Modal Day Analysis of Self Monitoring Blood Glucose Versus Continuous Glucose Monitoring
NCT ID: NCT01072565
Last Updated: 2015-11-26
Study Results
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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COMPLETED
NA
91 participants
INTERVENTIONAL
2010-02-28
2012-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
NONE
Study Groups
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SMBG Only
You will measure your blood glucose 4 times daily by finger sticks using a blood glucose meter and you will also wear a CGM device. The CGM measurements will be blinded (neither you nor the study doctor will be able to see the CGM measurements until your final study visit). Only your SMBG measurements will be considered to help manage your diabetes. Your medications will be changed or adjusted based on your HbA1c and/or glucose readings with a goal to achieve an HbA1c level of less than 7%.
SMBG to guide clinical decisions
The investigator will base clinical decisions on A1c and modal day analysis of SMBG.
SMBG and CGM
You will measure your blood glucose 4 times daily by finger sticks using a blood glucose meter and you will also wear a CGM device. The CGM measurements will be downloaded at each study visit and will be considered along with your SMBG measurements to help manage your diabetes. Your medications will be changed or adjusted based on your HbA1c and/or glucose readings with a goal to achieve an HbA1c level of 7%.
SMBG and CGM
The investigator will base clinical decisions on A1c, modal day analysis of SMBG and CGM data.
Interventions
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SMBG to guide clinical decisions
The investigator will base clinical decisions on A1c and modal day analysis of SMBG.
SMBG and CGM
The investigator will base clinical decisions on A1c, modal day analysis of SMBG and CGM data.
Eligibility Criteria
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Inclusion Criteria
* Clinical diagnosis of diabetes
* Diabetes duration ≥ 1 year
* HbA1c ≥7.2%
* Diabetes can be treated with any therapy including medical nutrition therapy alone and any pharmaceutical therapy
Exclusion Criteria
* 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
18 Years
75 Years
ALL
No
Sponsors
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International Diabetes Center at Park Nicollet
OTHER
Abbott Diabetes Care
INDUSTRY
HealthPartners Institute
OTHER
Responsible Party
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Principal Investigators
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Roger S Mazze, PhD
Role: PRINCIPAL_INVESTIGATOR
International Diabetes Center at Park Nicollet
Elinor S Strock, APRN, BC
Role: PRINCIPAL_INVESTIGATOR
International Diabetes Center at Park Nicollet
Locations
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International Diabetes Center
Minneapolis, Minnesota, United States
Countries
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Other Identifiers
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03914-09-C
Identifier Type: -
Identifier Source: org_study_id