- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02868606
Physiologic Insulin Therapy for the Management of Hyperglycemia in the Hospital
3. juni 2019 opdateret af: Donald Brand, PhD, Winthrop University Hospital
Many hospitals have begun giving insulin to nearly all patients with diabetes while they are in the hospital even if a patient does not use insulin at home.
Controlling blood sugar with insulin when a patient is hospitalized is believed to reduce the risk of complications and death, but research has not demonstrated these benefits except in patients who are critically ill.
The purpose of this study, therefore, is to evaluate whether such insulin therapy actually does reduce in-hospital complications, deaths, need for intensive care, or length of stay in the hospital.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
The primary aim of the proposed study is to determine if physiologic insulin therapy administered to general hospital inpatients with hyperglycemia favorably affects in-hospital complications and mortality, need for intensive care, or length of stay.
The secondary aim is to determine if the magnitude of benefit derived from this therapy differs (a) in patients with known vs. newly diagnosed diabetes, or (b) in medical vs. surgical patients.
The study will analyze data from a natural experiment that occurred when the applicant institution introduced universal physiologic insulin therapy as the standard of care for hyperglycemia.
A quasi-experimental before-and-after study will compare in-hospital complications, mortality, and resource use in patients with comorbid type 2 diabetes before vs. after implementation of this standard (n≈6400).
Outcomes measured at 7 nearby acute-care teaching hospitals during the same two time intervals will provide parallel control data (n≈35,000).
Data from the control hospitals will make it possible to evaluate whether temporal changes in patient characteristics or other variables affecting hospitals in the region could explain effects that might otherwise be erroneously attributed to the intervention.
Given the high prevalence of comorbid diabetes in the hospital and the possibility that universal physiologic insulin for managing hyperglycemia may not deliver the intended benefit or could even do more harm than good, answering this question is an important goal.
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
40391
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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New York
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Mineola, New York, Forenede Stater, 11501
- Winthrop-University Hospital
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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 og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Sandsynlighedsprøve
Studiebefolkning
Hospitalized patients with type 2 diabetes mellitus admitted to a medical or surgical service
Beskrivelse
Inclusion Criteria:
- Type 2 diabetes
Exclusion Criteria:
- Pregnant
- Admitted directly to an intensive care unit
- Length of stay <2 days
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: Kohorte
- Tidsperspektiver: Tilbagevirkende kraft
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
---|---|
Historical control group (H)
Winthrop patients with diabetes hospitalized between August 1, 2010 and March 31, 2011
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|
Intervention group (I)
Winthrop patients with diabetes hospitalized between August 1, 2011 and March 31, 2012
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|
Parallel control group (P-sub-H)
Patients with diabetes hospitalized between August 1, 2010 and March 31, 2011 at 7 control hospitals located in the New York City metropolitan region
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|
Parallel control group (I-sub-H)
Patients with diabetes hospitalized between August 1, 2011 and March 31, 2012 at 7 control hospitals located in the New York City metropolitan region
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Transfer to intensive care unit (y/n)
Tidsramme: Upon hospital discharge (median length of stay, 5 days)
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Assigned "y" if patient is transferred to an intensive care unit for any length of time; otherwise, assigned "n".
|
Upon hospital discharge (median length of stay, 5 days)
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Day-weighted proportion of blood glucose values within target range (100-180 mg/dL)
Tidsramme: Upon hospital discharge (median length of stay, 5 days)
|
Upon hospital discharge (median length of stay, 5 days)
|
Proportion of inpatient days involving any hypoglycemia (blood glucose<70 mg/dL)
Tidsramme: Upon hospital discharge (median length of stay, 5 days)
|
Upon hospital discharge (median length of stay, 5 days)
|
Proportion of inpatient days involving severe hypoglycemia (blood glucose<40 mg/dL)
Tidsramme: Upon hospital discharge (median length of stay, 5 days)
|
Upon hospital discharge (median length of stay, 5 days)
|
Proportion of inpatient days involving any hyperglycemia (blood glucose>200 mg/dL)
Tidsramme: Upon hospital discharge (median length of stay, 5 days)
|
Upon hospital discharge (median length of stay, 5 days)
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Proportion of inpatient days involving severe hyperglycemia (blood glucose>300 mg/dL)
Tidsramme: Upon hospital discharge (median length of stay, 5 days)
|
Upon hospital discharge (median length of stay, 5 days)
|
Development of any complication (y/n)
Tidsramme: Upon hospital discharge (median length of stay, 5 days)
|
Upon hospital discharge (median length of stay, 5 days)
|
In-hospital death (y/n)
Tidsramme: Upon hospital discharge (median length of stay, 5 days)
|
Upon hospital discharge (median length of stay, 5 days)
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Donald A Brand, Ph.D., Winthrop University Hospital
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. juli 2015
Primær færdiggørelse (Faktiske)
15. august 2017
Studieafslutning (Faktiske)
30. juni 2018
Datoer for studieregistrering
Først indsendt
29. juli 2016
Først indsendt, der opfyldte QC-kriterier
15. august 2016
Først opslået (Skøn)
16. august 2016
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
4. juni 2019
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
3. juni 2019
Sidst verificeret
1. juni 2019
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 756440-2
- R18DK104110 (U.S. NIH-bevilling/kontrakt)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Ingen
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 .
Kliniske forsøg med Sliding-Scale Insulin Therapy
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St Vincent's Hospital MelbourneJuvenile Diabetes Research Foundation; MedtronicAfsluttetType 1 diabetesAustralien