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Completed

NCT Number: NCT05661149

Closed-Loop Insulin Delivery During Pregnancy (IADIABENCEINTE)

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.

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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Centre Hospitalier Sud Francilien

Corbeil-Essonnes, France, 91106

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hybrid closed loop insulin delivery systems

Device

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

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Sud Francilien

Other

Registry information

Official study title

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

Acronym: IADIABENCEIN

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Dec 22, 2022
Registry last updated
Nov 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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