Performance of an Investigational Blood Glucose Monitoring System

NCT01824355 | Completed Results

• 1 other identifier: CTD-2012-010-01
• Study Type: interventional
• Target: 113
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study was to demonstrate that untrained subjects who have diabetes can operate the Investigational Blood Glucose Monitoring System (BGMS) and obtain valid glucose results.

Conditions

Diabetes

Outcome Measures

Primary Outcomes (1)

• Percent of Self Test Fingerstick Blood Glucose Results Within ±15 mg/dL (< 75 mg/dL) and Within ±20% (≥ 75 mg/dL) of the Laboratory Glucose Method

  Untrained subjects with diabetes who self-tested fingerstick blood used the Ninja 3 PLUS investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with capillary plasma BG results obtained with a reference laboratory glucose method - YSI Life Sciences (YSI) Analyzer. BG meter results were used to calculate the number of BGMS results within +/- 15mg/dL (for reference BG results \<75mg/dL) and within +/- 20% (for reference BG results \>=75mg/dL) of the YSI reference method results.

  1 hour

Secondary Outcomes (5)

• Percent of Self Test Fingerstick Blood Glucose Results Within ±15 mg/dL (< 100 mg/dL) and Within ±15% (≥ 100 mg/dL) of the Laboratory Glucose Method

  1 hour

• Percent of Self Test Fingerstick Blood Glucose Results Within ±12.5 mg/dL (< 100 mg/dL) and Within ±12.5% (≥ 100 mg/dL) of the Laboratory Glucose Method

  1 hour

• Percent of Blood Glucose Results From Alternative Site Testing (AST) of the Palm Within ±15 mg/dL (< 75 mg/dL) and Within ±20% (≥ 75 mg/dL) of the Laboratory Method.

  1 hour

• Percent of Fingerstick Blood Glucose Results Within ±15 mg/dL (< 75 mg/dL) and Within ±20% (≥ 75 mg/dL) of the Laboratory Glucose Method When Tested by Study Staff

  one hour

• Number of Subject Responses That 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements

  1 hour

Study Arms (1)

Intended Users of the Monitoring System

EXPERIMENTAL

Untrained subjects with diabetes used the Ninja 3 PLUS Investigational BG Monitoring System. General enrollment criteria for the 'Intended Users' population: 1. At least 60% of subjects were younger than 65 years of age. 2. At least 20% had type 1 diabetes. 3. At least 50% with type 2 diabetes were insulin users.

Device: Ninja 3 PLUS Investigational BG Monitoring System

Interventions

Ninja 3 PLUS Investigational BG Monitoring System DEVICE

Untrained subjects with diabetes performed self Blood Glucose (BG) tests with capillary fingerstick and palm blood using the Ninja 3 PLUS Investigational BG Monitoring System. Study staff tested subject fingerstick blood. All BG results were compared to a reference laboratory glucose method.

Intended Users of the Monitoring System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females, 18 years of age or older.
• People with type 1 or type 2 diabetes.
• Able to speak, read and understand English.
• Willing to complete all study procedures.

You may not qualify if:

• Hemophilia or any other bleeding disorder.
• Pregnancy.
• Physical, visual or neurological impairments that would make the person unable to perform testing with the BGM.
• Previously participated in a blood glucose monitoring study using the Ninja 3 Plus BGMS.
• Working for a medical laboratory, hospital or other clinical setting that involves training on or clinical use of blood glucose meters.
• Working for a competitive medical device company, or having an immediate family member who works for such a company.
• A condition, which in the opinion of the investigator or designee, would put the person or study conduct at risk.

Sponsors & Collaborators

• Ascensia Diabetes Care: lead

Study Sites (1)

Consumer Product Testing Co.

Fairfield, New Jersey, 07004, United States

Location

Related Publications (1)

• Caswell M, Brown D, Frank J, Wallace JF, Pardo S. Accuracy and user performance evaluation of a blood glucose monitoring system which wirelessly transmits results to compatible insulin pumps. Curr Med Res Opin. 2020 May;36(5):757-764. doi: 10.1080/03007995.2020.1734919. Epub 2020 Mar 17.

  PMID: 32096654 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Jane Wallace
• Organization: Ascensia Healthcare

jane.wallace@ascensia.com

574-257-3063

Study Officials

• Michael Caswell, PhD

  Consumer Product Testing Co.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2013
• First Posted: April 4, 2013
• Study Start: March 1, 2013
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: February 29, 2016
• Results First Posted: January 6, 2015

Record last verified: 2016-01

Locations

US (1)