Diabetes Type One in Pregnancy and Continuos Glucose Monitoring

Phase

N/A

Condition

Hormone Deficiencies

Pregnancy Complications

Diabetes (Pediatric)

Treatment

N/A

Clinical Study ID

NCT04997460

8.1-21/4-2, 02/21 AG

Ages 18-40
Female

Study Summary

Type I diabetes mellitus (T1DM) affects about 0.1-0.2% of all pregnancies. T1DM in pregnancy increases the risk of maternal and neonatal complications.

Continuous glucose monitoring systems (CGM) provide a continuous display of measured glucose. Studies have shown improved pregnancy outcomes for patients with T1DM using CGM when compared to capillary blood glucose measurements.

This prospective observational study analyses impact of glycemic variability on development of large-for-gestational-age neonates and effects of hypoglycemia during pregnancy on pregnancy outcomes.

Furthermore, overall glycemic regulation, different insulin metrics and C-peptide concentration during pregnancy will also be assesed.

Eligibility Criteria

Inclusion

Inclusion Criteria:

confirmed diagnosis of type one diabetes
duration of the disease for minimum of one year before inclusion in the study
multiple daily insulin injection therapy or insulin pump
glycemia monitoring with continuous glucose monitoring systems (FreeStyle Libre FlashGlucose Monitoring System, Abott) for a minimum of 3 months before inclusion in thestudy
glucose data availability from the sensor > 80% for a determined period of monitoring
patient age > 18 years and < 40 years
available medical records from the preconception period (3 months before conception)
first trimester of pregnancy
body mass index < 25kg/m2
glycated haemoglobin < 7.0%
signed informed consent

Exclusion

Exclusion Criteria:

other types of diabetes except type one: type 2 diabetes, diabetes developed duringpregnancy, diabetes as a result of genetic defect of beta-cells of the pancreas
using other therapy besides insulin in treating diabetes
changes to the specific insulin therapy in preconception period or during pregnancy;defined as switching from multiple daily insulin injection therapy to insulin pumpsand vice versa
patient's inability for regular hospital visits (defined as once monthly duringpregnancy)
patients unable to understand the protocol and the goal of the study
patients unable to read and write
multiple pregnancy
glycated haemoglobin > 7.0% in all pregnancy trimesters
significant weight gain during pregnancy (>20 kilograms)
glucose data availability from the sensor < 80%
unavailability of preconception medical records
unavailability of medical records from pregnancy and pregnancy outcomes

Study Design

January 11, 2021

January 11, 2024

Study Description

Up to 200 patients with type one diabetes will be enrolled in the study during first trimester of pregnancy. Medical history, clinical examination, anthropometric measurements and laboratory work-up will be obtained at first visit. Glucose metrics are provided from continuous glucose monitoring systems and blood glucose measurements .

Following the initial evaluation, patients will be regularly examined in the hospital setting once a month during pregnancy. Following evaluations will include the same procedures as the first one.

Pregnancy outcomes that will be analysed: spontaneous abortion, preterm birth, large-for-gestational-age neonates, macrosomia, small-for-gestational-age neonates, birth weight, congenital anomalies, APGAR score, neonatal hypoglycemia, intensive care unit admission for mother and/or infant.

Connect with a study center

University hospital centre Zagreb
Zagreb, 10000
Croatia
Active - Recruiting

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