Clinical trial NCT02790060: Fear of Hypoglycemia and Glycemic Variability
Official title: Peur De l'Hypoglycémie et Variabilité Glycémique Chez Les Sujets Diabétiques de Type 1
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 1 Diabetes
Keywords: diabetes
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2016-06-03
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Type 1 diabetes

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.

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

Eligibility 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

Primary outcomes:
measure: Fear of hypoglycemia score
timeFrame: 2 weeks
Secondary outcomes:
measure: quality of life
timeFrame: from 2 weeks up to 3 months
measure: Standard Deviation (SD) of recorded Home Monitoring of Blood Glucose (HMPG)
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Angers
country: France
facility: Angers University Hospital
city: Brest
country: France
facility: Brest University Hospital
city: La Roche sur Yon
country: France
facility: La Roche sur Yon Hospital
city: La Rochelle
country: France
facility: La Rochelle Hospital
city: Lorient
country: France
facility: CH Bretagne sud
city: Nantes
country: France
facility: Chu de Nantes
city: Poitiers
country: France
facility: Poitiers University Hospital
city: Rennes
country: France
facility: Chu de Rennes
city: Tours
country: France
facility: University Hospital of Tours
Study officials:
References:
citation: 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.