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

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.

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Key information

Conditions

Diabetes Mellitus Type 2 Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

35 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alessandria, Italy

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Accu-Chek Aviva Meter

Device

4-point daily glucose monitoring profile 3 times per week

Primary outcomes

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).

Time frame: Visit 5 (52 weeks after Visit 1 +/- 2 weeks).

Secondary outcomes

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.

Time frame: Throughout study

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Important dates

Study start: 2008
Primary completion: 2011
Study completion: 2011
First posted: Mar 26, 2008
Registry last updated: Mar 3, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed