Diabetes Type One in Pregnancy and Continuos Glucose Monitoring

NCT04997460 | Unknown

• 1 other identifier: 8.1-21/4-2, 02/21 AG
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Large-for-gestational-age Neonates; Glycemic Variability; Hypoglycemia; Pregnancy Outcomes; C-peptide

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Pregnancy outcomes - maternal and fetal

  9 months

• Correlation of hypoglycemia and glycemic variability

  9 months

Other Outcomes (1)

• C-peptide concentration in different pregnancy trimesters

  9 months

Eligibility Criteria

• Age: 18 Years - 40 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• confirmed diagnosis of type one diabetes
• multiple daily insulin injection therapy or insulin pump
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Clinical Hospital Centre Zagreb: lead

Study Sites (1)

University hospital centre Zagreb

Zagreb, 10000, Croatia

RECRUITING

MeSH Terms

Conditions

Hypoglycemia

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Maja Baretic

  Clinical Hospital Centre Zagreb

  STUDY DIRECTOR

• Marina Ivanisevic

  Clinical Hospital Centre Zagreb

  STUDY CHAIR

• Gloria Leksic

  Clinical Hospital Centre Zagreb

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gloria Leksic

CONTACT

00385977818746; gleksic@gmail.com

Maja Baretic

CONTACT

mbaretic@kbc-zagreb.hr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident

Study Record Dates

• First Submitted: July 6, 2021
• First Posted: August 9, 2021
• Study Start: January 11, 2021
• Primary Completion: January 11, 2024
• Study Completion: January 11, 2024
• Last Updated: August 9, 2021

Record last verified: 2021-08

Locations

CR (1)