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Reversal of Hypoglycemia Unawareness Using Continuous Glucose Monitoring

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De klinische studie NCT00796848 is een interventioneel studie bij Diabetes mellitus met de status ingetrokken. Het doel is om N.v.t. deelnemers te includeren vanaf 1 maart 2009. De studie wordt geleid door Stanford-universiteit en de voltooiing is gepland op 1 maart 2010. Laatste update op ClinicalTrials.gov: 6 juni 2018.
Beknopte samenvatting
The purpose of doing this study is to see if continuous glucose monitoring can help people with type 1 diabetes who are sometimes unable to feel if they have a low blood glucose reading. For this study we will be using the Navigator Continuous Glucose Monitor. We think that your body may not have enough of a certain hormone that usually helps people know when they are going low. If you can keep from going low, we thi...Toon meer
Uitgebreide beschrijving
To enroll in this study you must be between the ages of 7 and 20, have type 1 diabetes, and experience at least two episodes of low blood glucose readings weekly that you do not feel. Up to 25 subjects will be enrolled at Stanford and another 25 at the Barbara Davis Center in Colorado. The study will last approximately 8 months for each participant.
Officiële titel

Reversal of Hypoglycemia Unawareness Using Continuous Glucose Monitoring

Aandoeningen
Diabetes mellitus
Andere studie-ID's
  • SU-10172008-1323
  • Stanford eprotocol #14728 (Overige identificatiecode) (Stanford IRB)
NCT-ID
NCT00796848
Startdatum (Werkelijk)
2009-03
Laatste update geplaatst
2018-06-06
Verwachte einddatum
2010-03
Studietype
Interventioneel
FASE
N.v.t.
Status
Ingetrokken
Primaire doel
Behandeling
Toewijzing
Gerandomiseerd
Interventiemodel
Cross-over
Blindering
Geen (Open-label)
Armen / Interventies
Deelnemersgroep/StudiearmInterventie/Behandeling
N.v.t.
Navigator Continuous Glucose Monitor
Primaire uitkomst
UitkomstmaatBeschrijving van de uitkomstmaatTijdsbestek
To evaluate the effectiveness of continuous glucose monitoring in the reduction of hypoglycemia unawareness.
Secundaire uitkomst
UitkomstmaatBeschrijving van de uitkomstmaatTijdsbestek
To assess the levels of epinephrine production in youth diagnosed with hypoglycemia unawareness with and without continuous glucose monitor wear.
Geschiktheidscriteria

Leeftijd van deelnemers
Kind, Volwassene
Minimumleeftijd
7 Years
Geslachten die in aanmerking komen voor de studie
Allen
  1. Be at least 7 to 20 years old
  2. Have been diagnosed with type 1 diabetes for at least 1 year
  3. Report 2 or more episodes per week of asymptomatic hypoglycemia as determined by completion of the Hypoglycemia Awareness Questionnaire (HAQ) or as determined by Investigator
  4. HbA1c level < 10%
  5. Internet access for downloading continuous glucose monitoring (CGM), access to a compatible computer (Windows Vista is not compatible for downloading.)
  6. For females, you are not intending to become pregnant during the study
  7. No expectation that you will be moving out of the area for the duration of the study

  1. The presence of a significant medical disorder (including epilepsy, or any cause of seizures other than hypoglycemia) that in the judgment of the Investigator will affect the wearing of the sensors or the completion of any aspect of the protocol
  2. Treatment with systemic or inhaled corticosteroids in the last six months
  3. Inpatient psychiatric treatment in the past six months for you or your primary caregiver
  4. Current use of oral/inhaled glucocorticoids or other medications, which in the judgment of the Investigator would be a contraindication to participation in the study
  5. Having two or more severe hypoglycemia episodes (seizure or loss of consciousness) in the six months prior to enrollment
  6. Having a severe hypoglycemic episode in the 30 days prior to enrollment
Stanford University logoStanford-universiteit665 actieve klinische studies om te verkennen
University of Colorado, Denver logoUniversity of Colorado, Denver480 actieve klinische studies om te verkennen
Verantwoordelijke instantie
Bruce A. Buckingham, Hoofdonderzoeker, Principle Investigator, Stanford University
Geen contactgegevens beschikbaar
1 Studielocaties in 1 landen

California

Stanford University School of Medicine, Stanford, California, 94305, United States