Clinical trial NCT01555788: DiaPort Closed-Loop Artificial Pancreas
Official title: Closed Loop Artificial Pancreas Using Intraperitoneal (IP) Insulin Via DiaPort®
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes Mellitus
Keywords: type 1 diabetes,
diaport,
artificial pancreas,
zone mpc algorithm,
ap system,
intraperitoneal insulin
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2012-03-15
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Percentage of time spent with blood glucose between 3.9 and 8.0 mmol/L (79 - 144 mg/dl)
timeFrame: in the post prandial period (8 first hours after meal) during the in-clinic closed-loop 24-hour study period
Secondary outcomes:
measure: Mean and standard deviation blood glucose
timeFrame: For the early postprandial period (first 4 hours after meal) and for the non-postprandial periods (from 8 hours after meal until next meal)
measure: Percentage of time spent in hypoglycemia with blood glucose <3.3mmol/l (60 mg/dl)
timeFrame: during the 2 hospitalisations period when loop is closed (for a total of 24 hours)
measure: Percentage of time spent in hyperglycemia
timeFrame: 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)
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Montpellier University Hospital
Study officials:
affiliation: Montpellier University Hospital
name: Eric ER RENARD, MD, PU-PH
role: PRINCIPAL_INVESTIGATOR
References: