NCT03644004

Brief Summary

Diabetes mellitus, type 2, is a chronic disease which can be linked with many complications in connexion with impaired blood glucose balance. It diagnosis in risky subjects such as in patients with medical history of gestational diabetes is therefore imperative to prevent its complications. Actual guidelines recommend an oral tolerance glucose test, measuring glucose levels after oral glucose intake (75g), between 6 an 12 weeks after childbirth. But studies reveal a low diagnosis rate. The study of the current practices of diagnosis methods seem to be essential in order to improve this diagnosis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
173

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 16, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 23, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

October 30, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 13, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 13, 2019

Completed
Last Updated

August 21, 2019

Status Verified

August 1, 2019

Enrollment Period

4 months

First QC Date

August 16, 2018

Last Update Submit

August 19, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Performing oral glucose tolerance test in order to detect type 2 diabetes

    Performing oral glucose tolerance test between 6 and 12 weeks after childbirth. As recommended by actual World Health Organisation (WHO) guidelines

    Month 6

Study Arms (1)

Women with medical history of gestational diabetes

Patients followed at the hospital of Vienne for gestational diabetes in 2016.

Other: frequency of diabetes mellitus, type 2, diagnosis in patients with medical history of gestational diabetes.

Interventions

Patients will be contacted by mail with sending of the information notice to ask them to participate in the study. If they don't reply, the subjects will be called by phone by the investigator to collect their non opposition of participation at the study. During this call, the investigator will be able to answer all the questions about the study. The report of this telephone conversation will be register in the medical file of the patient. Then, we will collect informatic data from the hospital concerning the patients. After that they will be contacted by phone to answer a survey. Beside, another secure survey will be send by email to each patient's family doctor. To finish, crossing data between those of the patients and the family doctor and anonymisation of the data.

Also known as: Evaluate the frequency of diabetes mellitus, type 2, diagnosis with an oral glucose tolerance test between 6 and 12 weeks after childbirth in patients with medical history of gestational diabetes.
Women with medical history of gestational diabetes

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Women who develop a gestational diabetes.

You may qualify if:

  • Patients followed in endocrinology at the hospital of Vienne for gestational diabetes, whom benefited an educational therapy session between the 01/01/2016 and the 31/12/2016 inclusive.

You may not qualify if:

  • Minor patients or under legal protection (guardianship)
  • Patients who not speak french
  • Patients who did not declared an attending physician
  • Refusal to take part in the survey
  • Patients lost to follow-up before childbirth
  • Patients whose pregnancy ended by foetal death.
  • Pre-existing diabet before pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre hospitalier Lucien Hussel

Vienne, France

Location

MeSH Terms

Conditions

Diabetes, Gestational

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Laura BOGENMANN, MD

    Centre Hospitalier de Vienne

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 16, 2018

First Posted

August 23, 2018

Study Start

October 30, 2018

Primary Completion

February 13, 2019

Study Completion

February 13, 2019

Last Updated

August 21, 2019

Record last verified: 2019-08

Locations