Closed-Loop Insulin Delivery During Pregnancy (IADIABENCEINTE)

Sponsor

Centre Hospitalier Sud Francilien (Other)

Overall Status

Recruiting

CT.gov ID

NCT05661149

Collaborator

(none)

Enrollment

Location

5.9

Anticipated Duration (Months)

2.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Type 1 Diabetes	Device: Hybrid closed loop insulin delivery systems

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 Design

Study Type:

Observational

Anticipated Enrollment :

14 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Jan 2, 2023

Anticipated Primary Completion Date :

Jun 30, 2023

Anticipated Study Completion Date :

Jun 30, 2023

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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