Real Time Continuous Glucose Monitoring System in T2DM With Pregnacy

Pregnancy Related Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05947916
• Other study ID #: T2DMCGMs
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2023
• Source: Peking University Third Hospital
• Contact: Haining Wang, Doctor
• Phone: 18211087263
• Email: hainingmail[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: December 31, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Continuous Glucose Monitoring
• Diabetes Mellitus, Type 2
• Pregnancy Outcome
• Pregnancy Related
• Time in Range

Intervention

Device:
• Real-time Continuous Glucose Monitoring System
The intervention group wore real-time CGM (120 cases) to monitor blood glucose, and was required to use real-time-CGM more than 50% of the time every 4 weeks, the more the better.

Locations

Country	Name	City	State
China	Peking University Third Hospital	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Peking University Third Hospital	Beijing Municipal Health Commission

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Security Index	Outpatient and emergency treatment of patients for any reason (except planned follow-up), record the number of visits, cause, diagnosis and corresponding treatment.	From enrollment to 6 weeks postpartum.
Other	Security Index-Medication other than insulin during pregnancy.	Medication other than insulin during pregnancy.	From enrollment to 6 weeks postpartum.
Other	Adverse event record	Adverse events other than those described above.	From enrollment to 6 weeks postpartum.
Primary	The difference of Time in Range (TIR)	The iPro2 device was used to calculate TIR(the control range of blood glucose during pregnancy was 3.5-7.8mmol/L), and the average value of TIR obtained from two measurements was used as the main outcome index.	24-28 weeks (second trimester), 34-38 weeks (2 weeks before delivery)
Secondary	Time Above Range(TAR)	The data were recorded via iPro2(the time above control range of blood glucose during pregnancy)	24-28 weeks (second trimester), 34-38 weeks (2 weeks before delivery)
Secondary	Time Below Range(TBR)	The data were recorded via iPro2 (the time below control range of blood glucose during pregnancy)	24-28 weeks (second trimester), 34-38 weeks (2 weeks before delivery)
Secondary	Mean Amplitude Of Glycemic Excursion(MAGE)	The data were recorded via iPro2.	24-28 weeks (second trimester), 34-38 weeks (2 weeks before delivery)
Secondary	Coefficient of Variation (CV)	The data were recorded via iPro2.	24-28 weeks (second trimester), 34-38 weeks (2 weeks before delivery)
Secondary	Standard difference (SD)	The data were recorded via iPro2.	24-28 weeks (second trimester), 34-38 weeks (2 weeks before delivery)
Secondary	Mean absolute relative difference (MARD)	The data were recorded via iPro2.	24-28 weeks (second trimester), 34-38 weeks (2 weeks before delivery)
Secondary	Interquartile range(IQR)	The data were recorded via iPro2.	24-28 weeks (second trimester), 34-38 weeks (2 weeks before delivery)
Secondary	Interdencile range (IDR)	The data were recorded via iPro2.	24-28 weeks (second trimester), 34-38 weeks (2 weeks before delivery)
Secondary	Patient-reported severe hypoglycemic events	Number of patient-reported severe hypoglycemic events (hypoglycemic events requiring assistance) from enrollment to 42 weeks of gestation.	From enrollment to 42 weeks gestation
Secondary	Patient-reported severe hypoglycemic events	(a) Number of patient-reported severe hypoglycemic events (hypoglycemic events requiring assistance) from enrollment to 42 weeks of gestation; (b) Number of mild hypoglycemic (<3.5 mmol/l) and moderate hypoglycemic (<2.8 mmol/L) events detected by patient self-monitoring from enrollment to 42 weeks of gestation (c) Area under the curve for mild hypoglycemia (<3.5 mmol/l) and moderate hypoglycemia (<2.8 mmol/L) at 24, 28 and 34 weeks of gestation as indicated by the ambulatory glucose monitoring device; (d) Area under the curve for mild hypoglycemia (<3.5 mmol/l) and moderate hypoglycemia (<2.8 mmol/L) at night (23:00-7:00) as indicated by the ambulatory glucose monitoring device at 24, 28 and 34 weeks of gestation.	From enrollment to 42 weeks gestation
Secondary	Number of moderate hypoglycemic events	Number of moderate hypoglycemic (<2.8 mmol/L) events detected by patient self-monitoring from enrollment to 42 weeks of gestation; Area under the curve for moderate hypoglycemia (<2.8 mmol/L) at 24, 28 and 34 weeks of gestation as indicated by the ambulatory glucose monitoring device; (d) Area under the curve for moderate hypoglycemia (<2.8 mmol/L) at night (23:00-7:00) as indicated by the ambulatory glucose monitoring device at 24, 28 and 34 weeks of gestation.	From enrollment to 42 weeks gestation
Secondary	Number of mild hypoglycemic events	Number of mild hypoglycemic (<3.5 mmol/l) events detected by patient self-monitoring from enrollment to 42 weeks of gestation (c) Area under the curve for mild hypoglycemia (<3.5 mmol/l) at 24, 28 and 34 weeks of gestation as indicated by the ambulatory glucose monitoring device; (d) Area under the curve for mild hypoglycemia (<3.5 mmol/l) at night (23:00-7:00) as indicated by the ambulatory glucose monitoring device at 24, 28 and 34 weeks of gestation.	From enrollment to 42 weeks gestation
Secondary	Total insulin	the whole day dose of insulin	At 4 weeks after enrollment, 24, 28, 34 weeks gestation and 6 weeks postpartum.
Secondary	Maternal weight gain	The absolute value of maternal weight gain during pregnancy	From enrollment to 42 weeks gestation
Secondary	Glycosylated hemoglobin	Glycosylated hemoglobin during delivery	During delivery
Secondary	Glycosylated albumin	Glycosylated albumin during delivery	During delivery
Secondary	Number of Patients with Adverse pregancy outcome	Includign gestational hypertension, preeclampsia/eclampsia, Cesarean section rate, puerperal infection.	6 weeks postpartum.
Secondary	Number of Pregnancy loss	Including abortion (less than 28 weeks gestation), stillbirth and neonatal death.	From enrollment to 6 weeks postpartum.
Secondary	Apgar score	Apgar score at birth, range from 0-10, evaluated activity, pulse, grimace, appearance, respiration. Score 8 to 10 is classified as no asphyxia, 4 to 7 is mild asphyxia, 0 to 3 is severe asphyxia	During delivery
Secondary	Number of neonatal hypoglycemia	Intravenous glucose infusion is required.	6 weeks postpartum.
Secondary	The length of a newborn is treated in the neonatal intensive care unit (NICU)	The length of a newborn is treated in the neonatal intensive care unit (NICU)	6 weeks postpartum.
Secondary	Gestational age at birth	The incidence of preterm delivery (28-37 weeks gestation at birth), full-term delivery (37-42 weeks gestation at birth), and overdue delivery (more than 42 weeks gestation at birth).	During delivery
Secondary	Number of macrosomia or fetal growth restriction	Macrosomia (birth weight greater than 4000 g) or fetal growth restriction (birth weight less than 2500)	During delivery
Secondary	Number of newborns with neonatal birth injury, shoulder dystocia, neonatal jaundice, neonatal respiratory distress syndrome (RDS)	Including neonatal birth injury, shoulder dystocia, neonatal jaundice, neonatal respiratory distress syndrome (RDS).	From birth to discharge.