Closed-Loop Insulin Delivery During Pregnancy (IADIABENCEINTE)

Type 1 Diabetes Clinical Trial

— IADIABENCEIN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05661149
• Other study ID #: 2022/0036
• Status: Completed
• Start date: May 11, 2023
• Est. completion date: December 11, 2023

Study information

• Verified date: January 2023
• Source: Centre Hospitalier Sud Francilien
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: December 11, 2023
• Est. primary completion date: August 30, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Device:
• Hybrid closed loop insulin delivery systems
Tandem Control-IQ ; DBLG1 system ; MiniMed 780G system

Locations

Country	Name	City	State
France	Centre Hospitalier Sud Francilien	Corbeil-Essonnes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Sud Francilien

Country where clinical trial is conducted

France, 

Outcome

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