Status:
COMPLETED
Overnight MD-Logic
Lead Sponsor:
Rabin Medical Center
Conditions:
Type 1 Diabetes
Eligibility:
All Genders
10-65 years
Phase:
NA
Brief Summary
Study design: Multicenter,randomized, prospective, open label, cross over, six segments, pilot trial to evaluate blood glucose control overnight under closed-loop insulin delivery with MD-Logic Artifi...
Detailed Description
In the last two decades, remarkable technological progress has been made with the development of continuous glucose sensors, miniature devices, implantable pumps and sensors and wireless communication...
Eligibility Criteria
Inclusion
- Subject with Type 1 diabetes (\>1yr since diagnosis)
- Insulin infusion pump therapy for at least 3 months
- Patients whom uses continuous glucose sensor for at least 2 weeks(for segment 5) or will undergo run-in period of 2 weeks of glucose sensor wear before continue to baseline assessment (only for patients participating at segment 3 and 4)
- Age ≥ 10 years until 65 years
- HbA1c at inclusion ≥ 6.5 and \<10
- Patients willing to follow trail instructions
- Patients live with at least one other adult person (segment 3, 5, and 6 only)
- BMI Standard Deviation Score - below the 97th percentile for age(in segment 5 and 6 BMI SDS - below the 95th percentile for age)
- An internet connection at patient's home (only for patients participating at segment 3 and 6)
- Patients with care givers who are capable of operating a computer based system
Exclusion
- Concomitant diseases that influence metabolic control
- Participation in any other interventional study
- 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
- Diabetic ketoacidosis in the past 1 month.
- 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.
Key Trial Info
Start Date :
March 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2017
Estimated Enrollment :
151 Patients enrolled
Trial Details
Trial ID
NCT01238406
Start Date
March 1 2011
End Date
January 1 2017
Last Update
January 11 2017
Active Locations (3)
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1
Diabetes -Zentrum fuer kinder und jugendliche
Hanover, Germany, 30173
2
Schneider Children's Medical center
Petah Tikva, Israel, 49202
3
University Children's Hospital
Ljubljana, Slovenia, SI-1000