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Creation of a Patient Database for Silicon Patient Simulation, Glucose Sensor Variability and Pharmacokinetic Study of Debiotech Jewelpump (DiabeloopWP3)

C

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

Status

Completed

Conditions

Type 1 Diabetes

Treatments

Device: Dexcom7

Study type

Interventional

Funder types

Other

Identifiers

NCT01640223
2011-A00726-35

Details and patient eligibility

About

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.

Enrollment

40 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

40 participants in 2 patient groups

D-3 sensor
Experimental group
Description:
patients will be equiped with 2 Dexcom sensors 3 days before hospitalization
Treatment:
Device: Dexcom7
Device: Dexcom7
D-1 sensor
Experimental group
Description:
patients will be equiped with 2 Dexcom sensors one day before hospitalization
Treatment:
Device: Dexcom7
Device: Dexcom7

Trial contacts and locations

7

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Data sourced from clinicaltrials.gov

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