Type 1 Diabetes
Conditions
Keywords
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
Interventions
None listed
Sponsors
Poitiers University Hospital
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fear of hypoglycemia score | 2 weeks | hypoglycemia questionnaire and hypoglycemia reported by patients |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
Countries
France
Outcome results
None listed