Creation of a Patient Database for Silicon Patient Simulation, Glucose Sensor Variability and Pharmacokinetic Study of Debiotech Jewelpump

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2012-10-31

Brief Summary

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The aim this study is the acquisition and management of a data base for the development of the glycaemic regulation algorithms. This database will integrate the measures of blood glucose and the glycaemia level of the Dexcom sensor on a regular time, the injections of insulin delivered by Debiotech JewelPUMP and the level of insulin in the blood. This database will also contain the bolus of insulin injected at meals and the content of meals, the reduction insulin level during physical activity and the quantification of this physical activity. A study will also be conducted to compare the pharmacokinetics of a bolus of insulin identical with the JewelPUMP either the usual pump of the patient.

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Detailed Description

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Conditions

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Type 1 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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D-3 sensor

patients will be equiped with 2 Dexcom sensors 3 days before hospitalization

Group Type EXPERIMENTAL

Dexcom7

Intervention Type DEVICE

patients will wear 2 Dexcom sensors 3 days before hospitalization.

D-1 sensor

patients will be equiped with 2 Dexcom sensors one day before hospitalization

Group Type EXPERIMENTAL

Dexcom7

Intervention Type DEVICE

patients will wear 2 Dexcom sensor one day before hospitalization

Interventions

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Dexcom7

patients will wear 2 Dexcom sensors 3 days before hospitalization.

Intervention Type DEVICE

Dexcom7

patients will wear 2 Dexcom sensor one day before hospitalization

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients with diabetes type 1 Treaty by external insulin pump
* Duration of diabetes than 2 years or c indosable peptide
* Practicing insulin functional (IF) or food plan sets
* Patient having a HbA1c \< 10%
* Patient age over 18 years
* Patient having signed the form of collection of free consent and informed
* Patient affiliated with the social security

Exclusion Criteria

* Patients with diabetes type 2
* Patient pregnant or likely to be
* All serious pathologies that can interfere with the study (in particular kidney or heart failure)
* Psychiatric pathologies incompatible with the study

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No