Clinical trial NCT05510583: MyDiabby Healthcare Vs Diary in Gestational Diabetes Mellitus.
Official title: Non Inferiority Study of Glycemic Monitoring Via MyDiabby Healthcare Vs Conventional Diary in Patients with Gestational Diabetes Mellitus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gestational Diabetes
Keywords: diabetes mellitus
tele-medicine
Pregnancy
Lead sponsor: Hôpital NOVO
Sponsor class: OTHER
First posted: 2022-08-22
Enrollment: 668
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women (≥ 18 years old) with gestational diabetes who gave birth between 01/01/2013 and 30/06/2015 for the control group (paper blood glucose diaries) or between 01/01/2021 and 31/12/2021 if they have benefited from remote monitoring with myDiabby Healthcare

Brief 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.

Eligibility 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

Primary outcomes:
measure: Assessment of the non-inferiority of the occurrence of maternal, fetal, and neonatal complications for patients of both groups
timeFrame: At the end of the Study, an average of 8 month
Secondary outcomes:
measure: Comparison, for each maternal and each Foetal/Neonatal composite items, between both groups
timeFrame: At the end of the Study, an average of 8 month
measure: Comparison of the rate of patients put on insulin in both groups
timeFrame: At the end of the Study, an average of 8 month
Other outcomes:
Locations:
city: Pontoise
country: France
facility: Endocrinology department - Centre Hospitalier René Dubos
Study officials:
affiliation: Hôpital NOVO
name: Pr Christophe Poncelet
role: PRINCIPAL_INVESTIGATOR
affiliation: Hôpital NOVO
name: Dr Catherine Campinos
role: PRINCIPAL_INVESTIGATOR
References: