MyDiabby Healthcare Vs Diary in Gestational Diabetes Mellitus. (TELESUR-GDM)

Hôpital NOVO

Status: Completed

Conditions: Gestational Diabetes

Treatments: Other: Control group; Other: Treated group

Study type: Observational

Funder types: Other

Identifiers

NCT05510583

CHRD2421

Details and patient eligibility

About

The purpose of the study is to demonstrate the non-inferiority of the onset of maternal, foetal, and neonatal complications for patients who had Gestational diabetes mellitus (GDM) and who had been monitored by myDiabby Healthcare compared to patients who had a classic glycemic blood monitoring by diary

Full description

TELESUR-GDM is a descriptive and comparative study which will be compared to ERD2 study. ERD2 (personal data) was a retrospective study leaded in Rene Dubos hospital. The primary objective was to evaluate de proportion of patients who had a blood screening for type 2 diabetes after having a gestational diabetes and who gave birth between 2013 and 2015 in Rene Dubos hospital. The primary outcome was the discovery of a diabetes after the OGTT test (75g of glucose), 2 to 3 months after delivery, a fasting blood glucose rate ≥ 1,26 g/L and a plasma glucose after 2 hours ≥ 2g/L

• In ERD2 study 391 subjects were included. The patients were over 18 years old and had a gestational diabetes and were informed by a survey. The main criteria of maternal and neonatal complications were a maternal high blood pressure, a neonatal jaundice, neonatal hypocalcemia and hypoglycemia, and shoulders dystocia. In this study the patients were followed up with classic diary for glycemic blood rate.
• With TELESUR-GDM study, the objective is to prove the non-inferiority of the new method of monitoring for blood glucose rate (myDiabby Healthcare) for patients who had a gestational diabetes and who gave birth between 01/01/2021 and the 31/12/2021. The data will be collected with an informatic secured data base.

Enrollment: 668 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria :

• Age ≥18 years old
• Date of delivery between 01/01/2013 and 30/06/2015 Or
• Date of delivery between 01/01/2021 and 31/12/2021 and monitored by myDiabby Healthcare
• Patients who had a gestational diabetes tested according to CNGOF recommendations

Exclusion Criteria :

• Patients with type 2 or type 1 diabetes
• Opposition of the patient for participating to the study
• Patients who have had a multiple pregnancy

Trial design

668 participants in 2 patient groups

Group 1

Description:

Pregnant women (≥18 years) with gestational diabetes who gave birth between 01/01/2013 and 30/06/2015. Patients received traditional paper-based blood glucose monitoring.

Treatment:

Other: Control group

Group 2

Description:

Pregnant women (≥18 years) with gestational diabetes who gave birth between 01/01/2021 and 31/12/2021. Patients received remote monitoring with myDiabby Healthcare

Treatment:

Other: Treated group