Large-for-gestational-age NeonatesDIP1/CRONCT04997460
Diabetes Type One in Pregnancy and Continuos Glucose Monitoring
An observational study of Large-for-gestational-age Neonates and Glycemic Variability, run by Clinical Hospital Centre Zagreb at 1 site in Croatia.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Large-for-gestational-age Neonates, Glycemic Variability, Hypoglycemia
- How many people
- 200 participants
- Where
- 1 siteCroatia
- Study dates
- 11 Jan 2021to 11 Jan 2024
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Maja Baretic contact
Croatia1 site, 1 recruiting
- Recruiting
University hospital centre Zagreb
Zagreb, 10000
Gloria Leksic, gleksic@gmail.com
Marija Radic
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Large-for-gestational-age Neonates, Glycemic Variability, Hypoglycemia, Pregnancy Outcomes, C-peptide
- Medical subject headings
- Hypoglycemia
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 9 months
Secondary outcomes (2)
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).
Measured: 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.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2021
- Study start11 Jan 2021
- Primary completion11 Jan 2024 (estimated)
- Study completion11 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Large-for-gestational-age NeonatesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinical Hospital Centre Zagreb
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gloria Leksic, Clinical Hospital Centre Zagreb
- Investigators
- Maja Baretic, Study director, Clinical Hospital Centre ZagrebMarina Ivanisevic, Study chair, Clinical Hospital Centre ZagrebGloria Leksic, Principal investigator, Clinical Hospital Centre Zagreb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04997460
- Sponsor's protocol ID
- 8.1-21/4-2, 02/21 AG
- Acronym
- DIP1/CRO
- Status last verified
- Aug 2021
- First submitted
- 6 Jul 2021
- Last updated
- 9 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided