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Search / Trial NCT05661149

Closed-Loop Insulin Delivery During Pregnancy (IADIABENCEINTE)

Launched by CENTRE HOSPITALIER SUD FRANCILIEN · Dec 13, 2022

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Trial Information

Current as of February 05, 2025

Completed

Keywords

Artificial Pancreas Closed Loop Insulin Delivery Glucose Control Pregnancy Type 1 Diabetes Observational Study

ClinConnect Summary

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.

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Gender

FEMALE

Eligibility criteria

  • Inclusion Criteria:
  • • aged at least 18 years
  • • had been diagnosed with type 1 diabetes before pregnancy
  • • using an hybrid closed-loop insulin delivery system before or at any time of pregnancy
  • Exclusion Criteria:
  • • Patient opposed to the research

Trial Officials

Alfred PENFRONIS, PHD

Principal Investigator

Centre Hospitalier Sud Francilien

About Centre Hospitalier Sud Francilien

Centre Hospitalier Sud Francilien (CHSF) is a prominent healthcare institution located in the Île-de-France region, committed to advancing medical knowledge and improving patient care through innovative clinical research. As a sponsor of clinical trials, CHSF harnesses its state-of-the-art facilities and multidisciplinary expertise to conduct robust studies across various therapeutic areas. With a focus on patient safety and ethical standards, CHSF collaborates with leading researchers and healthcare professionals to explore new treatments and enhance clinical outcomes, ultimately contributing to the evolution of evidence-based medicine.

Locations

Corbeil Essonnes, , France

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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