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חזרה לחיפוש

Glucose Empowerment Through Monitoring and Social Support in Pregnancy (GEMS-P) 70 הריון פעילות גופנית

מגייס
פרטי הניסויים הקליניים זמינים בעיקר באנגלית. רדאר קליני AI יכול לעזור! לחץ על 'הסבר את המחקר' כדי לצפות ולשוחח על מידע מהמחקר בשפה המועדפת עליך.
הניסוי הקליני NCT07009704 (GEMS-P) הוא מחקר מסוג התערבותי עבור סיבוכי הריון, סוכרת הריונית, שנמצא כעת במצב מגייס. המחקר התחיל ב-1 ביולי 2025 ומתוכנן לכלול 70 משתתפים. המחקר מנוהל על ידי Tufts Medical Center וצפוי להסתיים ב-1 ביולי 2026. מידע זה עודכן לאחרונה באתר ClinicalTrials.gov ב-22 בספטמבר 2025.
סיכום קצר
The purpose of the research is to learn whether wearing a continuous glucose monitor that shows blood glucose levels in real time on a smart phone app and participating in a group chat with other research participants will help participants keep a healthy blood glucose level during pregnancy.

High levels of blood glucose during pregnancy can lead to health problems during and after pregnancy. It may also increase th...

הצג עוד
כותרת רשמית

Real-time Continuous Glucose Monitoring and Mobile-based Social Support to Promote Glucose Management During Pregnancy

מצבים רפואיים
סיבוכי הריוןסוכרת הריונית
מזהי מחקר נוספים
מספר NCT
NCT07009704
תחילת המחקר (בפועל)
2025-07-01
עדכון אחרון שפורסם
2025-09-22
סיום המחקר (מוערך)
2026-07
משתתפים (מתוכנן)
70
סוג המחקר
התערבותי
שלב
לא ישים
סטטוס
מגייס
מילות מפתח
pregnancy
gestational diabetes
GDM
intervention
hyperglycemia
group chat
continuous glucose monitoring
mobile-based
behavioral change
CGM
מטרה ראשית
מניעה
הקצאת טיפול
אקראי
דגם מתערב
קבוצות מקבילות
עיוורון
אין (מחקר פתוח)
זרועות / התערבויות
קבוצת משתתפים/זרועהתערבות/טיפול
ניסיGroup 1- Group chat intervention
Participants in group 1 will be randomized to wear a real-time continuous glucose monitor for 14 days and participate in a secure mobile-based group chat where they will provide and receive social support for glucose management. Participants will be in the group chat for 60 days.
Mobile-based social support
Participants will be invited to join an encrypted group chat where they will be encouraged to provide and receive social support related to glucose management during early pregnancy. Other study participants and study team members will be in the group chat.
Real-time continuous glucose monitoring
Participants will receive a real-time continuous glucose monitor that pairs with an existing smartphone app that shows minute-by-minute glucose levels and records glucose levels in 5 minute increments.
ניסיGroup 2- No group chat intervention
Participants in group 2 will be randomized to wear a real-time continuous glucose monitor for 14 days.
Real-time continuous glucose monitoring
Participants will receive a real-time continuous glucose monitor that pairs with an existing smartphone app that shows minute-by-minute glucose levels and records glucose levels in 5 minute increments.
מדדי תוצאה ראשיים
מדד תוצאהתיאור המדידהטווח זמן
Self-efficacy for glucose management
Self-efficacy will be adapted from a validated survey of self-efficacy for type II diabetes management (DMSES UK)
Baseline, Day 3 of CGM, Day 7 of CGM, Day 14 of CGM, Day 60 of study
מדדי תוצאה משניים
מדד תוצאהתיאור המדידהטווח זמן
Motivation for glucose management
Assessed using items from the Treatment Self-Regulation Questionnaire (TSRQ)
Baseline, Day 3 of CGM, Day 7 of CGM, Day 14 of CGM, Day 60 of study
Pregnancy-specific stress
Pregnancy-specific stress will be measured (via questionnaire) using a validated scale that was empirically associated with birth outcomes
Baseline, Day 60 of study participation
Social support
A social support survey was adapted from the validated Inventory of Socially Supportive Behaviors (ISSB) that assess multiple subtypes of social support (emotional, informational, instrumental/tangible, belonging, appraisal)
Baseline, Day 3 of CGM, Day 7 of CGM, Day 14 of CGM, Day 30 of group chat participation, Day 60 of study participation
Pre-natal care satisfaction
Prenatal care satisfaction will be assessed using a combination of questions from Raube and colleague's validated questionnaire and the Mother's Autonomy in Decision Making (MADM) scale. The combination of questionnaires is scored as "Excellent, Good, Average, Poor, N/A".
Baseline, Day 60 of study completion
עוזר השתתפות
קריטריוני זכאות

גילאים מוערכים למחקר
מבוגר
גיל מינימלי למחקר
18 Years
מגדרים מוערכים למחקר
נקבה
  • Pregnant (<20w0d)
  • At least 18 years to 45 years old
  • BMI >25, personal history of GDM, or first-degree family member with type II diabetes
  • Comfortable conversing in English
  • Own a smartphone and willing to use the CGM app and Signal
  • Receiving prenatal care and planning to deliver at Tufts Medicine (Boston)
  • Signed the consent form
  • Currently located in the United States

  • Current pregnancy a multiple gestation (e.g., twins)
  • Smoked during this current pregnancy
  • Active hepatitis or HIV infection
  • Current pregnancy have any documented fetal congenital anomalies
  • Current history of heroin, cocaine, crack, LSD, or methamphetamines
  • Current history of alcohol abuse
  • Previous gastric bypass
  • Shift work that alters the sleep/wake periods
  • Have known rheumatological or chronic inflammatory state (i.e., arthritis, inflammatory bowel disease)?
  • Chronic illnesses, including diabetes and dialysis, that require regular medication use
  • Uncontrolled hypothyroidism
  • Known culture of positive chorioamnionitis?
  • An adult who is unable to consent (e.g., cognitively impaired adults)
  • Ward of the state
  • Unable to read or write English
Tufts Medical Center logoTufts Medical Center
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) logoEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) logoNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
איש קשר מרכזי למחקר
איש קשר: Larissa Calancie, PhD, (617) 636-0976, [email protected]
1 מיקומי המחקר ב-1 מדינות

Massachusetts

Tufts Medical Center, Boston, Massachusetts, 02111, United States
Larissa Calancie, איש קשר
מגייס