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Feasibility and Effectiveness of Real-time, Remote Continuous Glucose Monitoring in Adolescents With Poorly Controlled Type 1 Diabetes ٢٠ المراهقون عن بُعد

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 NCT04540536 كانت دراسة تدخُّلية لـداء السكري النوع 1، عدم الامتثال، المريض وهي الآن مكتمل. بدأت في ٢٦ ربيع الأول ١٤٤٣ هـ مع خطة لتجنيد ٢٠ مشاركًا. بقيادة جامعة جنوب غرب تكساس الطبية، وكان من المتوقع اكتمالها في ٢٩ جمادى الأولى ١٤٤٦ هـ. تم تحديث البيانات الأخيرة من ClinicalTrials.gov في ١٤ رمضان ١٤٤٧ هـ.
الملخص
Adolescents with Type 1 Diabetes (age 13-18 years, T1D duration >6 months managed on insulin) and poor glycemic control will wear a blinded CGM to obtain baseline data. After assuring adherence to CGM wear, participants will receive a non-blinded CGM and will share their blood glucose levels with the study team. Clinical personnel will remotely monitor patients in real-time for 3 months and communicate regularly ove...عرض المزيد
العنوان الرسمي

Feasibility and Effectiveness of Real-time, Remote Continuous Glucose Monitoring in Adolescents With Poorly Controlled Type 1 Diabetes

الحالات الطبية
داء السكري النوع 1عدم الامتثال، المريض
معرّفات دراسة أخرى
  • STU-2020-0699
NCT معرّف
NCT04540536
تاريخ البدء (فعلي)
2021-11-01
آخر تحديث مُنشور
2026-03-03
تاريخ الاكتمال (المقدر)
2024-12-01
عدد المشاركين المخطط لهم
٢٠
نوع الدراسة
تدخُّلية
المرحلة
غ/م
الحالة
مكتمل
الكلمات الرئيسية
Type 1 Diabetes
Continuous Glucose Monitors
Telemedicine
Remote Monitoring
Secure Texting
Poorly controlled diabetes
الغرض الأساسي
الرعاية الداعمة
طريقة توزيع المشاركين
غ/م
نموذج التدخل
المجموعة الواحدة
التعمية
لا شيء (تجربة مفتوحة)
مجموعات/التدخلات
مجموعة المشاركين/الذراعالتدخل/العلاج
غ/م
مراقبة الجلوكوز المستمرة
Participants will be provided with a Dexcom G6 continuous glucose monitor for the duration of the study.
Secure Texting
A secure platform (TigerConnect) will be used for three-way communication between parents, participants, and clinical personnel
النتيجة الرئيسية
مقياس النتيجةوصف القياسالإطار الزمني
Change in Hemoglobin A1c From Baseline to 3 Months
Change in hemoglobin A1c from baseline to 3 months (three-month follow-up visit after remote continuous glucose monitoring and secure text messaging)
3 months
النتيجة الثانوية
مقياس النتيجةوصف القياسالإطار الزمني
Change in Depression Score After Clinical Remote CGM Monitoring and Secure Text Messaging.
Depression screening will be assessed by Patient Health Questionnaire (PHQ-9A), a depression questionnaire consisting of 9 items answered on a scale from "0" (not at all) to "3" (nearly every day). Total depression severity score ranges of 0-4 none, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe.
3 months
معايير الأهلية

الأعمار المؤهلة للدراسة
طفل, بالغ
العمر الأدنى للدراسة
13 Years
الجنس المؤهل
الكل
  • Age between 13-18
  • Diagnosis of type 1 diabetes for at least six months.
  • Both sexes and all ethnicities included.
  • Subject and at least one parent able to communicate in English.
  • Poorly controlled T1D as evidenced by a >30% annual risk of developing DKA in the following year OR Hemoglobin A1c ≥ 12%
  • Treated with subcutaneous insulin, either with a basal/bolus insulin regimen or a continuous subcutaneous insulin infusion (CSII) device.
  • Willing to wear CGM and utilize the share function to clinician and guardian, with measuring blood glucose checks as required by the CGM.
  • Owning a smartphone compatible with Dexcom G6 software to allow the use of share/follow features with internet access capabilities
  • Willing to participate in secure text messaging with study personnel.
  • Female participants must have a negative pregnancy test.

  • Type 2 diabetes, secondary diabetes or CF related diabetes.
  • Other severe chronic disease (e.g., cancer) which in the judgment of the investigator is likely to significantly affect glycemic control.
  • Patients cannot be taking systemic corticosteroids at enrollment because of adverse effects on glycemic control, but we will not disqualify subjects who require such therapy during the study. Inhaled or topical corticosteroids are permissible.
  • Patients with uncontrolled hypothyroidism (TSH >20) or uncontrolled hyperthyroidism will be excluded from the study. Patients with out of range values may be retested after medication dose adjustment.
  • Developmental delay or behavioral disorder in the patient of sufficient severity, in the judgment of the investigator, to interfere with study activities. Severe uncontrolled depression defined as PHQ-9A >15 at time of enrollment is an exclusion criterion.
  • Medical or psychiatric disorder in a parent of sufficient severity, in the judgment of the investigator, to interfere with study activities.
  • Pregnancy, planned pregnancy or breast feeding
  • CGM adhesive allergy
  • Skin condition that makes CGM placement contraindicated.
  • Sickle cell disease or hemoglobinopathy
  • Red blood cell transfusion within 3 months prior to study enrollment
University of Texas Southwestern Medical Center logoجامعة جنوب غرب تكساس الطبية
DexCom, Inc. logoDexCom, Inc.
الجهة المسؤولة عن الدراسة
Abha Choudhary, المحقق الرئيسي, Assistant Professor of Pediatrics, University of Texas Southwestern Medical Center
لا توجد بيانات اتصال.
2 مواقع الدراسة في 1 بلدان

Texas

Childrens Medical Center, Dallas, Texas, 75390, United States
UT Southwestern Medical Center, Dallas, Texas, 75390, United States