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

Not Applicable

Completed

• Conditions: Type 1 Diabetes
• Interventions: Other: Blood samples

• Registration Number: NCT01282567
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-01-20
• Study First Submitted QC: 2011-01-24
• Study First Posted: 2011-01-25
• Study Start: 2011-05
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-02
• Last Update Posted: 2012-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
diabetic patients	Blood samples	-

Primary Outcome Measures

Name	Time	Method
Dosage of plasma insulin concentration and blood glucose every 20 minutes during 6 hours and 40 minutes	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®.

Trial Locations

Locations (1)

Rennes University Hospital; 🇫🇷 Rennes, Brittany, France