PRISMA Study (Prospective, Randomized Trial on Intensive Self-Monitoring Blood Glucose Management Added Value in Non-Insulin Treated Type 2 Diabetes Mellitus Patients)

Not Applicable

Completed

• Conditions: Diabetes Mellitus Type 2
• Interventions: Device: Accu-Chek Aviva Meter

• Registration Number: NCT00643474
• Lead Sponsor: Hoffmann-La Roche

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 glucose monitoring profile 3 times a week Monnier-based. These patients will also receive specific glycemic targets and suggestions on how to reach them following lifestyle recommendations. At the same time, investigators will use SMBG results, downloaded from glucometers, to improve patients' therapy. The second group (Control Group), will follow the SMBG standard care usually adopted in their centers. To be eligible, patients do not to have performed a previous intensive SMBG management (the execution of SMBG measurements used to modify lifestyle, diet or physical activity, in a systematic/structured manner and/or to manage therapeutic approach). The anticipated duration of the trial is 12 months, and the target sample size is 1000 individuals.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2008-03
• Study First Submitted: 2008-03-20
• Study First Submitted QC: 2008-03-25
• Study First Posted: 2008-03-26
• Status Verified: 2010-05
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Last Update Submitted: 2016-03-01
• Last Update Posted: 2016-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• 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%

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Exclusion Criteria

• 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Accu-Chek Aviva Meter	-
B	Accu-Chek Aviva Meter	-

Primary Outcome Measures

Name	Time	Method
Change from baseline in HbAlc level; percentage of subjects reaching or maintaining the risk target (represented by a combination of LBGI<=2.5 together with HBGI<=5).	Visit 5 (52 weeks after Visit 1 +/- 2 weeks).

Secondary Outcome Measures

Name	Time	Method
Changes in HBGI & LBGI; blood glucose test frequency, blood glucose profile, diabetes therapy, urinary 8-isoPGF2alpha, blood pressure, creatinine clearance, lipid profile & BMI; QoL & Locus of Control analysis; hypoglycemic episodes; study-related SAEs.	Throughout study