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Study for the Artificial Pancreas Project : Determination of a Tuning Strategy of Metabolic Profiles

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Rennes University Hospital
ClinicalTrials.gov Identifier:
NCT01282567
First received: January 20, 2011
Last updated: February 2, 2012
Last verified: February 2012
History of Changes
  Purpose

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.


Condition Intervention
Type 1 Diabetes
 Other: Blood samples

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Preliminary Study for the Artificial Pancreas Project : Determination of a Tuning Strategy of Metabolic Profiles

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Rennes University Hospital:

Primary Outcome Measures:
  • Dosage of plasma insulin concentration and blood glucose every 20 minutes during 6 hours and 40 minutes [ Time Frame: 3 months ] [ Designated as safety issue: No ]

    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®.



Enrollment: 3
Study Start Date: May 2011
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
diabetic patients Other: Blood samples
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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01282567

Locations
France
Rennes University Hospital
Rennes, Brittany, France, 35033
Sponsors and Collaborators
Rennes University Hospital
Investigators
Principal Investigator: jean-yves poirier Rennes University Hospital
Principal Investigator: isabelle guilhem Rennes University Hospital
  More Information

No publications provided

Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT01282567     History of Changes
Other Study ID Numbers: 2010-A01455-34, LOC/10-18
Study First Received: January 20, 2011
Last Updated: February 2, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
 Immune System Diseases
Pancrelipase
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013