Closed-Loop Insulin Delivery During Pregnancy (IADIABENCEINTE)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

14 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-05-11

Study Completion Date

2023-12-11

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Automated Insulin Delivery Amongst Pregnant Women With Type 1 Diabetes

NCT04938557

Diabetes

COMPLETED NA

Commercial or Open Source Closed Loop Impact on Pregnancy Study

NCT06654713

Type 1 Diabetes Pregnancy, High Risk Insulin Dependent Diabetes +1 more

RECRUITING

Closed-loop Insulin Delivery in Pregnant Women With Type 1 Diabetes

NCT04520971

Type1 Diabetes

COMPLETED NA

T1D Pregnancy & Me

NCT06959316

Diabetes Mellitus, Type 1 Pregnancy in Diabetics Pregnancy, High-Risk +1 more

RECRUITING

Automated Insulin Delivery Versus Usual Insulin Treatment Modality Before and During Pregnancy in Women With Type 1 Diabetes

NCT07240012

Diabete Type 1 Pregnancy Complications

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Type 1 Diabetes

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Hybrid closed loop insulin delivery systems

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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