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رادار التجارب AI
دراسة واحدة تطابق معايير الفلتر
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Blood Glucose Differences Using CGMs Between the Left and Right Arm in Patients With Diabetes ١٠

غير معروف
تفاصيل التجربة السريرية متاحة بشكل أساسي باللغة الإنجليزية. ومع ذلك، يمكن لـ رادار التجارب AI مساعدتك؛ ما عليك سوى النقر على «وصف الدراسة» لعرض ومناقشة معلومات الدراسة باللغة التي اخترتها.
التجربة السريرية NCT05849428 هي دراسة تدخُّلية لـداء السكري من النوع 1، داء السكري من النوع 2 وهي غير معروف. بدأت في ١١ شوال ١٤٤٤ هـ مع خطة لتجنيد ١٠ مشاركًا. يقودها University of the Pacific، ومن المتوقع اكتمالها بحلول ٢٠ شعبان ١٤٤٥ هـ. تم تحديث البيانات الأخيرة من ClinicalTrials.gov في ١٨ شوال ١٤٤٤ هـ.
الملخص
There are multiple CGMs that are FDA approved. However, there are few studies looking at the variability of measurements between the left and right arm, and none looking at this effect in diabetic patients. This study may identify if glucose differences exist in the left and right arm in patients with Type 1 or Type 2 Diabetes. Furthermore, it may point to future directions for research to standardize methods of gluc...عرض المزيد
وصف مفصل
The goal of this clinical trial is to determine the time-matched difference in glucose levels between the left arm and right arm in patients with Type 1 or Type 2 diabetes. The main objective aims to answer:

• Is there a difference in time-matched controlled glucose monitoring (CGM) - derived blood glucose between left and right arm in patients with Type 1 or Type 2 diabetes in target range (<70 mg/dL; 70-180 mg/dL...

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العنوان الرسمي

Blood Glucose Differences Between Left Arm and Right Arm in Patients With Type 1 or Type 2 Diabetes Using a Continuous Glucose Monitor

الحالات الطبية
داء السكري من النوع 1داء السكري من النوع 2
المنشورات
مقالات علمية وأوراق بحثية منشورة حول هذه التجربة السريرية:
معرّفات دراسة أخرى
  • IRB2023-25
NCT معرّف
NCT05849428
تاريخ البدء (فعلي)
2023-05
آخر تحديث مُنشور
2023-05-08
تاريخ الاكتمال (المقدر)
2024-03
عدد المشاركين المخطط لهم
١٠
نوع الدراسة
تدخُّلية
المرحلة
غ/م
الحالة
غير معروف
الغرض الأساسي
أخرى
طريقة توزيع المشاركين
غ/م
نموذج التدخل
المجموعة الواحدة
التعمية
لا شيء (تجربة مفتوحة)
مجموعات/التدخلات
مجموعة المشاركين/الذراعالتدخل/العلاج
أخرىMeasuring Arm
Participants will wear 2 Freestyle Libre 3 sensors on each arm, 1 on the left and 1 on the right for 2 consecutive weeks (total of 14 days).
Freestyle Libre 3
Freestyle Libre 3 consists of a sensor that is applied to the back of the upper arm. The sensor is a penny-sized flexible filament placed beneath the skin surface to measure interstitial fluid. This sensor is applied utilizing a sensor applicator provided in the packaging. The sensor will continuously read interstitial glucose readings every minute and syncs with the Freestyle View app. At the completion of the study...عرض المزيد
النتيجة الرئيسية
مقياس النتيجةوصف القياسالإطار الزمني
Time-matched CGM-derived blood glucose differences between left arm and right arm in patients with Type 1 or Type 2 Diabetes below target range (<70 mg/dL).
Data gathered from the CGM device will be sync'd with the Freestyle View app and made available to the study team for analysis below the target range (\<70 mg/dL).
14 days
النتيجة الثانوية
مقياس النتيجةوصف القياسالإطار الزمني
Time-matched CGM-derived blood glucose differences between left arm and right arm in patients in target range (70-180 mg/dL).
Data gathered from the CGM device will be sync'd with the Freestyle View app and made available to the study team for analysis at the target range (70-180 mg/dL).
14 days
Time-matched CGM-derived blood glucose differences between left arm and right arm in patients above target range (>180 mg/dL).
Data gathered from the CGM device will be sync'd with the Freestyle View app and made available to the study team for analysis at the target range (\>180180 mg/dL).
14 days
معايير الأهلية

الأعمار المؤهلة للدراسة
بالغ, كبار السن
العمر الأدنى للدراسة
18 Years
الجنس المؤهل
الكل
  • Adults 18-65 years of age
  • Diagnosed with Type 1 or Type 2 Diabetes
  • Willing to wear CGMs for 2 weeks on both arms
  • Willing to attend 3 virtual calls meetings over the course of the trial
  • Have active health insurance
  • Willing to refrain from any heat therapy for the duration of the study
  • Willing to refrain from consuming ascorbic acid and salicylic acid for the duration of the study due to known interaction with CGMs
  • Have access to 2 compatible mobile devices for the Freestyle Libre 3 CGMs
  • Not currently using any Freestyle Libre CGM
  • Willing to provide HbA1c readings within 3 months of the trial
  • Have a baseline HbA1c equal or above 6.5

  • Any active dermatologic condition on the upper arms
  • Implanted medical devices including another continuous glucose monitoring device (i.e.

pacemaker)

  • Critically ill or dialysis patients
  • Planned magnetic resonance imaging screening, computed tomography scan, X-ray imaging or high-frequency electrical heat treatment during study period
  • Current systemic infections
  • Subjects who are unable to fully understand the study or consent process will not be included in the study due to the lack of a qualified medical translator
  • Refusal to sign the informed consent document
  • Pregnant, planned pregnancy during study period, or currently breast-feeding
  • Fear of needles to the point where patients cannot self-administer the sensors
  • History of allergic reactions or hypersensitivity from adhesives
University of the Pacific logoUniversity of the Pacific
الجهة المسؤولة عن الدراسة
Sachin Shah, المحقق الرئيسي, Professor of Pharmacy, University of the Pacific
جهة اتصال مركزية للدراسة
جهة اتصال: Sarika Mujumdar, PharmD, 209-946-7754, [email protected]
جهة اتصال: Allen Lat, PharmD, 209-946-7754, [email protected]
1 مواقع الدراسة في 1 بلدان

California

University of the Pacific, Stockton, California, 95211, United States
Sachin Shah, جهة اتصال, [email protected]
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