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

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La sperimentazione clinica NCT04540536 è stata uno studio interventistico per Diabete mellito di tipo 1, Non aderenza del paziente, attualmente completato. Avviato il 1 novembre 2021, prevedeva di arruolare 20 partecipanti. Sotto la guida di il Centro Medico Surocdental dell'Università del Texas, si è concluso il 1 dicembre 2024. I dati più recenti da ClinicalTrials.gov sono stati aggiornati l'ultima volta il 3 marzo 2026.
Sommario breve
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...Mostra di più
Titolo ufficiale

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

Patologie
Diabete mellito di tipo 1Non aderenza del paziente
Altri ID dello studio
  • STU-2020-0699
Numero NCT
NCT04540536
Data di inizio (effettiva)
2021-11-01
Ultimo aggiornamento pubblicato
2026-03-03
Data di completamento (stimata)
2024-12-01
Arruolamento (previsto)
20
Tipo di studio
Interventistico
FASE
N.D.
Stato
Completato
Parole chiave
Type 1 Diabetes
Continuous Glucose Monitors
Telemedicine
Remote Monitoring
Secure Texting
Poorly controlled diabetes
Scopo principale
Terapia di supporto
Allocazione
N.D.
Modello di intervento
A gruppo singolo
Mascheramento
Nessuno (studio in aperto)
Bracci / Interventi
Gruppo/Braccio di partecipantiIntervento/Trattamento
N.D.
Monitoraggio continuo del glucosio
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
Esito primario
Misure di esitoDescrizione della misuraArco temporale
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
Esito secondario
Misure di esitoDescrizione della misuraArco temporale
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
Criteri di eleggibilità

Età idonea
Bambino, Adulto
Età minima
13 Years
Sessi idonei
Tutti
  • 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 logoCentro Medico Surocdental dell'Università del Texas284 studi clinici attivi da esplorare
DexCom, Inc. logoDexCom, Inc.
Parte responsabile dello studio
Abha Choudhary, Investigatore principale, Assistant Professor of Pediatrics, University of Texas Southwestern Medical Center
Nessun dato di contatto
2 Centri dello studio in 1 paesi

Texas

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