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

NCT ID: NCT03222284

Last Updated: 2017-07-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-17

Study Completion Date

2017-11-30

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.

Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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Group 1

N=10 Device intervention

1\. Cornerstones4Care Powered by Glooko App Visits Day 1 Day 7 Day 28

Group Type EXPERIMENTAL

Cornerstones4Care Powered by Glooko App

Intervention Type DEVICE

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.

Group 2

N=20 Device intervention

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

Group Type EXPERIMENTAL

Cornerstones4Care Powered by Glooko App

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role collaborator

Healthcare Innovation Technology Lab

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stan Kachnowski, PhD, MPP

Role: PRINCIPAL_INVESTIGATOR

Healthcare Innovation Technology Lab

Locations

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Healthcare Innovation and Technology Lab

New York, New York, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Claire Gutermuth

Role: CONTACT

9173492528

Facility Contacts

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Claire Gutermuth

Role: primary

917-349-2528

Other Identifiers

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Pro00022321

Identifier Type: -

Identifier Source: org_study_id

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