NCT01640223

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 5, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 13, 2012

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

October 27, 2014

Status Verified

October 1, 2014

Enrollment Period

7 months

First QC Date

July 5, 2012

Last Update Submit

October 24, 2014

Conditions

Type 1 Diabetes

Outcome Measures

Primary Outcomes (1)

  • Percentage of data collected

    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.

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

Study Arms (2)

D-3 sensor

EXPERIMENTAL

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

Device: Dexcom7

D-1 sensor

EXPERIMENTAL

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

Device: Dexcom7

Interventions

Dexcom7DEVICE

patients will wear 2 Dexcom sensors 3 days before hospitalization.

D-3 sensor

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Chu Montpellier

Montpellier, Montpellier, 34295, France

Location

CHU Toulouse

Toulouse, Toulouse, 31403, France

Location

CHU Jean Minjoz

Besançon, 25030, France

Location

CHU de Caen

Caen, 14000, France

Location

Centre Hospitalier Sud Francilien

Corbeil-Essonnes, 91106, France

Location

University Hospital Grenoble

Grenoble, 38043, France

Location

CHU de Nancy

Nancy, 54500, France

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Guillaume CHARPENTIER, MD

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

    STUDY CHAIR

  • Bruno GUERCI, MD PHD

    Central Hospital, Nancy, France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 5, 2012

First Posted

July 13, 2012

Study Start

March 1, 2012

Primary Completion

October 1, 2012

Study Completion

October 1, 2012

Last Updated

October 27, 2014

Record last verified: 2014-10

Locations

FR(7)