- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01555788
DiaPort Closed-Loop Artificial Pancreas
Closed Loop Artificial Pancreas Using Intraperitoneal (IP) Insulin Via DiaPort®
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
During this study, the investigators would like to evaluate the intra-peritoneal insulin delivery as a potential breakthrough method for delivering insulin within the artificial pancreas system.
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Montpellier, France, 34000
- Montpellier University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patient must be aged between 18 (inclusive) and 65 years old
- 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:
- Unwilling to perform repeated glucose checks, consume standardized meals, and/or take insulin as instructed
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: 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).
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of time spent with blood glucose between 3.9 and 8.0 mmol/L (79 - 144 mg/dl)
Time Frame: in the post prandial period (8 first hours after meal) during the in-clinic closed-loop 24-hour study period
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Percentage of time spent with blood glucose between 3.9 and 8.0 mmol/L (79 - 144 mg/dl):
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in the post prandial period (8 first hours after meal) during the in-clinic closed-loop 24-hour study period
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean and standard deviation blood glucose
Time Frame: For the early postprandial period (first 4 hours after meal) and for the non-postprandial periods (from 8 hours after meal until next meal)
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All analyses will include a comparison of the results in the Intraperitoneal versus Subcutaneous study days.
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For the early postprandial period (first 4 hours after meal) and for the non-postprandial periods (from 8 hours after meal until next meal)
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Percentage of time spent in hypoglycemia with blood glucose <3.3mmol/l (60 mg/dl)
Time Frame: during the 2 hospitalisations period when loop is closed (for a total of 24 hours)
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All analyses will include a comparison of the results in the Intraperitoneal versus Subcutaneous study days.
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during the 2 hospitalisations period when loop is closed (for a total of 24 hours)
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Percentage of time spent in hyperglycemia
Time Frame: in the early postprandial period (first 4 hours after meal) and in the basal or late postprandial period (from 8 hours after meal until next meal)
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in the early postprandial period (first 4 hours after meal) and in the basal or late postprandial period (from 8 hours after meal until next meal)
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Eric ER RENARD, MD, PU-PH, Montpellier University Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 8829
- ID-RCB : 2011-A001212-39 (OTHER: Afssaps)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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