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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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12 December 2020 |
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Main ID: |
NCT03047486 |
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Date of registration:
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07/02/2017 |
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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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Smartguard Use in Real Life : a Longitudinal Study in Patients With Type 1 Diabetes
Smartguard |
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Scientific title:
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Smartguard Use in Real Life : a Longitudinal Study in Patients With Type 1 Diabetes |
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Date of first enrolment:
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February 1, 2017 |
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Target sample size:
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30 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03047486 |
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Study type:
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Observational |
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Study design:
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Phase:
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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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Michael JOUBERT, 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, Caen |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Type 1 diabetes = 1 year
- CSII = 6 months
- Previous education to flexible insulin therapy
- Patient willing to use sensors and smartguard option for 1 year
- A1c = 7.5% and/or severe hypoglycemia = 2 episodes during the last 6 month and/or
recurrent hypoglycemia and/or hypoglycemia unawareness and/or brittle diabetes
Exclusion Criteria:
- No access to a computer and/or to the web making it impossible to follow patients
through telemedicine
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Type 1 Diabetes Mellitus Maturity Onset
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Primary Outcome(s)
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Glucose TIR (time in range) from CGM recording
[Time Frame: change between baseline and after 12 month]
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Glucose Time below range (hypoglycemia < 70 mg/dl) from CGM recording
[Time Frame: change between baseline and after 12 month]
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Secondary Outcome(s)
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HbA1c
[Time Frame: month 0, 3, 6, 9, 12]
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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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