Could a smart monitor help pregnant women with diabetes have healthier babies?
NCT ID NCT05947916
First seen Jul 02, 2026 · Last updated Jul 02, 2026
Summary
This study tests whether a real-time continuous glucose monitor (CGM) helps pregnant women with type 2 diabetes keep their blood sugar in a healthy range better than standard finger-prick testing. About 240 women in early pregnancy will either wear the CGM device for most of their pregnancy or use standard monitoring. The goal is to see if CGM leads to better blood sugar control and improved outcomes for mothers and their babies.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- real-time continuous glucose monitoring system
- What this could lead to
- If it works, this could show that real-time CGM helps pregnant women with type 2 diabetes keep blood sugar in a safer range, potentially reducing complications for both mother and baby.
- What could go wrong
- This is a moderate-sized trial, and the benefits may not be large or apply to all women. The device requires consistent wear and may cause skin irritation or inaccurate readings.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 240 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2024
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 40 years
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 ± 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Peking University Third Hospital
RECRUITINGBeijing, Beijing Municipality, 100191, China
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