Type 2 Diabetes
Conditions
Keywords
Type 2 Diabetes, A1c, Continuous Glucose Monitoring, Blood Glucose
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.
Interventions
OTHERSMBG to guide clinical decisions
The investigator will base clinical decisions on A1c and modal day analysis of SMBG.
OTHERSMBG and CGM
The investigator will base clinical decisions on A1c, modal day analysis of SMBG and CGM data.
Sponsors
International Diabetes Center at Park Nicollet
Abbott Diabetes Care
HealthPartners Institute
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluate the efficacy of SMBG for clinical decisions related to the management of type 2 diabetes. | Three, six and nine months. |
Secondary
| Measure | Time frame |
|---|---|
| Determine the incremental benefit of CGM for clinical decision-making. | Three, six and nine months. |
Countries
United States
Outcome results
None listed