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

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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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chu Montpellier, Montpellier, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexcom7

Device

patients will wear 2 Dexcom sensors 3 days before hospitalization.

Primary outcomes

Percentage of data collected

Time frame: Blood glucose and insuline will be collected during the hospital stay of patient (in average 25 hours)

The aim of the study is data collection of patient blood glucose and insulin in patients treated with continuous subcutaneous infusion insulin pump with a patchpump (JewelPUMPTM Debiotech) and equipped with two glucose sensors for the development of the control algorithm glucose.

Blood sample are done every hour (achievement of glucose and insulin assays) ans every 15 minutes during 2 hours after meals.

Sponsors and collaborators

Lead sponsor

Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète

Other

Registry information

Official study title

SEMI-CLOSED LOOP "FOR THE CONTROL OF BLOOD GLUCOSE IN DIABETIC SUBJECTS DIABELOOP First CLINICAL PROJECT: Under Project 3 (UP3), CREATING A DATABASE

Acronym: DiabeloopWP3

Important dates

Study start: 2012
Primary completion: 2012
Study completion: 2012
First posted: Jul 13, 2012
Registry last updated: Oct 27, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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