Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2025-12-28 @ 11:59 PM
Study NCT ID:
NCT02790060
Status:
COMPLETED
Last Update Posted:
2016-10-11
First Post:
2016-02-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fear of Hypoglycemia and Glycemic Variability
Sponsor:
Poitiers University Hospital
Organization:
Study Overview
Official Title:
Peur De l'Hypoglycémie et Variabilité Glycémique Chez Les Sujets Diabétiques de Type 1
Status:
COMPLETED
Status Verified Date:
2016-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VARDIA
Brief Summary:
Subjects with type 1 diabetes are invited to provide usual blood glucose monitoring and a blood glucose profile (Pre/ post prandial Blood Glucose + Night Blood Glucose) on 3 occasions in a 2 week time period, in addition to the filling of 5 questionnaires including fear of hypoglycemia-2 questionnaire.
Detailed Description:
Subjects with type 1 diabetes are invited to provide usual blood glucose monitoring and a blood glucose profile (Pre/ post prandial Blood Glucose + Night Blood Glucose) on 3 occasions in a 2 week time period, in addition to the filling of questionnaires including fear of hypoglycemia-2 questionnaire.
Biobanking of urine/blood Collection of key medical informations by investigators
Questionnaires :
* socio-economic status
* Fear of hypoglycemia-2
* Anxiety Depression scale (HAD)
* Health survey (SF36, SF12)
* Satisfaction to treatment (DHP-18)
* Dutch Eating Behavior Questionnaire (DEBQ)
* Pittsburgh quality of sleep (PSQI)
* Blood Glucose diary
Biobanking of urine/blood Collection of key medical informations by investigators
Questionnaires :
* socio-economic status
* Fear of hypoglycemia-2
* Anxiety Depression scale (HAD)
* Health survey (SF36, SF12)
* Satisfaction to treatment (DHP-18)
* Dutch Eating Behavior Questionnaire (DEBQ)
* Pittsburgh quality of sleep (PSQI)
* Blood Glucose diary
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: