DiaPort Closed-Loop Artificial Pancreas

University Hospital Center (CHU)

Status: Completed

Conditions: Type 1 Diabetes Mellitus

Treatments: Device: Artificial Pancreas for DiaPort system with Zone-MPC algorithm

Study type: Interventional

Funder types: Other

Identifiers

NCT01555788

ID-RCB : 2011-A001212-39 (Other Identifier)

8829

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

10 participants in 1 patient group

Type 1 diabetic population

Experimental group

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).

Treatment:

Device: Artificial Pancreas for DiaPort system with Zone-MPC algorithm