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Continuous Glucose Monitoring System Use in Pediatric Patients with Diabetes ٧٨ طب الأطفال

مكتمل
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 NCT06570551 كانت دراسة رصدية لـداء السكري وهي الآن مكتمل. بدأت في ٢٠ رمضان ١٤٤٥ هـ مع خطة لتجنيد ٧٨ مشاركًا. بقيادة Sinocare، وكان من المتوقع اكتمالها في ١٧ صفر ١٤٤٦ هـ. تم تحديث البيانات الأخيرة من ClinicalTrials.gov في ٢٣ ربيع الأول ١٤٤٦ هـ.
الملخص
To verify and evaluate the efficacy and safety of i3 CGM system manufactured by Changsha Sinocare Inc. for continuous or regular monitoring of interstitial fluid glucose level in pediatric patients with diabetes.
وصف مفصل
This clinical investigation is of a multi-center and self-controlled design.

This clinical investigation is planned to be conducted in 3 study sites, with a total of 78 subjects to be enrolled, of which no fewer than 15 cases are aged 2-5 years old, and no fewer than 60 cases are aged 6-17 years old. This clinical investigation is to verify the safety and efficacy of the investigational device. Referring to the numb...

عرض المزيد
العنوان الرسمي

Continuous Glucose Monitoring System Use in Pediatric Patients with Diabetes

الحالات الطبية
داء السكري
معرّفات دراسة أخرى
  • NPI031-CIP-005
NCT معرّف
NCT06570551
تاريخ البدء (فعلي)
2024-03-30
آخر تحديث مُنشور
2024-09-26
تاريخ الاكتمال (المقدر)
2024-08-21
عدد المشاركين المخطط لهم
٧٨
نوع الدراسة
رصدية
الحالة
مكتمل
مجموعات/التدخلات
مجموعة المشاركين/الذراعالتدخل/العلاج
2-5 year old participants
Wear the investigational device continuously for 15 days.
i3 CGM(continuous glucose monitor)
The i3 CGM consists of a Sensor Pack (including probe, iCGM-S3), a Transmitter Pack (iCGM-t3), and an application (iCGM-APP (released version: V02)).application (i3 CGM App). The user can view their glucose data on the i3 CGM App running on a compatible mobile device.
6-17 year old participants
Wear the investigational device continuously for 15 days.
i3 CGM(continuous glucose monitor)
The i3 CGM consists of a Sensor Pack (including probe, iCGM-S3), a Transmitter Pack (iCGM-t3), and an application (iCGM-APP (released version: V02)).application (i3 CGM App). The user can view their glucose data on the i3 CGM App running on a compatible mobile device.
النتيجة الرئيسية
مقياس النتيجةوصف القياسالإطار الزمني
Accuracy
percentage of i3 CGM values in the measuring range less than 4.4 mmol/L(80 mg/dL) within ± 1.1 mmol/L(20 mg/dL) of the EKF control.
0-15 days
معايير الأهلية

الأعمار المؤهلة للدراسة
طفل
العمر الأدنى للدراسة
2 Years
الجنس المؤهل
الكل
  • Aged 2 (inclusive) - 18 years (exclusive);
  • Clinically diagnosed with diabetes;
  • Being willing to wear the device continuously for 15 days and conduct blood collection for blood glucose testing in accordance with the requirements of this protocol;
  • Body weight not less than 10.0 kg;
  • Consent to participate in this clinical investigation, and sign the Informed Consent Form (ICF).

  • Need to undergo magnetic resonance imaging (MRI) during the clinical investigation;
  • Diffuse subcutaneous nodules;
  • Acute complications of diabetes;
  • Abnormal coagulation function (coagulation cannot be too quick or too slow); the criteria for judging abnormalities are: The activated partial thromboplastin time (APTT) is higher than 1.5 times the upper limit of normal value or lower than the lower limit of normal value; or The prothrombin time (PT) is higher than 1.5 times the upper limit of normal value or lower than the lower limit of normal value
  • Participation in other clinical investigations within the past 1 month;
  • Where the investigator does not consider the patient suitable for enrollment.
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لا توجد بيانات اتصال.
3 مواقع الدراسة في 1 بلدان

Hunan

Hunan Children's Hospital, Changsha, Hunan, China

Jiangsu

Children's Hospital of Soochow University, Suzhou, Jiangsu, China

Zhejiang

Women and Children's Hospital of Ningbo University, Ningbo, Zhejiang, China