Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05947916
Other study ID # T2DMCGMs
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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.
See also
  Status Clinical Trial Phase
Completed NCT05017974 - Research on Improving Sleep During Pregnancy N/A
Completed NCT03284515 - Vaccination In Pregnancy Gene Signature: VIP Signature Study
Recruiting NCT05969795 - Comparison of Live Birth Rate in Natural Cycle Single Euploid FET Versus Without Luteal Phase Support Phase 1
Recruiting NCT06051201 - Innovation for Small-scale Experiments: ReceptIVFity Test N/A
Recruiting NCT04828382 - Prospective Study of Pregnancy in Women With Cystic Fibrosis
Enrolling by invitation NCT04527926 - STEPuP: Prenatal Provider Education and Training to Improve Medication-assisted Treatment Use During Pregnancy N/A
Recruiting NCT04278651 - Early Antenatal Support for Iron Deficiency Anemia Phase 4
Recruiting NCT04405700 - Measuring Adverse Pregnancy and Newborn Congenital Outcomes
Recruiting NCT06258902 - Odevixibat Pregnancy and Lactation Surveillance Program: A Study to Evaluate the Safety of Odevixibat During Pregnancy and/or Lactation
Completed NCT05487196 - Effectiveness of Clonidine, Dexmedetomidine, and Fentanyl Adjuncts for Labor Epidural Analgesia Phase 2
Completed NCT03750968 - Lutein & Zeaxanthin in Pregnancy - Carotenoid Supplementation During Pregnancy: Ocular and Systemic Effects Phase 2
Enrolling by invitation NCT06127277 - Next4You: A Fully Mobile Relationships Based Program for Youth in Foster Care N/A
Completed NCT05897697 - Assessing Women's Preferences for Postpartum Thromboprophylaxis: the Prefer-Postpartum Study
Recruiting NCT05899101 - The Impact of Opioid and Cannabis Exposure on Fetal Growth
Completed NCT05502510 - Assessing the Effectiveness and Efficacy of the MyHealthyPregnancy Application
Completed NCT04296396 - Opioid Prescription After Cesarean Trial Phase 3
Not yet recruiting NCT06069869 - Multiple Micronutrient Supplementation (MMS) Iron Dose Acceptability Crossover Trial Phase 3
Not yet recruiting NCT06069856 - Multiple Micronutrient Supplementation (MMS) IFA- Iron Dose Acceptability Crossover Trial Phase 3
Not yet recruiting NCT06163651 - Evaluating a One-Year Version of the Parent-Child Assistance Program N/A
Not yet recruiting NCT06079918 - Multiple Micronutrient Supplementation for Maternal Anemia Prevention in Tanzania Phase 3