DiaPort Closed-Loop Artificial Pancreas

Type 1 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01555788
• Other study ID #: 8829
• Secondary ID: ID-RCB : 2011-A0
• Status: Completed
• Phase: N/A
• Start date: February 2012
• Est. completion date: March 2013

Study information

• Verified date: December 2014
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

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.

Locations

Country	Name	City	State
France	Montpellier University Hospital	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	in the post prandial period (8 first hours after meal) during the in-clinic closed-loop 24-hour study period
Secondary	Mean and standard deviation blood glucose	All analyses will include a comparison of the results in the Intraperitoneal versus Subcutaneous study days.	For the early postprandial period (first 4 hours after meal) and for the non-postprandial periods (from 8 hours after meal until next meal)
Secondary	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.	during the 2 hospitalisations period when loop is closed (for a total of 24 hours)
Secondary	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	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)