UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058650 |
|---|---|
| Receipt number | R000066231 |
| Scientific Title | An Interventional Study on Improving Gestational Diabetes Care in Island Communities via Telemedicine: A Collaborative Model with Diabetes and Obstetric Teams |
| Date of disclosure of the study information | 2025/08/01 |
| Last modified on | 2025/08/19 02:07:58 |
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Basic information
Public title
An Interventional Study on Improving Gestational Diabetes Care in Island Communities via Telemedicine: A Collaborative Model with Diabetes and Obstetric Teams
Acronym
SETOUCHI Project
Scientific Title
An Interventional Study on Improving Gestational Diabetes Care in Island Communities via Telemedicine: A Collaborative Model with Diabetes and Obstetric Teams
Scientific Title:Acronym
SETOUCHI Project
Region
| Japan |
Condition
Condition
Gestational diabetes
Classification by specialty
| Medicine in general | Endocrinology and Metabolism | Obstetrics and Gynecology |
| Pediatrics | Nursing | Adult |
| Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the impact of remote intervention by a multidisciplinary diabetes specialist team on glycemic control, mental health, and childbirth outcomes in pregnant women with gestational diabetes.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
To evaluate during the first, second and third trimesters of pregnancy, during childbirth, and at 12 weeks postpartum.
1.Items related to pregnancy and childbirth outcomes: birth weight, proportion of large for gestational age, incidence of neonatal hypoglycemia, incidence of perinatal complications, umbilical artery blood pH, transfer rate, and incubator usage rate
2.Items related to glycemic control: Summary of Diabetes Self-Care Activities (SDSCA), glycemic control indicators measured by CGM (GMI, average, median, standard deviation, coefficient of variation, maximum value, minimum value, TAR, TIR, TBR, M value, MAGE, MAG, MODD), glycemic control indicator measured by blood tests (fasting blood glucose level, random blood glucose level, HbA1c, GA)
3. Psychological aspects and quality of life (QOL) related items: Edinburgh Postnatal Depression Scale (EPDS), Labour Agentry Scale (LAS), Impact of Event Scale-Revised (IES-R), Evaluation of remote diabetes team intervention and digital health app.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Remote care support by a multidisciplinary diabetes specialist team during pregnancy.
Interventions/Control_2
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
| 20 | years-old | <= |
Age-upper limit
| 50 | years-old | > |
Gender
Female
Key inclusion criteria
Pregnant women with gestational diabetes in remote island communities.
Key exclusion criteria
1. Diabetes in pregnancy or overt diabetes in pregnancy.
2. Serious comorbidities (heart disease, collagen disease, blood disorders, mental illness, etc.)
3. Initiation of insulin therapy after study enrollment.
4. Inability to use the video calls via Microsoft Teams.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Akiko |
| Middle name | |
| Last name | Nishimura |
Organization
Kagawa University
Division name
Chronic Care Nursing, School of Nursing, Facalty of Medicine
Zip code
761-0793
Address
1750-1 Ikenobe,Miki-cho,Kita-gun,Kagawa
TEL
087-891-2240
gipsetouchi-honbu-m@kagawa-u.ac.jp
Public contact
Name of contact person
| 1st name | Akinori |
| Middle name | |
| Last name | Hayashi |
Organization
Kagawa University
Division name
Chronic Care Nursing, School of Nursing, Facalty of Medicine
Zip code
761-0793
Address
1750-1 Ikenobe,Miki-cho,Kita-gun,Kagawa
TEL
087-891-2240
Homepage URL
gipsetouchi-honbu-m@kagawa-u.ac.jp
Sponsor or person
Institute
Kagawa University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kagawa University Graduate School and Faculty of Medicine, Ethics Committee
Address
1750-1 Ikenobe,Miki-cho,Kita-gun,Kagawa
Tel
087-898-5111
chiken-m@kagawa-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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 08 | Month | 01 | 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
30
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
| 2025 | Year | 05 | Month | 30 | Day |
Date of IRB
| 2025 | Year | 06 | Month | 05 | Day |
Anticipated trial start date
| 2025 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2029 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
| 2030 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2025 | Year | 07 | Month | 30 | Day |
Last modified on
| 2025 | Year | 08 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066231
