Performance of an Investigational Blood Glucose Monitoring System

Ascensia Diabetes Care

Status: Completed

Conditions: Diabetes

Treatments: Device: Ninja 3 PLUS Investigational BG Monitoring System

Study type: Interventional

Funder types: Industry

Identifiers

NCT01824355

CTD-2012-010-01

Details and patient eligibility

About

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.

Enrollment: 113 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

• Inclusion Criteria:

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

• Exclusion Criteria:

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

113 participants in 1 patient group

Intended Users of the Monitoring System

Experimental group

Description:

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.

Treatment:

Device: Ninja 3 PLUS Investigational BG Monitoring System