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Trial record 59 of 126 for:    diabetes type 1 AND (woman OR women OR female) AND Metabolism

User Performance and System Accuracy Evaluations Using Glucose Adjustment

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ClinicalTrials.gov Identifier: NCT02374879
Recruitment Status : Completed
First Posted : March 2, 2015
Last Update Posted : August 16, 2017
Sponsor:
Information provided by (Responsible Party):
LifeScan

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Mellitus Device: Blood Glucose Monitoring Systems. Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: User Performance and System Accuracy Evaluations Using Glucose Adjustment
Actual Study Start Date : February 1, 2015
Actual Primary Completion Date : February 1, 2015
Actual Study Completion Date : February 1, 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Sugar
Drug Information available for: Dextrose

Arm Intervention/treatment
Experimental: Blood Glucose monitoring System (BGMS)
Intervention: Blood Glucose monitoring System (BGMS) Results obtained from the BGMS for UP and SA are compared to a reference instrument (YSI)
Device: Blood Glucose Monitoring Systems.
In vitro diagnostic medical device.




Primary Outcome Measures :
  1. User Performance (UP) evaluation. [ Time Frame: Up to 6 hours ]
    UP evaluation of blood glucose monitoring systems compared to a reference instrument. Samples collected by subject and HCP

  2. System Accuracy (SA) evaluation [ Time Frame: Up to 6 hours ]
    UP evaluation of blood glucose monitoring systems compared to a reference instrument. Samples collected by HCP only.



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02374879


Locations
United Kingdom
BioKinetic Europe Ltd
Belfast, Antrim, United Kingdom, BT2 7BA
Sponsors and Collaborators
LifeScan
Investigators
Principal Investigator: David J Bell BioKinetic Europe Ltd

Responsible Party: LifeScan
ClinicalTrials.gov Identifier: NCT02374879     History of Changes
Other Study ID Numbers: 3128466
First Posted: March 2, 2015    Key Record Dates
Last Update Posted: August 16, 2017
Last Verified: August 2017

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases