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Feasibility and Effectiveness of Real-time, Remote Continuous Glucose Monitoring in Adolescents With Poorly Controlled Type 1 Diabetes 20 किशोरावस्था रिमोट (दूरस्थ)

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चिकित्सा परीक्षण का विवरण मुख्य रूप से अंग्रेजी में उपलब्ध है। हालाँकि, ट्रायल रडार AI मदद कर सकता है! बस 'अध्ययन समझाएं' पर क्लिक करें और अपनी चुनी हुई भाषा में परीक्षण की जानकारी देखें और चर्चा करें।
क्लिनिकल ट्रायल NCT04540536 एक हस्तक्रियात्मक चिकित्सकीय अध्ययन था जो मधुमेह मेलिटस प्रकार 1, अनुपालनहीनता, रोगी से जुड़ा हुआ था। परीक्षण अब पूर्ण हो चुका है। इसकी शुरुआत 1 नवंबर 2021 को हुई थी और इसमें कुल 20 प्रतिभागियों को शामिल किया गया था। टेक्सास साउथवेस्टर्न मेडिकल सेंटर विश्वविद्यालय ने इस परीक्षण का नेतृत्व किया और यह 1 दिसंबर 2024 को पूरा हुआ। ClinicalTrials.gov वेबसाइट पर यह जानकारी 3 मार्च 2026 को अंतिम बार अपडेट की गई थी।
संक्षिप्त सारांश
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...और दिखाएँ
आधिकारिक शीर्षक

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

स्वास्थ्य स्थितियां
मधुमेह मेलिटस प्रकार 1अनुपालनहीनता, रोगी
अन्य अध्ययन आईडी
  • STU-2020-0699
NCT नंबर
NCT04540536
अध्ययन प्रारंभ तिथि (वास्तविक)
2021-11-01
अंतिम अद्यतन प्रकाशित
2026-03-03
अध्ययन की समाप्ति तिथि (अनुमानित)
2024-12-01
नामांकन (अनुमानित)
20
अध्ययन प्रकार
हस्तक्रियात्मक
चरण
निर्दिष्ट नहीं
स्थिति
पूर्ण
प्रमुख शब्द
Type 1 Diabetes
Continuous Glucose Monitors
Telemedicine
Remote Monitoring
Secure Texting
Poorly controlled diabetes
प्राथमिक उद्देश्य
सहायक देखभाल
डिज़ाइन आवंटन
निर्दिष्ट नहीं
हस्तक्षेप मॉडल
एकल समूह
अंधकरण
कोई नहीं (खुला लेबल)
समूह/हस्तक्षेप
प्रतिभागी समूह/शाखाहस्तक्षेप/उपचार
निर्दिष्ट नहीं
निरंतर ग्लूकोज निगरानी
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
प्राथमिक परिणाम माप
परिणाम मापमाप विवरणसमय सीमा
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
द्वितीयक परिणाम माप
परिणाम मापमाप विवरणसमय सीमा
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
पात्रता मानदंड

अध्ययन के लिए पात्र आयु
बच्चा, वयस्क
अध्ययन के लिए न्यूनतम आयु
13 Years
अध्ययन के लिए पात्र लिंग
सभी
  • 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 logoटेक्सास साउथवेस्टर्न मेडिकल सेंटर विश्वविद्यालय284 सक्रिय क्लिनिकल ट्रायल्स खोजे जाने के लिए
DexCom, Inc. logoDexCom, Inc.
अध्ययन उत्तरदायी पक्ष
Abha Choudhary, मुख्य अन्वेषक, Assistant Professor of Pediatrics, University of Texas Southwestern Medical Center
कोई संपर्क डेटा नहीं।
2 1 देशों में अध्ययन स्थान

Texas

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