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Completed

NCT Number: NCT05510583

MyDiabby Healthcare Vs Diary in Gestational Diabetes Mellitus.

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

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Key information

Conditions

Gestational Diabetes Diabetes Mellitus Diabetes, Gestational Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Pregnancy Complications Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Endocrinology department - Centre Hospitalier René Dubos

Pontoise, 95300, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Control Group

Other

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.

Treated group

Other

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

Primary outcomes

  1. Assessment of the non-inferiority of the occurrence of maternal, fetal, and neonatal complications for patients of both groups

    Time frame: At the end of the Study, an average of 8 month

    Comparison, for patients with GDM, of the composite score (maternal / foetal - neonatal) between the group with remote monitoring by the myDiabby Healthcare and the group of patients with traditional monitoring (paper glycemic diaries). For each item answered "yes" count 1 point and "no" count 0 point.

    For information, the composite score is based on the following items:

    Maternal :

    • High blood pressure (≥140/90 mmHG)
    • Caesarean section
    • Instrumental extraction
    • Perineal Trauma : complete or complicated perineal tearing
    • Pre-eclampsia

    Foetal and neonatal :

    • birth weight ≥ 95th percentile for gestational age (neonatal macrosomia)
    • intrauterine growth restriction (birth weight ≤ 5th percentile)
    • APGAR < 7 at 5 minutes
    • Fetal death in utero
    • Neonatal hypoglycemia
    • Neonatal hypocalcemia
    • Neonatal acidosis : pH<7,10 and lactate >6µmol
    • Shoulders dystocia
    • Collarbone fracture, brachial plexus
    • Neonatal jaundice

Secondary outcomes

  1. Comparison, for each maternal and each Foetal/Neonatal composite items, between both groups

    Time frame: At the end of the Study, an average of 8 month

    Prevalence of each maternal and each Foetal/Neonatal composite item in each group. For each item answered "yes" count 1 point and "no" count 0 point

    For information, the maternal composite items are as follows:

    • High blood pressure (≥140/90 mmHG)
    • Hospitalization during pregnancy
    • Caesarean section
    • Instrumental extraction
    • Perineal Trauma : complete or complicated perineal tearing
    • Pre-eclampsia

    For information, the Foetal/Neonatal composite items are as follows:

    • birth weight ≥ 95th percentile for gestational age (neonatal macrosomia)
    • intrauterine growth restriction (birth weight ≤ 5th percentile)
    • APGAR <7 at 5 minutes
    • Fetal death in utero
    • Neonatal hypoglycemia
    • Neonatal hypocalcemia
    • Neonatal acidosis : pH<7,10 and lactate >6µmol
    • Shoulders dystocia
    • Collarbone fracture, brachial plexus
    • Neonatal jaundice

  2. Comparison of the rate of patients put on insulin in both groups

    Time frame: At the end of the Study, an average of 8 month

    Number of patients put on insulin in each group and comparison.

Sponsors and collaborators

Lead sponsor

Hôpital NOVO

Other

Registry information

Official study title

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

Acronym: TELESUR-GDM

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 22, 2022
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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