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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Device: Cornerstones4Care Powered by Glooko App


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>N=10 Device intervention 1. Cornerstones4Care Powered by Glooko App Visits Day 1 Day 7 Day 28 | Device: Cornerstones4Care Powered by Glooko App<br>* 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.<br>|
| Experimental: Group 2<br>N=20 Device intervention 1. Cornerstones4Care Powered by Glooko App Visits Day 1 Day 28 | Device: Cornerstones4Care Powered by Glooko App<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetes, type 2 diabetes, type ii diabetes, insulin, mobile applications, Diabetes Mellitus, Diabetes Mellitus, Type 2, smartphone application, health application