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
10 participants
INTERVENTIONAL
2012-02-29
2013-03-31
Brief Summary
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Detailed Description
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The intent is to exploit the rapid action achieved by IP insulin to compensate for meals and for management of the basal insulin needs. Patients will come for two closed-loop admissions of 24 hours. The first closed-loop will be performed using subcutaneous route, whereas the second one will be performed using the intra-peritoneale route.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Type 1 diabetic population
The only one arm (type 1 diabetic patients treated by basal-bolus insulin and external pumps) of this study will test an artificial pancreas system that uses the intraperitoneal route to deliver insulin (through DiaPort).
Artificial Pancreas for DiaPort system with Zone-MPC algorithm
Artificial pancreas system uses the intraperitoneal route to deliver insulin (through DiaPort) in type 1 diabetic patients treated by basal-bolus insulin and external pumps.
Interventions
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Artificial Pancreas for DiaPort system with Zone-MPC algorithm
Artificial pancreas system uses the intraperitoneal route to deliver insulin (through DiaPort) in type 1 diabetic patients treated by basal-bolus insulin and external pumps.
Eligibility Criteria
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Inclusion Criteria
* Patient must have been clinically diagnosed with Type 1 diabetes mellitus for at least one year
* Patient must have been identified as presenting an indication for the DiaPort® system, i.e. showing poor glucose control under Sc insulin delivery as shown by a sustained HbA1C level \> 8% and/or high blood glucose variability including recurrent hypoglycemic events. Patient will be eligible for the study because he/she will have a DiaPort implanted.
* Patient must demonstrate proper mental status and cognition for the study
* Patient must be affiliated or beneficiary of a social medical insurance
* Patient has signed informed consent form prior to study entry
Exclusion Criteria
* Evidence of cardiovascular event during the previous 6 months, non stabilized retinopathy, or clinically significant screening laboratory abnormalities
* Pregnancy, breast feeding, or intention of becoming pregnant
* Medical condition requiring use of an acetaminophen-containing medication that cannot be withheld for the study admissions.
* Patient is actively enrolled in another clinical trial or was part of study within 30 days or whose annual study income is over 4 500€
* Persons deprived of freedom, adults protected by law or vulnerable persons
18 Years
65 Years
ALL
No
Sponsors
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University Hospital, Montpellier
OTHER
Responsible Party
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Principal Investigators
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Eric ER RENARD, MD, PU-PH
Role: PRINCIPAL_INVESTIGATOR
Montpellier University Hospital
Locations
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Montpellier University Hospital
Montpellier, , France
Countries
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Other Identifiers
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ID-RCB : 2011-A001212-39
Identifier Type: OTHER
Identifier Source: secondary_id
8829
Identifier Type: -
Identifier Source: org_study_id