We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01282567
Recruitment Status : Completed
First Posted : January 25, 2011
Last Update Posted : February 3, 2012
Sponsor:
Information provided by (Responsible Party):
Rennes University Hospital

Brief Summary:

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 or disease Intervention/treatment
Type 1 Diabetes Other: Blood samples

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Preliminary Study for the Artificial Pancreas Project : Determination of a Tuning Strategy of Metabolic Profiles
Study Start Date : May 2011
Primary Completion Date : September 2011
Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. 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®.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT01282567     History of Changes
Other Study ID Numbers: 2010-A01455-34
LOC/10-18
First Posted: January 25, 2011    Key Record Dates
Last Update Posted: February 3, 2012
Last Verified: February 2012

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