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Kaartweergave

Continuous Glucose Monitoring Devices in Hospitalized Veterans With Diabetes 218 Veteranen Innovatief

Actief, niet rekruterend
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De klinische studie NCT03508934 is een interventioneel studie bij Diabetes mellitus, type 2, Hypoglykemie met de status actief, niet rekruterend. Het doel is om 218 deelnemers te includeren vanaf 1 juli 2018. De studie wordt geleid door VA Office of Research and Development en de voltooiing is gepland op 30 april 2026. Laatste update op ClinicalTrials.gov: 7 januari 2026.
Beknopte samenvatting
More than 25% of the patients admitted in the general wards have a history of Diabetes Mellitus (DM). Up to 30% of the hospitalized diabetics develop hypoglycemia (low glucose values); a condition that is associated with seizures, cardiac arrhythmias, and even death. In Veterans, the prevalence is disproportionally higher. It is estimated that 40-50% of hospitalized Veterans are diabetics. In this clinical trial the ...Toon meer
Uitgebreide beschrijving
More than 25% of patients admitted to general wards/non Intensive Care Unit (non-ICU) setting have a history of Diabetes Mellitus (DM); and as for 2012, $125 billion dollars were costs associated with hospitalization of diabetics in the United States (US). Up to 30% of the hospitalized diabetics develop hypoglycemia, a condition that is associated with higher hospital charges, prolonged length of stay, and increased ...Toon meer
Officiële titel

Continuous Glucose Monitoring in Insulin Treated Hospitalized Veterans With DM2 at Higher Risk for Hypoglycemia

Aandoeningen
Diabetes mellitus, type 2Hypoglykemie
Publicaties
Wetenschappelijke artikelen en onderzoekspapers gepubliceerd over deze klinische studie:
Andere studie-ID's
  • ENDA-022-17F
  • CX001825-01 (Ander subsidie-/financieringsnummer) (VA Office of Research and Development)
NCT-ID
Startdatum (Werkelijk)
2018-07-01
Laatste update geplaatst
2026-01-07
Verwachte einddatum
2026-04-30
Inschrijving (Geschat)
218
Studietype
Interventioneel
FASE
N.v.t.
Status
Actief, niet rekruterend
Trefwoorden
Diabetes Mellitus, Type 2
hypoglycemia
Continuous Glucose Monitoring
hospital
inpatient
Primaire doel
Preventie
Toewijzing
Gerandomiseerd
Interventiemodel
Parallel
Blindering
Geen (Open-label)
Armen / Interventies
Deelnemersgroep/StudiearmInterventie/Behandeling
Actieve comparatorIntervention group (Continuous Glucose Monitroring and POC)
Hospitalized patients with DM2 will be monitored with Glucose Telemetry System (GTS) and Point of Care (POC) finger-stick blood glucose levels with application of hypoglycemia prevention protocol (activated based the GTS lower glucose alarms)
GTS (Continuous Glucose Monitoring)
Hospitalized patients with DM2 will be monitored with Glucose Telemetry System (GTS)
POC (Point of Care)
Hospitalized patients with DM2 will be monitored with POC (Point of Care) blood glucose levels.
Placebo-comparatorControl group (Point of Care-POC)
Hospitalized patients with DM2 will be monitored with POC blood glucose levels and application of hypoglycemia prevention protocol (activated based the POC values)
POC (Point of Care)
Hospitalized patients with DM2 will be monitored with POC (Point of Care) blood glucose levels.
Primaire uitkomst
UitkomstmaatBeschrijving van de uitkomstmaatTijdsbestek
Decrease in hypoglycemia during the hospitalization
GTS and the application of the hypoglycemia prevention protocol will lead to a decrease in hypoglycemia in the hospital
Through study completion-hospitalization (average length of stay at the hospital of 4-6 days)
Deelname-assistent
Geschiktheidscriteria

Leeftijd van deelnemers
Volwassene, Oudere volwassene
Minimumleeftijd
21 Years
Geslachten die in aanmerking komen voor de studie
Allen
  • Veterans with history of DM2 managed with insulin (either basal bolus, basal only or basal with per os DM medications), admitted to the Baltimore VA Medical Center, who have at

    • least 1 risk factor of hypoglycemia

  • Veterans with history of type 1 DM.
  • Veterans with history of DM2 managed with diet or any combination of oral antidiabetic drugs only.
  • Veterans hospitalized with significant hyperglycemia or diabetic ketoacidosis
  • Pregnant Veterans
  • Veterans receiving glucocorticosteroids in doses (equivalent) to 20 mg of hydrocortisone/day
  • Veterans that are expected to require a hospital stay <3 days will also be excluded
VA Office of Research and Development logoVA Office of Research and Development
Geen contactgegevens beschikbaar
1 Studielocaties in 1 landen

Maryland

Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD, Baltimore, Maryland, 21201, United States