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

Afgerond
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De klinische studie NCT04540536 was een interventioneel studie bij Diabetes mellitus type 1, Niet-naleving, patiënt en is nu afgerond. Er werd gestreefd naar inclusie van 20 deelnemers vanaf 1 november 2021. De studie werd geleid door de Universiteit van Texas Southwestern Medisch Centrum en was gepland te worden voltooid op 1 december 2024. Laatste update op ClinicalTrials.gov: 3 maart 2026.
Beknopte samenvatting
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...Toon meer
Officiële titel

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

Aandoeningen
Diabetes mellitus type 1Niet-naleving, patiënt
Andere studie-ID's
  • STU-2020-0699
NCT-ID
NCT04540536
Startdatum (Werkelijk)
2021-11-01
Laatste update geplaatst
2026-03-03
Verwachte einddatum
2024-12-01
Inschrijving (Geschat)
20
Studietype
Interventioneel
FASE
N.v.t.
Status
Afgerond
Trefwoorden
Type 1 Diabetes
Continuous Glucose Monitors
Telemedicine
Remote Monitoring
Secure Texting
Poorly controlled diabetes
Primaire doel
Ondersteunende zorg
Toewijzing
N.v.t.
Interventiemodel
Enkele groep
Blindering
Geen (Open-label)
Armen / Interventies
Deelnemersgroep/StudiearmInterventie/Behandeling
N.v.t.
Continue glucosemonitoring
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
Primaire uitkomst
UitkomstmaatBeschrijving van de uitkomstmaatTijdsbestek
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
Secundaire uitkomst
UitkomstmaatBeschrijving van de uitkomstmaatTijdsbestek
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
Geschiktheidscriteria

Leeftijd van deelnemers
Kind, Volwassene
Minimumleeftijd
13 Years
Geslachten die in aanmerking komen voor de studie
Allen
  • 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 logoUniversiteit van Texas Southwestern Medisch Centrum284 actieve klinische studies om te verkennen
DexCom, Inc. logoDexCom, Inc.
Verantwoordelijke instantie
Abha Choudhary, Hoofdonderzoeker, Assistant Professor of Pediatrics, University of Texas Southwestern Medical Center
Geen contactgegevens beschikbaar
2 Studielocaties in 1 landen

Texas

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