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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01640223

Acronym

DiabeloopWP3

Enrollment

Registered

2012-07-13

Start date

2012-03-31

Completion date

2012-10-31

Last updated

2014-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 1 Diabetes

Brief summary

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.

Interventions

DEVICEDexcom7

patients will wear 2 Dexcom sensors 3 days before hospitalization.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Percentage of data collected	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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026