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Efficacy of FSGM Cloud-based Remote Intervention for Insulin-dEpendent Diabetic Patients (FRIEND)

22. oktober 2022 opdateret af: Young Shin Song

Efficacy of Remote Intervention by Medical Staff Based on a Cloud System of Continuous Glucose Monitoring Data in Patients With Insulin-dependent Diabetes Using a Flash Sensor-based Glucose Monitoring (FSGM)

To investigate the efficacy of remote intervention by medical staff based on a cloud system of continuous glucose monitoring data in patients with insulin-dependent diabetes using flash sensor-based glucose monitoring (FSGM).

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

  • Previous studies have been reported on the efficacy of CGM or FSGM and education on glucose control in insulin-dependent diabetes patients.
  • This study aims to investigate whether it is more effective to receive remote intervention by medical staff based on a cloud system, than only to use FSGM and receive general education on FSGM.
  • Trial design : parallel group, allocation ratio 1:1, a superiority study design

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

36

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Korea, Republikken
    • Gyeonggi-do
      • Seongnam, Gyeonggi-do, Korea, Republikken, 13496
        • CHA Bundang Medical Center

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

19 år til 75 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Men or women aged 19 to 75 years old
  • Patients with type 1 diabetes
  • Patients on multiple daily insulin-injection or continuous subcutaneous insulin infusion therapy for more than 1 year
  • Patients with HbA1c ≥ 7.0% at screening
  • Patients willing to use a FSGM system
  • Patients with informed consent

Exclusion Criteria:

  • Gestational diabetes patients
  • Patients within 1 year of diabetic diagnosis
  • Patients taking drugs for severe cognitive impairment or psychiatric problems
  • Patients who received oral or parenteral corticosteroid therapy for more than 7 consecutive days within 1 month before screening test
  • Patients with severe infection, before and after surgery, and severe trauma
  • Patients on dialysis at the end of renal failure
  • Patients who have a history of substance abuse or alcoholism within 12 weeks through patient history taking, diagnosis records, and past treatment records
  • Pregnant or lactating women
  • Participating in other clinical trials under R&D other than this clinical trial, or if other clinical trial drugs are administered within 4 weeks before the trial
  • Patients who are using a CGMS/FSGM or who have been using it within 12 weeks

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Ingen indgriben: No intervention by medical staff
The patients who start FSGM and receive general education on FSGM only.
Eksperimentel: Intervention by medical staff based on a cloud system
The patients who start FSGM and receive general education on FSGM and remote intervention based on a cloud system.
Andet: Intervention by medical staff based on a cloud system

Remote intervention by medical staff (between Visit 1 and Visit 2; Week 2, 4, 6, 8, 10) : analyzing continuous glucose monitoring data for last two weeks in the cloud system

- Intervention contents

  1. Diet, exercise pattern
  2. Causes of hypoglycemia
  3. Causes of hyperglycemia
  4. Causes of glycemic variability
  5. Counseling for improvement plans for the cause
  6. Counseling to strengthen lifestyle modification
  7. Counseling for insulin administration
  8. Counseling for Insulin dose adjustment (adjusted dose)
  9. Counseling for how to use a FSGM

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Changes in glycemic control measured by HbA1c
Tidsramme: 3 months
Difference between baseline HbA1c and follow-up HbA1c
3 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Changes in the time in range
Tidsramme: 3 months
Difference in the duration of glucose values between 70 mg/dL and 180 mg/dL between baseline and the 3-month follow-up
3 months
Changes in the duration of hyperglycemic episodes
Tidsramme: 3 months
Difference in the duration of hyperglycemic glucose values (>180, 250 mg/dL) (baseline vs. follow-up)
3 months
Changes in the duration of hypoglycemic episodes
Tidsramme: 3 months
Difference in the duration of hypoglycemic glucose values (<70, 54 mg/dL) (baseline vs. follow-up)
3 months
Changes in hypoglycemic episodes
Tidsramme: 3 months
Difference between the frequency of hypoglycemic glucose values (<70, 54 mg/dL) (baseline vs. follow-up)
3 months
Changes in the mean glucose values
Tidsramme: 3 months
Difference in the mean glucose values (baseline vs. follow-up)
3 months
Changes in the frequency of use of trend arrows
Tidsramme: 3 months
Difference in the frequency of use of trend arrows (baseline vs. follow-up)
3 months
Changes in the mean number of scans
Tidsramme: 3 months
Difference in the mean number of scans per day (baseline vs. follow-up)
3 months
Changes in the insulin dose
Tidsramme: 3 months
Difference in the insulin dose (baseline vs. follow-up)
3 months
Changes in the lipid parameter
Tidsramme: 3 months
Difference in the levels of total cholesterol, triglycerides, HDL cholesterol, LDL cholesterol (baseline vs. follow-up)
3 months
Changes in blood pressure
Tidsramme: 3 months
Difference in systolic blood pressure and diastolic blood pressure (baseline vs. follow-up)
3 months
Changes in body weight
Tidsramme: 3 months
Difference in body weight (baseline vs. follow-up)
3 months
Lifestyle changes in diet
Tidsramme: 3 months
Difference in the average number of meals and snacks per day (baseline vs. follow-up)
3 months
Lifestyle changes in the number of exercises
Tidsramme: 3 months
Difference in the average number of exercises per week (baseline vs. follow-up)
3 months
Lifestyle changes in the duration of exercises
Tidsramme: 3 months
Difference in the average duration of exercises per week (baseline vs. follow-up)
3 months
Changes in the patient absolute satisfaction with treatment assessed by questionnaires
Tidsramme: 3 months
Difference in Diabetes Treatment Satisfaction Questionnaire Status (DTSQs) scores (baseline vs. follow-up)
3 months
Changes in the patient relative satisfaction with treatment assessed by questionnaires
Tidsramme: 3 months
Difference in Diabetes Treatment Satisfaction Questionnaire Change (DTSQc) scores (baseline vs. follow-up)
3 months
Changes in depression assessed by questionnaires
Tidsramme: 3 months
Difference in Patient Health Questionnaire-9 (PHQ-9) scores (baseline vs. follow-up)
3 months
Changes in anxiety assessed by questionnaires
Tidsramme: 3 months
Difference in General Anxiety Disorder-7 (GAD-7) scores (baseline vs. follow-up)
3 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Young Shin Song

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

30. juni 2021

Primær færdiggørelse (Faktiske)

30. april 2022

Studieafslutning (Faktiske)

30. april 2022

Datoer for studieregistrering

Først indsendt

24. maj 2021

Først indsendt, der opfyldte QC-kriterier

22. juni 2021

Først opslået (Faktiske)

23. juni 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

25. oktober 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

22. oktober 2022

Sidst verificeret

1. oktober 2022

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2021-03-032-001

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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