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Evaluation of a Single Center Expansion of Continuous Glucose Monitor Access in Patients With Type 2 Diabetes 15

Unbekannter Status
Die Details der klinischen Studie sind hauptsächlich auf Englisch verfügbar. Trial Radar KI kann jedoch helfen! Klicken Sie einfach auf 'Studie erklären', um die Informationen zur Studie in der ausgewählten Sprache anzuzeigen und zu besprechen.
Die klinische Studie NCT05200390 ist eine interventionsstudie zur Untersuchung von Typ-2-Diabetes und hat den Status unbekannter status. Die Studie startete am 24. Januar 2022 und soll 15 Teilnehmer aufnehmen. Durchgeführt von Chieh Chen ist der Abschluss für 1. Februar 2023 geplant. Die Daten von ClinicalTrials.gov wurden zuletzt am 4. Mai 2022 aktualisiert.
Kurzbeschreibung
The purpose of this pilot study is to hopefully generate interest that will lead to more robust trials evaluating FreeStyle Libre 2 sensors in patients with type 2 diabetes on any diabetes regimen. Hopefully the trial will ultimately pave the way to future trials that will prompt clinicians, policymakers, and insurers to re-evaluate the current criteria defining the coverage of continuous glucose monitors (CGM).

The...

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Ausführliche Beschreibung
This will be a prospective, single-center, pre-post pilot study where enrolled participants will be given free FreeStyle Libre 2 sensors for 3 months and will be followed by pharmacists in the Upstate Adult Medicine Clinic.

During the first visit, pharmacists will order a baseline hemoglobin A1c, confirm the participant's current medication list, provide CGM education and assess patient's willingness to scan. Partic...

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Offizieller Titel

Closing the Gap in Health Disparities and Improving Health Outcomes: Evaluation of a Single Center Expansion of Continuous Glucose Monitor Access in Patients With Type 2 Diabetes

