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Sensor Augmented Pump Therapy Versus Multiple Daily Injection Therapy

6. juni 2017 opdateret af: Medtronic Diabetes

Sensor Augmented Pump Therapy Versus Multiple Daily Injection Therapy for Hospitalized Patients in China With Type 2 Diabetes; Time to Target

This is a prospective, randomized (open label), multi-center and post-market study. The study is to compare effectiveness of sensor-augmented pump (SAP) therapy versus multiple daily injection (MDI) therapy in hospitalized patients with insulin treating type 2 diabetes in China

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Primary objective:

To compare the length of time to achieve target glucose range using Self-Monitoring Blood Glucose (SMBG), as reference method, with the 722 Paradigm Real-Time insulin pump versus MDI

Secondary Objectives:

To compare glycemic variability (using CGM as reference method) with the 722 Paradigm Real-Time insulin pump versus MDI

This is a prospective, randomized (open label), multi-center study. The clinical study staff will conduct screening tests according to inclusion/exclusion criteria in order to verify the subject's eligibility for the study.

Inpatient Period A patient is admitted into hospital for treatment of diabetes

Randomization

Subjects are randomized (at a 1:1 ratio) to group A or B in the study database. A total of 80 subjects will be randomized into 2 study groups:

  • Group A will wear 722 Paradigm Real-Time System (treated with 24h per day insulin infusion)
  • Group B will be on MDI and wear the CGMS-Gold (treated with 4 insulin injections).

It is anticipated that the total duration for the study will be within one year from site initiation to finalization of all data entry and monitoring.

Each subject will participate in the study approximately 2 weeks.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

118

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

      • Beijing, Kina
        • Chinese PLA General Hospital
    • Jilin
      • Changchun, Jilin, Kina
        • The Second Hospital of Jilin University

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

18 år til 65 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. Subject is 18 to 65 years old at time of screening
  2. A clinical diagnosis of type 2 diabetes > 6 months prior to the screening as determined by the Investigator,
  3. Treating with insulin at least one injection per day prior to participate in the study
  4. Glycosylated hemoglobin (A1C) > 8% at screening
  5. Subject needs to be hospitalized to receive treatment for glucose management according to Endocrinologists' discretion
  6. Subject is willing to follow protocol and underdo all study procedures
  7. Subject is willing and able to provide informed written consent personally or by legal proxy

Exclusion Criteria:

  1. Subject has known hypersensitivity to insulin or insulin infusion set
  2. Subject has been treated with drugs with a known effect on BG within 8 weeks before enrollment other than diabetes medications such as insulin or oral agents.
  3. random blood glucose is above 33 mmol/L
  4. Subject is currently using real time CGM therapy prior to screening
  5. Subject is currently using insulin pump therapy prior to screening
  6. Female subject who is pregnant, or plans to become pregnant during the course of the study
  7. Patients who are critically ill that must go to intensive critical care unit per Investigator discretion
  8. Subject has any systemic disease or medical condition found on the screening tests that may interfere with the safety of the patient and efficacy of the study treatment, in the opinion of the Investigator, may preclude him/her from participating in the study. The following includes, but not limited to, those conditions:

    • Female subject has a positive serum pregnancy screening test
    • Subject has visually impaired or disability limits the use of RT-CGM.
    • Subject has any unresolved adverse skin condition in the area of sensor placement or device replacement (e.g., psoriasis, rash, Staphylococcus infection)
    • Subject has disease with a known effect on BG such as Active Graves' disease
    • Subject has a history of alcohol abuse
  9. Any other condition, which may not be suitable for the study at physician's discretion.

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
Eksperimentel: Pump
Paradigm 722 insulin pump used for insulin infusion and continuous glucose monitoring
722 Paradigm Real-Time System
Aktiv komparator: MDI
Multiple daily insulin injections used for treatment
Device used to collect retrospective sensor data, blinded to the subjects, to compare to the treatment arm

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Time to Target
Tidsramme: Up to 14 days in hospital
length of time to achieve target glucose range using Self-Monitoring Blood Glucose (SMBG), as reference method, with the 722 Paradigm Real-Time insulin pump versus Multiple Daily Injection
Up to 14 days in hospital

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Glycemic Variability
Tidsramme: Up to 14 days in hospital
Glycemic variability (mean amplitude glycemic excursion) using CGM as reference method
Up to 14 days in hospital

Samarbejdspartnere og efterforskere

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

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

1. april 2013

Primær færdiggørelse (Faktiske)

1. maj 2015

Studieafslutning (Faktiske)

1. maj 2015

Datoer for studieregistrering

Først indsendt

9. august 2013

Først indsendt, der opfyldte QC-kriterier

12. august 2013

Først opslået (Skøn)

13. august 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

6. juli 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

6. juni 2017

Sidst verificeret

1. juni 2017

Mere information

Begreber relateret til denne undersøgelse

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ja

produkt fremstillet i og eksporteret fra U.S.A.

Ja

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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