Gestational Diabetes Clinical Trial
Official title:
The Effectiveness of Real Time Continuous Glucose Monitoring to Improve Glycemic Control and Pregnancy Outcome in Patients With Gestational Diabetes Mellitus
NCT number | NCT03981328 |
Other study ID # | 20181101 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | August 26, 2020 |
Est. completion date | December 2023 |
Real-time continuous glucose monitoring (CGM) systems provide users with information about current glucose levels and alert the patient before the upper or lower glucose threshold is reached or when glucose levels change rapidly. Hence, glycaemic excursions can be early identified and accordingly adapted by behavioural change or pharmacologic intervention. Randomized controlled studies adequately powered to evaluate the impact of long-term application of real-time CGM systems on the risk reduction of adverse obstetric outcomes are missing.
Status | Recruiting |
Enrollment | 372 |
Est. completion date | December 2023 |
Est. primary completion date | March 2023 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 55 Years |
Eligibility | Inclusion Criteria: - female patients between 18 and 55 years - gestational diabetes mellitus in accordance with the IADPSG criteria between 24 and 31+6 weeks of gestation by a 2h 75g OGTT Exclusion Criteria: - Overt diabetes (i.e. pregestationally known type 1 or type 2 diabetes or fasting plasma glucose during the OGTT =126 mg/dl [7.0 mmol/l] or HbA1c =6.5% [44 mmol/l] or 2h post-load OGTT levels =200 mg/dl [11.1 mmol/l] assessed before 24+0 weeks of gestation - history of bariatric surgery or other surgeries that induce malabsorption - long-term use (>2 weeks) of systemic steroids prior to enrolment - multiple pregnancy - Patients already using glucose lowering medications (metformin or insulin) before study entry - fetal growth restriction due to placental dysfunction at study entry - Inpatient psychiatric treatment up to 1 year before enrolment - Participation in this study in previous pregnancy |
Country | Name | City | State |
---|---|---|---|
Austria | Department of Obstetrics and Gynecology, Division of Obstetrics and Feto-maternal Medicine, Medical University of Vienna | Vienna |
Lead Sponsor | Collaborator |
---|---|
Medical University of Vienna |
Austria,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | LGA newborns | To assess differences in the proportion of LGA newborns (birth weight >90. pct) in women with GDM using real-time CGM as compared to women with GDM using SMBG via capillary blood glucose monitoring. | postpartum - up to 48 hours after delivery | |
Secondary | neonatal hypoglycaemia | newborn measurement | postpartum - up to 48 hours after delivery | |
Secondary | rate of caesarean section | statistics | postpartum - up to 48 hours after delivery | |
Secondary | shoulder dystocia | frequency of occurrences | postpartum - up to 48 hours after delivery | |
Secondary | neonatal anthropometry | newborn measurement | postpartum - up to 48 hours after delivery | |
Secondary | differences in neonatal hyperinsulinemia | differences in neonatal hyperinsulinemia | postpartum - up to 48 hours after delivery | |
Secondary | CGM measures such as mean, glycaemic variability, time in range as well as hyper- and hypoglycaemia | maternal measurements | through study completion, an average of 9 months | |
Secondary | duration and frequency postprandial hyperglycaemic excursions | maternal | through study completion, an average of 9 months | |
Secondary | start and amount of glucose lowering therapy | development until birth | through study completion, an average of 9 months | |
Secondary | HbA1c | maternal measurements | through study completion, an average of 9 months | |
Secondary | glycosylated Fibronectin | maternal measurements | through study completion, an average of 9 months | |
Secondary | change in bodyweight during pregnancy and after delivery as well as glucose disposal at postpartum | development until birth | through study completion, an average of 1 year | |
Secondary | Health-related quality of life | development until birth | through study completion, an average of 9 months |
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