- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02374879
User Performance and System Accuracy Evaluations Using Glucose Adjustment
14. august 2017 opdateret af: LifeScan
This is an open-label, non-randomised pilot study, to evaluate user performance and system accuracy in blood Glucose monitoring system with glucose adjustment.
Twelve male and female volunteers aged 18-45, with a documented diagnosis of Type I diabetes for at least 12 will be enrolled in this study.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
12
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Antrim
-
Belfast, Antrim, Det Forenede Kongerige, BT2 7BA
- BioKinetic Europe Ltd
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 45 år (Voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Summary of inclusion criteria.
- Male and female volunteers aged 18-45, with a documented diagnosis of Type I diabetes for at least 12 months and treated with a basal bolus insulin regime, and deemed otherwise healthy as determined by medical history, physical examination, laboratory test values, vital signs and 12-lead ECGs at screening.
- Non-smokers from at least 12 months before study start and for the duration of the study.
- Body mass index (BMI) ≥ 18 and ≤ 30 kg/m2.
- Able to voluntarily provide written informed consent to participate in the study.
- Must understand the purposes and risks of the study and agree to follow the restrictions and schedule of procedures as defined in the protocol, as confirmed during the informed consent process.
- Must be willing to consent to have data entered into The Over Volunteering Prevention System (TOPS).
- The volunteer's primary care physician has confirmed within the last 12 months that there is nothing in their medical history that would preclude their enrolment into a clinical study.
- User Performance Accuracy Testing Only: Self-Monitoring - Volunteer is currently performing unassisted self-monitoring of blood glucose.
Summary of exclusion criteria.
- A severe hypoglycaemic reaction, defined as causing loss of consciousness and/or requiring outside assistance with oral or intravenous glucose or a glucagon injection, within 7 days of the study start date.
- Female volunteers who are pregnant or lactating.
- Positive for human immunodeficiency virus (HIV), hepatitis B or hepatitis C.
- Current or history of drug or alcohol abuse or a positive drugs of abuse or alcohol test at screening or check-in.
- Participation in a clinical drug study during the 90 days prior to study start.
- Any clinically significant illness within 30 days prior to study start.
- Donation of blood or blood products within 30 days prior to study start, or at any time during the study, except as required by this protocol.
- Weekly alcohol intake exceeding the equivalent of 14 units per week for females or 21 units per week for males.
- Consumption of alcoholic beverages within 48 hours prior to check-in.
- Volunteers with a substantial change in eating habits within 30 days prior to study start or volunteers who cannot comply with the standardised meals proposed for use in the study.
- Prior experience with the BGMSs used for the study.
- Volunteers who are currently working for, have previously worked for, or have an immediate family member working for a company that manufactures or markets blood glucose monitoring products.
- Volunteers who have laboratory training or experience (medical technologist, laboratory technician, laboratory assistant etc).
- Volunteers who, in the opinion of the Investigator, are unsuitable for participation in the study.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Blodsukkerovervågningssystem (BGMS)
Intervention: Blodglukosemonitoreringssystem (BGMS) Resultater opnået fra BGMS for UP og SA sammenlignes med et referenceinstrument (YSI)
|
In vitro diagnostic medical device.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
User Performance (UP) evaluation.
Tidsramme: Up to 6 hours
|
UP evaluation of blood glucose monitoring systems compared to a reference instrument.
Samples collected by subject and HCP
|
Up to 6 hours
|
System Accuracy (SA) evaluation
Tidsramme: Up to 6 hours
|
UP evaluation of blood glucose monitoring systems compared to a reference instrument.
Samples collected by HCP only.
|
Up to 6 hours
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: David J Bell, BioKinetic Europe Ltd
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. februar 2015
Primær færdiggørelse (Faktiske)
1. februar 2015
Studieafslutning (Faktiske)
1. februar 2015
Datoer for studieregistrering
Først indsendt
18. februar 2015
Først indsendt, der opfyldte QC-kriterier
24. februar 2015
Først opslået (Skøn)
2. marts 2015
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
16. august 2017
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
14. august 2017
Sidst verificeret
1. august 2017
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 3128466
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
produkt fremstillet i og eksporteret fra U.S.A.
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Type 1 diabetes mellitus
-
University of Colorado, DenverMassachusetts General Hospital; Beta Bionics, Inc.AfsluttetDiabetes mellitus, type 1 | Type 1 diabetes | Diabetes type 1 | Type 1 diabetes mellitus | Autoimmun diabetes | Diabetes mellitus, insulinafhængig | Juvenil-Debut Diabetes | Diabetes, autoimmun | Insulinafhængig diabetes mellitus 1 | Diabetes mellitus, insulinafhængig, 1 | Diabetes mellitus, skør | Diabetes Mellitus... og andre forholdForenede Stater
-
University of California, San FranciscoJuvenile Diabetes Research FoundationAfsluttetType 1 diabetes mellitus | Diabetes mellitus, type I | Insulinafhængig diabetes mellitus 1 | Diabetes mellitus, insulinafhængig, 1 | IDDMForenede Stater, Australien
-
Capillary Biomedical, Inc.AfsluttetDiabetes mellitus, type 1 | Type 1 diabetes | Type 1 diabetes mellitus | Diabetes mellitus, insulinafhængig, 1Australien
-
Spiden AGDCB Research AGRekrutteringType 1 diabetes mellitus | Type 1 diabetes mellitus med hypoglykæmi | Type 1 diabetes mellitus med hyperglykæmiSchweiz
-
Capillary Biomedical, Inc.AfsluttetType 1 diabetes | Type 1 diabetes mellitus | Diabetes mellitus, type I | Diabetes mellitus, insulinafhængig, 1 | IDDMØstrig
-
Instytut Diabetologii Sp. z o.o.National Center for Research and Development, Poland; Nalecz Institute...UkendtType 1 diabetes mellitus med hyperglykæmi | Type 1 diabetes mellitus med hypoglykæmiPolen
-
National Institute of Allergy and Infectious Diseases...PPD; Rho Federal Systems Division, Inc.; Immune Tolerance Network (ITN)AfsluttetType 1 diabetes mellitus | T1DM | T1D | Nyopstået type 1-diabetes mellitusForenede Stater, Australien
-
Shanghai Changzheng HospitalRekrutteringSkør type 1 diabetes mellitusKina
-
National Institute of Diabetes and Digestive and...AfsluttetDiabetes mellitus type 1Forenede Stater
-
Stem Cells ArabiaAfsluttetGlukosemetabolismeforstyrrelser | Metaboliske sygdomme | Sygdomme i immunsystemet | Autoimmune sygdomme | Sygdomme i det endokrine system | Diabetes mellitus type 1Jordan
Kliniske forsøg med Blood Glucose Monitoring Systems.
-
Ascensia Diabetes CareAfsluttet
-
Ascensia Diabetes CareAfsluttetDiabetesForenede Stater
-
Ascensia Diabetes CareAfsluttetDiabetesForenede Stater
-
Ascensia Diabetes CareAfsluttetDiabetesForenede Stater
-
Ascensia Diabetes CareAfsluttetDiabetesForenede Stater
-
Biotronik Japan, Inc.Afsluttet
-
Celero Systems, Inc.Rekruttering
-
National Institute on Aging (NIA)Afsluttet
-
Abbott Diabetes CareAfsluttetDiabetes mellitusForenede Stater