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
NA
12 participants
INTERVENTIONAL
2014-01-31
2017-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
Study Groups
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experimental
Night under closed loop system
Artificial pancreas system consisting of a predictive rule-based algorithm integrated on the Medtronic Portable Glucose Control System (PGCS)
Interventions
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Artificial pancreas system consisting of a predictive rule-based algorithm integrated on the Medtronic Portable Glucose Control System (PGCS)
Eligibility Criteria
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Inclusion Criteria
* Diabetes duration \> 3 years
* Continuous Subcutaneous Insulin Infusion (CSII) treatment for more than 1 year
* A1c 6-9%
* No ketoacidosis during the previous 12 months
* Glomerular Filtration Rate (GFR) \> 60 ml/kg/min m2
* Willingness of participate and signed and dated written informed consent in accordance with Good Clinical Practice
Exclusion Criteria
* Hypoglycemia unawareness
* Uncorrected visual impairment
* Deafness
* BMI\> 35 kg/m2
18 Years
70 Years
ALL
No
Sponsors
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Corporacion Parc Tauli
OTHER
Responsible Party
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Mercedes Rigla
MD, PhD
Principal Investigators
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Mercedes Rigla, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Parc Tauli University Hospital
Locations
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Parc Tauli University Hospital
Sabadell, Barcelona, Spain
Countries
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Other Identifiers
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NIGHT CONTROL
Identifier Type: -
Identifier Source: org_study_id
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