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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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 :
Foetal and neonatal :
| At the end of the Study, an average of 8 month |
| 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:
For information, the Foetal/Neonatal composite items are as follows:
|
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Inclusion Criteria :
Exclusion Criteria :
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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
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| Name | Affiliation | Role |
|---|---|---|
| Pr Christophe Poncelet | Hôpital NOVO | Principal Investigator |
| Dr Catherine Campinos | Hôpital NOVO | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Endocrinology department - Centre Hospitalier René Dubos | Pontoise | 95300 | France |
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| ID | Term |
|---|---|
| D016640 | Diabetes, Gestational |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D044882 | Glucose Metabolism Disorders |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
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| 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 |
|
| 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 |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D008722 | Methods |