- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT00841919
Insulin Therapy in the Hospital Comparing Two Protocols
8 september 2009 bijgewerkt door: 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.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Verwacht)
60
Fase
- Fase 4
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
-
-
Illinois
-
Chicago, Illinois, Verenigde Staten, 60612
- John H Stroger Jr. Hospital
-
-
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar tot 80 jaar (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Actieve vergelijker: 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.
|
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.
|
Experimenteel: 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.
Andere namen:
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.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
---|---|
The rate of correct timing of insulin and food administration
Tijdsspanne: 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
|
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
|
Pre and post- prandial glucose levels
Tijdsspanne: Pre prandial glucose levels were obtained from 0 to 15 minutes before meal , post prandial glucose levels were obtained 2 hours after mealtime
|
Pre prandial glucose levels were obtained from 0 to 15 minutes before meal , post prandial glucose levels were obtained 2 hours after mealtime
|
Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
---|---|
Length of hospital stay
Tijdsspanne: Measured 24 hours after patient is dischargerd, from day 1 of admission until day of discharge
|
Measured 24 hours after patient is dischargerd, from day 1 of admission until day of discharge
|
Nursing staff satisfaction scores for evaluation of the two methods
Tijdsspanne: 24 hours after last patient is discharged
|
24 hours after last patient is discharged
|
Hypoglycemia rates.
Tijdsspanne: From day 1 of admission until day of discharge, obtained from capillary blood checks done QAC and 2 hours postprandial
|
From day 1 of admission until day of discharge, obtained from capillary blood checks done QAC and 2 hours postprandial
|
High excursions of blood sugars (>300 mg/dl).
Tijdsspanne: From day 1 of admission until day of discharge, obtained from capillary blood checks done QAC and 2 hours postprandial
|
From day 1 of admission until day of discharge, obtained from capillary blood checks done QAC and 2 hours postprandial
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Leon Fogelfeld, MD, John H Stroger Jr. Hospital
- Studie stoel: Evelyn Lacuesta, MD, John H Stroger Jr. Hospital
- Studie stoel: Yannis Guerra, MD, Rush University Hospital
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 december 2006
Primaire voltooiing (Werkelijk)
1 maart 2009
Studie voltooiing (Werkelijk)
1 juni 2009
Studieregistratiedata
Eerst ingediend
9 februari 2009
Eerst ingediend dat voldeed aan de QC-criteria
11 februari 2009
Eerst geplaatst (Schatting)
12 februari 2009
Updates van studierecords
Laatste update geplaatst (Schatting)
9 september 2009
Laatste update ingediend die voldeed aan QC-criteria
8 september 2009
Laatst geverifieerd
1 september 2009
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Glucosemetabolismestoornissen
- Metabole ziekten
- Endocriene systeemziekten
- Suikerziekte
- Diabetes mellitus, type 2
- Hypoglycemische middelen
- Fysiologische effecten van medicijnen
- Insuline
- Insuline, Globin Zink
- Insuline Glargine
- Insuline Lispro
- Insuline, isofaan
- Isofane insuline, menselijk
- Isofane insuline, rundvlees
Andere studie-ID-nummers
- BBJHS200901
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
Klinische onderzoeken op Diabetes mellitus, type 2
-
Diabetes Foundation, IndiaNational Diabetes Obesity and Cholesterol FoundationWervingDiabetes mellitus type 2 met complicatiesIndië
-
SanofiVoltooidDiabetes mellitus type 1 - Diabetes mellitus type 2Hongarije, Russische Federatie, Duitsland, Polen, Japan, Verenigde Staten, Finland
-
India Diabetes Research Foundation & Dr. A. Ramachandran...Voltooid
-
AstraZenecaWerving
-
Daewoong Pharmaceutical Co. LTD.Nog niet aan het wervenT2DM (diabetes mellitus type 2)
-
Zhongda HospitalWervingDiabetes mellitus type 2 (T2DM)China
-
Newsoara Biopharma Co., Ltd.WervingT2DM (diabetes mellitus type 2)China
-
Shanghai Golden Leaf MedTec Co. LtdActief, niet wervendDiabetes mellitus type 2 (T2DM)China
-
SanofiVoltooid
-
Haisco Pharmaceutical Group Co., Ltd.VoltooidT2DM (diabetes mellitus type 2)China
Klinische onderzoeken op NPH insulin and regular insulin
-
Universiti Sains MalaysiaVoltooid
-
Julphar Gulf Pharmaceutical IndustriesParexel; Profil Institut für Stoffwechselforschung GmbHVoltooid