Type 1 Diabetes Clinical Trial
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.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | |
Est. primary completion date | July 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 16 Years to 65 Years |
Eligibility |
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 |
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Israel | Schneider Medical Center | Petach Tikva | |
Israel | Sourasky Medical Center, | Tel Aviv |
Lead Sponsor | Collaborator |
---|---|
Medingo Ltd |
Israel,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Device related safety issues | Subject complaints documented in the R&D questionnaire and Complaint Report Forms which were assessed and found to be device related safety issues. | with in the first month of use | Yes |
Primary | SOLO use errors | Use errors or potential use errors reported in Subject Diary which may be related to SOLO safety. | within the first month of use | Yes |
Primary | Device-related adverse outcome | Device-related adverse outcome, such as significant skin irritation or infection at the attachment site | within the first month of use | Yes |
Secondary | Diabetes-related adverse outcome | Diabetes-related adverse outcome. i.e. hypoglycemia, hyperglycemia and diabetic ketoacidosis (DKA) events. | with in first month of use | Yes |
Secondary | Satisfaction iwth SOLO | Subject satisfaction with SOLO as reported in: SOLO performance questionnaire DTSQ analysis |
within the first month of use | No |
Secondary | Product quality (MTBF) | Product quality will be assessed by Mean Time Between Failures (MTBF) calculation that include three types of failure modes: Type 1: Non-functional device Type 2: Dysfunction that can be recovered by the subject Type 3: Minor issues reported by the user |
within the first month of use | No |
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