Fear of Hypoglycemia and Glycemic Variability (VARDIA)

October 10, 2016 updated by: Poitiers University Hospital

Peur De l'Hypoglycémie et Variabilité Glycémique Chez Les Sujets Diabétiques de Type 1

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Anticipated)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Angers, France, 49100
        • Angers University Hospital
      • Brest, France, 29200
        • Brest University Hospital
      • La Roche sur Yon, France, 85925
        • La Roche Sur Yon Hospital
      • La Rochelle, France, 17019
        • La Rochelle Hospital
      • Lorient, France
        • CH Bretagne Sud
      • Nantes, France, 44035
        • CHU de Nantes
      • Poitiers, France, 86021
        • Poitiers University Hospital
      • Rennes, France, 35033
        • CHU de Rennes
      • Tours, France, 37170
        • University Hospital of Tours

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Type 1 diabetes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fear of hypoglycemia score
Time Frame: 2 weeks
hypoglycemia questionnaire and hypoglycemia reported by patients
2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
quality of life
Time Frame: from 2 weeks up to 3 months
SF12 questionnaire done once at home and sent at least 2 weeks after onsite visit
from 2 weeks up to 3 months
Standard Deviation (SD) of recorded Home Monitoring of Blood Glucose (HMPG)
Time Frame: 2 weeks
reports of 2 weeks 4 points profil of HMPG and 3 days of 7 points profil of HMPG
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Poitiers University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (ACTUAL)

June 1, 2016

Study Registration Dates

First Submitted

February 2, 2016

First Submitted That Met QC Criteria

May 30, 2016

First Posted (ESTIMATE)

June 3, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

October 11, 2016

Last Update Submitted That Met QC Criteria

October 10, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VARDIA

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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