UMIN ID: UMIN000056332
Registered date:03/12/2024
A Randomized Controlled Trial to Evaluate the Effects of IoT support system in preventing the progression of postpartum diabetes on women with Gestational Diabetes Mellitus
Basic Information
| Recruitment status | Pending |
|---|---|
| Health condition(s) or Problem(s) studied | gestational diabetes mellitus |
| Date of first enrollment | 2025/01/14 |
| Target sample size | 60 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | Use of wearable devices and remote interview guidance 9 months |
Outcome(s)
| Primary Outcome | Blood glucose level at postpartum 12 months (fasting, 2 hours after meal) |
|---|---|
| Secondary Outcome | Activity level, glycemic index (GI) value, nutritional intake status, mental health, and ability to manage food intake postpartum 12 months |
Key inclusion & exclusion criteria
| Age minimum | 18years-old |
|---|---|
| Age maximum | 50years-old |
| Gender | Female |
| Include criteria | |
| Exclude criteria | overt diabetes in pregnancy |
Related Information
| Primary Sponsor | Osaka University |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Japan Science and Technology Agency |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Hiroko Non Watanabe |
| Address | 1-7 Yamadaoka, Suita, Osaka 565-0871, JAPAN Japan 565-0871 |
| Telephone | 06-6879-2520 |
| watanabe@sahs.med.osaka-u.ac.jp | |
| Affiliation | Osaka University Graduate School of Medicine Division of Health Science |
| scientific contact | |
| Name | Hiroko Non Watanabe |
| Address | 1-7 Yamadaoka, Suita, Osaka 565-0871, JAPAN Japan |
| Telephone | 06-6879-2520 |
| watanabe@sahs.med.osaka-u.ac.jp | |
| Affiliation | Osaka University Graduate School of Medicine Division of Health Science |