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Real Time Continuous Glucose Monitoring System in T2DM With Pregnacy

Primary Purpose

Type2diabetes, Pregnancy Related, Continuous Glucose Monitoring

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Real-time Continuous Glucose Monitoring System
Sponsored by
Peking University Third Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type2diabetes

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Peking University Third HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention group

Control group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Time Above Range(TAR)
The data were recorded via iPro2(the time above control range of blood glucose during pregnancy)
Time Below Range(TBR)
The data were recorded via iPro2 (the time below control range of blood glucose during pregnancy)
Mean Amplitude Of Glycemic Excursion(MAGE)
The data were recorded via iPro2.
Coefficient of Variation (CV)
The data were recorded via iPro2.
Standard difference (SD)
The data were recorded via iPro2.
Mean absolute relative difference (MARD)
The data were recorded via iPro2.
Interquartile range(IQR)
The data were recorded via iPro2.
Interdencile range (IDR)
The data were recorded via iPro2.
Patient-reported severe hypoglycemic events
Number of patient-reported severe hypoglycemic events (hypoglycemic events requiring assistance) from enrollment to 42 weeks of gestation.
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.
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.
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.
Total insulin
the whole day dose of insulin
Maternal weight gain
The absolute value of maternal weight gain during pregnancy
Glycosylated hemoglobin
Glycosylated hemoglobin during delivery
Glycosylated albumin
Glycosylated albumin during delivery
Number of Patients with Adverse pregancy outcome
Includign gestational hypertension, preeclampsia/eclampsia, Cesarean section rate, puerperal infection.
Number of Pregnancy loss
Including abortion (less than 28 weeks gestation), stillbirth and neonatal death.
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
Number of neonatal hypoglycemia
Intravenous glucose infusion is required.
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)
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).
Number of macrosomia or fetal growth restriction
Macrosomia (birth weight greater than 4000 g) or fetal growth restriction (birth weight less than 2500)
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).

Full Information

First Posted
March 26, 2023
Last Updated
July 8, 2023
Sponsor
Peking University Third Hospital
Collaborators
Beijing Municipal Health Commission
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1. Study Identification

Unique Protocol Identification Number
NCT05947916
Brief Title
Real Time Continuous Glucose Monitoring System in T2DM With Pregnacy
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
September 30, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking University Third Hospital
Collaborators
Beijing Municipal Health Commission

