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Closed-Loop Insulin Delivery During Pregnancy (IADIABENCEINTE) — IADIABENCEIN  

Type 1 Diabetes Clinical Trial

Official title:
Closed-Loop Insulin Delivery in Pregnant Women With Type 1 Diabetes

Clinical Trial Summary

The imbalance of diabetes is associated with an increased risk of maternal and fetal complications. In women, it can cause abortion, hypertension, preeclampsia, and obstructed labor; in the fetus, it increases the risk of many malformations, including neurological and cardiac, fetal death in utero, intrauterine growth retardation, macrosomia, prematurity and metabolic complications. Despite the various therapeutic tools available and used during pregnancy, maintaining blood sugar levels within this narrow range remains a challenge. Automated Insulin Therapy (IA) Could Further Improve Outcomes With Continuous Glucose Monitoring and Increase Percentage of Time Spent on Target Between 63 and 140 mg/dL The objective of this observational study is to describe the clinical characteristics, metabolic data on MCG and maternal and/or fetal complications in women with T1D treated during pregnancy with an AI system available in France.

Clinical Trial Description

Diabetes imbalance is associated with an increased risk of maternal and fetal complications, and achieving target blood glucose levels before and during pregnancy in women with type 1 diabetes (T1DM) significantly reduces these complications. In women, it can cause abortion, hypertension, pre-eclampsia, and dystocic deliveries; in the fetus, it increases the risk of numerous malformations, including neurological and cardiac, fetal death in utero, intrauterine growth retardation, macrosomia, prematurity, and metabolic complications at birth such as neonatal hypoglycemia and hypocalcemia. The recommended glycemic targets during pregnancy are strict: HbA1c < 6.5% and time in target (between 63 and 140 mg/dL) > 70% (6). Despite the various therapeutic tools available and used during pregnancy, maintaining blood glucose within this narrow range remains a challenge. Automated insulin therapy (AI) could improve further on the results obtained with continuous glucose monitoring and increase the percentage of time spent in target between 63 and 140 mg/dL The objective of this present observational study is to describe the clinical characteristics, metabolic data on MCG and maternal and/or fetal complications in women with T1DM treated during pregnancy with an AI system available in France, whether this system is used before the beginning of the pregnancy or during it. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05661149
Study type Observational
Source Centre Hospitalier Sud Francilien
Contact
Status Completed
Phase
Start date May 11, 2023
Completion date December 11, 2023
View Details
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