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Type 1 Diabetes clinical trials

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NCT ID: NCT00499954 Completed - Type 1 Diabetes Clinical Trials

Investigation of Correlation Between Concentrations of Glucose in Blood and Interstitial Fluid in Type 1 Diabetics

Start date: February 2006
Phase: N/A
Study type: Observational

This is a mono-centre trial performed at the Center for Clinical Research at the Medical University Graz. There will be a screening information and a study visit.In the study visit arterialized venous blood glucose values will be monitored and subcutaneous sampling of interstitial fluid (ISF) with microdialysis for glucose determination will be performed. Additionally to the laboratory analysis of the subcutaneous glucose samples, the glucose will be measured with extracorporeal on-line sensors and two marketed devices (Guardian RT and Glucoday S).The study visit will last 30 hours starting with the insertion of microdialysis catheters in the abdominal subcutaneous tissue and the insertion of the catheters for the Glucoday S system and Guardian RT system. The primary hypothesis of the study is: Interstitial fluid glucose concentration profiles correlate to the arterialized venous blood glucose concentration profile in type 1 diabetic subjects.

NCT ID: NCT00489645 Completed - Type 1 Diabetes Clinical Trials

Effect of Hyperglycemia on Gastric Emptying Interactions With Pramlintide

Start date: January 2005
Phase: N/A
Study type: Interventional

• To examine the influence of acute glycaemia (normoglycaemia and hyperglycaemia) on gastric emptying kinetics in patients with type 1 diabetes and non diabetic subjects when treated with subcutaneous (SC) injections of pramlintide.

NCT ID: NCT00486109 Completed - Type 2 Diabetes Clinical Trials

A Prospective, Randomized, Parallel Crossover Study Demonstrating Subject Wearability and Usability of the I-Port Injection Port

Start date: October 2006
Phase: N/A
Study type: Interventional

This study investigated wearability and usability of the I-PORT™ Injection Port (I-PORT™), a new disposable injection port through which prescribed medication is injected subcutaneously from a standard syringe or pen. Additional investigation compared subject opinion towards using the I-PORT™ device compared to standard injection therapy.

NCT ID: NCT00480493 Completed - Type 1 Diabetes Clinical Trials

STEP: Social Support To Empower Parents

STEP
Start date: June 2004
Phase: Phase 3
Study type: Interventional

This RCT intervention provides parental social support (informational, affirmational, and emotional) using parent mentors (experienced in the management of the chronic illness) for mothers and fathers of young children newly diagnosed with type 1 diabetes. The parent mentors provide both home visits and phone call support over the course of the first year after diagnosis. The hypothesis is that newly diagnosed parents who receive the intervention will perceive less parental concern and worry, less negative impact on the family, more perceived confidence and social support compared to those mothers and fathers not receiving the intervention.

NCT ID: NCT00467688 Completed - Type 1 Diabetes Clinical Trials

Effect of Continuous Glucose Monitoring on Course of Glucose in Type 1 Diabetes

Start date: February 2007
Phase: N/A
Study type: Interventional

The objective of this cross over study is to access if continuous glucose monitoring (CGMS) with a real time feed back and hypoglycemic as well as hyperglycemic glucose alerts vs. only retrospective analysis of glucose values is able to improve course of glucose with special regard to time spent in hypoglycemic glucose ranges in type 1 diabetic patients with impaired hypoglycemia awareness or a history of severe hypoglycemia. The second objective is to access satisfaction with CGMS during both conditions

NCT ID: NCT00460304 Completed - Type 1 Diabetes Clinical Trials

The Effect of Pramlintide on Meal Time Insulin Bolus

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

The primary objective is to establish the mean percentage of change in the insulin-to-carbohydrate ratio due to pramlintide treatment once a maximum tolerated dose or 6 mcg before each meal is reached. The secondary objective is to establish which insulin bolus wave form is associated with the lowest post-bolus without hypoglycemia in subjects treated with maximum pramlintide dosage.

