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| Name | Class |
|---|---|
| Hangzhou Jianhai Technology Company Limited | UNKNOWN |
| Quzhou Maternal and Child Health Care Hospital | UNKNOWN |
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Gestational diabetes mellitus (GDM) can lead to adverse perinatal and long-term outcomes, and it is so important to manage this disease in pregnancy. Digitalized managements have been proved economical and effective in some chronic diseases like type II diabetes mellitus. The purpose of the current study was to develop and evaluate a digitalized mode for GDM management using mobile healthcare and some wearable devices. Subjects were randomly divided into a conventional management group and combined digitalized management group after diagnosed with GDM during 24-28 weeks of gestation. The conventional mangement group received conventional GDM management and could freely use the mobile healthcare application. The mobile management group received digitalized healthcare services from artificial intelligence under the supervision of obstetricians, in addition to conventional management. The effectiveness of digitalized management were evaluated mainly through the result values of the labotatory tests related to blood glucose controlling and perinatal outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional management group | No Intervention | Received conventional management based on Guidelines for GDM in China | |
| Digitalized management group | Experimental | Reveived conventional management and digitalized management |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Digitalized management | Other | In addition to conventional management, Patients also receive digitalized management, which provides personalized guidance in diet, excercise, prenatal visit, blood glucose monitoring,etc., from artificail intelliegence (AI) supevised by obstetricians, through a smartphone application and some werable devices (like sports bracelet). The pivotal AI are based on clinical experience from obstetricians, therapeutic principle from official Guidelines and abundant data in previous work, and it will works under strict supervision. |
| Measure | Description | Time Frame |
|---|---|---|
| Concentration of glycosylated hemoglobin A1c | Reflecting the average glucose level in the last 8-12 weeks | 37-42 weeks of gestation |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of neonate large for gestational age | May reflecting maternal glucose level in pregnancy | At the 1 day of delivery |
| rate of caesarean as the delivery mode | An indicator associated with fetal weight or perinatal condition |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Danqing Chen, PhD | Contact | +860571-87061501 | chendq@zju.edu.cn | |
| Menglin Zhou, MD | Contact | +8613738008135 | marlin_zhou@zju.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Danqing Chen | Hangzhou | Zhejiang | 310006 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40353986 | Derived | Du M, Yi S, Wei Y, Jiang Y, Bao S, Lu J, Chen D. Effect of FSL-CGM on Maternal and Neonatal Outcomes in GDM: A Propensity Score Matching Study in Hangzhou, China. Diabetes Ther. 2025 Jul;16(7):1385-1397. doi: 10.1007/s13300-025-01749-0. Epub 2025 May 12. |
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| At the 1 day of delivery |
| Hospitalization cost of neonate and puerperae for delivery | A health economic indicator | At the 1 day discharging from hospital |
| Proportion of patients with abnormal resulets of postnatal oral glucose tolerance test | Reflecting postpartum glucose metabolism | 42 days postpartum |