Diabetic Mellitus Patients Glucose Range Awareness After Experiencing a New Blood Glucose Meter Feature

LifeScan

Status: Completed

Conditions: Diabetes Mellitus

Treatments: Behavioral: Education with new meter feature.

Study type: Interventional

Funder types: Industry

Identifiers

NCT02498054

3135718

Details and patient eligibility

About

A single visit & single arm study in 80 subjects with diabetes to determine if a short educational experience with a new blood glucose meter feature improves the ability of each subject to better classify glucose results into acceptable glucose ranges.

Enrollment: 80 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosed with Type 1 diabetes Mellitus (T1DM) or Type 2 diabetes Mellitus (T2DM) for ≥ 3 months
• Currently performing self monitoring of blood glucose (SMBG) at home
• Aged ≥16 years

Exclusion criteria

• Previous use of any blood glucose meter with the colour range indicator feature to be evaluated in this study.

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

80 participants in 1 patient group

Education with new meter feature.

Experimental group

Description:

Subjects experience a computer stimulation of a new meter feature ( colour range indicator) to help subjects interpret whether blood glucose results are low, in-range or high based on accepted guidance.

Treatment:

Behavioral: Education with new meter feature.