Diabetes Type One in Pregnancy and Continuos Glucose Monitoring

Hypoglycemia Clinical Trial

— DIP1/CRO  

Official title:

Diabetes Type One in Pregnancy and Continuous Glucose Monitoring - Observational Prospective Study in Croatia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04997460
• Other study ID #: 8.1-21/4-2, 02/21 AG
• Status: Recruiting
• Start date: January 11, 2021
• Est. completion date: January 11, 2024

Study information

• Verified date: August 2021
• Source: Clinical Hospital Centre Zagreb
• Contact: Gloria Leksic
• Phone: 00385977818746
• Email: gleksic[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: January 11, 2024
• Est. primary completion date: January 11, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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 Flash Glucose Monitoring System, Abott) for a minimum of 3 months before inclusion in the study
• 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 Criteria:

• other types of diabetes except type one: type 2 diabetes, diabetes developed during pregnancy, 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 pumps and vice versa
• patient's inability for regular hospital visits (defined as once monthly during pregnancy)
• 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

Related Conditions & MeSH terms

• C-peptide
• Fetal Macrosomia
• Glycemic Variability
• Hypoglycemia
• Pregnancy Outcomes

Locations

Country	Name	City	State
Croatia	University hospital centre Zagreb	Zagreb

Sponsors (1)

Lead Sponsor	Collaborator
Clinical Hospital Centre Zagreb

Country where clinical trial is conducted

Croatia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	C-peptide concentration in different pregnancy trimesters	C-peptide concentration will be determined from venous blood sample in every pregnancy trimester.	9 months
Primary	Incidence of large-for-gestational-age neonates	Incidence of large-for-gestational-age neonates will be determined in group of patients with increased glycemic variability (%CV> 36%) and in the group of patients with normal glycemic variability (%CV < 36%) during different pregnancy trimesters.; Glycemic variability parameters are available from continuous glucose monitoring system:percent coefficient of variation (%CV), interquartile range (IQR), standard deviation (SD).	9 months
Primary	Correlation of glycated hemoglobin and glycemic variability	Correlation of glycemic variability parameters (%CV, IQR, SD) and glycated hemoglobin in different pregnancy trimesters will be performed.Both parameters are available from continuos glucose monitoring systems.	9 months
Secondary	Pregnancy outcomes - maternal and fetal	Effects of hypoglycemia on pregnancy outcomes will be analysed. Pregnancy outcomes included in the analysis: 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.; Hypoglycemia will be assesed through parameters available from continuos glucose monitoring systems (low glucose events, time spent below target).	9 months
Secondary	Correlation of hypoglycemia and glycemic variability	Correlation between hypoglycemia parameters (time below target, low glucose events) and glycemic variability parameters (%CV, SD, IQR) will be performed. Both parameters are available from continuous glucose monitoring systems.	9 months