GDMNCT04424238
the Effect of Mobile Medical Used for the Standardized Management of Gestational Diabetes
A study testing m-health management in people with GDM and Blood Glucose, run by Peking Union Medical College Hospital.
Trial summary
A multicenter, randomized controlled trial was conducted to investigate whether health education and life style management through WeChat group chat was more effective in controlling blood glucose (BG) than standard clinic prenatal care in women with GDM. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- GDM, Blood Glucose, Compliance, Patient
- What is being tested?
- m-health management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- 15 Mar 2016to 30 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Aged between 18 and 45 years.
- With singleton pregnancy
- Diagnosed as GDM by 75g oral glucose tolerance test (OGTT) and insulin treatment is not required assessed by multi-disciplinary consultation.
- Be able to use smart phone for chatting, read and write basic Chinese.
- Volunteer for research.
Who cannot join
- Pregnancies with diagnosed chronic disease
- Pregnancies with other pregnancy complications except GDM
- Pregnancies had recent trauma and treatment of glucocorticoids
About this study
Official title: Clinical Research on Mobile Medical Used for the Standardized Management of Gestational Diabetes: a Randomized Control Trail
A multicenter, randomized controlled trial was conducted to investigate whether health education and life style management through WeChat group chat was more effective in controlling blood glucose (BG) than standard clinic prenatal care in women with GDM.
Read the detailed description
Most gestational diabetes mellitus (GDM) can be well controlled by health education and life style management, expecting a better pregnancy outcome. But standard clinic prenatal care which consist of clinic visit every two weeks may not give full play to the effects of GDM management. Telemedicine shows its potential to fill this gap. A multicenter, randomized controlled trial was designed to investigate whether health education and life style management through WeChat group chat was more effective in controlling blood glucose (BG) than standard clinic prenatal care in women with GDM. Women with GDM diagnosed by oral glucose tolerance test between 23-30+6 gestational weeks were randomized to a WeChat group chat-based blood glucose management group or routine clinic prenatal care. In PUMCH, investigators also equip CGM for m-health group allowing a more detailed BG information. The primary outcome was change of glycemic qualification rate during follow up period in both groups. The second outcome was pregnancy outcomes. Also, a case-control study is designed to compare the glucose control status between rice-richen meal and wheaten-richen meal, and all other macronutrients and micronutrients are all calculated and same between two groups, which may provide more clues for type of carbohydrate recommendation for Chinese women with GDM.
- Conditions
- GDM, Blood Glucose, Compliance, Patient, Diet Habit
- Being tested
- m-health management
- Keywords
- GDM, CGM, m-health, diet modification, blood glucose, compliance
- Medical subject headings
- Patient Compliance, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
m-health managementBehavioural
Patients in intervention group received additional WeChat group management when conducted standard clinic prenatal care.
| Study group | Role | What they receive |
|---|---|---|
| Standard Clinic Prenatal Care (Control Group) | No intervention | pregnancy's prenatal care appointment would be changed to once every two weeks when diagnosed with GDM. Doctors generally ask GDM women record their daily diet, exercise, weight, BG and blood pressure for at least three days between two visits and give lifestyle guidance according to the records. If they fail to show diaries, doctors would ask them come back with record next week. If BG control is poor, medicine intervention would be considered. |
| m-health group (Intervention Group) | Experimental | participants were managed continuously through WeChat group chat. Receives: Behavioral: m-health management |
What is being measured
The primary outcome is the main question the study is designed to answer.
