Status:
UNKNOWN
Performance Study of the SOLO 2.0 Insulin Pump
Lead Sponsor:
Medingo Ltd
Conditions:
Type 1 Diabetes
Eligibility:
All Genders
16-65 years
Phase:
NA
Brief Summary
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.
Detailed Description
This is a multi center, one arm, open label and prospective study to assess the safety and quality of the SOLO 2.0 MicroPump Insulin Delivery System, following changes that were done to the SOLO previ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01500928
Start Date
July 1 2011
Last Update
December 29 2011
Active Locations (2)
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1
Schneider Medical Center
Petah Tikva, Israel
2
Sourasky Medical Center,
Tel Aviv, Israel