Fear of Hypoglycemia and Glycemic Variability

Completed

• Conditions: Type 1 Diabetes

• Registration Number: NCT02790060
• Lead Sponsor: Poitiers University Hospital

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

Study Timeline

• Study Start: 2015-06
• Study First Submitted: 2016-02-02
• Status Verified: 2016-05
• Study First Submitted QC: 2016-05-30
• Primary Completion: 2016-06
• Study First Posted: 2016-06-03
• Last Update Submitted: 2016-10-10
• Last Update Posted: 2016-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Fear of hypoglycemia score	2 weeks	hypoglycemia questionnaire and hypoglycemia reported by patients

Secondary Outcome Measures

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

Trial Locations

Locations (9)

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, France