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NCT05661149Completed

Closed-Loop Insulin Delivery During Pregnancy (IADIABENCEINTE)

Closed-Loop Insulin Delivery in Pregnant Women with Type 1 Diabetes

Source: ClinicalTrials.gov · Last updated 26 Nov 2024

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Observational
Enrollment
14 (actual)
First submitted
21 Nov 2022
Start date
11 May 2023
Primary completion date
30 Aug 2023
Lead sponsor
Centre Hospitalier Sud Francilien
NCT number
NCT05661149

What you commit to

  • Study type: Observational
  • Participants enrolled: 14
  • From 11 May 2023 to the primary completion date, 30 Aug 2023
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

  • Patient opposed to the research

Who the study is looking for

  • 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

Age in the registry: 18 years to 45 years · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Centre Hospitalier Sud Francilien
Coordinator of this site? Confirm its status
Corbeil-EssonnesFranceUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.