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

Diabetes Mellitus Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00643474
• Other study ID #: RD000577
• Secondary ID: RD0107
• Status: Completed
• Phase: N/A
• First received: March 20, 2008
• Last updated: March 1, 2016
• Start date: March 2008
• Est. completion date: June 2011

Study information

• Verified date: May 2010
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Osservatorio Nazionale sulla Sperimentazione Clinica
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Gender: Both
• Age group: 35 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus Type 2
• Diabetes Mellitus, Type 2

Intervention

Device:
• Accu-Chek Aviva Meter
4-point daily glucose monitoring profile 3 times per week
• Accu-Chek Aviva Meter
Frequency and timing of SMBG not specified

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	No
Secondary	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	No