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Inpatient Diabetes on Corticosteroids

9. september 2019 opdateret af: Hennepin Healthcare Research Institute
Despite a significant problem with out-of-control glucose levels in patients with diabetes receiving corticosteroids for a variety of illnesses, there are no published protocols addressing how to adequately treat corticosteroid-induced hyperglycemia. Investigators propose to test a protocol using scheduled dosing of NPH (Neutral protamine Hagedorn) insulin for inpatients with diabetes receiving corticosteroids. NPH insulin action is ideally timed to counteract corticosteroid-induced hyperglycemia, and the dose is added to the patient's usual insulin regimen and timed to correspond to the corticosteroid dosing regimen. Investigators will prospectively enroll eligible consented patients with diabetes who are receiving corticosteroids as part of their treatment in a large county hospital, will randomize them to intervention or control groups, and will monitor their glucose levels during their inpatient stay. The protocol will demonstrate improved control of glucose levels with minimal risk of hypoglycemia, and will provide a practical and readily implementable protocol using NPH insulin as therapy for corticosteroid-induced diabetes.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

As above.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

85

Fase

  • Fase 4

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Minnesota
      • Minneapolis, Minnesota, Forenede Stater, 55415
        • Hennepin County Medical Center

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 til 79 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Prior history of diabetes
  • Able to provide informed consent
  • Receiving corticosteroids while hospitalized of greater than 10 mg/d prednisone or the equivalent of dexamethasone or methylprednisolone
  • Expect to be hospitalized for 48 hours

Exclusion Criteria:

  • Renal failure with GFR (glomerular filtration rate) < 30 ml/min/1.73m2
  • ALT (alanine aminotransferase) > 2 times upper normal for laboratory

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: NPH with steroid dose

Receive NPH with each corticosteroid dose during the study duration (2-5 days).

Low dose corticosteroids High dose corticosteroids Eating and 6a-8p 0.15 units NPH/kg 0.3 units NPH/kg NPO(nothing by mouth) or 8p-6a 0.1 units NPH/kg 0.2 units NPH/kg
Medicin: NPH
NPH given per study table based on steroid dose and patient weight in kg.
Andre navne:
  • NPH Lilly Insulin
Medicin: Correction Factor
Given at 2 units per 50 mg/dl over 200 mg/dl and increased to 3 units/50 mg/dl over 200 if glucose rises to over 300 mg/dl. Administered qid during study duration.
Andre navne:
  • Rapid acting regular insulin
Aktiv komparator: Control - Background and correction insulin
Receive usual care with background insulin and correction factor for duration of study (2-5 days)
Medicin: Correction Factor
Given at 2 units per 50 mg/dl over 200 mg/dl and increased to 3 units/50 mg/dl over 200 if glucose rises to over 300 mg/dl. Administered qid during study duration.
Andre navne:
  • Rapid acting regular insulin

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Mean POC Glucose Level Between Groups
Tidsramme: Assessed from enrollment to discharge or enrollment to day five.
Primary outcome measure was mean blood glucose levels measured pre-meal and at bedtime in study patients and controls for the duration of the intervention. Values shown are the overall mean point of care blood glucose.
Assessed from enrollment to discharge or enrollment to day five.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Episodes of Hypoglycemia Between NPH and Control Groups
Tidsramme: Glucose levels measured pre-meal, at bedtime, and during symptoms of hypoglycemia in study patients and controls for the duration of the intervention. Values shown represent cumulative episodes of hypoglycemia per group.
Hypoglycemia was defined as point of care glucose less than 70 mg/dL.
Glucose levels measured pre-meal, at bedtime, and during symptoms of hypoglycemia in study patients and controls for the duration of the intervention. Values shown represent cumulative episodes of hypoglycemia per group.