glycemic qualification rate
Glycemic qualification rate was calculated by the number of BG within the control range /30*100%. BG control range were fasting BG (fasting and before-sleep BG)<95 mg/dL (5.3 mmol/L) and two-hour postprandial BG (post-breakfast, post-lunch, post-dinner BG)<120 mg/dL (6.7 mmol/L)
Measured: From enrollment to 42 days postpartum
Secondary outcomes (1)
pregnancy outcome
delivery mode, premature rupture of the membranes, preterm birth, birthweight and postpartum hemorrhage
Measured: delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start15 Mar 2016
- Primary completion15 Jun 2020 (estimated)
- Study completion30 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GDMStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Liangkun Ma, Study chair, Chinese Academy of Medical Science & Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04424238
- Sponsor's protocol ID
- JS-1012
- Status last verified
- May 2020
- First submitted
- 5 Jun 2020
- Last updated
- 16 Jun 2020
- 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 16 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Research on Mobile Medical Used for the Standardized Management of Gestational Diabetes: a Randomized Control Trail
- ClinicalTrials.gov ID
- NCT04424238
- Acronym / sponsor ID
- JS-1012
- Conditions
- GDM, Blood Glucose, Compliance, Patient, Diet Habit
- Keywords
- GDM, CGM, m-health, diet modification, blood glucose, compliance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 15 Mar 2016 (actual)
- Primary completion
- 15 Jun 2020 (estimated)
- Study completion
- 30 Jun 2020 (estimated)
- First posted
- 9 Jun 2020 (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.
A multicenter, randomized controlled trial was conducted to investigate whether health education and life style management through WeChat group chat was more effective in controlling blood glucose (BG) than standard clinic prenatal care in women with GDM.
Detailed description
Most gestational diabetes mellitus (GDM) can be well controlled by health education and life style management, expecting a better pregnancy outcome. But standard clinic prenatal care which consist of clinic visit every two weeks may not give full play to the effects of GDM management. Telemedicine shows its potential to fill this gap. A multicenter, randomized controlled trial was designed to investigate whether health education and life style management through WeChat group chat was more effective in controlling blood glucose (BG) than standard clinic prenatal care in women with GDM. Women with GDM diagnosed by oral glucose tolerance test between 23-30+6 gestational weeks were randomized to a WeChat group chat-based blood glucose management group or routine clinic prenatal care. In PUMCH, investigators also equip CGM for m-health group allowing a more detailed BG information. The primary outcome was change of glycemic qualification rate during follow up period in both groups. The second outcome was pregnancy outcomes. Also, a case-control study is designed to compare the glucose control status between rice-richen meal and wheaten-richen meal, and all other macronutrients and micronutrients are all calculated and same between two groups, which may provide more clues for type of carbohydrate recommendation for Chinese women with GDM.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Clinic Prenatal Care (Control Group) | No intervention | –pregnancy's prenatal care appointment would be changed to once every two weeks when diagnosed with GDM. Doctors generally ask GDM women record their daily diet, exercise, weight, BG and blood pressure for at least three days between two visits and give lifestyle guidance according to the records. If they fail to show diaries, doctors would ask them come back with record next week. If BG control is poor, medicine intervention would be considered. |
| m-health group (Intervention Group) | Experimental | Behavioral: m-health managementparticipants were managed continuously through WeChat group chat. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Aged between 18 and 45 years.
- With singleton pregnancy
- Diagnosed as GDM by 75g oral glucose tolerance test (OGTT) and insulin treatment is not required assessed by multi-disciplinary consultation.
- Be able to use smart phone for chatting, read and write basic Chinese.
- Volunteer for research.
Key exclusion criteria (3 listed)
- Pregnancies with diagnosed chronic disease
- Pregnancies with other pregnancy complications except GDM
- Pregnancies had recent trauma and treatment of glucocorticoids
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 |
|---|---|---|
| m-health managementPatients in intervention group received additional WeChat group management when conducted standard clinic prenatal care. | Behavioural | m-health group (Intervention Group) |
Primary outcome
glycemic qualification rate
Time frame: From enrollment to 42 days postpartum
Glycemic qualification rate was calculated by the number of BG within the control range /30*100%. BG control range were fasting BG (fasting and before-sleep BG)<95 mg/dL (5.3 mmol/L) and two-hour postprandial BG (post-breakfast, post-lunch, post-dinner BG)<120 mg/dL (6.7 mmol/L)
1 secondary outcome
pregnancy outcome
Time frame: delivery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2020.
- 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. This study is not recruiting at the moment.
Liangkun Ma study chair
Chinese Academy of Medical Science & Peking Union Medical College Hospital
Questions about this trial
What is this clinical trial studying?
A study testing m-health management in people with GDM and Blood Glucose, 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 5 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 16 Jun 2020. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
glycemic qualification rate (time frame: From enrollment to 42 days postpartum). 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 16 Jun 2020.