Diabetes Clinical Trials

Smart Glucose Meter Project

Start date: April 2011
Phase: N/A
Study type: Interventional

Currently, in the U.S., 1 in 3 males and 2 in 5 females born after 2000 are expected to develop diabetes during his or her lifetime. Research has demonstrated that control of blood glucose (BG) reduces the complications of diabetes. As a result, almost half of Americans diagnosed with diabetes, are prescribed finger-stick glucose meters to monitor their BG. The value of this approach is known to be limited by a high rate of patient non-compliance with BG testing, where patients test less often than prescribed. Increased communication between patient and care manager along with feedback has been shown to increase self monitoring of blood glucose (SMBG) test compliance. However, this feedback loop is largely absent from the current, episodic model of patient / care manager interaction and not available in existing BG meters given to diabetic patients. In this study, we propose to pilot test a cellular-embedded glucose meter. This device can transmit glucose readings directly over a cellular network to a care management server and then the patient will receive feedback on the screen of the glucose meter.

NCT ID: NCT01268644 Terminated - Type 1 Diabetes Clinical Trials

Effects of Metreleptin in Type 1 Diabetes Mellitus

Start date: September 2010
Phase: Phase 1
Study type: Interventional

This study will add leptin therapy to the current insulin therapy of Type 1 Diabetics with the aim of lowering the total insulin requirements and suppressing the steep fluctuations typically associated with Type 1 Diabetes.

NCT ID: NCT01247649 Terminated - Type 1 Diabetes Clinical Trials

Assessing Continuous Non- Invasive Blood Glucose Sensor- Physical Logic AG

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

The present study is aimed to evaluate the feasibility of a new noninvasive method to measure continuous glucose values using electromagnetic radiation.

NCT ID: NCT01017965 Terminated - Type 1 Diabetes Clinical Trials

Impact of Objective Sleep Duration on Blood Glucose Control in Type 1 Diabetes Adult Patients

DIAPASOM2
Start date: November 2009
Phase: N/A
Study type: Observational

The objective of this study is to assess the impact of objective sleep duration on blood glucose control in type 1 diabetes adult patients. This study will also evaluate the impact of objective sleep duration on blood pressure over a 24-hour period and the impact of objective sleep duration on quality of life. Last, it will investigate the influence of objective physical activity duration on blood glucose control, blood pressure and quality of life.

NCT ID: NCT00974740 Terminated - Type 1 Diabetes Clinical Trials

DIATOR-Diabetes Intervention With Atorvastatin

Start date: March 2004
Phase: Phase 1
Study type: Interventional

Clinical studies have shown that immunomodulators (like Anti-CD3 antibodies) have effects on beta-cell-preservation. The lipid-lowering agent atorvastatin is also a potent immunomodulator. In this study the effects of 80 mg atorvastatin per day on preservation of beta-cell function in recent onset type 1 diabetes were studied, as determined by stimulated C-peptide levels.

NCT ID: NCT00946517 Terminated - Type 1 Diabetes Clinical Trials

Impaired Family Dynamics Leads to Non Compliance in Type I Diabetes

Start date: July 2009
Phase: N/A
Study type: Observational

This study will test the hypothesis that certain parenting styles are associated with greater non-adherence to therapy in children and teens with type 1 diabetes. To test their hypothesis, the investigators will use standardized and validated questionnaires for parents and children to determine: parenting styles (the investigators will measure parental strictness, parental attachment, and parental monitoring), parent ability to cope with stress, parent comfort with the parenting role, parent and child level of depression and parent perception of financial resources. The investigators will also measure parent and child's perception of the child's underlying temperament and parent-child conflict. The investigators will correlate these findings with both parent and child subjective measures of adherence to therapy. The investigators will also obtain objective measures of therapy adherence including: HbA1c, number of hospitalizations for diabetes ketoacidosis and number of missed outpatient appointments. These measures will be correlated with our other findings.