DiaPort Closed-Loop Artificial Pancreas

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Type 1 Diabetes Mellitus

Intervention / Treatment
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* Device: Artificial Pancreas for DiaPort system with Zone-MPC algorithm


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Type 1 diabetic population<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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) | 
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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type 1 diabetes,, diaport,, artificial pancreas,, zone mpc algorithm,, ap system,, intraperitoneal insulin