Oral Glucose Tolerance Test and Post Partum Diagnosis of Diabetes Mellitus, Type 2 (DT2 Post-Partum)

Descriptive Study of the Diabetes Mellitus, Type 2 Diagnosis Methods During Postpartum Period in Patients With Medical History of Gestational Diabetes Whom Benefited an Educational Therapy Session.

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.

Study Overview

• Status: Completed
• Conditions: Gestational Diabetes
• Intervention / Treatment: Other: frequency of diabetes mellitus, type 2, diagnosis in patients with medical history of gestational diabetes.

• Study Type: Observational
• Enrollment (Actual): 173

Contacts and Locations

Study Locations

• France
  • Vienne, France
    • Centre Hospitalier Lucien Hussel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Women who develop a gestational diabetes.

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.; 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.; Other Names: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Investigators: Study Director: Laura BOGENMANN, MD, Centre Hospitalier de Vienne

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2018
• Primary Completion (Actual): February 13, 2019
• Study Completion (Actual): February 13, 2019

Study Registration Dates

• First Submitted: August 16, 2018
• First Submitted That Met QC Criteria: August 21, 2018
• First Posted (Actual): August 23, 2018

Study Record Updates

• Last Update Posted (Actual): August 21, 2019
• Last Update Submitted That Met QC Criteria: August 19, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Pregnancy Complications; Diabetes Mellitus; Diabetes Mellitus, Type 2; Diabetes, Gestational
• Other Study ID Numbers: 69HCL18_0210

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No