An Interventional Study on Improving Gestational Diabetes Care in Island Communities via Telemedicine: A Collaborative Model with Diabetes and Obstetric Teams

An Interventional Study on Improving Gestational Diabetes Care in Island Communities via Telemedicine: A Collaborative Model with Diabetes and Obstetric Teams - SETOUCHI Project

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000058650

Enrollment

Registered

2025-08-01

Start date

2025-08-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gestational diabetes

Interventions

Remote care support by a multidisciplinary diabetes specialist team during pregnancy.

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: Pregnant women with gestational diabetes in remote island communities.

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Countries

Japan

Contacts

Public ContactAkinori Hayashi

Kagawa University Chronic Care Nursing, School of Nursing, Facalty of Medicine

gipsetouchi-honbu-m@kagawa-u.ac.jp087-891-2240

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026