Status:
COMPLETED
Treatment Satisfaction of Using OmniPod System Compared With Conventional Insulin Pump in Adults With Type 1 Diabetes
Lead Sponsor:
Rabin Medical Center
Conditions:
Type 1 Diabetes
Eligibility:
All Genders
18-35 years
Phase:
NA
Brief Summary
Randomized, two arms, open study in order to evaluate treatment satisfaction of using OmniPod system compared with conventional insulin pump in adults with type 1 diabetes. The study will include two...
Detailed Description
A Randomized, two arms, open, crossover study in order to evaluate treatment satisfaction of using OmniPod system compared with conventional insulin pump in adults with type 1 diabetes. The study wil...
Eligibility Criteria
Inclusion
- Type 1 diabetes diagnosed at least 1 year prior to study entry
- Use of continuous subcutaneous insulin infusion therapy for at least one year
- Age: 18-35 years old
- HbA1c \>8.0
- At least 4 self blood glucose measurements per day
- No more than one severe hypoglycaemic or ketoacidosis episode within the past year and none within the past month
- Capable of reading pump screen in English
- Able to understand and sign subject informed consent forms
Exclusion
- Any significant disease or conditions, including psychiatric disorders that in the opinion of the principal investigator are likely to effect subject compliance or the subjects ability to complete the study.
- Patients participating in other device or drug studies
- Clinical diagnosis of hypoglycaemic unawareness
- Known dermal hypersensitivity to products that contain medical adhesive
- Taking prescription medications that could complicate the management of glycemic control.
- Inability to understand/complete the Treatment satisfaction questionnaire
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2011
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00935129
Start Date
August 1 2009
End Date
February 1 2011
Last Update
May 8 2012
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Schnider children's medical center
Petah Tikva, Israel, 49202