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

July 25, 2017 updated by: Healthcare Innovation Technology Lab
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10032
        • Recruiting
        • Healthcare Innovation and Technology Lab
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1

N=10 Device intervention

1. Cornerstones4Care Powered by Glooko App Visits Day 1 Day 7 Day 28
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.
Experimental: Group 2

N=20 Device intervention

1. Cornerstones4Care Powered by Glooko App Visits Day 1 Day 28
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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Healthcare Innovation Technology Lab

Collaborators

Novo Nordisk A/S

Investigators

  • Principal Investigator: Stan Kachnowski, PhD, MPP, Healthcare Innovation Technology Lab

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 17, 2017

Primary Completion (Anticipated)

November 30, 2017

Study Completion (Anticipated)

November 30, 2017

Study Registration Dates

First Submitted

July 17, 2017

First Submitted That Met QC Criteria

July 17, 2017

First Posted (Actual)

July 19, 2017

Study Record Updates

Last Update Posted (Actual)

July 26, 2017

Last Update Submitted That Met QC Criteria

July 25, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00022321

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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