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

November 22, 2024 updated by: Centre Hospitalier Sud Francilien

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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 Type

Observational

Enrollment (Actual)

14

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Corbeil-Essonnes, France, 91106
        • Centre hospitalier Sud Francilien

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients followed in the diabetology department of the Centre Hospitalier Sud-Francilien

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage time spent in the euglycaemic range specific for pregnancy (63-140 mg/dL)
Time Frame: 12 weeks before the start of pregnancy (week 0)
Data drawn from continuous glucose monitoring systems
12 weeks before the start of pregnancy (week 0)
Percentage time spent in the euglycaemic range specific for pregnancy (63-140 mg/dL)
Time Frame: week 0
Data drawn from continuous glucose monitoring systems
week 0
Percentage time spent in the euglycaemic range specific for pregnancy (63-140 mg/dL)
Time Frame: Week 14
Data drawn from continuous glucose monitoring systems
Week 14
Percentage time spent in the euglycaemic range specific for pregnancy (63-140 mg/dL)
Time Frame: Week 26
Data drawn from continuous glucose monitoring systems
Week 26
Percentage time spent in the euglycaemic range specific for pregnancy (63-140 mg/dL)
Time Frame: Wekk 38
Data drawn from continuous glucose monitoring systems
Wekk 38

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Sud Francilien

Investigators

  • Principal Investigator: Alfred PENFRONIS, PHD, Centre hospitalier Sud Francilien

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 11, 2023

Primary Completion (Actual)

August 30, 2023

Study Completion (Actual)

December 11, 2023

Study Registration Dates

First Submitted

November 21, 2022

First Submitted That Met QC Criteria

December 13, 2022

First Posted (Actual)

December 22, 2022

Study Record Updates

Last Update Posted (Estimated)

November 26, 2024

Last Update Submitted That Met QC Criteria

November 22, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022/0036

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Type 1 Diabetes

Clinical Trials on Hybrid closed loop insulin delivery systems

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Georgia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe