The Usability, Acceptability, and Perceived Value of the Cornerstones4Care Powered by Glooko App

Not Applicable

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Device: Cornerstones4Care Powered by Glooko App

• Registration Number: NCT03222284
• Lead Sponsor: Healthcare Innovation Technology Lab

Brief Summary

This is a two-armed mixed methods study of participants (n=30) diagnosed with type 2 diabetes who use a blood glucose meter as part of their treatment regimen. Participants will have either two or three visits at HITLAB during the 28-day study period.

Detailed Description

The purpose of this study is to evaluate the utility and user experience of a mobile application, called Cornerstones4Care Powered by Glooko App (C4C), for persons diagnosed with diabetes type 2.Subjects will be asked to use the Cornerstones4Care Powered by Glooko App for an approximately 20 minute monitored demonstration session, followed by a 28-day period of daily engagement with the application.The Cornerstones4Care Powered by Glooko App lets users input nutrition, medication, exercise and other daily information to assist in the management of diabetes type 2. It also has the ability to sync with connected devices, such as blood glucose monitors. Additionally, the application offers a library of educational content for users.

Study Timeline

• Status Verified: 2017-07
• Study Start: 2017-07-17
• Study First Submitted: 2017-07-17
• Study First Submitted QC: 2017-07-17
• Study First Posted: 2017-07-19
• Last Update Submitted: 2017-07-25
• Last Update Posted: 2017-07-26
• Primary Completion: 2017-11-30
• Study Completion: 2017-11-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Be diagnosed with type 2 diabetes
2. Live in the New York Metropolitan area
3. Be at least 18 years of age
4. Able to read, write, and speak in English
5. Have an iPhone or Android phone
6. Use a blood glucose meter
7. Regularly take insulin by injection
8. Be willing to follow study requirements for a 28-day period

Exclusion Criteria

1. Not be diagnosed with type 2 diabetes
2. Not living in the New York Metropolitan area
3. Be less than 18 years of age
4. Be unable to read, write, and speak in English
5. Not have an iPhone or Android phone
6. Not use a blood glucose meter
7. Not regularly take insulin by injection
8. Be unwilling to follow study requirements for a 28-day period

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2	Cornerstones4Care Powered by Glooko App	N=20 Device intervention 1. Cornerstones4Care Powered by Glooko App Visits Day 1 Day 28
Group 1	Cornerstones4Care Powered by Glooko App	N=10 Device intervention 1. Cornerstones4Care Powered by Glooko App Visits Day 1 Day 7 Day 28

Primary Outcome Measures

Name	Time	Method
Device usability as assessed by the System Usability Scale (SUS)	28 days
Usage of the Cornerstones4Care Powered by Glooko App as assessed by self-report	28 days

Trial Locations

Locations (1)

Healthcare Innovation and Technology Lab; 🇺🇸 New York, New York, United States