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DiaPort Closed-Loop Artificial Pancreas

This study is currently recruiting participants.
Verified March 2012 by University Hospital, Montpellier
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier
ClinicalTrials.gov Identifier:
NCT01555788
First received: February 28, 2012
Last updated: March 14, 2012
Last verified: March 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Type 1 Diabetes Mellitus
 Device: Artificial Pancreas for DiaPort system with Zone-MPC algorithm
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Closed Loop Artificial Pancreas Using Intraperitoneal (IP) Insulin Via DiaPort®

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital, Montpellier:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

    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 [ 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) ] [ Designated as safety issue: No ]
    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) [ Time Frame: during the 2 hospitalisations period when loop is closed (for a total of 24 hours) ] [ Designated as safety issue: No ]
    All analyses will include a comparison of the results in the Intraperitoneal versus Subcutaneous study days.

  • 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) ] [ Designated as safety issue: No ]
    • 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


Estimated Enrollment: 10
Study Start Date: February 2012
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).
 Device: 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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01555788

Contacts
Contact: Eric ER RENARD, MD, PU-PH + 33 4 67 33 83 82 e-renard@chu-montpellier.fr
Contact: Anne AF FARRET, MD + 33 4 67 33 83 82 a-farret@chu-montpellier.fr

Locations
France
Montpellier University Hospital Recruiting
Montpellier, France, 34000
Contact: Eric ER RENARD, MD, PU-PH     +33 4 67 33 83 82     e-renard@chu-montpellier.fr    
Contact: Anne AF FARRET, MD     +33 4 67 33 83 82     a-farret@chu-montpellier.fr    
Principal Investigator: Eric ER RENARD, MD, PU-PH            
Sub-Investigator: Anne AF FARRET, MD            
Sponsors and Collaborators
University Hospital, Montpellier
Investigators
Principal Investigator: Eric ER RENARD, MD, PU-PH Montpellier University Hospital
  More Information

No publications provided

Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT01555788     History of Changes
Other Study ID Numbers: UF 8829, ID-RCB : 2011-A001212-39
Study First Received: February 28, 2012
Last Updated: March 14, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Committee for the Protection of Personnes

Keywords provided by University Hospital, Montpellier:
type 1 diabetes,
diaport,
artificial pancreas,
 zone mpc algorithm,
ap system,
intraperitoneal insulin

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin
 Pancreatin
Pancrelipase
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Gastrointestinal Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013