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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03222284
• Other study ID #: Pro00022321
• Status: Recruiting
• Phase: N/A
• First received: July 17, 2017
• Last updated: July 25, 2017
• Start date: July 17, 2017
• Est. completion date: November 30, 2017

Study information

• Verified date: July 2017
• Source: Healthcare Innovation Technology Lab
• Contact: Claire Gutermuth
• Phone: 9173492528
• Email: C4C[@]hitlab.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: November 30, 2017
• Est. primary completion date: November 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Device:
• Cornerstones4Care Powered by Glooko App
Cornerstones4Care Powered by Glooko App is an iOS or Android smartphone application designed to support diabetes management by offering people with diabetes easily accessible, personalized tools for self-monitoring and education. C4C allows people with diabetes to monitor personal health metrics and blood glucose levels, with the aim to achieve participant behavior changes that may contribute to lower hospitalizations, diabetes-related complications and overall healthcare costs.

Locations

Country	Name	City	State
United States	Healthcare Innovation and Technology Lab	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Healthcare Innovation Technology Lab	Novo Nordisk A/S

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Usage of the Cornerstones4Care Powered by Glooko App as assessed by self-report		28 days
Primary	Device usability as assessed by the System Usability Scale (SUS)		28 days