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Inpatient Diabetes on Corticosteroids

9 settembre 2019 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

As above.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

85

Fase

  • Fase 4

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Stati Uniti
    • Minnesota
      • Minneapolis, Minnesota, Stati Uniti, 55415
        • Hennepin County Medical Center

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 79 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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
Droga: NPH
NPH given per study table based on steroid dose and patient weight in kg.
Altri nomi:
  • NPH Lilly Insulin
Droga: 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.
Altri nomi:
  • Rapid acting regular insulin
Comparatore attivo: Control - Background and correction insulin
Receive usual care with background insulin and correction factor for duration of study (2-5 days)
Droga: 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.
Altri nomi:
  • Rapid acting regular insulin

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Mean POC Glucose Level Between Groups
Lasso di tempo: 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.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Episodes of Hypoglycemia Between NPH and Control Groups
Lasso di tempo: 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.

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Percentage of Point of Care Glucose Measurements Between 70 - 180 mg/dL
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Measured once at the time of enrollment
Measured once at the time of enrollment
Correlation of C-peptide With eGFR
Lasso di tempo: Measured once at the time of enrollment
Measured once at the time of enrollment
Correlation of C-peptide With Serum Creatinine
Lasso di tempo: Measured once at the time of enrollment
Measured once at the time of enrollment
Correlation of C-peptide With ALT
Lasso di tempo: Measured once at the time of enrollment
Measured once at the time of enrollment
Correlation of C-peptide With Hemoglobin A1c
Lasso di tempo: Measured once at the time of enrollment
Measured once at the time of enrollment
Correlation of C-peptide With Duration of Diabetes
Lasso di tempo: Measured once at the time of enrollment
Measured once at the time of enrollment
Correlation of C-peptide With Plasma Glucose
Lasso di tempo: Measured the time of enrollment
Measured the time of enrollment
Correlation of C-peptide With Length of Stay
Lasso di tempo: Measured once at the time of enrollment
Measured once at the time of enrollment

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Hennepin Healthcare Research Institute

Collaboratori

Eli Lilly and Company

Investigatori

  • Investigatore principale: Lisa Fish, MD, Hennepin County Medical Center, Minneapolis

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 luglio 2014

Completamento primario (Effettivo)

1 giugno 2016

Completamento dello studio (Effettivo)

1 giugno 2016

Date di iscrizione allo studio

Primo inviato

4 settembre 2013

Primo inviato che soddisfa i criteri di controllo qualità

24 ottobre 2013

Primo Inserito (Stima)

28 ottobre 2013

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

1 ottobre 2019

Ultimo aggiornamento inviato che soddisfa i criteri QC

9 settembre 2019

Ultimo verificato

1 settembre 2019

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • MMRF-13-3658

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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