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OpenTrials
Completed

NCT Number: NCT02790060

Fear of Hypoglycemia and Glycemic Variability

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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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital of Tours, Tours, France

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Fear of hypoglycemia score

    Time frame: 2 weeks

    hypoglycemia questionnaire and hypoglycemia reported by patients

Secondary outcomes

  1. quality of life

    Time frame: from 2 weeks up to 3 months

    SF12 questionnaire done once at home and sent at least 2 weeks after onsite visit

  2. Standard Deviation (SD) of recorded Home Monitoring of Blood Glucose (HMPG)

    Time frame: 2 weeks

    reports of 2 weeks 4 points profil of HMPG and 3 days of 7 points profil of HMPG

Sponsors and collaborators

Lead sponsor

Poitiers University Hospital

Other

Registry information

Official study title

Peur De l'Hypoglycémie et Variabilité Glycémique Chez Les Sujets Diabétiques de Type 1

Acronym: VARDIA

Important dates

Study start
2015
Primary completion
2016
First posted
Jun 3, 2016
Registry last updated
Oct 11, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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