DiaPort Closed-Loop Artificial Pancreas
Primary Purpose
Type 1 Diabetes Mellitus
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Artificial Pancreas for DiaPort system with Zone-MPC algorithm
Sponsored by
About this trial
This is an interventional treatment trial for Type 1 Diabetes Mellitus focused on measuring type 1 diabetes,, diaport,, artificial pancreas,, zone mpc algorithm,, ap system,, intraperitoneal insulin
Eligibility Criteria
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
Sites / Locations
- Montpellier University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Type 1 diabetic population
Arm Description
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).
Outcomes
Primary Outcome Measures
Percentage of time spent with blood glucose between 3.9 and 8.0 mmol/L (79 - 144 mg/dl)
Percentage of time spent with blood glucose between 3.9 and 8.0 mmol/L (79 - 144 mg/dl):
in the basal or late postprandial period
in the early postprandial period (first 4 hours). All analyses will be done by using the YSI blood glucose measurements unless otherwise noted.
Secondary Outcome Measures
Mean and standard deviation blood glucose
All analyses will include a comparison of the results in the Intraperitoneal versus Subcutaneous study days.
Percentage of time spent in hypoglycemia with blood glucose <3.3mmol/l (60 mg/dl)
All analyses will include a comparison of the results in the Intraperitoneal versus Subcutaneous study days.
Percentage of time spent in hyperglycemia
Percentage of time spent in hyperglycemia with blood glucose >10 mmol/l (180 mg/dl) in the early postprandial period
and Percentage of time spent in hyperglycemia>8mmol/l (144 mg/dl) in the basal or late postprandial period All analyses will include a comparison of the results in the Intraperitoneal versus Subcutaneous study days
Full Information
NCT ID
NCT01555788
First Posted
February 28, 2012
Last Updated
October 18, 2021
Sponsor
University Hospital, Montpellier
1. Study Identification
Unique Protocol Identification Number
NCT01555788
Brief Title
DiaPort Closed-Loop Artificial Pancreas
Official Title
Closed Loop Artificial Pancreas Using Intraperitoneal (IP) Insulin Via DiaPort®
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The primary purpose of this pilot study is to test an artificial pancreas system which uses the intra-peritoneal (IP) route for insulin delivery in type 1 diabetic patients.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes Mellitus
Keywords
type 1 diabetes,, diaport,, artificial pancreas,, zone mpc algorithm,, ap system,, intraperitoneal insulin
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Type 1 diabetic population
Arm Type
Experimental
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
Artificial Pancreas for DiaPort system with Zone-MPC algorithm
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percentage of time spent with blood glucose between 3.9 and 8.0 mmol/L (79 - 144 mg/dl)
Description
Percentage of time spent with blood glucose between 3.9 and 8.0 mmol/L (79 - 144 mg/dl):
in the basal or late postprandial period
in the early postprandial period (first 4 hours). All analyses will be done by using the YSI blood glucose measurements unless otherwise noted.
Time Frame
in the post prandial period (8 first hours after meal) during the in-clinic closed-loop 24-hour study period
Secondary Outcome Measure Information:
Title
Mean and standard deviation blood glucose
Description
All analyses will include a comparison of the results in the Intraperitoneal versus Subcutaneous study days.
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)
Title
Percentage of time spent in hypoglycemia with blood glucose <3.3mmol/l (60 mg/dl)
Description
All analyses will include a comparison of the results in the Intraperitoneal versus Subcutaneous study days.
Time Frame
during the 2 hospitalisations period when loop is closed (for a total of 24 hours)
Title
Percentage of time spent in hyperglycemia
Description
Percentage of time spent in hyperglycemia with blood glucose >10 mmol/l (180 mg/dl) in the early postprandial period
and Percentage of time spent in hyperglycemia>8mmol/l (144 mg/dl) in the basal or late postprandial period All analyses will include a comparison of the results in the Intraperitoneal versus Subcutaneous study days
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric ER RENARD, MD, PU-PH
Organizational Affiliation
Montpellier University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Montpellier University Hospital
City
Montpellier
ZIP/Postal Code
34000
Country
France
12. IPD Sharing Statement
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DiaPort Closed-Loop Artificial Pancreas
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