Status:
COMPLETED
PRISMA Study (Prospective, Randomized Trial on Intensive Self-Monitoring Blood Glucose Management Added Value in Non-Insulin Treated Type 2 Diabetes Mellitus Patients)
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Diabetes Mellitus Type 2
Eligibility:
All Genders
35-75 years
Phase:
NA
Brief Summary
This randomized, parallel study compares 2 groups of type 2 non-insulin treated (NIT) diabetes patients using the Accu-Chek Aviva glucometers. One group (Intensive Group) will perform a 4-point daily ...
Eligibility Criteria
Inclusion
- Adult patients, 35-75 years of age
- Non-insulin treated type 2 diabetes for 1-10 years before enrollment
- Treatment with diet and oral hypoglycemic agents, or with diet only
- HbAlc of 7.0-9.0%
Exclusion
- Type 1 diabetes
- Insulin treatment (for \>7 consecutive days)
- Previous intensive SMBG management (the execution of SMBG measurements used to modify lifestyle, diet or physical activity in a systemic/structured manner and/or to manage therapeutic approach)
- impending complications of diabetes;
- serious diseases, including cardiovascular damage or limited life expectancy;
- pregnancy
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT00643474
Start Date
March 1 2008
End Date
June 1 2011
Last Update
March 3 2016
Active Locations (43)
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1
Alessandria, Italy, 15100
2
Ancona, Italy, 60131
3
Asti, Italy, 14100
4
Bari, Italy, 70124