NCT01282567

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2011

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 20, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 25, 2011

Completed
3 months until next milestone

Study Start

First participant enrolled

May 1, 2011

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

February 3, 2012

Status Verified

February 1, 2012

Enrollment Period

4 months

First QC Date

January 20, 2011

Last Update Submit

February 2, 2012

Conditions

Type 1 Diabetes

Outcome Measures

Primary Outcomes (1)

  • Dosage of plasma insulin concentration and blood glucose every 20 minutes during 6 hours and 40 minutes

    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

Study Arms (1)

diabetic patients

OTHER
Other: Blood samples

Interventions

Blood samplesOTHER

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.

diabetic patients

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rennes University Hospital

Rennes, Brittany Region, 35033, France

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • jean-yves poirier

    Rennes University Hospital

    PRINCIPAL INVESTIGATOR

  • isabelle guilhem

    Rennes University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 20, 2011

First Posted

January 25, 2011

Study Start

May 1, 2011

Primary Completion

September 1, 2011

Study Completion

September 1, 2011

Last Updated

February 3, 2012

Record last verified: 2012-02

Locations

FR(1)