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type2diabetes, Pregnancy Related, Continuous Glucose Monitoring, Time in Range, Pregnancy Outcome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
The control group will be followed up with traditional SMBG (120 cases) monitoring.
Intervention Type
Device
Intervention Name(s)
Real-time Continuous Glucose Monitoring System
Intervention Description
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.
Primary Outcome Measure Information:
Title
The difference of Time in Range (TIR)
Description
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.
Time Frame
24-28 weeks (second trimester), 34-38 weeks (2 weeks before delivery)
Secondary Outcome Measure Information:
Title
Time Above Range(TAR)
Description
The data were recorded via iPro2(the time above control range of blood glucose during pregnancy)
Time Frame
24-28 weeks (second trimester), 34-38 weeks (2 weeks before delivery)
Title
Time Below Range(TBR)
Description
The data were recorded via iPro2 (the time below control range of blood glucose during pregnancy)
Time Frame
24-28 weeks (second trimester), 34-38 weeks (2 weeks before delivery)
Title
Mean Amplitude Of Glycemic Excursion(MAGE)
Description
The data were recorded via iPro2.
Time Frame
24-28 weeks (second trimester), 34-38 weeks (2 weeks before delivery)
Title
Coefficient of Variation (CV)
Description
The data were recorded via iPro2.
Time Frame
24-28 weeks (second trimester), 34-38 weeks (2 weeks before delivery)
Title
Standard difference (SD)
Description
The data were recorded via iPro2.
Time Frame
24-28 weeks (second trimester), 34-38 weeks (2 weeks before delivery)
Title
Mean absolute relative difference (MARD)
Description
The data were recorded via iPro2.
Time Frame
24-28 weeks (second trimester), 34-38 weeks (2 weeks before delivery)
Title
Interquartile range(IQR)
Description
The data were recorded via iPro2.
Time Frame
24-28 weeks (second trimester), 34-38 weeks (2 weeks before delivery)
Title
Interdencile range (IDR)
Description
The data were recorded via iPro2.
Time Frame
24-28 weeks (second trimester), 34-38 weeks (2 weeks before delivery)
Title
Patient-reported severe hypoglycemic events
Description
Number of patient-reported severe hypoglycemic events (hypoglycemic events requiring assistance) from enrollment to 42 weeks of gestation.
Time Frame
From enrollment to 42 weeks gestation
Title
Patient-reported severe hypoglycemic events
Description
(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.
Time Frame
From enrollment to 42 weeks gestation
Title
Number of moderate hypoglycemic events
Description
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.
Time Frame
From enrollment to 42 weeks gestation
Title
Number of mild hypoglycemic events
Description
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.
Time Frame
From enrollment to 42 weeks gestation
Title
Total insulin
Description
the whole day dose of insulin
Time Frame
At 4 weeks after enrollment, 24, 28, 34 weeks gestation and 6 weeks postpartum.
Title
Maternal weight gain
Description
The absolute value of maternal weight gain during pregnancy
Time Frame
From enrollment to 42 weeks gestation
Title
Glycosylated hemoglobin
Description
Glycosylated hemoglobin during delivery
Time Frame
During delivery
Title
Glycosylated albumin
Description
Glycosylated albumin during delivery
Time Frame
During delivery
Title
Number of Patients with Adverse pregancy outcome
Description
Includign gestational hypertension, preeclampsia/eclampsia, Cesarean section rate, puerperal infection.
Time Frame
6 weeks postpartum.
Title
Number of Pregnancy loss
Description
Including abortion (less than 28 weeks gestation), stillbirth and neonatal death.
Time Frame
From enrollment to 6 weeks postpartum.
Title
Apgar score
Description
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 Frame
During delivery
Title
Number of neonatal hypoglycemia
Description
Intravenous glucose infusion is required.
Time Frame
6 weeks postpartum.
Title
The length of a newborn is treated in the neonatal intensive care unit (NICU)
Description
The length of a newborn is treated in the neonatal intensive care unit (NICU)
Time Frame
6 weeks postpartum.
Title
Gestational age at birth
Description
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 Frame
During delivery
Title
Number of macrosomia or fetal growth restriction
Description
Macrosomia (birth weight greater than 4000 g) or fetal growth restriction (birth weight less than 2500)
Time Frame
During delivery
Title
Number of newborns with neonatal birth injury, shoulder dystocia, neonatal jaundice, neonatal respiratory distress syndrome (RDS)
Description
Including neonatal birth injury, shoulder dystocia, neonatal jaundice, neonatal respiratory distress syndrome (RDS).
Time Frame
From birth to discharge.
Other Pre-specified Outcome Measures:
Title
Security Index
Description
Outpatient and emergency treatment of patients for any reason (except planned follow-up), record the number of visits, cause, diagnosis and corresponding treatment.
Time Frame
From enrollment to 6 weeks postpartum.
Title
Security Index-Medication other than insulin during pregnancy.
Description
Medication other than insulin during pregnancy.
Time Frame
From enrollment to 6 weeks postpartum.
Title
Adverse event record
Description
Adverse events other than those described above.
Time Frame
From enrollment to 6 weeks postpartum.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Haining Wang, Doctor
Phone
18211087263
Email
hainingmail@163.com
Facility Information:
Facility Name
Peking University Third Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100191
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wang Haining, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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Real Time Continuous Glucose Monitoring System in T2DM With Pregnacy

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