Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
38 participants
INTERVENTIONAL
2012-01-31
2013-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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MDRS system
Participants will be using the MDRS system combined with their regular treatment with Continuous Glucose Monitoring during nightime for 2 weeks. The MDRS will allow the supervising personal to get real time remote data of glucose level and to alarm the patients and intervene in cases such as pending hypoglycemia, long standing hyperglycemia or technical faults
MDRS System (Remote & Safety diabetes management system)
Participants will be using the MDRS system combined with their regular Continuous Glucose Monitoring during nightime for 2 weeks. The MDRS will allow the supervising personal to get real time remote data of glucose level and to alarm the patients and intervene in cases such as pending hypoglycemia, long standing hyperglycemia or technical faults
Continuous Glucose Monitoring
Participants will be using their regular Continuous Glucose Monitoring during nightime for 2 weeks, without using the MDRS remote control system
Continuous Glucose Monitoring
Participants will be using their regular Continuous Glucose Monitoring during nightime for 2 weeks, without using the MDRS remote control system
Interventions
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MDRS System (Remote & Safety diabetes management system)
Participants will be using the MDRS system combined with their regular Continuous Glucose Monitoring during nightime for 2 weeks. The MDRS will allow the supervising personal to get real time remote data of glucose level and to alarm the patients and intervene in cases such as pending hypoglycemia, long standing hyperglycemia or technical faults
Continuous Glucose Monitoring
Participants will be using their regular Continuous Glucose Monitoring during nightime for 2 weeks, without using the MDRS remote control system
Eligibility Criteria
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Inclusion Criteria
* Continuous subcutaneous insulin infusion pump for at least 3 month prior to study entry
* Use of continuous glucose measurement device for at least one month prior to study entry
* Age: 4-24 years old
* HbA1c \< =8.5%
* No more than one severe hypoglycemia or an episode diabetic ketoacidosis within the year prior to study entry, and none within the month prior to study entry.
* Capable of reading a pump screen in English
* Capable of operating the MDRS software
* A patient older than 18 years- leaving routinely with at least one more adult(age above 18 years) capable of connecting the C\&C center and properly reacting to the instructions given by the attending personal.
* A patient younger than 18 years- leaving routinely with at least two adults (age above 18 years) capable of connecting the C\&C center and properly reacting to the instructions given by the attending personal.
* All participants must provide an adult independent contact person, leaving near by the participant, capable of connecting the C\&C center and properly reacting to the instructions given by the attending personal. This person will be called into action in emergency cases in which the participant or his household members can not be reached.
* Capable of completing the hypoglycemia the relevant surveys
* Able to understand and sign an informed consent forms
Exclusion Criteria
* Patients participating in other device or drug studies
* Known dermal hypersensitivity to trial products or those that contain medical adhesive
* Current use of oral glucocorticoids or other medications, which in the judgment of the investigator would be a contraindication for participation in the study.
* Inability to understand/complete the hypoglycemia fear survey
* Female subject who is pregnant or planning to become pregnant within the planned study duration
4 Years
24 Years
ALL
No
Sponsors
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Rabin Medical Center
OTHER
Responsible Party
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Principal Investigators
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Moshe Phillip, Prof
Role: PRINCIPAL_INVESTIGATOR
Rabin Medical Center
Locations
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Schneider Medical Center
Petah Tikva, , Israel
Countries
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References
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Oron T, Farfel A, Muller I, Miller S, Atlas E, Nimri R, Phillip M. A remote monitoring system for artificial pancreas support is safe, reliable, and user friendly. Diabetes Technol Ther. 2014 Nov;16(11):699-705. doi: 10.1089/dia.2014.0090. Epub 2014 Sep 11.
Other Identifiers
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rmc006447ctil
Identifier Type: -
Identifier Source: org_study_id
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