Real Time Continuous Glucose Monitoring System in T2DM With Pregnacy

NCT05947916 | Unknown

• 1 other identifier: T2DMCGMs
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Type2diabetes; Pregnancy Related; Continuous Glucose Monitoring; Time in Range; Pregnancy Outcome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (24)

• Time Above Range(TAR）

  24-28 weeks (second trimester), 34-38 weeks (2 weeks before delivery)

• Time Below Range(TBR)

  24-28 weeks (second trimester), 34-38 weeks (2 weeks before delivery)

• Mean Amplitude Of Glycemic Excursion(MAGE)

  24-28 weeks (second trimester), 34-38 weeks (2 weeks before delivery)

• Coefficient of Variation (CV)

  24-28 weeks (second trimester), 34-38 weeks (2 weeks before delivery)

• Standard difference (SD)

  24-28 weeks (second trimester), 34-38 weeks (2 weeks before delivery)

Other Outcomes (3)

• Security Index

  From enrollment to 6 weeks postpartum.

• Security Index-Medication other than insulin during pregnancy.

  From enrollment to 6 weeks postpartum.

• Adverse event record

  From enrollment to 6 weeks postpartum.

Study Arms (2)

Intervention group

EXPERIMENTAL

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.

Device: Real-time Continuous Glucose Monitoring System

Control group

NO INTERVENTION

The control group will be followed up with traditional SMBG (120 cases) monitoring.

Interventions

Real-time Continuous Glucose Monitoring System DEVICE

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.

Intervention group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University Third Hospital: lead
• Beijing Municipal Health Commission: collaborator

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

RECRUITING

Central Study Contacts

Haining Wang, Doctor

CONTACT

18211087263; hainingmail@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2023
• First Posted: July 17, 2023
• Study Start: January 1, 2022
• Primary Completion: September 30, 2024
• Study Completion: December 31, 2024
• Last Updated: July 17, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)