Real Time Continuous Glucose Monitoring System in T2DM With Pregnacy

Not Applicable

Recruiting

• Conditions: Type2diabetes; Pregnancy Outcome; Pregnancy Related; Continuous Glucose Monitoring; Time in Range
• Interventions: Device: Real-time Continuous Glucose Monitoring System

• Registration Number: NCT05947916
• Lead Sponsor: Peking University Third Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-01
• Status Verified: 2023-03
• Study First Submitted: 2023-03-26
• Study First Submitted QC: 2023-07-08
• Last Update Submitted: 2023-07-08
• Study First Posted: 2023-07-17
• Last Update Posted: 2023-07-17
• Primary Completion: 2024-09-30
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 240

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Real-time Continuous Glucose Monitoring System	The intervention group will wear real-time CGM (120 cases) to monitor blood glucose and is required to use real-time-CGM more than 50% of the time every 4 weeks, the more the better.

Primary Outcome Measures

Name	Time	Method
The difference of Time in Range (TIR)	24-28 weeks (second trimester), 34-38 weeks (2 weeks before delivery)	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.

Secondary Outcome Measures

Name	Time	Method
Coefficient of Variation (CV)	24-28 weeks (second trimester), 34-38 weeks (2 weeks before delivery)	The data were recorded via iPro2.
Standard difference (SD)	24-28 weeks (second trimester), 34-38 weeks (2 weeks before delivery)	The data were recorded via iPro2.
Maternal weight gain	From enrollment to 42 weeks gestation	The absolute value of maternal weight gain during pregnancy
Number of Pregnancy loss	From enrollment to 6 weeks postpartum.	Including abortion (less than 28 weeks gestation), stillbirth and neonatal death.
Number of macrosomia or fetal growth restriction	During delivery	Macrosomia (birth weight greater than 4000 g) or fetal growth restriction (birth weight less than 2500)
Number of moderate hypoglycemic events	From enrollment to 42 weeks gestation	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.
Glycosylated hemoglobin	During delivery	Glycosylated hemoglobin during delivery
Number of newborns with neonatal birth injury, shoulder dystocia, neonatal jaundice, neonatal respiratory distress syndrome (RDS)	From birth to discharge.	Including neonatal birth injury, shoulder dystocia, neonatal jaundice, neonatal respiratory distress syndrome (RDS).
Gestational age at birth	During delivery	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).
Time Above Range(TAR）	24-28 weeks (second trimester), 34-38 weeks (2 weeks before delivery)	The data were recorded via iPro2(the time above control range of blood glucose during pregnancy)
Interquartile range(IQR)	24-28 weeks (second trimester), 34-38 weeks (2 weeks before delivery)	The data were recorded via iPro2.
Number of mild hypoglycemic events	From enrollment to 42 weeks gestation	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.
Total insulin	At 4 weeks after enrollment, 24, 28, 34 weeks gestation and 6 weeks postpartum.	the whole day dose of insulin
Number of Patients with Adverse pregancy outcome	6 weeks postpartum.	Includign gestational hypertension, preeclampsia/eclampsia, Cesarean section rate, puerperal infection.
Mean Amplitude Of Glycemic Excursion(MAGE)	24-28 weeks (second trimester), 34-38 weeks (2 weeks before delivery)	The data were recorded via iPro2.
Mean absolute relative difference (MARD)	24-28 weeks (second trimester), 34-38 weeks (2 weeks before delivery)	The data were recorded via iPro2.
Patient-reported severe hypoglycemic events	From enrollment to 42 weeks gestation	(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.
Glycosylated albumin	During delivery	Glycosylated albumin during delivery
Apgar score	During delivery	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
Time Below Range(TBR)	24-28 weeks (second trimester), 34-38 weeks (2 weeks before delivery)	The data were recorded via iPro2 (the time below control range of blood glucose during pregnancy)
Interdencile range (IDR)	24-28 weeks (second trimester), 34-38 weeks (2 weeks before delivery)	The data were recorded via iPro2.
The length of a newborn is treated in the neonatal intensive care unit (NICU)	6 weeks postpartum.	The length of a newborn is treated in the neonatal intensive care unit (NICU)
Number of neonatal hypoglycemia	6 weeks postpartum.	Intravenous glucose infusion is required.

Trial Locations

Locations (1)

Peking University Third Hospital; 🇨🇳 Beijing, Beijing, China