myDiabby Healthcare vs Diary in Gestational Diabetes Mellitus. (TELESUR-GDM)

Non Inferiority Study of Glycemic Monitoring Via myDiabby Healthcare vs Conventional Diary in Patients With 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

Study Overview

• Status: Completed
• Conditions: Gestational Diabetes
• Intervention / Treatment: Other: Control group; Other: Treated group

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.

• Study Type: Observational
• Enrollment (Actual): 668

Contacts and Locations

• Study Contact: Name: Véronique Da Costa; Phone Number: +33 130 75 50 69; Email: veronique.dacosta@ght-novo.fr

Study Locations

• France
  • Pontoise, France, 95300
    • Endocrinology department - Centre Hospitalier René Dubos

Participation Criteria

Eligibility Criteria

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

• 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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1; 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: 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.
Group 2; 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	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of the non-inferiority of the occurrence of maternal, fetal, and neonatal complications for patients of both groups	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	At the end of the Study, an average of 8 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison, for each maternal and each Foetal/Neonatal composite items, between both groups	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	At the end of the Study, an average of 8 month
Comparison of the rate of patients put on insulin in both groups	Number of patients put on insulin in each group and comparison.	At the end of the Study, an average of 8 month

Collaborators and Investigators

• Sponsor: Centre Hospitalier René Dubos
• Investigators: Principal Investigator: Pr Christophe Poncelet, Centre Hospitalier Rene Dubos; Principal Investigator: Dr Catherine Campinos, Centre Hospitalier Rene Dubos

Study record dates

Study Major Dates

• Study Start (Actual): August 2, 2022
• Primary Completion (Actual): April 17, 2023
• Study Completion (Actual): April 17, 2023

Study Registration Dates

• First Submitted: August 19, 2022
• First Submitted That Met QC Criteria: August 19, 2022
• First Posted (Actual): August 22, 2022

Study Record Updates

• Last Update Posted (Actual): May 12, 2023
• Last Update Submitted That Met QC Criteria: May 11, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Pregnancy; diabetes mellitus; tele-medicine
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Pregnancy Complications; Diabetes Mellitus; Diabetes, Gestational
• Other Study ID Numbers: CHRD2421

Drug and device information, study documents

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