Erkrankungen
Typ-2-Diabetes
Weitere Studien-IDs
  • 1788320
NCT-Nummer
NCT05200390
Studienbeginn (tatsächlich)
2022-01-24
Zuletzt aktualisiert
2022-05-04
Studienende (vorauss.)
2023-02
Geplante Rekrutierung
15
Studientyp
Interventionsstudie
PHASE
Nicht zutreffend
Status
Unbekannter Status
Stichwörter
continuous glucose monitor
FreeStyle Libre 2
health disparity
pharmacists
Primäres Ziel
Behandlung
Zuteilungsmethode
Nicht zutreffend
Interventionsmodell
Einarmige Studie
Verblindung
Keine (offene Studie)
Studienarme/Interventionen
Teilnehmergruppe/StudienarmIntervention/Behandlung
ExperimentellContinuous Glucose Monitor
Adult patients with Type 2 Diabetes on any anti-diabetic regimen utilizing continuous glucose monitors for 3 months
Kontinuierlicher Glukosemonitor
FreeStyle Libre 2 system
Hauptergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
Change in percent time in range of 70-180mg/dL (%TIR)
Percentage
From baseline and at 3 months
Nebenergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
Change in Glucose Monitoring Satisfaction Survey (GMSS) scores
Numeric number
From baseline and at 3 month
Change in %TIR
Percentage
From baseline and at 1 month
Change in %TIR
Percentage
From baseline and at 2 months
Change in hemoglobin A1c
Percentage
From baseline and at 3 months
Change in Percent Time Active
Percentage
From baseline and at 1 month
Change in Percent Time Active
Percentage
From baseline and at 2 months
Change in Percent Time Active
Percentage
From baseline and at 3 months
Change in Percent Time Below Range less than 54mg/dL (%TBR <54mg/dL)
Percentage
From baseline and at 1 month
Change in %TBR <54mg/dL
Percentage
From baseline and at 2 months
Change in %TBR <54mg/dL
Percentage
From baseline and at 3 months
Change in Percent Time Below Range less than 70mg/dL (%TBR <70mg/dL)
Percentage
From baseline and at 1 month
Change in %TBR <70mg/dL
Percentage
From baseline and at 2 months
Change in %TBR <70mg/dL
Percentage
From baseline and at 3 months
Change in Percent Time Above Range more than 180mg/dL (%TAR >180mg/dL)
Percentage
From baseline and at 1 month
Change in %TAR >180mg/dL
Percentage
From baseline and at 2 months
Change in %TAR >180mg/dL
Percentage
From baseline and at 3 months
Change in Percent Time Above Range more than 250mg/dL (%TAR >250mg/dL)
Percentage
From baseline and at 1 month
Change in %TAR >250mg/dL
Percentage
From baseline and at 2 months
Change in %TAR >250mg/dL
Percentage
From baseline and at 3 months
Change in Percent Coefficient of Variation (%CV)
Percentage
From baseline and at 1 month
Change in %CV
Percentage
From baseline and at 2 months
Change in %CV
Percentage
From baseline and at 3 months
Percentage of patients at goal %TIR
Percentage
1 month
Percentage of patients at goal %TIR
Percentage
2 months
Percentage of patients at goal %TIR
Percentage
3 months
Percentage of patients at goal % Time Active
Percentage
1 month
Percentage of patients at goal % Time Active
Percentage
2 months
Percentage of patients at goal % Time Active
Percentage
3 months
Percentage of patients at goal %TBR <54mg/dL
Percentage
1 month
Percentage of patients at goal %TBR <54mg/dL
Percentage
2 months
Percentage of patients at goal %TBR <54mg/dL
Percentage
1, 2, and
Percentage of patients at goal %TBR <70mg/dL
Percentage
1 month
Percentage of patients at goal %TBR <70mg/dL
Percentage
2 months
Percentage of patients at goal %TBR <70mg/dL
Percentage
3 months
Percentage of patients at goal %TAR >180mg/dL
Percentage
1 month
Percentage of patients at goal %TAR >180mg/dL
Percentage
2 months
Percentage of patients at goal %TAR >180mg/dL
Percentage
3 months
Percentage of patients at goal %TAR >250mg/dL
Percentage
1 month
Percentage of patients at goal %TAR >250mg/dL
Percentage
2 months
Percentage of patients at goal %TAR >250mg/dL
Percentage
3 months
Percentage of patients at goal % CV
Percentage
1 month
Percentage of patients at goal % CV
Percentage
2 months
Percentage of patients at goal % CV
Percentage
3 months
Eignungskriterien

Zugelassene Altersgruppen
Erwachsene, Ältere Erwachsene
Mindestalter
18 Years
Zugelassene Geschlechter
Alle

  • Diagnosis of Type 2 Diabetes with

    1. Hemoglobin A1c above goal 6.5%-8% based on participant specific factors defined in the ADA guidelines (e.g. comorbidities and age) OR
    2. Identified glycemic excursions, including hypoglycemia based on documented blood glucose readings of < 70 mg/dL via point-of-care glucose testing, lab testing or self-monitoring or reported signs and symptoms of hypoglycemia documented in the medical record

  • Referred and actively followed by pharmacy for at least 3 months prior to study enrollment

  • Have at least one encounter with pharmacist within the last 3 months

  • Have at least one A1c documented while under pharmacist care

  • On at least one anti-diabetic medication

  • Demonstrates willingness (at the discretion of the investigators) to scan the CGM several times a day

  • Demonstrates willingness (at the discretion of the investigators) to attend regular office visits or phone calls

  • Currently pregnant or actively trying to conceive
  • Receiving dialysis
  • Currently followed by the endocrinology clinic for diabetes
  • Current or past CGM use in the last 6 months prior to study enrollment
  • Participant meets criteria for insurance coverage of CGM
  • Known allergy to medical adhesive
  • Wearing any implanted medical device
Chieh Chen logoChieh Chen
St. John Fisher College logoSt. John Fisher College
Verantwortliche Partei
Chieh Chen, Prüfsponsor, Pharmacy Resident - PGY2, State University of New York - Upstate Medical University
Keine Kontaktdaten vorhanden
1 Studienstandorte in 1 Ländern

New York

Upstate Health Care Center, Syracuse, New York, 13202, United States