UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056332 |
|---|---|
| Receipt number | R000063368 |
| Scientific Title | 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 |
| Date of disclosure of the study information | 2024/12/03 |
| Last modified on | 2025/12/03 12:45:54 |
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Basic information
Public title
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
Acronym
The effectiveness of IoT in preventing the progression of postpartum diabetes Mellitus
Scientific Title
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
Scientific Title:Acronym
The effectiveness of IoT in preventing the progression of postpartum diabetes Mellitus
Region
| Japan |
Condition
Condition
gestational diabetes mellitus
Classification by specialty
| Obstetrics and Gynecology | Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to examine the effectiveness of using IoT and remote follow-up interviews to prevent the progression of postpartum diabetes in women with gestational diabetes mellitus.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood glucose level at postpartum 12 months (fasting, 2 hours after meal)
Key secondary outcomes
Activity level, glycemic index (GI) value, nutritional intake status, mental health, and ability to manage food intake postpartum 12 months
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Use of wearable devices and remote interview guidance
Interventions/Control_2
9 months
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 50 | years-old | > |
Gender
Female
Key inclusion criteria
women with gestational diabetes mellitus
Key exclusion criteria
overt diabetes in pregnancy
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Hiroko |
| Middle name | Non |
| Last name | Watanabe |
Organization
The University of Osaka Graduate School of Medicine
Division name
Division of Health Science
Zip code
565-0871
Address
1-7 Yamadaoka, Suita, Osaka 565-0871, JAPAN
TEL
06-6879-2520
watanabe@sahs.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiroko |
| Middle name | Non |
| Last name | Watanabe |
Organization
The University of Osaka Graduate School of Medicine
Division name
Division of Health Science
Zip code
565-0871
Address
1-7 Yamadaoka, Suita, Osaka 565-0871, JAPAN
TEL
06-6879-2520
Homepage URL
watanabe@sahs.med.osaka-u.ac.jp
Sponsor or person
Institute
The University of Osaka
Institute
Department
Personal name
Hiroko Watanabe
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka University Hospital
Address
1-7 Yamadaoka, Suita, Osaka 565-0871, JAPAN
Tel
06-6879-6106
watanabe@sahs.med.osaka-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
永井マザーズホスピタル（埼玉県）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 12 | Month | 03 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 12 | Month | 02 | Day |
Date of IRB
| 2025 | Year | 04 | Month | 10 | Day |
Anticipated trial start date
| 2025 | Year | 01 | Month | 14 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2027 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2027 | Year | 05 | Month | 31 | Day |
Date analysis concluded
| 2027 | Year | 07 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2024 | Year | 12 | Month | 02 | Day |
Last modified on
| 2025 | Year | 12 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063368
