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

Primary Purpose

Diabetes Mellitus, Type 2

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cornerstones4Care Powered by Glooko App
Sponsored by
Healthcare Innovation Technology Lab
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Diabetes Mellitus, Type 2 focused on measuring diabetes, type 2 diabetes, type ii diabetes, insulin, mobile applications, Diabetes Mellitus, Diabetes Mellitus, Type 2, smartphone application, health application

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Healthcare Innovation and Technology LabRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group 1

Group 2

Arm Description

N=10 Device intervention 1. Cornerstones4Care Powered by Glooko App Visits Day 1 Day 7 Day 28

N=20 Device intervention 1. Cornerstones4Care Powered by Glooko App Visits Day 1 Day 28

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
July 17, 2017
Last Updated
July 25, 2017
Sponsor
Healthcare Innovation Technology Lab
Collaborators
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT03222284
Brief Title
The Usability, Acceptability, and Perceived Value of the Cornerstones4Care Powered by Glooko App
Official Title
The Usability, Acceptability, and Perceived Value of the Cornerstones4Care Powered by Glooko App
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Unknown status
Study Start Date
July 17, 2017 (Actual)
Primary Completion Date
November 30, 2017 (Anticipated)
Study Completion Date
November 30, 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Healthcare Innovation Technology Lab
Collaborators
Novo Nordisk A/S

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
diabetes, type 2 diabetes, type ii diabetes, insulin, mobile applications, Diabetes Mellitus, Diabetes Mellitus, Type 2, smartphone application, health application

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm Description
N=10 Device intervention 1. Cornerstones4Care Powered by Glooko App Visits Day 1 Day 7 Day 28
Arm Title
Group 2
Arm Type
Experimental
Arm Description
N=20 Device intervention 1. Cornerstones4Care Powered by Glooko App Visits Day 1 Day 28
Intervention Type
Device
Intervention Name(s)
Cornerstones4Care Powered by Glooko App
Intervention Description
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.
Primary Outcome Measure Information:
Title
Usage of the Cornerstones4Care Powered by Glooko App as assessed by self-report
Time Frame
28 days
Title
Device usability as assessed by the System Usability Scale (SUS)
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Be diagnosed with type 2 diabetes Live in the New York Metropolitan area Be at least 18 years of age Able to read, write, and speak in English Have an iPhone or Android phone Use a blood glucose meter Regularly take insulin by injection Be willing to follow study requirements for a 28-day period Exclusion Criteria: Not be diagnosed with type 2 diabetes Not living in the New York Metropolitan area Be less than 18 years of age Be unable to read, write, and speak in English Not have an iPhone or Android phone Not use a blood glucose meter Not regularly take insulin by injection Be unwilling to follow study requirements for a 28-day period
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Claire Gutermuth
Phone
9173492528
Email
C4C@hitlab.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stan Kachnowski, PhD, MPP
Organizational Affiliation
Healthcare Innovation Technology Lab
Official's Role
Principal Investigator
Facility Information:
Facility Name
Healthcare Innovation and Technology Lab
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claire Gutermuth
Phone
917-349-2528
Email
C4C@hitlab.org

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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