Diabetes Type One in Pregnancy and Continuos Glucose Monitoring (DIP1/CRO)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Hypoglycemia; Pregnancy Outcomes; Glycemic Variability; C-peptide; Large-for-gestational-age Neonates

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Gloria Leksic; Phone Number: 00385977818746; Email: gleksic@gmail.com
• Study Contact Backup: Name: Maja Baretic; Email: mbaretic@kbc-zagreb.hr

Study Locations

• Croatia
  • Zagreb, Croatia, 10000
    • Recruiting
    • University Hospital Centre Zagreb
    • Contact: Gloria Leksic; Email: gleksic@gmail.com
    • Sub-Investigator: Marija Radic
    • Sub-Investigator: Lara Gudelj

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Patients enrolled in the study are women who are patients of the Clinic for gynecology and obstetrics and who match the inclusion criteria.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
C-peptide concentration in different pregnancy trimesters	C-peptide concentration will be determined from venous blood sample in every pregnancy trimester.	9 months

Collaborators and Investigators

• Sponsor: Clinical Hospital Centre Zagreb
• Investigators: Study Director: Maja Baretic, Clinical Hospital Centre Zagreb; Study Chair: Marina Ivanisevic, Clinical Hospital Centre Zagreb; Principal Investigator: Gloria Leksic, Clinical Hospital Centre Zagreb

Study record dates

Study Major Dates

• Study Start (Actual): January 11, 2021
• Primary Completion (Anticipated): January 11, 2024
• Study Completion (Anticipated): January 11, 2024

Study Registration Dates

• First Submitted: July 6, 2021
• First Submitted That Met QC Criteria: August 2, 2021
• First Posted (Actual): August 9, 2021

Study Record Updates

• Last Update Posted (Actual): August 9, 2021
• Last Update Submitted That Met QC Criteria: August 2, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Hypoglycemia
• Other Study ID Numbers: 8.1-21/4-2, 02/21 AG

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No