Inpatient Diabetes on Corticosteroids
maanantai 9. syyskuuta 2019 päivittänyt: 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.
Tutkimuksen yleiskatsaus
Yksityiskohtainen kuvaus
As above.
Opintotyyppi
Interventio
Ilmoittautuminen (Todellinen)
85
Vaihe
- Vaihe 4
Yhteystiedot ja paikat
Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.
Opiskelupaikat
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Minnesota
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Minneapolis, Minnesota, Yhdysvallat, 55415
- Hennepin County Medical Center
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Osallistumiskriteerit
Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.
Kelpoisuusvaatimukset
Opintokelpoiset iät
18 vuotta - 79 vuotta (Aikuinen, Vanhempi Aikuinen)
Hyväksyy terveitä vapaaehtoisia
Ei
Sukupuolet, jotka voivat opiskella
Kaikki
Kuvaus
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
Opintosuunnitelma
Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
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Kokeellinen: 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 |
NPH given per study table based on steroid dose and patient weight in kg.
Muut nimet:
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.
Muut nimet:
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Active Comparator: Control - Background and correction insulin
Receive usual care with background insulin and correction factor for duration of study (2-5 days)
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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.
Muut nimet:
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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Mean POC Glucose Level Between Groups
Aikaikkuna: 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.
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Assessed from enrollment to discharge or enrollment to day five.
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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Episodes of Hypoglycemia Between NPH and Control Groups
Aikaikkuna: 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.
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Hypoglycemia was defined as point of care glucose less than 70 mg/dL.
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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.
|
Muut tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Percentage of Point of Care Glucose Measurements Between 70 - 180 mg/dL
Aikaikkuna: 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.
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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.
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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.
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Incidence of Hyperglycemia Defined as Point of Care Glucose 180 - 300 mg/dL
Aikaikkuna: 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.
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Incidence of Hyperglycemia Defined as Point of Care Glucose 300 - 400 mg/dl
Aikaikkuna: 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.
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Incidence of Hyperglycemia Defined as Point of Care Glucose > 400 mg/dL
Aikaikkuna: 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.
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Difference in Length of Stay Between NPH and Control Group
Aikaikkuna: Measured from the day of admission till the day of discharge
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Time difference of hospitalization between the NPH and control groups.
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Measured from the day of admission till the day of discharge
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Mean Point of Care (POC) Glucose Level in Both Groups.
Aikaikkuna: On day 1 of study enrollment. Point of care glucose was checked before breakfast, lunch, dinner, and bed time.
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The overall mean point of care glucose levels in the NPH group and control group on the first day of the study.
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On day 1 of study enrollment. Point of care glucose was checked before breakfast, lunch, dinner, and bed time.
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Mean Point of Care (POC) Glucose Level in Both Groups.
Aikaikkuna: 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.
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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.
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Correlation of C-peptide With Age
Aikaikkuna: plasma C-peptide was measured once at the time of enrollment
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plasma C-peptide was measured once at the time of enrollment
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Correlation of C-peptide With BMI
Aikaikkuna: Measured once at the time of enrollment
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Measured once at the time of enrollment
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Correlation of C-peptide With eGFR
Aikaikkuna: Measured once at the time of enrollment
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Measured once at the time of enrollment
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Correlation of C-peptide With Serum Creatinine
Aikaikkuna: Measured once at the time of enrollment
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Measured once at the time of enrollment
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Correlation of C-peptide With ALT
Aikaikkuna: Measured once at the time of enrollment
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Measured once at the time of enrollment
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Correlation of C-peptide With Hemoglobin A1c
Aikaikkuna: Measured once at the time of enrollment
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Measured once at the time of enrollment
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Correlation of C-peptide With Duration of Diabetes
Aikaikkuna: Measured once at the time of enrollment
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Measured once at the time of enrollment
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Correlation of C-peptide With Plasma Glucose
Aikaikkuna: Measured the time of enrollment
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Measured the time of enrollment
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Correlation of C-peptide With Length of Stay
Aikaikkuna: Measured once at the time of enrollment
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Measured once at the time of enrollment
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Yhteistyökumppanit ja tutkijat
Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.
Yhteistyökumppanit
Tutkijat
- Päätutkija: Lisa Fish, MD, Hennepin County Medical Center, Minneapolis
Julkaisuja ja hyödyllisiä linkkejä
Tutkimusta koskevien tietojen syöttämisestä vastaava henkilö toimittaa nämä julkaisut vapaaehtoisesti. Nämä voivat koskea mitä tahansa tutkimukseen liittyvää.
Opintojen ennätyspäivät
Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan julkisella verkkosivustolla.
Opi tärkeimmät päivämäärät
Opiskelun aloitus
Tiistai 1. heinäkuuta 2014
Ensisijainen valmistuminen (Todellinen)
Keskiviikko 1. kesäkuuta 2016
Opintojen valmistuminen (Todellinen)
Keskiviikko 1. kesäkuuta 2016
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Keskiviikko 4. syyskuuta 2013
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Torstai 24. lokakuuta 2013
Ensimmäinen Lähetetty (Arvio)
Maanantai 28. lokakuuta 2013
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Tiistai 1. lokakuuta 2019
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Maanantai 9. syyskuuta 2019
Viimeksi vahvistettu
Sunnuntai 1. syyskuuta 2019
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- MMRF-13-3658
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