Rationale: We hypothesize that our newly developed dual-hormone insulin-glucagon closed-loop system (DCL) is safe, efficient and superior to our single-hormone insulin-only closed-loop system (SCL). The study aims to compare the glucose control achieved by DCL with our SCL.
Design: A randomized
To confirm hypoglycemia unawareness, patients answered a questionnaire based on the items explored by the model of Clarke 19 about hypoglycemia and hypoglycemia awareness. The eligibility of patients was confirmed by a blinded CG M recording using the trademark iPro ™ 2 sensor for 6 days. During
1. Sponsor Name (PI): Carole Bitar, MD
2. Sub-PI: Erin Boh, MD, PhD; Brittany Stumpf, MD; Collaborator: Nakhle Saba, MD
3. # of Participants Sites: 1, Tulane University 4: Participant Countries: United States
II. PRODUCT INFORMATION
1. Study Title: A phase 2, open label single arm study for
Introduction:
Spinal anesthesia is considered the first choice for cesarean sections if there are no absolute or relative contraindications. It is easy and has lower risks for mother and baby for most of cases. Anesthetists, especially junior staff, prefer spinal anesthesia for cesarean sections
Background: In January 2012, the US Food and Drug Administration approved a once-weekly form of exenatide, Bydureon, for the treatment of type 2 diabetes mellitus. Evidence from clinical trials suggested that Bydureon improves glucose control with low risk of hypoglycemia. Bydureon does not require
This investigation will be single center, prospective, randomized, double blinded placebo controlled study conducted in type 1 diabetics. The study will be conducted at Diabetes - Endocrinology Center of WNY, affiliated to the State University of New York at Buffalo.
Visit 1: Screening Day (day
Crohn's Disease (CD) is an immunologically mediated chronic illness that has a relapsing and remitting course, most commonly presenting in the 2nd or 3rd decade and causing lifelong impairment of health and quality of life. Mainstay of clinical treatment for severe disease is combination of
Introduction:
Diabetes mellitus type 2 (noninsulin-dependent diabetes mellitus (NIDDM) or adult-onset diabetes) is a metabolic disorder that is characterized by hyperglycemia (high blood sugar) in the context of insulin resistance and relative lack of insulin. According to recent survey reports
Scientific background. Diabetes mellitus is associated with an increased prevalence and incidence of cardiovascular diseases. It is believed that the high cardiovascular risk in diabetes is attributable to the adverse effects of glucotoxicity and lipotoxicity on endothelial cells. Recent data
Glucose is the most important physiologic substance involved in the regulation of insulin release. The effect of glucose on the beta cell is dose related. Dose-dependent increases in concentrations of insulin and C-peptide and in rates of insulin secretion have been observed after oral and
In the unfortunate case of severe hypoglycaemia, glucagon is the first-line treatment because of its potent and rapid action starting as fast as 5 minutes after subcutaneous or intramuscular injection. Current instructions for the treatment of severe hypoglycaemia call for the immediate injection of
RESEARCH DESIGN AND METHODS This investigation will be a prospective, randomized, double blind, placebo controlled study conducted in type 1 diabetics. The study will be conducted at Diabetes - Endocrinology Center of WNY at Millard Fillmore Hospital, affiliated to the State University of New York
Background:
Metformin hydrochloride, a biguanide, is an effective treatment for type 2 diabetes, lowering both basal and postprandial hyperglycemia either as monotherapy or in combination with other antihyperglycemic drugs. Metformin hydrochloride in its immediate release form (IR) has been used for
Anakinra is a fully human IL-1ra (interleukin 1 receptor agonist) licensed in 2001 by FDA for the treatment of rheumatoid arthritis. It competitively binds to the IL-1 receptor, thus blocking IL-1 signaling. It is a short-acting agent that requires daily subcutaneous administration at 1-2 mg/kg,
This is a double-blind (neither the physician nor the patient will know the name of assigned treatment) study to determine the effectiveness of cisapride tablets compared to placebo tablets (a tablet identical in appearance to cisapride but does not contain active drug) at improving symptoms
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