NCT05510583

MyDiabby Healthcare Vs Diary in Gestational Diabetes Mellitus.

Non Inferiority Study of Glycemic Monitoring Via MyDiabby Healthcare Vs Conventional Diary in Patients with Gestational Diabetes Mellitus

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 668 (actual)
• Sponsor: Hôpital NOVO · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Gestational Diabetes

Interventions

Type	Name	Description
OTHER	Control group	Retrospective study on 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.
OTHER	Treated group	Retrospective study on 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

Timeline

• Start date: 2022-08-02
• Primary completion: 2023-04-17
• Completion: 2023-04-17
• First posted: 2022-08-22
• Last updated: 2024-09-19

Locations

1 site across 1 country: France