The Usability, Acceptability, and Perceived Value of the Cornerstones4Care Powered by Glooko App
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable diabetes-mellitus-type-2
Started Jul 2017
Shorter than P25 for not_applicable diabetes-mellitus-type-2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 17, 2017
CompletedStudy Start
First participant enrolled
July 17, 2017
CompletedFirst Posted
Study publicly available on registry
July 19, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2017
CompletedJuly 26, 2017
July 1, 2017
5 months
July 17, 2017
July 25, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Study Arms (2)
Group 1
EXPERIMENTALN=10 Device intervention 1\. Cornerstones4Care Powered by Glooko App Visits Day 1 Day 7 Day 28
Group 2
EXPERIMENTALN=20 Device intervention 1\. Cornerstones4Care Powered by Glooko App Visits Day 1 Day 28
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Healthcare Innovation Technology Lablead
- Novo Nordisk A/Scollaborator
Study Sites (1)
Healthcare Innovation and Technology Lab
New York, New York, 10032, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stan Kachnowski, PhD, MPP
Healthcare Innovation Technology Lab
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DEVICE FEASIBILITY
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 17, 2017
First Posted
July 19, 2017
Study Start
July 17, 2017
Primary Completion
November 30, 2017
Study Completion
November 30, 2017
Last Updated
July 26, 2017
Record last verified: 2017-07
Data Sharing
- IPD Sharing
- Will not share