PRISMA Study (Prospective, Randomized Trial on Intensive Self-Monitoring Blood Glucose Management Added Value in Non-Insulin Treated Type 2 Diabetes Mellitus Patients)
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Treatments
Details and patient eligibility
About
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.
Enrollment
Sex
Ages
Volunteers
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%
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
1,000 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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