User Performance and System Accuracy Evaluations Using Glucose Adjustment

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.

Study Overview

• Status: Completed
• Conditions: Type 1 Diabetes Mellitus
• Intervention / Treatment: Device: Blood Glucose Monitoring Systems.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Antrim
    • Belfast, Antrim, United Kingdom, BT2 7BA
      • BioKinetic Europe Ltd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
User Performance (UP) evaluation.	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	UP evaluation of blood glucose monitoring systems compared to a reference instrument. Samples collected by HCP only.	Up to 6 hours

Collaborators and Investigators

• Sponsor: LifeScan
• Investigators: Principal Investigator: David J Bell, BioKinetic Europe Ltd

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2015
• Primary Completion (Actual): February 1, 2015
• Study Completion (Actual): February 1, 2015

Study Registration Dates

• First Submitted: February 18, 2015
• First Submitted That Met QC Criteria: February 24, 2015
• First Posted (Estimate): March 2, 2015

Study Record Updates

• Last Update Posted (Actual): August 16, 2017
• Last Update Submitted That Met QC Criteria: August 14, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: 3128466

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No