Type 1 DiabetesVARDIANCT02790060
Fear of Hypoglycemia and Glycemic Variability
An observational study of Type 1 Diabetes, run by Poitiers University Hospital at 9 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type 1 Diabetes
- How many people
- 600 participants
- Where
- 9 sitesFrance
- Study dates
- Jun 2015to Jun 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Type 1 diabetes
Who may be able to join
- type 1 diabetes
- at least 2 Blood Glucose monitoring daily
- on insulin for more than 5 years
Who cannot join
- 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
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
France9 sites
Angers University Hospital
Angers, 49100
Brest University Hospital
Brest, 29200
La Roche sur Yon Hospital
La Roche-sur-Yon, 85925
La Rochelle Hospital
La Rochelle, 17019
CH Bretagne sud
Lorient
Chu de Nantes
Nantes, 44035
Poitiers University Hospital
Poitiers, 86021
Chu de Rennes
Rennes, 35033
University Hospital of Tours
Tours, France, 37170
About this study
Official title: Peur De l'Hypoglycémie et Variabilité Glycémique Chez Les Sujets Diabétiques de Type 1
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.
Read the 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
- Conditions
- Type 1 Diabetes
- Keywords
- diabetes
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus
What is being measured
The primary outcome is the main question the study is designed to answer.
Fear of hypoglycemia score
hypoglycemia questionnaire and hypoglycemia reported by patients
Measured: 2 weeks
Secondary outcomes (2)
quality of life
SF12 questionnaire done once at home and sent at least 2 weeks after onsite visit
Measured: from 2 weeks up to 3 months
Standard Deviation (SD) of recorded Home Monitoring of Blood Glucose (HMPG)
reports of 2 weeks 4 points profil of HMPG and 3 days of 7 points profil of HMPG
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2016 (estimated)
- Study startJun 2015
- Primary completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by Poitiers University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02790060
- Sponsor's protocol ID
- VARDIA
- Acronym
- VARDIA
- Status last verified
- May 2016
- First submitted
- 2 Feb 2016
- Last updated
- 11 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 31182337
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peur De l'Hypoglycémie et Variabilité Glycémique Chez Les Sujets Diabétiques de Type 1
- ClinicalTrials.gov ID
- NCT02790060
- Acronym / sponsor ID
- VARDIA / VARDIA
- Conditions
- Type 1 Diabetes
- Keywords
- diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Jun 2016 (actual)
- First posted
- 3 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Type 1 diabetes
Key inclusion criteria (3 listed)
- type 1 diabetes
- at least 2 Blood Glucose monitoring daily
- on insulin for more than 5 years
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Fear of hypoglycemia score
Time frame: 2 weeks
hypoglycemia questionnaire and hypoglycemia reported by patients
2 secondary outcomes
quality of life
Time frame: from 2 weeks up to 3 months
Standard Deviation (SD) of recorded Home Monitoring of Blood Glucose (HMPG)
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2016.
- Derived from this study: PubMed 31182337Saulnier 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 1 Diabetes, run by Poitiers University Hospital at 9 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fear of hypoglycemia score (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02790060, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2016.