رادار التجارب AI | ||
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حالة التجربة السريرية NCT01514292 لـ السكري هي مكتمل. اطلعوا على جميع التفاصيل في عرض البطاقة الخاص برادار التجارب السريرية وأدوات اكتشاف الذكاء الاصطناعي. أو يمكنكم طرح أي سؤال هنا. | ||
دراسة واحدة تطابق معايير الفلتر
عرض البطاقة
Effectiveness and Safety Study of the Dexcom G4™ Continuous Glucose Monitoring System ٧٢
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 NCT01514292 كانت دراسة تدخُّلية لـالسكري وهي الآن مكتمل. بدأت في ٦ محرم ١٤٣٣ هـ مع خطة لتجنيد ٧٢ مشاركًا. بقيادة DexCom, Inc.، وكان من المتوقع اكتمالها في ٩ ربيع الأول ١٤٣٣ هـ. تم تحديث البيانات الأخيرة من ClinicalTrials.gov في ٢٢ ذو الحجة ١٤٣٦ هـ.
الملخص
The purpose of this study is to evaluate the effectiveness and safety of the Dexcom G4 System when used as an adjuvant to blood glucose testing over a 7-day period in people >18 years-old with diabetes mellitus.
The primary objective is to characterize the System performance with respect to laboratory reference venous sample measurements. The device performance will be primarily evaluated in terms of point and rate...
عرض المزيدوصف مفصل
The primary objective is to characterize the System performance with respect to laboratory reference venous sample measurements. The device performance will be primarily evaluated in terms of point and rate accuracy of the G4 System in reference to YSI. The trend accuracy of the device performance, i.e., continuous glucose error grid analysis, will be evaluated as well as the temporal G4 System accuracy at different ...عرض المزيد
العنوان الرسمي
PTL-900590 Effectiveness and Safety Study of the Dexcom G4™ Continuous Glucose Monitoring System
الحالات الطبية
السكريمعرّفات دراسة أخرى
- PTL-900590
NCT معرّف
تاريخ البدء (فعلي)
2011-12
آخر تحديث مُنشور
2015-10-05
تاريخ الاكتمال (المقدر)
2012-02
عدد المشاركين المخطط لهم
٧٢
نوع الدراسة
تدخُّلية
المرحلة
غ/م
الحالة
مكتمل
الغرض الأساسي
العلاج
طريقة توزيع المشاركين
غ/م
نموذج التدخل
المجموعة الواحدة
التعمية
لا شيء (تجربة مفتوحة)
مجموعات/التدخلات
| مجموعة المشاركين/الذراع | التدخل/العلاج |
|---|---|
تجريبيةReal Time Continuous Glucose Monitoring System 7 day use of real time continuous glucose monitoring system | Continuous Glucose Monitoring of glucose levels (Dexcom) Manipulation of glucose levels during multiple clinic days. Achieved through diet, exercise and insulin regimen defined in protocol.Evaluation of CGM performance characteristics in reference to a laboratory standard. |
النتيجة الرئيسية
| مقياس النتيجة | وصف القياس | الإطار الزمني |
|---|---|---|
CGM Relative Differences to Laboratory Reference | The outcome measure is measured as the relative differences (%) of the CGM glucose value in reference to a laboratory reference, yellow spring instrument( YSI) glucose measurements. | 7 days |
معايير الأهلية
الأعمار المؤهلة للدراسة
بالغ, كبار السن
العمر الأدنى للدراسة
18 Years
الجنس المؤهل
الكل
Age 18 years or older;
Diagnosed with diabetes mellitus;
Use one of the following for their diabetes management:
- intensive insulin therapy (IIT) or
- non-intensive insulin therapy (non-IIT)
Intensive-insulin using (IIT) subjects only - During each in-clinic session, willing to have their blood glucose levels manipulated into high and low glucose levels. Subjects not on IIT will only be observed during each in-clinic session.
For subjects that exercise routinely (at least 3 times per week), willing to exercise on each in-clinic session, if asked;
Willing to take a minimum of 7 fingersticks per day during home use days;
Willing to refrain from the use of acetaminophen during sensor wear period and the day prior to sensor insertion;
- Have extensive skin changes/diseases that preclude wearing the required number of devices on normal skin (e.g., extensive psoriasis, recent burns or severe sunburn, extensive eczema, extensive scarring, extensive tattoos, dermatitis herpetiformis) at the proposed wear sites;
- Have a known allergy to medical-grade adhesives;
- Are pregnant as demonstrated by a positive pregnancy test within 72 hours of sensor insertion,
- Are on dialysis;
- Have a hematocrit that is less than 36% or greater than 55% at screening visit;
- Currently participating in another investigational study protocol (if a subject has recently completed participation in another drug study, the subject must have completed that study at least 30 days prior to being enrolled in this study);
- Have a history of cardiovascular disease (including, but not limited to ischemic heart disease, peripheral vascular disease, cardiomyopathy, cerebrovascular disease, congenital heart disease, or significant arrhythmias), epilepsy, severe migraines in the past 6 months, adrenal disease, syncope, significant hypoglycemia unawareness, or a history of severe hypoglycemia (requiring emergency medical intervention) within the last 6 months;
- Have any chronic infectious disease or intercurrent illness that would interfere with their participation in the study or pose an excessive risk to study staff handling venous or capillary blood samples (e.g. HIV/AIDS, Hepatitis B or C);
- Have a MRI scan, CT scan, or diathermy scheduled during the week of the study. If any of these procedures are required urgently during the study, subjects will notify the study staff, end their CGM session, and remove their sensor.
DexCom, Inc.لا توجد بيانات اتصال.
4 مواقع الدراسة في 1 بلدان
California
Profil Institute for Clinical Research, Chula Vista, California, 91911, United States
AMCR Institute, Inc., Escondido, California, 92026, United States
Diablo Clinical Research, Walnut Creek, California, 94598, United States
Idaho
Rocky Mountain Diabetes and Osteoporosis Center, Idaho Falls, Idaho, 83404, United States