Type2diabetesNCT05947916
Real Time Continuous Glucose Monitoring System in T2DM With Pregnacy
A study testing Real-time Continuous Glucose Monitoring System in people with Type2diabetes and Pregnancy Related, run by Peking University Third Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Type2diabetes, Pregnancy Related, Continuous Glucose Monitoring
- What is being tested?
- Real-time Continuous Glucose Monitoring System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteChina
- Study dates
- 30 Jan 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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 ± 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
Wang Haining, PhD
About this study
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
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
- Being tested
- Real-time Continuous Glucose Monitoring System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Real-time Continuous Glucose Monitoring SystemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Real-time Continuous Glucose Monitoring System |
| Control group | No intervention | The control group will be followed up with traditional SMBG (120 cases) monitoring. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24-28 weeks (second trimester), 34-38 weeks (2 weeks before delivery)
Secondary outcomes (24)
Time Above Range(TAR）
The data were recorded via iPro2(the time above control range of blood glucose during pregnancy)
Measured: 24-28 weeks (second trimester), 34-38 weeks (2 weeks before delivery)
Time Below Range(TBR)
The data were recorded via iPro2 (the time below control range of blood glucose during pregnancy)
Measured: 24-28 weeks (second trimester), 34-38 weeks (2 weeks before delivery)
Mean Amplitude Of Glycemic Excursion(MAGE)
The data were recorded via iPro2.
Measured: 24-28 weeks (second trimester), 34-38 weeks (2 weeks before delivery)
Coefficient of Variation (CV)
The data were recorded via iPro2.
Measured: 24-28 weeks (second trimester), 34-38 weeks (2 weeks before delivery)
Standard difference (SD)
The data were recorded via iPro2.
Measured: 24-28 weeks (second trimester), 34-38 weeks (2 weeks before delivery)
Mean absolute relative difference (MARD)
The data were recorded via iPro2.
Measured: 24-28 weeks (second trimester), 34-38 weeks (2 weeks before delivery)
Interquartile range(IQR)
The data were recorded via iPro2.
Measured: 24-28 weeks (second trimester), 34-38 weeks (2 weeks before delivery)
Interdencile range (IDR)
The data were recorded via iPro2.
Measured: 24-28 weeks (second trimester), 34-38 weeks (2 weeks before delivery)
Patient-reported severe hypoglycemic events
Number of patient-reported severe hypoglycemic events (hypoglycemic events requiring assistance) from enrollment to 42 weeks of gestation.
Measured: From enrollment to 42 weeks 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.
Measured: From enrollment to 42 weeks 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.
Measured: From enrollment to 42 weeks 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.
Measured: From enrollment to 42 weeks gestation
Total insulin
the whole day dose of insulin
Measured: At 4 weeks after enrollment, 24, 28, 34 weeks gestation and 6 weeks postpartum.
Maternal weight gain
The absolute value of maternal weight gain during pregnancy
Measured: From enrollment to 42 weeks gestation
Glycosylated hemoglobin
Glycosylated hemoglobin during delivery
Measured: During delivery
Glycosylated albumin
Glycosylated albumin during delivery
Measured: During delivery
Number of Patients with Adverse pregancy outcome
Includign gestational hypertension, preeclampsia/eclampsia, Cesarean section rate, puerperal infection.
Measured: 6 weeks postpartum.
Number of Pregnancy loss
Including abortion (less than 28 weeks gestation), stillbirth and neonatal death.
Measured: From enrollment to 6 weeks postpartum.
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
Measured: During delivery
Number of neonatal hypoglycemia
Intravenous glucose infusion is required.
Measured: 6 weeks postpartum.
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)
Measured: 6 weeks postpartum.
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).
Measured: During delivery
Number of macrosomia or fetal growth restriction
Macrosomia (birth weight greater than 4000 g) or fetal growth restriction (birth weight less than 2500)
Measured: During delivery
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).
Measured: From birth to discharge.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2023
- Study start30 Jan 2024
- Primary completion31 Dec 2025
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type2diabetesStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Municipal Health Commission
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05947916
- Sponsor's protocol ID
- T2DMCGMs
- Status last verified
- Nov 2025
- First submitted
- 26 Mar 2023
- Last updated
- 2 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05947916
- Acronym / sponsor ID
- T2DMCGMs
- Conditions
- Type2diabetes, Pregnancy Related, Continuous Glucose Monitoring, Time in Range, Pregnancy Outcome
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Collaborators
- Beijing Municipal Health Commission
- Study start
- 30 Jan 2024 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 17 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Device: Real-time Continuous Glucose Monitoring SystemThe 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. |
| Control group | No intervention | –The control group will be followed up with traditional SMBG (120 cases) monitoring. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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 ± 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Real-time Continuous Glucose Monitoring SystemThe 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. | Device | Intervention group |
Primary outcome
The difference of Time in Range (TIR)
Time frame: 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.
24 secondary outcomes
Time Above Range(TAR）
Time frame: 24-28 weeks (second trimester), 34-38 weeks (2 weeks before delivery)
Time Below Range(TBR)
Time frame: 24-28 weeks (second trimester), 34-38 weeks (2 weeks before delivery)
Mean Amplitude Of Glycemic Excursion(MAGE)
Time frame: 24-28 weeks (second trimester), 34-38 weeks (2 weeks before delivery)
Coefficient of Variation (CV)
Time frame: 24-28 weeks (second trimester), 34-38 weeks (2 weeks before delivery)
Standard difference (SD)
Time frame: 24-28 weeks (second trimester), 34-38 weeks (2 weeks before delivery)
Mean absolute relative difference (MARD)
Time frame: 24-28 weeks (second trimester), 34-38 weeks (2 weeks before delivery)
Interquartile range(IQR)
Time frame: 24-28 weeks (second trimester), 34-38 weeks (2 weeks before delivery)
Interdencile range (IDR)
Time frame: 24-28 weeks (second trimester), 34-38 weeks (2 weeks before delivery)
Patient-reported severe hypoglycemic events
Time frame: From enrollment to 42 weeks gestation
Patient-reported severe hypoglycemic events
Time frame: From enrollment to 42 weeks gestation
Number of moderate hypoglycemic events
Time frame: From enrollment to 42 weeks gestation
Number of mild hypoglycemic events
Time frame: From enrollment to 42 weeks gestation
Total insulin
Time frame: At 4 weeks after enrollment, 24, 28, 34 weeks gestation and 6 weeks postpartum.
Maternal weight gain
Time frame: From enrollment to 42 weeks gestation
Glycosylated hemoglobin
Time frame: During delivery
Glycosylated albumin
Time frame: During delivery
Number of Patients with Adverse pregancy outcome
Time frame: 6 weeks postpartum.
Number of Pregnancy loss
Time frame: From enrollment to 6 weeks postpartum.
Apgar score
Time frame: During delivery
Number of neonatal hypoglycemia
Time frame: 6 weeks postpartum.
The length of a newborn is treated in the neonatal intensive care unit (NICU)
Time frame: 6 weeks postpartum.
Gestational age at birth
Time frame: During delivery
Number of macrosomia or fetal growth restriction
Time frame: During delivery
Number of newborns with neonatal birth injury, shoulder dystocia, neonatal jaundice, neonatal respiratory distress syndrome (RDS)
Time frame: From birth to discharge.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Real-time Continuous Glucose Monitoring System in people with Type2diabetes and Pregnancy Related, run by Peking University Third Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Haining Wang, Doctor (18211087263, hainingmail@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The difference of Time in Range (TIR) (time frame: 24-28 weeks (second trimester), 34-38 weeks (2 weeks before delivery)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2026.