|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
7 January 2013 |
|
Main ID: |
NCT00541515 |
|
Date of registration:
|
08/10/2007 |
|
Primary sponsor: |
|
|
Public title:
|
Closing the Loop Between Glucose Sensor and Insulin Pump-developing an Algorithm
|
|
Scientific title:
|
Closing the Loop Between Glucose Sensor and Insulin Pump-developing an Algorithm |
|
Date of first enrolment:
|
October 2007 |
|
Target sample size:
|
80 |
|
Recruitment status: |
Recruiting |
|
URL:
|
http://clinicaltrials.gov/show/NCT00541515 |
|
Study type:
|
Interventional |
|
Study design:
|
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
|
|
|
Countries of recruitment
|
|
Israel
| | | | | | | |
|
Contacts
|
|
Name:
|
Moshe Phillip, Prof. |
|
Address:
|
|
|
Telephone:
|
03-9253778 |
|
Email:
|
mosheph@clalit.org.il |
|
Affiliation:
|
|
|
|
Name:
|
Moshe Phillip, Professor |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Schneider Children Medical Center |
| |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
1. Diabetes type 1 for at least one year.
2. ages >10 years.
3. signed informed consent form.
4. willing to cooperate with all study requirements.
Exclusion Criteria:
1. Sensor allergy.
2. Psychiatrist diseases.
3. other chronic diseases.
4. Participation in another study that involves a medicine or a medical device.Subjects
have to finish participating in other studies at least 30 days before joining this
study. Each subject can participate in this study only once.
Age minimum:
10 Years
Age maximum:
65 Years
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Diabetes, Type I
|
|
Intervention(s)
|
|
Device: continuous glucose sensors and insulin pump
|
|
Primary Outcome(s)
|
|
Blood glucose levels
[Time Frame: countinuasly]
|
|
Secondary ID(s)
|
|
rmc004706ctil
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|