Fear of Hypoglycemia and Glycemic Variability

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-06-30

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Type 1 Diabetes

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No