Synopsis of Completed and Current Studies

• Asthma
• Attention Deficit Hyperactivity Disorder (Pediatric)
• Bacteria Vaginosis
• Cardiac Studies
• Chronic Pain
• Depression
• Diabetes - Type 1
• Diabetes - Type 2
• Diabetic Device Studies
• Diabetic Complications
• Gastroenterology
• Herpes Zoster
• Hypertension
• Hypercholesterolemia
• Hyperthyroid
• Hypogonadism
• Insomnia
• Metabolic Syndrome
• Osteoporosis
• Other Indications
• Panic Disorder
• Phase 1
• Weight Loss / Obesity

Diabetic Device Studies

2011 – PI – Ronald Brazg, MD
Accuracy and User Performance Evaluation of the An Investigational Blood Glucose Test Strip for Finger Capillary Blood Testing   

2011 – PI – Leslie Klaff, MD, Ph.D
A Regulatory Clinical Evaluation – Human Factors, Instructions for Use, and Marketing Claims Study

2011 – PI – Leslie Klaff, MD, Ph.D
A Regulatory Clinical Evaluation – Lay User and Professional Comparison to a Validated Method.

2011 – PI – Ronald Brazg, MD
Phase I Performance and Safety Evaluation of An Investigational Intradermal Delivery Device

2011 – PI – Allen Sussman, MD
Comparison of Insulin Dose Derived From An Investigational Glucose Meter Software and Conventional Manual Calculation

2011 – PI – Ronald Brazg, MD
Accuracy Evaluation of the An Investigational Blood Glucose Monitoring System for Venous Blood

2010 –PI – Leslie Klaff, MD, Ph.D
A Regulatory Clinical Evaluation of An Investigational Blood Glucose Meter – Lay User and Professional Comparison to a Validated Method and Instructions for Use Evaluation

2010 –PI – Allen Sussman, MD
A Study of A Blood Glucose Monitoring System with the An Investigational Test Strip Alternative Site Capillary Evaluation Patient vs. Technician

2010 –PI – Ronald Brazg, MD
An Inpatient Performance Evaluation of a New Subcutaneous Glucose Sensor

2010 –PI – Ronald Brazg, MD
An Investigatonal Test Strip with A Blood Glucose Monitoring System Alternative Site Capillary Evaluation

2010 – PI – Leslie Klaff, MD, Ph.D
A Regulatory Clinical Evaluation of An Investigational Blood Glucose Meter – Lay User and Professional Comparison to a Validated Method, Instructions for Use, Human Factors, and Marketing Claims Study

2010 PI - Ronald  Brazg, MD
An In-Clinic, Randomized, Cross-Over Study to Assess the Efficacy of the Low Glucose Suspend (LGS) Feature of An Investigational Insulin Pump System with Hypoglycemic Induction from Exercise.

2010 PI - Ronald  Brazg, MD
Design Validation Study of the An Investigational Continuous Glucose Monitoring System

2010 –PI-Ronald  Brazg, MD
A Study of An Investigational Glucose Test Strip with An Approved Glucose Meter Alternative Site Capillary Evaluation Patient vs. Technician.

2010 –PI -  Allen Sussman, MD
Protocol for User Evaluation of the Performance of An Investigational Blood Glucose Monitoring System

2010 –PI -  Ronald Brazg, MD
Accuracy and User Performance Evaluation of the Modified FreeStyle Blood Glucose Test Strip for Finger and Alternative Site Capillary Blood Testing

2010 –PI -  Ronald Brazg, MD
Project Gemini (Gen 1 meter)- GDHFAD System) Blood Glucose Monitoring System: Comparison of Lay User and Professional Glucose Results to a Validated Method

2010 –  PI -  Ronald Brazg, MD
An Inpatient Performance Evaluation of a New Subcutaneous Glucose Sensor

2010 – PI Ronald Brazg, MD
Accuracy and User Performance Evaluation of An Investigational Modified Blood Glucose Test Strip for Alternative Site Capillary Blood Testing  (included 9 subjects with blood glucose under 75 mg/dL)

2010 – PI -  Leslie Klaff, MD, Ph.D
Labeling Comprehension and Human Factors Clinical Regulatory Study

2010 – PI – Ronald Brazg, MD
A Study of An Investigational Glucose Test Strip Patient Vs. Technician Capillary Evaluation

2009 – PI – Ronald Brazg, MD                                     
Accuracy and User Performance Evaluation of An Investigational Blood Glucose Test Strip for Finger and Alternative Site Capillary Blood Testing

2009 – PI – Ronald Brazg, MD                                     
Accuracy and User Performance Evaluation of An Investigational Blood Glucose Test Strip for Finger and Alternative Site Capillary Blood Testing

2009  - PI - Ronald Brazg, MD
A Study of An Investigational Glucose Test Strip Patient Vs. Technician Capillary Evaluation

2009  - PI – Ronald Brazg, MD

An Inpatient Evaluation of a Six-Day Subcutaneous Glucose Sensor Performance

2009  - PI – Leslie Klaff, MD, Ph.D

A Study to Determine the Comprehensibility of the User Instructions for the A Marketed Home Collection Kit

2009 –PI – Leslie Klaff, MD, Ph.D

An Investigational Blood Glucose Monitoring System Professional and Lay User Performance, Labeling Comprehension, AST, and Marketing Claims Regulatory Study

2009 –PI – Leslie Klaff, MD, Ph.D

Accuracy Evaluation of the Modified Investigational Blood Glucose Test Strip for Venous Blood Testing

2009 –PI – Leslie Klaff, MD, Ph.D  

Comparison of Glycemic Control Among Diabetics Using An Investigational Pen Needle Versus the 8mm x 31G BD Pen Needle and the 5mm x 31G BD Pen Needle

2009 – PI – Leslie Klaff, MD, Ph.D
Ultrasound Evaluation of the Skin and Subcutaneous Layer Thickness of Anatomical Sites Commonly Used for Subcutaneous Insulin Injections.

2008 –PI – Ronald Brazg, MD
Patient Reporting of Type 2 Diabetes Symptoms

2008 - PI - Ronald Brazg, MD
In Clinic Evaluation of An Investigational Continuous Glucose Monitoring System

2008 - PI - Leslie Klaff, MD, Ph D
A Study of an Investigational Blood Glucose Monitoring System Lay User and Professional Clinical Accuracy, Labeling Comprehension, Human Factors, and AST Regulatory Study