Gestational Diabetes Mellitus (GDM)NCT07173959
Digital Therapy for Individualized Intervention and Management of Gestational Diabetes Mellitus
A study testing GDM digital Therapy mini-program and Pregnancy record and education mini-program in people with Gestational Diabetes Mellitus (GDM), run by Peking Union Medical College Hospital.
Trial summary
Existing studies have shown that the management combined with digital health technology can increase the qualified rate of blood glucose in pregnant women with gestational diabetes mellitus (GDM), and the earlier the intervention, the better the effect of blood glucose control. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gestational Diabetes Mellitus (GDM)
- What is being tested?
- GDM digital Therapy mini-program and Pregnancy record and education mini-program
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- No sites listed yet
- Study dates
- 8 Oct 2025to 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 24 to 28 weeks of pregnancy GDM was diagnosed by OGTT test single pregnancy Be able to use smart phone APP to conduct intervention management based on digital therapy software program
Who cannot join
- Suffering from type 1 or type 2 diabetes Other serious organic diseases With severe mental disorders Intervention management cannot be carried out as planned using digital therapeutics
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Existing studies have shown that the management combined with digital health technology can increase the qualified rate of blood glucose in pregnant women with gestational diabetes mellitus (GDM), and the earlier the intervention, the better the effect of blood glucose control. Previously, there was a lack of relevant research on digital therapeutics for the systematic management of gestational diabetes in China. A data-driven digital therapy product for gestational diabetes (doctor's end + patient's end) was established. This product integrates functions such as information recording, risk assessment, evaluation and suggestion, prescription issuance, and knowledge popularization. It aims to provide personalized blood glucose regulation plans for pregnant women with gestational diabetes and enhance the health awareness and self-management ability of families with gestational diabetes.
- Conditions
- Gestational Diabetes Mellitus (GDM)
- Being tested
- GDM digital Therapy mini-program, Pregnancy record and education mini-program
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GDM digital Therapy mini-programDevice
The main functions of digital therapy products include personalized recipe recommendations, exercise and diet records and personalized analysis, blood sugar and weight monitoring, and the generation of weekly and monthly electronic comprehensive reports. The content of the electronic comprehensive reports includes the weight gain, blood sugar status, examination indicators, mood, and the proportion of diet and exercise of pregnant women in line with the system's recommendations during this period of time.
Pregnancy record and education mini-programDevice
This mini-program looks the same as digital therapy products but only has the functions of education and record-keeping
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | This group of pregnant women received nutritional intervention and feedback provided by a digital therapy product (mini-program) relying on an AI system on the basis of routine obstetric care Receives: Device: GDM digital Therapy mini-program |
| control group | Placebo comparator | Pregnant women randomly assigned to the control group used a mini-program that looked the same as digital therapy products but only had educational and recording functions on the basis of routine obstetric care Receives: Device: Pregnancy record and education mini-program |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of achieving blood glucose targets
Measured: From enrollment to the end of treatment at 16 weeks
Secondary outcomes (2)
Weight gain during pregnancy
Measured: From enrollment to the end of treatment at 16 weeks
The incidence of adverse pregnancy outcomes
Measured: During childbirth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2025
- Study start8 Oct 2025 (estimated)
- Primary completion31 May 2026 (estimated)
- 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 Gestational Diabetes Mellitus (GDM)Studies of the same condition, open and under way.
- More trials run by Peking Union Medical College 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07173959
- Sponsor's protocol ID
- K8156
- Status last verified
- Sep 2025
- First submitted
- 8 Sep 2025
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Therapy for Individualized Intervention and Management of Gestational Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT07173959
- Acronym / sponsor ID
- K8156
- Conditions
- Gestational Diabetes Mellitus (GDM)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 8 Oct 2025 (estimated)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 15 Sep 2025 (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.
Existing studies have shown that the management combined with digital health technology can increase the qualified rate of blood glucose in pregnant women with gestational diabetes mellitus (GDM), and the earlier the intervention, the better the effect of blood glucose control. Previously, there was a lack of relevant research on digital therapeutics for the systematic management of gestational diabetes in China. A data-driven digital therapy product for gestational diabetes (doctor's end + patient's end) was established. This product integrates functions such as information recording, risk assessment, evaluation and suggestion, prescription issuance, and knowledge popularization. It aims to provide personalized blood glucose regulation plans for pregnant women with gestational diabetes and enhance the health awareness and self-management ability of families with gestational diabetes.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Device: GDM digital Therapy mini-programThis group of pregnant women received nutritional intervention and feedback provided by a digital therapy product (mini-program) relying on an AI system on the basis of routine obstetric care |
| control group | Placebo comparator | Device: Pregnancy record and education mini-programPregnant women randomly assigned to the control group used a mini-program that looked the same as digital therapy products but only had educational and recording functions on the basis of routine obstetric care |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 24 to 28 weeks of pregnancy GDM was diagnosed by OGTT test single pregnancy Be able to use smart phone APP to conduct intervention management based on digital therapy software program
Key exclusion criteria (1 listed)
- Suffering from type 1 or type 2 diabetes Other serious organic diseases With severe mental disorders Intervention management cannot be carried out as planned using digital therapeutics
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 |
|---|---|---|
| GDM digital Therapy mini-programThe main functions of digital therapy products include personalized recipe recommendations, exercise and diet records and personalized analysis, blood sugar and weight monitoring, and the generation of weekly and monthly electronic comprehensive reports. The content of the electronic comprehensive reports includes the weight gain, blood sugar status, examination indicators, mood, and the proportion of diet and exercise of pregnant women in line with the system's recommendations during this period of time. | Device | intervention group |
| Pregnancy record and education mini-programThis mini-program looks the same as digital therapy products but only has the functions of education and record-keeping | Device | control group |
Primary outcome
The rate of achieving blood glucose targets
Time frame: From enrollment to the end of treatment at 16 weeks
2 secondary outcomes
Weight gain during pregnancy
Time frame: From enrollment to the end of treatment at 16 weeks
The incidence of adverse pregnancy outcomes
Time frame: During childbirth
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 15 Sep 2025.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing GDM digital Therapy mini-program and Pregnancy record and education mini-program in people with Gestational Diabetes Mellitus (GDM), run by Peking Union Medical College Hospital.
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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 Liangkun Ma (+8613021961166, maliangkun@pumch.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of achieving blood glucose targets (time frame: From enrollment to the end of treatment at 16 weeks). 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 15 Sep 2025.