Continuous Glucose Monitoring Self-Monitored Blood Glucose Type 2 Therapy Matrix Definition
REACT4
Observational Evaluation Using Continuous Glucose Monitoring to Determine Timing and Frequency of Self-Monitored Blood Glucose by Therapy Type in Patients With Type 2 Diabetes (REACT-4 Matrix Definition Study)
1 other identifier
observational
27
1 country
1
Brief Summary
The purpose of this study is to use data from the Continuous Glucose Monitoring (CGM) device and your Self-Monitored Blood Glucose (SMBG) levels to determine the best times to test blood glucose levels using SMBG.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jun 2011
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
Study Start
First participant enrolled
June 1, 2011
CompletedFirst Submitted
Initial submission to the registry
June 29, 2011
CompletedFirst Posted
Study publicly available on registry
July 11, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2013
CompletedNovember 26, 2015
April 1, 2013
1.6 years
June 29, 2011
November 25, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Derive optimum Self Monitored Blood Glucose (SMBG) testing patterns from CGM data. CGM data will be graphically and statistically represented by an Ambulatory Glucose Profile (AGP).
2 weeks of CGM data
Eligibility Criteria
Twenty seven persons with type 2 diabetes age 18 and older.
You may qualify if:
- Male or female
- Diagnosed with type 2 diabetes and treated with diabetes medication(s) as required by the protocol (See Section 3.1)
- Age 18 and older
- Willing to give informed consent
- Motivated and capable of following the protocol and instructions provided by the healthcare professional
- Available for the study on the scheduled visit days
- Have not participated in a prior research trial at IDC that utilized CGM
You may not qualify if:
- Under 18 years of age
- Skin abnormalities at the CGM insertion sites that would confound assessment of the effect of the device on the skin
- Allergy to adhesives
- Taken prednisone or cortisone medications in the previous 30 days
- Currently pregnant or planning pregnancy during the study period
- Presence of any severe medical or psychological condition or chronic conditions/infections that in the opinion of the Investigator would compromise the subject's safety or successful participation in the study
- Unable to follow the study protocol
- Unable to speak, read and write in English
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- HealthPartners Institutelead
- Abbott Diabetes Carecollaborator
Study Sites (1)
International Diabetes Center
Minneapolis, Minnesota, 55416, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Roger S Mazze, PhD
International Diabetes Center at Park Nicollet
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 29, 2011
First Posted
July 11, 2011
Study Start
June 1, 2011
Primary Completion
January 1, 2013
Study Completion
January 1, 2013
Last Updated
November 26, 2015
Record last verified: 2013-04