DiaPort Closed-Loop Artificial Pancreas

Sponsor

University Hospital, Montpellier (Other)

Overall Status

Completed

CT.gov ID

NCT01555788

Collaborator

(none)

Enrollment

Location

Arm

12.9

Duration (Months)

0.8

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Type 1 Diabetes Mellitus	Device: Artificial Pancreas for DiaPort system with Zone-MPC algorithm	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Closed Loop Artificial Pancreas Using Intraperitoneal (IP) Insulin Via DiaPort®

Study Start Date :

Feb 1, 2012

Actual Primary Completion Date :

Mar 1, 2013

Actual Study Completion Date :

Mar 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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.

Outcome Measures

Primary Outcome Measures

Percentage of time spent with blood glucose between 3.9 and 8.0 mmol/L (79 - 144 mg/dl) [in the post prandial period (8 first hours after meal) during the in-clinic closed-loop 24-hour study period]
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 [For the early postprandial period (first 4 hours after meal) and for the non-postprandial periods (from 8 hours after meal until next meal)]
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) [during the 2 hospitalisations period when loop is closed (for a total of 24 hours)]
All analyses will include a comparison of the results in the Intraperitoneal versus Subcutaneous study days.
Percentage of time spent in hyperglycemia [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)]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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