MyDiabby Healthcare Vs Diary in Gestational Diabetes Mellitus.

NCT05510583 | Completed

• 1 other identifier: CHRD2421
• Study Type: observational
• Target: 668
• Locations: 1 country
• Sites: 1

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

Conditions

Gestational Diabetes

Keywords

diabetes mellitus; tele-medicine; Pregnancy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

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

  At the end of the Study, an average of 8 month

• Comparison of the rate of patients put on insulin in both groups

  At the end of the Study, an average of 8 month

Study Arms (2)

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

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

Interventions

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.

Group 1

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

Group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Hôpital NOVO: lead

Study Sites (1)

Endocrinology department - Centre Hospitalier René Dubos

Pontoise, 95300, France

Location

MeSH Terms

Conditions

Diabetes, Gestational; Diabetes Mellitus

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Pr Christophe Poncelet

  Hôpital NOVO

  PRINCIPAL INVESTIGATOR

• Dr Catherine Campinos

  Hôpital NOVO

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2022
• First Posted: August 22, 2022
• Study Start: August 2, 2022
• Primary Completion: April 17, 2023
• Study Completion: April 17, 2023
• Last Updated: September 19, 2024

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)