Tokyo, Aug. 2 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058650) titled 'An Interventional Study on Improving Gestational Diabetes Care in Island Communities via Telemedicine: A Collaborative Model with Diabetes and Obstetric Teams' on Aug. 1.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Historical
Primary Sponsor:
Institute - Kagawa University
Condition:
Condition - Gestational diabetes
Classification by malignancy - Others
Genomic information - NO
Objective:
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
Intervention:
Interventions/Control_1 - Remote care support by a multidisciplinary diabetes specialist team during pregnancy.
Eligibility:
Age-lower limit - 20
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 Size - 30
Recruitment Status:
Recruitment status - Preinitiation
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
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066231
Disclaimer: Curated by HT Syndication.
