Modal Day Analysis of Self Monitoring Blood Glucose Versus Continuous Glucose Monitoring
Not Applicable
Completed
- Conditions
- Type 2 Diabetes
- Registration Number
- NCT01072565
- Lead Sponsor
- HealthPartners Institute
- Brief Summary
The purpose of this study is to evaluate the effectiveness of Self Monitoring of Blood Glucose (SMBG) for clinical decisions related to the management of type 2 diabetes and to determine the benefit of using Continuous Glucose Monitoring (CGM) for clinical diabetes management.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 91
Inclusion Criteria
- Male or female subjects ≥18 and ≤75 years of age
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Primary Outcome Measures
Name Time Method Evaluate the efficacy of SMBG for clinical decisions related to the management of type 2 diabetes. Three, six and nine months.
- Secondary Outcome Measures
Name Time Method Determine the incremental benefit of CGM for clinical decision-making. Three, six and nine months.
Trial Locations
- Locations (1)
International Diabetes Center
🇺🇸Minneapolis, Minnesota, United States
International Diabetes Center🇺🇸Minneapolis, Minnesota, United States