Sidekick® Convenient, All-in-One Blood Glucose Testing System

Clinical Evaluation of the Sidekick® Blood Glucose Monitoring System

Summary

• Study was conducted to evaluate the accuracy of the Sidekick® Blood Glucose Testing System
   
• Independent clinical evaluations were performed at four clinical sites across the United States
   
• 229 people with diabetes were recruited by healthcare professionals to participate in the study
   
• While all participants were experienced in self monitoring of blood glucose, participants read the Sidekick® System instructions for use, including the owner's manual and quick reference guide
   
• Each participant performed a fingerstick blood glucose test using the Sidekick® System; at the same time, trained healthcare professionals obtained fingerstick samples from each participant for analysis using the Yellow Springs Instrument (YSI) 2300 STAT blood glucose analyzer
   
• Accuracy was determined by comparing the test results obtained by participants using the Sidekick® System to the test results obtained by professionals using the YSI blood glucose analyzer

Results

Patient results using the Sidekick® System showed excellent correlation with the results taken by healthcare professionals and analyzed using the YSI laboratory standard over a wide range of blood glucose values (52-473 mg/dL). More importantly, the study concludes that participants successfully used the Sidekick® System to obtain accurate blood glucose results.

In a similar study performed at diabetes clinics of a large urban area hospital and diabetes care centers, results were obtained from 212 patients using the Sidekick® System and were compared to parallel results obtained on a Yellow Springs Model 2300 STAT. This study once again proved that patients, when self testing, were able to obtain accurate results when compared to results obtained from a laboratory system.

Comparing Forearm and Fingerstick Results Using the Sidekick® System

A clinical study was performed to compare forearm and fingerstick blood glucose results using the Sidekick® System. 100 patients performed blood glucose self testing on the forearm and fingertip, while healthcare professionals performed both forearm and fingertip blood glucose testing using the blood of 108 patients.

During a steady glucose state, this study demonstrates substantial equivalence between the forearm and finger blood glucose values obtained by patients and healthcare professionals using the Sidekick® System.

See complete clinical evaluation study results.

Patient Evaluation of Satisfaction and Ease of Use of the Sidekick® Blood Glucose Monitoring System

Summary

• The study was conducted to determine patient satisfaction with design features and ease of use of the Sidekick® System
   
• 116 patients with diabetes participated in the study; 36% were Type 1 and 64% Type 2; median age of study participants was 49 years; the average length of time the participants had been self monitoring was seven to eight years
   
• Study participants were given a demonstration on the use of the Sidekick® System; then they were asked to use the Sidekick® System to perform a blood glucose test
   
• Study participants utilized a total of 22 different brands of blood glucose meters; the most common were:
  – OneTouch® Ultra® (37%)
  – Accu-Chek® Advantage (22%)
  – Freestyle® (19%)
   
• After using the Sidekick® System, participants were asked to complete a questionnaire about their experiences with the Sidekick® System

Results

Evaluation of the Overall Experience With the Sidekick® System

• 77% agreed that the Sidekick® System was easier to use than their current systems
• 85% said the said that the Sidekick® System is more convenient to use than their current systems
• 59% responded that they would test more frequently
• 51% indicated that they would use the Sidekick® System as their primary system

Satisfaction With Sidekick® System Design Features

• 93% were satisfied or very satisfied with the size of the system
• 98% were satisfied or very satisfied with the all-in-one design
• 91% were satisfied or very satisfied with the size of the display
• 93% were satisfied or very satisfied that no coding was required
• 92% were satisfied or very satisfied with the test time
• 95% were satisfied or very satisfied with the sample size

Satisfaction With Using the Sidekick® System

• 97% rated opening the vial as easy or very easy
• 94% rated accessing the test strips as easy or very easy
• 95% rated applying a sample to the test strip as easy or very easy
• 96% rated performing glucose testing as easy or very easy

See complete patient satisfaction evaluation study results.

Healthcare Professionals' Evaluation on the Design and Ease of Use of the Sidekick® Blood Glucose Monitoring System

Summary

• The study was conducted to gauge healthcare professional satisfaction with the design and ease of use of the Sidekick® System
   
• 197 healthcare professionals participated in the evaluation; 70% were Certified Diabetes Educators; 30% of participants saw greater than 75 diabetes patients per month
   
• Participants observed a product demonstration and were then given a Sidekick® System to try for themselves
   
• Participants were asked to complete an evaluation on the design features and ease of use of the Sidekick® System

Results

The Sidekick® System received very high ratings in terms of satisfaction with the overall design and features that the system offered.

Healthcare professionals were very satisfied with the Sidekick® System features: all-in-one design, no coding, test time, size of the meter and strips, alternate site testing capabilities, and display size.

In terms of ease of use:

• 96% strongly agree or agree that the system would be good for their patients
   
• 87% agree that the all-in-one design of the system is more convenient for their patients
   
• 64% strongly agree or agree that their patients would test more frequently using the Sidekick® System

See complete healthcare professional evaluation study results.

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