NCT ID: NCT00456300 Completed - Type 1 Diabetes Clinical Trials

Role of Exenatide in Type 1 Diabetes

Start date: March 2007
Phase: Phase 2
Study type: Interventional

The purpose of this study is to see if giving exenatide and insulin before a meal would lower blood sugars after the meal. This study may help in developing new treatments to help control high blood sugars after meals. This may help improve overall blood sugar control and prevent the long-term effects of diabetes.

NCT ID: NCT00446264 Completed - Type 1 Diabetes Clinical Trials

Islet Allotransplantation With Steroid Free Immunosuppression

Start date: May 2003
Phase: Phase 2
Study type: Interventional

The restoration of endogenous insulin secretion carries significant hopes for shifting the paradigm of life long exogenous insulin therapy in selected groups of patients with type 1 diabetes(T1D). After decades of frustrating clinical attempts, the Edmonton group set up in 2000 new standards for islet transplantation in patients with brittle T1D by achieving insulin independence in 80 percent of patients. These seminal results have however proved much more difficult to duplicate than initially expected. This single center phase 2 clinical trial, duplicating the Edmonton protocol, is designed for confirming the consistent short term efficacy and safety of sequential islet allotransplantation with steroid free immunosuppression in patients with severe T1D.

NCT ID: NCT00445913 Completed - Type 1 Diabetes Clinical Trials

Autologous Dendritic Cell Therapy for Type 1 Diabetes Suppression: A Safety Study

Start date: March 2007
Phase: Phase 1
Study type: Interventional

The proposed studies describe a randomized trial to evaluate the safety of a new diabetes-suppressive cell vaccine, consisting of autologous monocyte-derived dendritic cells treated ex vivo with antisense phosphorothioate-modified oligonucleotides targeting the primary transcripts of the CD40, CD80 and CD86 co-stimulatory molecules (immunoregulatory DC; iDC). The hypothesis to be tested in this study is that iDC are safe and without toxicity in established type 1 diabetic patients. Fifteen (15) individuals exhibiting fully-established, insulin-dependent type 1 diabetics, without any diabetes-related complications, infectious disease, or other medical anomaly, will be enrolled to establish safety of the approach. 7/15 volunteers will be administered autologous control dendritic cells and 8/15 will be administered iDC. The study is anticipated to be complete by twelve (12) months. Currently, other than a humanized anti-CD3 antibody with considerable side effects, there is no other means to reverse new-onset type 1 diabetes. These studies will be the first ever to employ autologous dendritic cell transfer to suppress an autoimmune disease and to perhaps reverse it early on in the clinical process.

NCT ID: NCT00444899 Completed - Type 2 Diabetes Clinical Trials

Clinical and Economic Benefits of Cardiovascular Risk Management by a Dietician in Type 2 Diabetes Patients

GRC
Start date: March 2007
Phase: N/A
Study type: Interventional

Worldwide, health systems and practitioners are facing obesity epidemics. High blood pressure, dyslipidemia and diabetes prevalence will explode during the 21st century. The two main objectives of this 2-year controlled prospective study are: 1. to demonstrate that, for patients with high blood pressure, diabetes and dyslipidemia, dietician conducted survey and management in combination with annual endocrinologist follow-up enable both attainment and maintenance of recommended blood pressure, glycemic and lipid goals, as well as smoking cessation; 2. to demonstrate that dietician management is more cost effective than conventional care provided by general practitioners and endocrinologists. Results are expected to show significantly different cardiovascular risk profiles (BMI and waist circumference, systolic and diastolic blood pressure, LDL-C, triglycerides and Total cholesterol/HDL ratio, HbA1c, smoking) between baseline and after 2 years follow-up. Sample size was determined in order to show statistically significant differences between the two groups. Results will document for the benefit of care givers, health economists and policy makers alike an innovative and integrated model of care which is expected to be effective at the patient level as well as cost effective with respect to the increasing financial burden of diabetes on the health system.