Clinical trial NCT05661149: Closed-Loop Insulin Delivery During Pregnancy (IADIABENCEINTE)
Official title: Closed-Loop Insulin Delivery in Pregnant Women with Type 1 Diabetes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 1 Diabetes
Keywords: artificial pancreas
closed loop insulin delivery
glucose control
pregnancy
type 1 diabetes
observational study
Lead sponsor: Centre Hospitalier Sud Francilien
Sponsor class: OTHER
First posted: 2022-12-22
Enrollment: 14
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients followed in the diabetology department of the Centre Hospitalier Sud-Francilien

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage time spent in the euglycaemic range specific for pregnancy (63-140 mg/dL)
timeFrame: 12 weeks before the start of pregnancy (week 0)
measure: Percentage time spent in the euglycaemic range specific for pregnancy (63-140 mg/dL)
timeFrame: week 0
measure: Percentage time spent in the euglycaemic range specific for pregnancy (63-140 mg/dL)
timeFrame: Week 14
measure: Percentage time spent in the euglycaemic range specific for pregnancy (63-140 mg/dL)
timeFrame: Week 26
measure: Percentage time spent in the euglycaemic range specific for pregnancy (63-140 mg/dL)
timeFrame: Wekk 38
Secondary outcomes:
Other outcomes:
Locations:
city: Corbeil-Essonnes
country: France
facility: Centre Hospitalier Sud Francilien
Study officials:
affiliation: Centre Hospitalier Sud Francilien
name: Alfred PENFRONIS, PHD
role: PRINCIPAL_INVESTIGATOR
References: