- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00841919
Insulin Therapy in the Hospital Comparing Two Protocols
8. september 2009 oppdatert av: John H. Stroger Hospital
Basal/Bolus Insulin Therapy in the Hospital Ward Comparison of Two Protocols: Feasibility Study
The purpose of this study is to determine if by using insulin analog (Glargine and lispro insulin) with an insulin pen the investigators are able to obtain a higher rate of correct timing of insulin and food administration as when compared to the usual therapy (insulin NPH and regular) with syringes.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Forventet)
60
Fase
- Fase 4
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Illinois
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Chicago, Illinois, Forente stater, 60612
- John H Stroger Jr. Hospital
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 80 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
Uncontrolled blood sugar:
- Random blood sugar ≥ 200mg/dl
- Pre-prandial blood sugar greater than 180 mg/dl on two occasions within 24 hours.
- Patient may be off insulin or on subcutaneous inpatient insulin regimen less than 36 hours.
- Transition from an Insulin Drip in the intensive care units to subcutaneous insulin upon transfer to general ward.
- Patient is able to eat and oral feeding is expected.
Exclusion Criteria:
- Patients receiving inpatient oral hypoglycemic agents
- Patients with chronic kidney disease stages 4 & 5 (estimated GFR of <30ml/min) and on dialysis
- Patient with chronic liver disease
- Patient with hypoglycemia unawareness
- Pregnancy
- Patients who are on "NPO" for medical reasons.
- Patient is expected to stay in the hospital for less than 3 days.
- Patient on a new inpatient insulin regimen for > 36 hours.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Aktiv komparator: 2
The active control group will receive twice daily NPH insulin as basal insulin and bolus (prandial) insulin as regular insulin to be administered 30 minutes before meals.
The administration of basal (prandial) regular insulin and food will be done as the current usual care on the hospital ward.
The protocol for initial insulin dose and subsequent dose adjustment has been developed by the "Inpatient Diabetes Advisory Group" and is detailed in appendix B. The patient will receive information regarding diabetes treatments, appropriate diet and diabetic self management which will be provided by the nursing and nutritional staff.
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The active control group will receive twice daily NPH insulin as basal insulin and bolus (prandial) insulin as regular insulin to be administered 30 minutes before meals.
The administration of basal (prandial) regular insulin and food will be done as the current usual care on the hospital ward.
The protocol for initial insulin dose and subsequent dose adjustment has been developed by the "Inpatient Diabetes Advisory Group" and is detailed in appendix B. The patient will receive information regarding diabetes treatments, appropriate diet and diabetic self management which will be provided by the nursing and nutritional staff.
|
Eksperimentell: 1
The study group will receive Insulin Glargine as basal insulin and bolus (prandial) insulin as lispro insulin (choice between pens or vials will be made).
The administration of bolus (prandial) insulin pen or syringe will be delivered concurrently with the food tray (the concept of "insulin pen/syringe on the food tray") by the nursing staff that together with hospital food services identifies the food tray for the patients in the study group.
The protocol for initial insulin dose and subsequent dose adjustment has been developed by the "Inpatient Diabetes Advisory Group" and is detailed in appendix A. The patient will receive information regarding diabetes treatments, appropriate diet and diabetic self management which will be provided by the nursing and nutritional staff
|
The study group will receive Insulin Glargine as basal insulin.
The protocol for initial insulin dose and subsequent dose adjustment has been developed by the "Inpatient Diabetes Advisory Group" and is detailed in appendix A. The patient will receive information regarding diabetes treatments, appropriate diet and diabetic self management which will be provided by the nursing and nutritional staff.
Andre navn:
Bolus (prandial) insulin as lispro insulin (choice between pens or vials will be made).
The administration of bolus (prandial) insulin pen or syringe will be delivered concurrently with the food tray (the concept of "insulin pen/syringe on the food tray") by the nursing staff that together with hospital food services identifies the food tray for the patients in the study group.
The protocol for initial insulin dose and subsequent dose adjustment has been developed by the "Inpatient Diabetes Advisory Group" and is detailed in appendix A. The patient will receive information regarding diabetes treatments, appropriate diet and diabetic self management which will be provided by the nursing and nutritional staff.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
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The rate of correct timing of insulin and food administration
Tidsramme: Correct time was 30 min before to 30 minutes after meal was given for control group, and 15 minutes before to 15 minutes after in case group
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Correct time was 30 min before to 30 minutes after meal was given for control group, and 15 minutes before to 15 minutes after in case group
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Pre and post- prandial glucose levels
Tidsramme: Pre prandial glucose levels were obtained from 0 to 15 minutes before meal , post prandial glucose levels were obtained 2 hours after mealtime
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Pre prandial glucose levels were obtained from 0 to 15 minutes before meal , post prandial glucose levels were obtained 2 hours after mealtime
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Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Length of hospital stay
Tidsramme: Measured 24 hours after patient is dischargerd, from day 1 of admission until day of discharge
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Measured 24 hours after patient is dischargerd, from day 1 of admission until day of discharge
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Nursing staff satisfaction scores for evaluation of the two methods
Tidsramme: 24 hours after last patient is discharged
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24 hours after last patient is discharged
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Hypoglycemia rates.
Tidsramme: From day 1 of admission until day of discharge, obtained from capillary blood checks done QAC and 2 hours postprandial
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From day 1 of admission until day of discharge, obtained from capillary blood checks done QAC and 2 hours postprandial
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High excursions of blood sugars (>300 mg/dl).
Tidsramme: From day 1 of admission until day of discharge, obtained from capillary blood checks done QAC and 2 hours postprandial
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From day 1 of admission until day of discharge, obtained from capillary blood checks done QAC and 2 hours postprandial
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Leon Fogelfeld, MD, John H Stroger Jr. Hospital
- Studiestol: Evelyn Lacuesta, MD, John H Stroger Jr. Hospital
- Studiestol: Yannis Guerra, MD, Rush University Hospital
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. desember 2006
Primær fullføring (Faktiske)
1. mars 2009
Studiet fullført (Faktiske)
1. juni 2009
Datoer for studieregistrering
Først innsendt
9. februar 2009
Først innsendt som oppfylte QC-kriteriene
11. februar 2009
Først lagt ut (Anslag)
12. februar 2009
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
9. september 2009
Siste oppdatering sendt inn som oppfylte QC-kriteriene
8. september 2009
Sist bekreftet
1. september 2009
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Glukosemetabolismeforstyrrelser
- Metabolske sykdommer
- Sykdommer i det endokrine systemet
- Sukkersyke
- Diabetes mellitus, type 2
- Hypoglykemiske midler
- Fysiologiske effekter av legemidler
- Insulin
- Insulin, Globin sink
- Insulin Glargine
- Insulin Lispro
- Insulin, isofan
- Isophan insulin, menneskelig
- Isophan insulin, biff
Andre studie-ID-numre
- BBJHS200901
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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