Status:
COMPLETED
MD Logic Pump Advisor- Adults Study
Lead Sponsor:
Rabin Medical Center
Collaborating Sponsors:
Medtronic
Conditions:
Type 1 Diabetes
Insulin Pump Therapy
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
Prospective, randomized, controlled, 30-78 days trial comparing MD-Logic pump algorithm to the standard of care of patients with type 1 diabetes. The objective of this feasibility study is to evaluat...
Detailed Description
the MD-Logic Pump Advisor was design by the Diabetes Technology Center, the Institute of Endocrinology and Diabetes, National Center for Childhood Diabetes, Schneider Children's Medical Center of Isra...
Eligibility Criteria
Inclusion
- Subject with Type 1 diabetes (\>1yr since diagnosis)
- Medtronic( MiniMed Paradigm 522, 512 , 722 or 712) insulin infusion pump CSII therapy for at least 3 months
- Age ≥ 18 years
- HbA1c at inclusion ≥ 6.0%
- No concomitant diseases that influence metabolic control
- No current use of CGM
- Subjects do not participate in any other interventional study
Exclusion
- Known or suspected allergy to trial products.
- Any significant diseases or conditions including psychiatric disorders and substance abuse that, in the opinion of the investigator, is likely to affect the subject's ability to complete the study, or compromise patient safety
- Subject is currently using CGM device
- Diabetic ketoacidosis in the past 3 months.
- Severe hypoglycemia resulting in seizure or loss of consciousness in the month prior to enrollment.
- Current use of oral glucocorticoids or other medications, which in the judgment of the investigator would be a contraindication to participation in the study.
- Subject is participating in another drug or device study that could affect glucose measurements or glucose management.
- Female subject who is pregnant or planning to become pregnant within the planned study duration
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2016
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT01157923
Start Date
July 1 2010
End Date
July 1 2016
Last Update
January 11 2017
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Schneider Children's Medical center
Petaach-Tikva, Israel, 49202
2
University Children's Hospital
Ljubljana, Slovenia