Closed-Loop Insulin Delivery During Pregnancy (IADIABENCEINTE)

NCT05661149 | Completed

• 1 other identifier: 2022/0036
• Study Type: observational
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 1 Diabetes

Keywords

artificial pancreas; closed loop insulin delivery; glucose control; pregnancy; type 1 diabetes; observational study

Outcome Measures

Primary Outcomes (5)

• 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)

• Percentage time spent in the euglycaemic range specific for pregnancy (63-140 mg/dL)

  Data drawn from continuous glucose monitoring systems

  week 0

• Percentage time spent in the euglycaemic range specific for pregnancy (63-140 mg/dL)

  Data drawn from continuous glucose monitoring systems

  Week 14

• Percentage time spent in the euglycaemic range specific for pregnancy (63-140 mg/dL)

  Data drawn from continuous glucose monitoring systems

  Week 26

• Percentage time spent in the euglycaemic range specific for pregnancy (63-140 mg/dL)

  Data drawn from continuous glucose monitoring systems

  Wekk 38

Interventions

Hybrid closed loop insulin delivery systems DEVICE

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

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients followed in the diabetology department of the Centre Hospitalier Sud-Francilien

You may qualify if:

• 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

You may not qualify if:

• Patient opposed to the research

Sponsors & Collaborators

• Centre Hospitalier Sud Francilien: lead

Study Sites (1)

Centre Hospitalier Sud Francilien

Corbeil-Essonnes, France, 91106, France

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Alfred PENFRONIS, PHD

  Centre Hospitalier Sud Francilien

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2022
• First Posted: December 22, 2022
• Study Start: May 11, 2023
• Primary Completion: August 30, 2023
• Study Completion: December 11, 2023
• Last Updated: November 26, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)