Clinical trial NCT05947916: Real Time Continuous Glucose Monitoring System in T2DM With Pregnacy
Official title: Effect of Real Time Continuous Glucose Monitoring System on Management of Women With Type 2 Diabetes Mellitus During Pregnancy in a Multidisciplinary Comprehensive System
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Type2diabetes
Pregnancy Related
Continuous Glucose Monitoring
Time in Range
Pregnancy Outcome
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
Collaborators: name: Beijing Municipal Health Commission
First posted: 2023-07-17
Enrollment: 240
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The prevalence of type 2 diabetes mellitus (T2DM) in women of childbearing age is increasing rapidly, and low glucose compliance leads to an increased risk of adverse pregnancy outcomes for mothers and infants during pregnancy in women with T2DM. Real-time continuous glucose monitoring (CGM) is an important tool for glucose monitoring and patient education, as it can continuously record blood glucose throughout the day and provide real-time feedback on high and low blood glucose levels. This is a multicenter, open-label, randomized controlled clinical study to investigate the efficacy, safety, and maternal and infant pregnancy outcomes of using real-time CGM monitoring compared with conventional self-monitoring of blood glucose (SMBG) on the basis of multidisciplinary management in pregnant women with T2DM. One hundred and twenty pregnant women with T2DM in early pregnancy who were enrolled in intensive insulin therapy were randomly divided into the real-time CGM group and the conventional SMBG group. The real-time CGM intervention group wore real-time CGM for more than 50% of the pregnancy in addition to regular SMBG; the control group only performed regular SMBG. Both groups wore Medtronic iPro 2 for 3 days in early, mid and late pregnancy, and the time in the target range of blood glucose (TIR) was recorded in a blinded manner. Primary outcome: differences in TIR between the two groups of pregnant women in early, mid, and late pregnancy. Secondary outcomes included differences in glycated hemoglobin, hypoglycemia, insulin dose before delivery, pregnancy weight gain, and maternal and infant pregnancy outcomes.


Eligibility criteria: Inclusion Criteria:

* A clear history of type 2 diabetes, or a history of type 2 diabetes diagnosed in early pregnancy
* Singleton gestation at 4-12 weeks, with substandard glycemic control (i.e., fasting glucose \> 5.3 mmol/L, and or 1 hour postprandial glucose \> 7.8 mmol/L, and or 2 hours postprandial glucose \> 6.7 mmol/L) after lifestyle intervention ± basal insulin therapy, as assessed by the endocrinology department. Patients who need insulin regimen with basal plus meal or insulin pump regimen.
* Patients are willing and committed to establish and follow up in the obstetrics and gynecology departments of Peking University Third Hospital, Haidian District Hospital and Yanqing District Hospital during pregnancy, and are willing to provide information on obstetric examination and perinatal medical records if they are transferred to the hospital for special reasons for follow-up or delivery.
* Voluntarily participate in the study, examine and follow up according to this project and sign informed consent.
* Able to pass the screening period Adherence evaluation

Exclusion Criteria:

* Patients with type 1 diabetes, specific type of diabetes or gestational diabetes
* Pregnancy with severe comorbidities or diabetic complications for which obstetrics does not recommend continuation of pregnancy, including but not limited to the following: proliferative retinopathy, chronic kidney disease (eGFR less than 60 mL/min/1.73± massive proteinuria), known coronary and cerebrovascular disease, autoimmune system disease and receiving exogenous glucocorticoids or immunosuppressive therapy.
* Patients who have been hospitalized for psychiatric treatment within 6 months prior to enrollment or are still on psychiatric medications.
* Patients who have received other interventional studies.

Primary outcomes:
measure: The difference of Time in Range (TIR)
timeFrame: 24-28 weeks (second trimester), 34-38 weeks (2 weeks before delivery)
Secondary outcomes:
measure: Time Above Range(TAR）
timeFrame: 24-28 weeks (second trimester), 34-38 weeks (2 weeks before delivery)
measure: Time Below Range(TBR)
timeFrame: 24-28 weeks (second trimester), 34-38 weeks (2 weeks before delivery)
measure: Mean Amplitude Of Glycemic Excursion(MAGE)
timeFrame: 24-28 weeks (second trimester), 34-38 weeks (2 weeks before delivery)
measure: Coefficient of Variation (CV)
timeFrame: 24-28 weeks (second trimester), 34-38 weeks (2 weeks before delivery)
measure: Standard difference (SD)
timeFrame: 24-28 weeks (second trimester), 34-38 weeks (2 weeks before delivery)
measure: Mean absolute relative difference (MARD)
timeFrame: 24-28 weeks (second trimester), 34-38 weeks (2 weeks before delivery)
measure: Interquartile range(IQR)
timeFrame: 24-28 weeks (second trimester), 34-38 weeks (2 weeks before delivery)
measure: Interdencile range (IDR)
timeFrame: 24-28 weeks (second trimester), 34-38 weeks (2 weeks before delivery)
measure: Patient-reported severe hypoglycemic events
timeFrame: From enrollment to 42 weeks gestation
measure: Patient-reported severe hypoglycemic events
timeFrame: From enrollment to 42 weeks gestation
measure: Number of moderate hypoglycemic events
timeFrame: From enrollment to 42 weeks gestation
measure: Number of mild hypoglycemic events
timeFrame: From enrollment to 42 weeks gestation
measure: Total insulin
timeFrame: At 4 weeks after enrollment, 24, 28, 34 weeks gestation and 6 weeks postpartum.
measure: Maternal weight gain
timeFrame: From enrollment to 42 weeks gestation
measure: Glycosylated hemoglobin
timeFrame: During delivery
measure: Glycosylated albumin
timeFrame: During delivery
measure: Number of Patients with Adverse pregancy outcome
timeFrame: 6 weeks postpartum.
measure: Number of Pregnancy loss
timeFrame: From enrollment to 6 weeks postpartum.
measure: Apgar score
timeFrame: During delivery
measure: Number of neonatal hypoglycemia
timeFrame: 6 weeks postpartum.
measure: The length of a newborn is treated in the neonatal intensive care unit (NICU)
timeFrame: 6 weeks postpartum.
measure: Gestational age at birth
timeFrame: During delivery
measure: Number of macrosomia or fetal growth restriction
timeFrame: During delivery
measure: Number of newborns with neonatal birth injury, shoulder dystocia, neonatal jaundice, neonatal respiratory distress syndrome (RDS)
timeFrame: From birth to discharge.
Other outcomes:
measure: Security Index
timeFrame: From enrollment to 6 weeks postpartum.
measure: Security Index-Medication other than insulin during pregnancy.
timeFrame: From enrollment to 6 weeks postpartum.
measure: Adverse event record
timeFrame: From enrollment to 6 weeks postpartum.
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
Study officials:
References: