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Closed-Loop Insulin Delivery During Pregnancy (IADIABENCEINTE)

NCT05661149 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 14

Last updated 2024-11-26

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

Hybrid closed loop insulin delivery systems

Tandem Control-IQ ; DBLG1 system ; MiniMed 780G system

Sponsors & Collaborators

  • Centre Hospitalier Sud Francilien

    lead OTHER

Principal Investigators

  • Alfred PENFRONIS, PHD · Centre Hospitalier Sud Francilien

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-11
Primary Completion
2023-08-30
Completion
2023-12-11

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05661149 on ClinicalTrials.gov