## Protocol Section
### Identification Module
**NCT ID:** NCT02374879

**Brief Title:** User Performance and System Accuracy Evaluations Using Glucose Adjustment

**Official Title:** User Performance and System Accuracy Evaluations Using Glucose Adjustment

#### Organization Study ID Info
**ID:** 3128466
#### Organization
**Class:** INDUSTRY
**Full Name:** LifeScan
### Status Module
#### Completion Date
**Date:** 2015-02-01

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2017-08-16

**Type:** ACTUAL

**Last Update Submit Date:** 2017-08-14

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2015-02-01

**Type:** ACTUAL

#### Start Date
**Date:** 2015-02-01

**Type:** ACTUAL

**Status Verified Date:** 2017-08

#### Study First Post Date
**Date:** 2015-03-02
**Type:** ESTIMATED
**Study First Submit Date:** 2015-02-18
**Study First Submit QC Date:** 2015-02-24
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** LifeScan

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Type 1 Diabetes Mellitus

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** OTHER

#### Enrollment Info

**Count:** 12

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Intervention: Blood Glucose monitoring System (BGMS) Results obtained from the BGMS for UP and SA are compared to a reference instrument (YSI)

**Intervention Names:**

- Device: Blood Glucose Monitoring Systems.

**Label:** Blood Glucose monitoring System (BGMS)

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Blood Glucose monitoring System (BGMS)

**Description:** In vitro diagnostic medical device.

**Name:** Blood Glucose Monitoring Systems.

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** UP evaluation of blood glucose monitoring systems compared to a reference instrument. Samples collected by subject and HCP

**Measure:** User Performance (UP) evaluation.

**Time Frame:** Up to 6 hours

**Description:** UP evaluation of blood glucose monitoring systems compared to a reference instrument. Samples collected by HCP only.

**Measure:** System Accuracy (SA) evaluation

**Time Frame:** Up to 6 hours

### Eligibility Module

**Eligibility 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.

**Maximum Age:** 45 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Belfast

**Country:** United Kingdom

**Facility:** BioKinetic Europe Ltd

**State:** Antrim

**Zip:** BT2 7BA

#### Overall Officials

**Official 1:**

**Affiliation:** BioKinetic Europe Ltd

**Name:** David J Bell

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000003920

- Term: Diabetes Mellitus

- ID: D000044882

- Term: Glucose Metabolism Disorders

- ID: D000008659

- Term: Metabolic Diseases

- ID: D000004700

- Term: Endocrine System Diseases

- ID: D000001327

- Term: Autoimmune Diseases

- ID: D000007154

- Term: Immune System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: BC19

- Name: Gland and Hormone Related Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC20

- Name: Immune System Diseases

### Condition Browse Module - Browse Leaves

- ID: M7115

- Name: Diabetes Mellitus

- Relevance: LOW

- As Found: Unknown

- ID: M7117

- Name: Diabetes Mellitus, Type 1

- Relevance: HIGH

- As Found: Type 1 Diabetes Mellitus

- ID: M11639

- Name: Metabolic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M25403

- Name: Glucose Metabolism Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M7862

- Name: Endocrine System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M4629

- Name: Autoimmune Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10200

- Name: Immune System Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000003922

- Term: Diabetes Mellitus, Type 1

### Misc Info Module

- Version Holder: 2024-05-24
