- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01282567
Study for the Artificial Pancreas Project : Determination of a Tuning Strategy of Metabolic Profiles
Preliminary Study for the Artificial Pancreas Project : Determination of a Tuning Strategy of Metabolic Profiles
The Artificial Pancreas Project developed by SUPELEC and the University Hospital of Rennes is focused on the evaluation of an original control algorithm that computes appropriate subcutaneous insulin infusion in response to continuous glucose measurements The results during a 24-hour closed-loop period will be compared with those of the open-loop. The implementation of this algorithm named Error Dynamics Shaping (EDS) requires as a preliminary a phase of identification of the parameters of the model (insulin pharmacokinetics and effect on glucose metabolism) followed by a phase of optimization i.e. a personalized adjustment of the damping parameters of EDS.
The present study aims to formalize this procedure of identification/optimization of the parameters of the model and controller EDS. They will be determined in type -1 diabetic patients using insulin therapy and under conditions free from disturbances such as those generated by the glucidic meals, i.e. during a period of glucidic fast. Three variables will determine this procedure: blood glucose, insulin concentration and insulin doses.
Study Overview
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Brittany
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Rennes, Brittany, France, 35033
- Rennes University Hospital
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Type 1 diabetic patients (age : 18-70)
- Diabetes duration higher than three years
- Insulin pump with Humalog®
- Hospitalized for a 24-hour glucidic fast test
- Written informed consent
Exclusion Criteria:
- Pregnancy or nursing
- Acute infectious disease
- Corticoid treatment
- Creatinine clearance <40 ml/mn
- Patients using Apidra® or Novorapid®
- People major being the object of a legal protection (safeguard of justice, supervision, trusteeship)
Study Plan
How is the study designed?
Design Details
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: diabetic patients
|
The study will be proposed to four patients hospitalized in the Diabetes Unit for a glucidic fast test carried out during 24 hours (lunch, dinner and breakfast).
Blood samples will be taken every 20 minutes during 6 hours and 40 minutes to measure plasma insulin concentration and blood glucose.
T0 will correspond to the first modification of the insulin basal flow (in more or less) or to the first insulin bolus corrector, usually administered if capillary blood glucose reaches 1.8 g/l.
The capillary blood glucose monitoring will be performed every two hours by the nurse.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dosage of plasma insulin concentration and blood glucose every 20 minutes during 6 hours and 40 minutes
Time Frame: 3 months
|
Identification of the eight parameters of the model including the five parameters of the glucose/insulin metabolism (p1, p2, p3, GB and Ib) and the three parameters of the model of subcutaneous insulin absorption Optimization of the four damping parameters of EDS. These coefficients can be tuned to adjust the damping degree of the error dynamics. These procedures of identification and optimization will be carried out under Matlab® and Simulink®. |
3 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Isabelle Guilhem, Rennes University Hospital
- Principal Investigator: jean-yves poirier, Rennes University Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2010-A01455-34
- LOC/10-18
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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