- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00645827
Use of an Insulin Infusion Conversion Equation (IICE) to Control Blood Glucose in Hospitalized Patients (IICE)
12. september 2014 opdateret af: G. Randy Smith, Jr., M.D., Emory University
Use of an Insulin Infusion Conversion Equation (IICE) to Improve Inpatient Glycemic Control: A Randomized Controlled Trial
Insulin infusions are commonly used in hospitalized diabetics to control blood sugar, and they are effective.
However, insulin infusions require the use of limited resources.
Insulin infusions are therefore changed to insulin shots as a patient recovers.
Once an insulin infusion is stopped and shots are started, blood sugar control is harder to maintain.
This is, in part, because physicians have different ideas on how to dose insulin shots in hospitalized patients.
A math equation has been developed by the research staff that attempts to predict the effective doses of insulin shots in patients whose insulin infusion have just been stopped.
The math equation was developed for patients with type 2 diabetes mellitus.
In this study, all patients will be treated with the same type of insulin shots, with doses of the insulin shots chosen either by the math equation or by the judgment of the patient's physician.
The study will then follow blood sugar values for 24 hours to see if the math equation is effective.
If the equation is proven to be effective, a new tool will exist for physicians to determine the best dose of insulin shots for type 2 diabetics.
Such a tool would, in turn, allow for widespread use of insulin infusions to determine a patient's insulin needs before discharge from the hospital.
Blood sugar control for type 2 diabetics that are inpatient or outpatient would improve as a result, with potentially far reaching public health benefits.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
78
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
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Georgia
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Atlanta, Georgia, Forenede Stater, 30308
- Emory Crawford Long 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
Beskrivelse
Inclusion Criteria:
- Inpatients at an urban, mixed academic and community tertiary care hospital who were on IV insulin were enrolled.
- Patients were taken from medical, general surgical, and cardiothoracic services, and were located both inside and outside the intensive care unit (ICU).
Exclusion Criteria:
- At time of enrollment, patients with type I diabetes mellitus,
- active acute or chronic pancreatitis,
- history of pancreatic surgery,
- use of a self-titratable insulin pump, or
- history of β-islet cell transplantation were excluded.
- At time of randomization, patients with insulin drip rates ≤ 2 units/hr, ∆ in serum creatinine of > 20% in previous 24 hours, or
- those without caloric intake while on IV insulin were excluded.
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: Insulin infusion conversion equation
Insulin infusion conversion equation is used to determine subcutaneous insulin dosing for first 24 hours after cessation of an IV insulin infusion.
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Subcutaneous insulin was dosed according to an equation (too long for publication here) which gives the patient's 24 hour SC insulin requirement.
If patient was eating, 65% of equation result was given as insulin glargine SC qHS and 35% of equation result was divided evenly between three qAC doses of insulin aspart.
If patient was not eating, 100% of ISC was given as insulin glargine.
If IV insulin was stopped between 7 AM and 3 PM, 1/2 to 1/3 of scheduled insulin glargine dose was given as a one time insulin NPH SC dose at time of IV insulin cessation.
Correctional insulin was given as follows: For BG ≥ 150 mg/dL, (BG-100)/X units insulin aspart SC, X = 1500 / (scheduled glargine dose + [3 x scheduled aspart dose]).
For BG < 70 mg/dL, ½ ampule D50W IV x1 was given.
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Aktiv komparator: Control
Judgment of patient's healthcare provider is used to determine subcutaneous insulin dosing for first 24 hours after cessation of IV insulin infusion.
|
Twenty-four hour subcutaneous insulin dosing requirement was determined according to the judgment of the patient's healthcare provider.
If patient was eating, insulin glargine SC qHS and three qAC doses of insulin aspart was given according to the judgment of the patients's healthcare provider.
If patient was not eating, 100% of insulin was given as insulin glargine.
If IV insulin was stopped between 7 AM and 3 PM, 1/2 to 1/3 of scheduled insulin glargine dose was given as a one time insulin NPH SC dose at time of IV insulin cessation.
Correctional insulin was given as follows: For BG ≥ 150 mg/dL, (BG-100)/X units insulin aspart SC, X = 1500 / (scheduled glargine dose + [3 x scheduled aspart dose]).
For BG < 70 mg/dL, ½ ampule D50W IV x1 was given.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Percentage of Blood Glucose Values Within 80-140 mg/dL
Tidsramme: Within 24 hours after cessation of IV insulin
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Fingerstick glucose measurements were obtained up to six times for each participant.
Percentage of blood glucose values within the target range of 80-140 mg/dL
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Within 24 hours after cessation of IV insulin
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Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Hypoglycemia (Serum Blood Glucose < 70 mg/dL)
Tidsramme: Within 24 hours after cessation of IV insulin
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Within 24 hours after cessation of IV insulin
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Gregory R Smith, Jr., MD, Emory University
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. januar 2008
Primær færdiggørelse (Faktiske)
1. marts 2009
Studieafslutning (Faktiske)
1. marts 2009
Datoer for studieregistrering
Først indsendt
25. marts 2008
Først indsendt, der opfyldte QC-kriterier
27. marts 2008
Først opslået (Skøn)
28. marts 2008
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
15. september 2014
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
12. september 2014
Sidst verificeret
1. september 2014
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- IRB00006564
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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