Fear of Hypoglycemia and Glycemic Variability (VARDIA)

Poitiers University Hospital

Status: Completed

Conditions: Type 1 Diabetes

Study type: Observational

Funder types: Other

Identifiers

NCT02790060

VARDIA

Details and patient eligibility

About

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.

Full 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

Enrollment: 600 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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