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De klinische studie NCT01514292 voor Diabetes is afgerond. Bekijk de kaartweergave van de Klinische Studies Radar en de AI-ontdekkingstools voor alle details. Of stel hier een vraag. | ||
Eén studie komt overeen met de filtercriteria
Kaartweergave
Effectiveness and Safety Study of the Dexcom G4™ Continuous Glucose Monitoring System 72
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De klinische studie NCT01514292 was een interventioneel studie bij Diabetes en is nu afgerond. Er werd gestreefd naar inclusie van 72 deelnemers vanaf 1 december 2011. De studie werd geleid door DexCom, Inc. en was gepland te worden voltooid op 1 februari 2012. Laatste update op ClinicalTrials.gov: 5 oktober 2015.
Beknopte samenvatting
The purpose of this study is to evaluate the effectiveness and safety of the Dexcom G4 System when used as an adjuvant to blood glucose testing over a 7-day period in people >18 years-old with diabetes mellitus.
The primary objective is to characterize the System performance with respect to laboratory reference venous sample measurements. The device performance will be primarily evaluated in terms of point and rate...
Toon meerUitgebreide beschrijving
The primary objective is to characterize the System performance with respect to laboratory reference venous sample measurements. The device performance will be primarily evaluated in terms of point and rate accuracy of the G4 System in reference to YSI. The trend accuracy of the device performance, i.e., continuous glucose error grid analysis, will be evaluated as well as the temporal G4 System accuracy at different ...Toon meer
Officiële titel
PTL-900590 Effectiveness and Safety Study of the Dexcom G4™ Continuous Glucose Monitoring System
Aandoeningen
DiabetesAndere studie-ID's
- PTL-900590
NCT-ID
Startdatum (Werkelijk)
2011-12
Laatste update geplaatst
2015-10-05
Verwachte einddatum
2012-02
Inschrijving (Geschat)
72
Studietype
Interventioneel
FASE
N.v.t.
Status
Afgerond
Primaire doel
Behandeling
Toewijzing
N.v.t.
Interventiemodel
Enkele groep
Blindering
Geen (Open-label)
Armen / Interventies
| Deelnemersgroep/Studiearm | Interventie/Behandeling |
|---|---|
ExperimenteelReal Time Continuous Glucose Monitoring System 7 day use of real time continuous glucose monitoring system | Continuous Glucose Monitoring of glucose levels (Dexcom) Manipulation of glucose levels during multiple clinic days. Achieved through diet, exercise and insulin regimen defined in protocol.Evaluation of CGM performance characteristics in reference to a laboratory standard. |
Primaire uitkomst
| Uitkomstmaat | Beschrijving van de uitkomstmaat | Tijdsbestek |
|---|---|---|
CGM Relative Differences to Laboratory Reference | The outcome measure is measured as the relative differences (%) of the CGM glucose value in reference to a laboratory reference, yellow spring instrument( YSI) glucose measurements. | 7 days |
Geschiktheidscriteria
Leeftijd van deelnemers
Volwassene, Oudere volwassene
Minimumleeftijd
18 Years
Geslachten die in aanmerking komen voor de studie
Allen
Age 18 years or older;
Diagnosed with diabetes mellitus;
Use one of the following for their diabetes management:
- intensive insulin therapy (IIT) or
- non-intensive insulin therapy (non-IIT)
Intensive-insulin using (IIT) subjects only - During each in-clinic session, willing to have their blood glucose levels manipulated into high and low glucose levels. Subjects not on IIT will only be observed during each in-clinic session.
For subjects that exercise routinely (at least 3 times per week), willing to exercise on each in-clinic session, if asked;
Willing to take a minimum of 7 fingersticks per day during home use days;
Willing to refrain from the use of acetaminophen during sensor wear period and the day prior to sensor insertion;
- Have extensive skin changes/diseases that preclude wearing the required number of devices on normal skin (e.g., extensive psoriasis, recent burns or severe sunburn, extensive eczema, extensive scarring, extensive tattoos, dermatitis herpetiformis) at the proposed wear sites;
- Have a known allergy to medical-grade adhesives;
- Are pregnant as demonstrated by a positive pregnancy test within 72 hours of sensor insertion,
- Are on dialysis;
- Have a hematocrit that is less than 36% or greater than 55% at screening visit;
- Currently participating in another investigational study protocol (if a subject has recently completed participation in another drug study, the subject must have completed that study at least 30 days prior to being enrolled in this study);
- Have a history of cardiovascular disease (including, but not limited to ischemic heart disease, peripheral vascular disease, cardiomyopathy, cerebrovascular disease, congenital heart disease, or significant arrhythmias), epilepsy, severe migraines in the past 6 months, adrenal disease, syncope, significant hypoglycemia unawareness, or a history of severe hypoglycemia (requiring emergency medical intervention) within the last 6 months;
- Have any chronic infectious disease or intercurrent illness that would interfere with their participation in the study or pose an excessive risk to study staff handling venous or capillary blood samples (e.g. HIV/AIDS, Hepatitis B or C);
- Have a MRI scan, CT scan, or diathermy scheduled during the week of the study. If any of these procedures are required urgently during the study, subjects will notify the study staff, end their CGM session, and remove their sensor.
DexCom, Inc.Geen contactgegevens beschikbaar
4 Studielocaties in 1 landen
California
Profil Institute for Clinical Research, Chula Vista, California, 91911, United States
AMCR Institute, Inc., Escondido, California, 92026, United States
Diablo Clinical Research, Walnut Creek, California, 94598, United States
Idaho
Rocky Mountain Diabetes and Osteoporosis Center, Idaho Falls, Idaho, 83404, United States