DiaPort Closed-Loop Artificial Pancreas

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01555788
• Date of registration: 28/02/2012
• Primary sponsor: University Hospital, Montpellier
• Public title: DiaPort Closed-Loop Artificial Pancreas
• Scientific title: Closed Loop Artificial Pancreas Using Intraperitoneal (IP) Insulin Via DiaPort®
• Date of first enrolment: February 2012
• Target sample size: 10
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT01555788
• Study type: Interventional
• Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

France

Contacts

• Name: Eric ER RENARD, MD, PU-PH

• Name: Eric ER RENARD, MD, PU-PH

• Name: Eric ER RENARD, MD, PU-PH
• Affiliation: Montpellier University Hospital

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Type 1 Diabetes Mellitus

Intervention(s)

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

Primary Outcome(s)

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]

Secondary Outcome(s)

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)]

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)]

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)]

Secondary ID(s)

ID-RCB : 2011-A001212-39

UF 8829

Source(s) of Monetary Support

Please refer to primary and secondary sponsors