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Use of an Insulin Infusion Conversion Equation (IICE) to Control Blood Glucose in Hospitalized Patients (IICE)

12 september 2014 uppdaterad av: 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Faktisk)

78

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Förenta staterna
    • Georgia
      • Atlanta, Georgia, Förenta staterna, 30308
        • Emory Crawford Long Hospital

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.
Övrig: IICE Dosing
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.
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.
Övrig: Healthcare Provider dosing
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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Percentage of Blood Glucose Values Within 80-140 mg/dL
Tidsram: Within 24 hours after cessation of IV insulin
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
Within 24 hours after cessation of IV insulin

Sekundära resultatmått

Resultatmått
Tidsram
Hypoglycemia (Serum Blood Glucose < 70 mg/dL)
Tidsram: Within 24 hours after cessation of IV insulin
Within 24 hours after cessation of IV insulin

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Emory University

Utredare

  • Huvudutredare: Gregory R Smith, Jr., MD, Emory University

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 januari 2008

Primärt slutförande (Faktisk)

1 mars 2009

Avslutad studie (Faktisk)

1 mars 2009

Studieregistreringsdatum

Först inskickad

25 mars 2008

Först inskickad som uppfyllde QC-kriterierna

27 mars 2008

Första postat (Uppskatta)

28 mars 2008

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

15 september 2014

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

12 september 2014

Senast verifierad

1 september 2014

Mer information

Termer relaterade till denna studie

Nyckelord

Andra studie-ID-nummer

  • IRB00006564

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Kliniska prövningar på Glucose, Blood

Kliniska prövningar på IICE Dosing

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