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VARDIA: Fear of Hypoglycemia and Glycemic Variability

Sponsor
Poitiers University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT02790060
Collaborator
(none)
600
Enrollment
9
Locations
66.7
Patients Per Site

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    600 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Peur De l'Hypoglycémie et Variabilité Glycémique Chez Les Sujets Diabétiques de Type 1
    Study Start Date :
    Jun 1, 2015
    Actual Primary Completion Date :
    Jun 1, 2016

    Outcome Measures

    Primary Outcome Measures

    1. Fear of hypoglycemia score [2 weeks]

      hypoglycemia questionnaire and hypoglycemia reported by patients

    Secondary Outcome Measures

    1. quality of life [from 2 weeks up to 3 months]

      SF12 questionnaire done once at home and sent at least 2 weeks after onsite visit

    2. Standard Deviation (SD) of recorded Home Monitoring of Blood Glucose (HMPG) [2 weeks]

      reports of 2 weeks 4 points profil of HMPG and 3 days of 7 points profil of HMPG

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria :

    • type 1 diabetes

    • at least 2 Blood Glucose monitoring daily

    • on insulin for more than 5 years

    Exclusion Criteria :

    • not stable metabolic condition (infection, steroid therapy)

    • below 3 months change in insulin treatment

    • other clinical trial

    • renal failure (eDFG below 30 ml/min/1.73 m²)

    • Pregnancy and/or lactation

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Angers University Hospital Angers France 49100
    2 Brest University Hospital Brest France 29200
    3 La Roche sur Yon Hospital La Roche sur Yon France 85925
    4 La Rochelle Hospital La Rochelle France 17019
    5 CH Bretagne sud Lorient France
    6 Chu de Nantes Nantes France 44035
    7 Poitiers University Hospital Poitiers France 86021
    8 Chu de Rennes Rennes France 35033
    9 University Hospital of Tours Tours France 37170

    Sponsors and Collaborators

    • Poitiers University Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Poitiers University Hospital
    ClinicalTrials.gov Identifier:
    NCT02790060
    Other Study ID Numbers:
    • VARDIA
    First Posted:
    Jun 3, 2016
    Last Update Posted:
    Oct 11, 2016
    Last Verified:
    May 1, 2016
    Keywords provided by Poitiers University Hospital
    diabetes
    Additional relevant MeSH terms:
    Diabetes Mellitus, Type 1

    Study Results

    No Results Posted as of Oct 11, 2016