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Diabetes Mellitus, Type 2 clinical trials

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NCT ID: NCT00627029 Active, not recruiting - Cancer Clinical Trials

Evaluation of Programs of Coordinated Care and Disease Management

Coca
Start date: September 2000
Phase: N/A
Study type: Interventional

This is a Congressionally mandated study. In the original study, 16 demonstration programs provided care coordination services to beneficiaries with chronic illness in Medicare's fee-for-service program. A five-year CMS-funded study tested whether the programs can improve patients' use of medical services, improve patients' outcomes and satisfaction with care, and reduce Medicare costs. The study also assessed physicians' satisfaction with the programs. In 2008 Congress extended the project for two of the original programs--Mercy Medical Center - North Iowa and Health Quality Partners in Pennsylvania--and they will enroll Medicare beneficiaries and provide care coordination services into the spring of 2010.

NCT ID: NCT00605592 Active, not recruiting - Clinical trials for Diabetes Mellitus, Type 1

UVA Islet Cell Transplantation in Patients With Type I Diabetes

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

This protocol will provide islet cell transplantation to two separate populations in need of a pancreas transplant: Group I: Islet Cell Transplantation in Type I Diabetics without Kidney Problems Group II: Islet Cell Transplantation in Type I Diabetics Who Have a Stable Functioning Kidney Transplant The targeted patients have very brittle diabetes or dangerous hypoglycemic unawareness and may benefit from transplantation over continuing insulin therapy, even though chronic immunosuppression is required. We believe that in these patients, the islet transplant procedure promises enough potential benefit to justify subjecting patients who have not previously had a transplant to the risk of immunosuppression. In patients who are already subject to the dangers of chronic immunosuppression for other reasons, i.e. to prevent rejection of a kidney allograft, the islet transplantation procedure itself is the principal additional risk and this risk should be minimal. In these patients (our Group II), the potential benefit from improved glycemic control is that it promises to slow or even reverse diabetic complications, such as vascular problems leading to kidney damage. It is this rationale that has made pancreas transplantation a widely accepted option in patients with renal failure, despite the risks associated with whole pancreas transplantation. Islet cell transplantation aims to provide a potentially lower risk procedure that has similar relief from diabetic complications.

NCT ID: NCT00573456 Active, not recruiting - Diabetes Mellitus Clinical Trials

Far Infrared Radiation Treatment for Diabetes

Start date: May 2006
Phase: Phase 1
Study type: Interventional

A study to determine the use of far infrared (FIR) radiation for treatment of diabetes.

NCT ID: NCT00552903 Active, not recruiting - Heart Failure Clinical Trials

Randomised Trial of Health Coaching in Secondary Prevention of Diabetes and Heart Disease

TerVa
Start date: November 2007
Phase: Phase 3
Study type: Interventional

A randomised trial with individual patients as units of observation will be carried out. Health coaching is used to modify health behaviour and thus improve disease control and health status, as well as use of health care services. A personal health coach is assigned to each patient and they are in weekly contact through telephone. The intervention lasts for 12 months. No intervention is offered to the patients in the control arm.

NCT ID: NCT00529815 Active, not recruiting - Clinical trials for Diabetes Mellitus Type 2

Continuous Glucose Monitoring in Patients With Type 2 Diabetes

CGM
Start date: September 2007
Phase: Phase 4
Study type: Interventional

The purpose of this pilot study is to determine if a Real-Time Continuous Glucose Monitoring System (CGMS) is a more effective method of improving glycemic control in patients with type 2 diabetes than is episodic self blood glucose monitoring(SBGM) in the both the short- and long-term. CGMS, which includes a sensor that can be self- inserted under the skin and a discrete monitor that records and displays blood sugar levels nearly continuously, allows for real time blood glucose monitoring. This will be a prospective, randomized control trial comparing participants with type II diabetes use of CGMS versus SBGM. The primary endpoint will be improvement of glycemic control as measured by glycosylated hemoglobin (A1C). The secondary endpoints will compare mean daily glucose levels, the number of both hypoglycemic and hyperglycemic events, the amount of time spent in target blood glucose, and the perceived level of diabetes-related stress between the two groups. Participants will be randomized to either the control (SBGM) or intervention (CGMS) group. Subjects in the intervention group will alternate the use of the CGMS with episodic self blood glucose monitoring for four cycles of two weeks during the 12 week study. The control group will perform episodic SBGM throughout the study. The intensified monitoring schedules for both groups will end at the end of week 12, but glycemic control measurement by A1C will continue through 52 weeks. A1C levels will be drawn at 0, 12, 24, 38, and 52 weeks. Mean daily blood glucose levels, number of hypo and hyperglycemic events, and duration of time spent in target blood glucose range will be downloaded from patients' meters periodically throughout the study. The SF-8, a general quality of life questionnaire for people with chronic disease, and Problem Areas in Diabetes (PAID), a diabetes-related quality of life questionnaire, will be completed at the beginning and end of the study. The results of this study may help highlight which blood glucose monitoring methods are most likely to improve patients' ability to achieve and maintain target levels of glycemic control.

NCT ID: NCT00525577 Active, not recruiting - Diabetes Clinical Trials

ANDES-AGI-1067 as a Novel Antidiabetic Agent Evaluation Study

ANDES
Start date: August 2007
Phase: Phase 2/Phase 3
Study type: Interventional

This double-blind, placebo-controlled, dose-finding study is designed to identify the lowest AGI-1067 dose that improves glycemic control as measured by HbA1c and fasting glucose in subjects with Type 2 diabetes mellitus. Glycemic control will be measured during a 6-month treatment period in subjects who are on 1 or no antidiabetic drugs

NCT ID: NCT00521937 Active, not recruiting - Diabetes Clinical Trials

Efficacy and Safety Study of DERMAGEN® vs Conventional Treatment to Treat Diabetic Neuropathic Foot Ulcer

DERMAGEN®
Start date: January 2009
Phase: Phase 3
Study type: Interventional

It is estimated that 300 million people worldwide will have diabetes by the year 2025. About 12 percent of those with diabetes will have had a foot ulcer, which is a major source of morbidity, concern, and cost. The foot ulcers are the leading cause of hospitalization among people with diabetes and often lead to amputation. The costs of treatment and the high morbidity and mortality associated with diabetic foot problems necessitate the need for a systemic approach to a foot ulcer management. Current local treatments of this type of ulcer are: dressings (hydrocolloids, alginate…), and growth factors. However modern dressings may not avoid infection and the results of the clinical studies are not significant in terms of complete healing rate or in terms of time to healing. Concerning growth factors, the only one whose therapeutic application made proof is the rhPDGF (Regranex®) with an increase in the number of ulcers completely healed at the twentieth week compared to placebo (50% and 35%, respectively). The advancement of tissue-engineering has made possible dermal replacement on human wounds to facilitate healing. A new sponge composed of collagen and glycosaminoglycans (chondroitins 4 and 6 sulphate), reticulated by ionic bonds with chitosan before freeze-drying, was developed in France. This sponge is a non-toxic product due to its non-chemical reticulation (ionic bonds), biocompatible and biodegradable processes, handling and storable easily. The objective of this study is to demonstrate that such a substitute, cellularized by functional allogenic fibroblasts, and complying with all safety conditions, enables to lead to healing of diabetic foot ulcers.

NCT ID: NCT00520182 Active, not recruiting - Diabetes Type 2 Clinical Trials

Dietary Interventions in Type 2 Obese Diabetic Patients in the Community

DIPAC
Start date: March 2004
Phase: Phase 3
Study type: Interventional

Obese patients with type 2 diabetes often fail to loose weight and thus do not succeed in improving their sugar and lipid profiles and remain at high risk for diabetes complications The study enrolled 259 obese diabetic patients attending HMO clinics in central Israel. Over a 6 month period the participants met with a dietitian every fortnight and attended group lectures every 2 months. The objective of this intervention was to compare three dietary intervention along with close monitoring of the patients by dietitians, regarding blood lipid and sugar balance as well as weight loss. The three diets are the American Diabetes Association (ADA) diet from 2003; a diet containing low glycemic index carbohydrate otherwise similar to the ADA diet; and a low glycemic index diet with more fat than the other 2 diets with high proportion of mono-unsaturated fatty acids. Patients were individually randomized to receive one of the three diets. Among the measures obtained every 3 months for the first year and every 6 months thereafter are weight, fasting insulin and glucose, glycosylated hemoglobin, blood and urine chemistry profiles and lipid profile.

NCT ID: NCT00506272 Active, not recruiting - Diabetes Mellitus Clinical Trials

Inpatient Self Monitoring and Administration Study (ISMAS)

ISMAS
Start date: December 2007
Phase: N/A
Study type: Interventional

ISMAS is designed to test the hypothesis that self management of insulin dependent diabetes mellitus by selected patients admitted for elective surgery is more efficacious than standard care with respect to overall glycemic control, attaining finger-stick blood sugars, and administering insulin.

NCT ID: NCT00498147 Active, not recruiting - Clinical trials for Diabetic Retinopathy

Determining Rates of Cardiovascular Complications Among Patients of a Managed Diabetes Care Program

DECIDE
Start date: July 2007
Phase: N/A
Study type: Observational

The primary objective of this study is to identify whether cardiovascular complication rates are lower in patients who participate in managed diabetes care, in comparison to provincial and national rates. This study will involve an electronic medical record (EMR) chart audit, augmented by a manual review of hospital and other pertinent medical records, as necessary.