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of Point of Care Glucose Measurements Between 70 - 180 mg/dL
Tidsramme: From day 1 (day of enrollment) to day 5 (last day of study participation) or final day of hospitalization if less than 5 days. Point of care glucose was checked before breakfast, lunch, dinner, bed time and during symptoms of hypoglycemia.
Glucose levels measured pre-meal, at bedtime, and during symptoms of hypoglycemia in study patients and controls for the duration of the intervention. Values shown are the overall percentage of glucose measurements between 70 - 180 mg/dl.
From day 1 (day of enrollment) to day 5 (last day of study participation) or final day of hospitalization if less than 5 days. Point of care glucose was checked before breakfast, lunch, dinner, bed time and during symptoms of hypoglycemia.
Incidence of Hyperglycemia Defined as Point of Care Glucose 180 - 300 mg/dL
Tidsramme: From day 1 (day of enrollment) to day 5 (last day of study participation) or final day of hospitalization if less than 5 days. Point of care glucose was checked before breakfast, lunch, dinner, bed time and during symptoms of hypoglycemia.
Glucose levels measured pre-meal, at bedtime, and during symptoms of hypoglycemia in study patients and controls for the duration of the intervention. Values shown are the overall percentage of glucose measurements 180 - 300 mg/dL.
From day 1 (day of enrollment) to day 5 (last day of study participation) or final day of hospitalization if less than 5 days. Point of care glucose was checked before breakfast, lunch, dinner, bed time and during symptoms of hypoglycemia.
Incidence of Hyperglycemia Defined as Point of Care Glucose 300 - 400 mg/dl
Tidsramme: From day 1 (day of enrollment) to day 5 (last day of study participation) or final day of hospitalization if less than 5 days. Point of care glucose was checked before breakfast, lunch, dinner, bed time and during symptoms of hypoglycemia.
Glucose levels measured pre-meal, at bedtime, and during symptoms of hypoglycemia in study patients and controls for the duration of the intervention. Values shown are the overall percentage of glucose measurements 300 - 400 mg/dl.
From day 1 (day of enrollment) to day 5 (last day of study participation) or final day of hospitalization if less than 5 days. Point of care glucose was checked before breakfast, lunch, dinner, bed time and during symptoms of hypoglycemia.
Incidence of Hyperglycemia Defined as Point of Care Glucose > 400 mg/dL
Tidsramme: From day 1 (day of enrollment) to day 5 (last day of study participation) or final day of hospitalization if less than 5 days. Point of care glucose was checked before breakfast, lunch, dinner, bed time and during symptoms of hypoglycemia.
Glucose levels measured pre-meal, at bedtime, and during symptoms of hypoglycemia in study patients and controls for the duration of the intervention. Values shown are the overall percentage of glucose measurements > 400 mg/dL.
From day 1 (day of enrollment) to day 5 (last day of study participation) or final day of hospitalization if less than 5 days. Point of care glucose was checked before breakfast, lunch, dinner, bed time and during symptoms of hypoglycemia.
Difference in Length of Stay Between NPH and Control Group
Tidsramme: Measured from the day of admission till the day of discharge
Time difference of hospitalization between the NPH and control groups.
Measured from the day of admission till the day of discharge
Mean Point of Care (POC) Glucose Level in Both Groups.
Tidsramme: On day 1 of study enrollment. Point of care glucose was checked before breakfast, lunch, dinner, and bed time.
The overall mean point of care glucose levels in the NPH group and control group on the first day of the study.
On day 1 of study enrollment. Point of care glucose was checked before breakfast, lunch, dinner, and bed time.
Mean Point of Care (POC) Glucose Level in Both Groups.
Tidsramme: On day 5 or last day of hospitalization (if less than 5 days) glucose level as measured by point of care glucose before breakfast, lunch, dinner and bed time.
The overall mean point of care glucose levels in the NPH group and control group on the last day of the study.
On day 5 or last day of hospitalization (if less than 5 days) glucose level as measured by point of care glucose before breakfast, lunch, dinner and bed time.
Correlation of C-peptide With Age
Tidsramme: plasma C-peptide was measured once at the time of enrollment
plasma C-peptide was measured once at the time of enrollment
Correlation of C-peptide With BMI
Tidsramme: Measured once at the time of enrollment
Measured once at the time of enrollment
Correlation of C-peptide With eGFR
Tidsramme: Measured once at the time of enrollment
Measured once at the time of enrollment
Correlation of C-peptide With Serum Creatinine
Tidsramme: Measured once at the time of enrollment
Measured once at the time of enrollment
Correlation of C-peptide With ALT
Tidsramme: Measured once at the time of enrollment
Measured once at the time of enrollment
Correlation of C-peptide With Hemoglobin A1c
Tidsramme: Measured once at the time of enrollment
Measured once at the time of enrollment
Correlation of C-peptide With Duration of Diabetes
Tidsramme: Measured once at the time of enrollment
Measured once at the time of enrollment
Correlation of C-peptide With Plasma Glucose
Tidsramme: Measured the time of enrollment
Measured the time of enrollment
Correlation of C-peptide With Length of Stay
Tidsramme: Measured once at the time of enrollment
Measured once at the time of enrollment

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Hennepin Healthcare Research Institute

Samarbejdspartnere

Eli Lilly and Company

Efterforskere

  • Ledende efterforsker: Lisa Fish, MD, Hennepin County Medical Center, Minneapolis

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

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 2014

Primær færdiggørelse (Faktiske)

1. juni 2016

Studieafslutning (Faktiske)

1. juni 2016

Datoer for studieregistrering

Først indsendt

4. september 2013

Først indsendt, der opfyldte QC-kriterier

24. oktober 2013

Først opslået (Skøn)

28. oktober 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

1. oktober 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. september 2019

Sidst verificeret

1. september 2019

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • MMRF-13-3658

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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