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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00324584 |
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Date of registration:
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10/05/2006 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Web-Based Follow-Up Using Cellular Phone in Type 1 Diabetic Patients Under Insulin Pump Therapy : The PumpNet Study
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Scientific title:
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Surveillance Des données De l’Autosurveillance glycémique Via Internet Et Le réseau téléphonique GSM Chez Le diabétique De Type 1 Sous Traitement Insulinique Par Pompe Externe : Etude Prospective randomisée PumpNet. |
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Date of first enrolment:
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April 2003 |
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Target sample size:
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40 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00324584 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 3
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Countries of recruitment
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France
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Contacts
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Name:
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Pierre Y Benhamou, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Universty Hospital, Grenoble, France |
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Name:
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Helene Hanaire, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Hospital, Toulouse, France |
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Name:
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Jean L Bosson, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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CIC-INSERM |
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Name:
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Serge Halimi, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Hospital, Grenoble, France |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Type 1 diabetes mellitus
- Age = 18
- HbA1c between 7.5 and 10%
- Treated with continuous subcutaneous insulin infusion for a minimum of 3 months
Exclusion Criteria:
- Unstabilized diabetic microangiopathy
- Ongoing pregnancy or planned pregnancy
- Unwilling to perform a minimum of 4 capillary blood tests per day
- Unable to use the GlucoNet device
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Type 1 Diabetes Mellitus
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Intervention(s)
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Device: Telemonitoring of glucose values using GlucoNet device
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Primary Outcome(s)
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Glycated hemoglobin HbA1c
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monthly mean capillary blood glucose value
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blood glucose variability index (MAGE Index and LBGI index)
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frequency of hypoglycemic episodes (<70 mg/dl)
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quality of life score (DQOL score)
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Secondary ID(s)
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DCIC 03 01
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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