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Real Time Continuous Glucose Monitoring System in T2DM With Pregnacy

RecruitingNAAges 18 Years - 40 YearsFemalePeking University Third Hospital
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In plain words

What the trial is, and whether it could suit you

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 enrol

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * A clear history of type 2 diabetes, or a history of type 2 diabetes diagnosed in early pregnancy * Singleton gestation at 4-26 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 ยฑ 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/1.73ยฑ 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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What it tests

  • Real-time Continuous Glucose Monitoring System
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Where

1 site
Peking University Third Hospital
Beijing, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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