Fear of Hypoglycemia and Glycemic Variability

Type 1 Diabetes Clinical Trial

— VARDIA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02790060
• Other study ID #: VARDIA
• Status: Completed
• Phase: N/A
• First received: February 2, 2016
• Last updated: October 10, 2016
• Start date: June 2015

Study information

• Verified date: May 2016
• Source: Poitiers University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Locations

Country	Name	City	State
France	Angers University Hospital	Angers
France	Brest University Hospital	Brest
France	La Roche sur Yon Hospital	La Roche sur Yon
France	La Rochelle Hospital	La Rochelle
France	CH Bretagne sud	Lorient
France	Chu de Nantes	Nantes
France	Poitiers University Hospital	Poitiers
France	Chu de Rennes	Rennes
France	University Hospital of Tours	Tours

Sponsors (1)

Lead Sponsor	Collaborator
Poitiers University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fear of hypoglycemia score	hypoglycemia questionnaire and hypoglycemia reported by patients	2 weeks	No
Secondary	quality of life	SF12 questionnaire done once at home and sent at least 2 weeks after onsite visit	from 2 weeks up to 3 months	No
Secondary	Standard Deviation (SD) of recorded Home Monitoring of Blood Glucose (HMPG)	reports of 2 weeks 4 points profil of HMPG and 3 days of 7 points profil of HMPG	2 weeks	No