Fear of Hypoglycemia and Glycemic Variability
VARDIA
Peur De l'Hypoglycémie et Variabilité Glycémique Chez Les Sujets Diabétiques de Type 1
1 other identifier
observational
600
1 country
9
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2015
CompletedFirst Submitted
Initial submission to the registry
February 2, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedFirst Posted
Study publicly available on registry
June 3, 2016
CompletedOctober 11, 2016
May 1, 2016
1 year
February 2, 2016
October 10, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Fear of hypoglycemia score
hypoglycemia questionnaire and hypoglycemia reported by patients
2 weeks
Secondary Outcomes (2)
quality of life
from 2 weeks up to 3 months
Standard Deviation (SD) of recorded Home Monitoring of Blood Glucose (HMPG)
2 weeks
Eligibility Criteria
Type 1 diabetes
You may qualify if:
- type 1 diabetes
- at least 2 Blood Glucose monitoring daily
- on insulin for more than 5 years
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
University Hospital of Tours
Tours, France, 37170, France
Angers University Hospital
Angers, 49100, France
Brest University Hospital
Brest, 29200, France
La Roche sur Yon Hospital
La Roche-sur-Yon, 85925, France
La Rochelle Hospital
La Rochelle, 17019, France
CH Bretagne sud
Lorient, France
Chu de Nantes
Nantes, 44035, France
Poitiers University Hospital
Poitiers, 86021, France
Chu de Rennes
Rennes, 35033, France
Related Publications (1)
Saulnier PJ, Briet C, Gand E, Chaillous L, Dubois S, Bonnet F, Leguerrier AM, Fradet G, Delcourt Crespin I, Kerlan V, Gouet D, Perlemoine C, Ducluzeau PH, Pichelin M, Wargny M, Gonder-Frederick L, Ragot S, Hadjadj S, Cariou B; VARDIA study group. No association between fear of hypoglycemia and blood glucose variability in type 1 diabetes: The cross-sectional VARDIA study. J Diabetes Complications. 2019 Aug;33(8):554-560. doi: 10.1016/j.jdiacomp.2019.05.003. Epub 2019 May 10.
PMID: 31182337DERIVED
Biospecimen
* blood (whole blood + plasma + serum) * urines
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 2, 2016
First Posted
June 3, 2016
Study Start
June 1, 2015
Primary Completion
June 1, 2016
Last Updated
October 11, 2016
Record last verified: 2016-05