Type 1 Diabetes | Performance Study of the SOLO 2.0 Insulin Pump
Type 1 Diabetes research study
What is the primary objective of this study?
The Purpose of the study is to to evaluate the performance of the SOLO (version 2.0) micropump insulin delivery system, in Type 1 diabetic patients who use insulin pumps for their treatment.
Who is eligible to participate?
Inclusion Criteria: - Age range: - 16 to 65 years (Graz) - 18 to 65 years (Israel) - Diabetic insulin pump user with diagnosis duration of more than 6 months. - Subjects who are using Humalog®, NovoRapid®/NovoLog or Apidra® 100U/ml in- - Measures glucose at least four times per day. - No more than one severe hypoglycemic or ketoacidosis episode within one year - Willing to sign an informed consent. - Cooperative, willing to attend all study visits Exclusion Criteria: - A1c >= 10.0% - Two or more documented events of severe hypoglycemia within the previous 12 months - Diabetes related hospitalization over the past 12 months - Current significant diabetes-related complications - Pregnant, lactating or planning to become pregnant during the course of the study - Substance or alcohol abuse - Uncontrolled hypertension - Known dermal hypersensitivity to medical adhesive - Recurrent episodes of skin infections or dermatological allergies - Serious or unstable medical or psychological conditions - Current participation in other clinical studies. - Working for a competitor company
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Type 1 Diabetes
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Device:SOLO insulin pumpUse of the SOLO insulin pump for treatment of type 1 diabetes.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Start Date: July 2011
Primary Outcome: Device related safety issues
Secondary Outcome: Diabetes-related adverse outcome
Study sponsors, principal investigator, and references
Principal Investigator: Thomas Pieber, MD
Lead Sponsor: Medingo Ltd