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Feasibility and Effectiveness of Real-time, Remote Continuous Glucose Monitoring in Adolescents With Poorly Controlled Type 1 Diabetes 20 Adolescent À distance

Terminé
Les détails de l'essai clinique sont principalement disponibles en anglais. Cependant, l'IA Trial Radar peut vous aider ! Cliquez simplement sur 'Expliquer l'étude' pour voir et discuter des informations sur l'étude dans la langue sélectionnée.
L'essai clinique NCT04540536 a été une étude interventionnel pour Diabète sucré de type 1, Non-observance, patient. Son statut actuel est : terminé. L'étude a commencé le 1 novembre 2021, avec un objectif de recruter 20 participants. Dirigée par le Centre médical du Sud-Ouest de l'Université du Texas, l'étude s'est terminée le 1 décembre 2024. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 3 mars 2026.
Résumé succinct
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...Afficher plus
Titre officiel

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

Pathologies
Diabète sucré de type 1Non-observance, patient
Autres identifiants de l'étude
  • STU-2020-0699
Numéro NCT
NCT04540536
Date de début (réel)
2021-11-01
Dernière mise à jour publiée
2026-03-03
Date de fin (estimée)
2024-12-01
Inscription (estimée)
20
Type d'étude
Interventionnel
PHASE
N/A
Statut
Terminé
Mots clés
Type 1 Diabetes
Continuous Glucose Monitors
Telemedicine
Remote Monitoring
Secure Texting
Poorly controlled diabetes
Objectif principal
Soins de soutien
Méthode d'allocation
N/A
Modèle d'intervention
Groupe unique
Masquage
Aucun (ouvert)
Bras / Interventions
Groupe de participants/BrasIntervention/Traitement
N/A
Surveillance continue de la glycémie
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
Critère principal d'évaluation
Critères d'évaluationDescription de la mesurePériode
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
Critère secondaire d'évaluation
Critères d'évaluationDescription de la mesurePériode
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
Critères d'éligibilité

Âges éligibles
Enfant, Adulte
Âge minimum
13 Years
Sexes éligibles
Tous
  • 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 logoCentre médical du Sud-Ouest de l'Université du Texas284 essais cliniques actifs à explorer
DexCom, Inc. logoDexCom, Inc.
Partie responsable de l'étude
Abha Choudhary, Investigateur principal, Assistant Professor of Pediatrics, University of Texas Southwestern Medical Center
Aucune donnée de contact disponible
2 Centres de l'étude dans 1 pays

Texas

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