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

Sponsor
Hoffmann-La Roche (Industry)
Overall Status
Completed
CT.gov ID
NCT00643474
Collaborator
(none)
1,000
Enrollment
43
Locations
2
Arms
39
Duration (Months)
23.3
Patients Per Site
0.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Accu-Chek Aviva Meter
  • Device: Accu-Chek Aviva Meter
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
1000 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
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)
Study Start Date :
Mar 1, 2008
Actual Primary Completion Date :
Jun 1, 2011
Actual Study Completion Date :
Jun 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Experimental: A

Device: Accu-Chek Aviva Meter
4-point daily glucose monitoring profile 3 times per week
Experimental: B

Device: Accu-Chek Aviva Meter
Frequency and timing of SMBG not specified

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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]

Eligibility Criteria

Criteria

Ages Eligible for Study:
35 Years to 75 Years
Sexes Eligible for Study:
All
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Alessandria Italy 15100
2 Ancona Italy 60131
3 Asti Italy 14100
4 Bari Italy 70124
5 Bassano del Grappa Italy 36061
6 Bergamo Italy 24128
7 Cagliari Italy 09042
8 Catania Italy 95122
9 Catanzaro Italy 88100
10 Fermo Italy 60023
11 Foggia Italy 71100
12 Forlì Italy 47034
13 Genova Italy 16149
14 Lanusei Italy 08045
15 Mariano Comense Italy 22066
16 Messina Italy 98126
17 Milano Italy 20121
18 Milano Italy 20132
19 Milano Italy 20150
20 Monfalcone Italy 34074
21 Napoli Italy 80131
22 Olbia Italy 07026
23 Padova Italy 35128
24 Palermo Italy 90047
25 Perugia Italy 06100
26 Pescara Italy 65124
27 Prato Italy 59100
28 Quartu S. Elena - Cagliari Italy 09045
29 Ravenna Italy 48100
30 Roma Italy 00195
31 Rome Italy 00100
32 Rome Italy 00157
33 Rome Italy 0151
34 Rovigo Italy 45100
35 S. Benedetto del Tronto (AP) Italy 63039
36 Salerno Italy 84100
37 Siena Italy 53100
38 Terni Italy 05100
39 Torino Italy 10126
40 Treviso Italy 31100
41 Trieste Italy 34148
42 Udine Italy 33100
43 Vicenza Italy 36100

Sponsors and Collaborators

  • Hoffmann-La Roche

Investigators

  • Study Director: Raffaele Marino, Roche Diagnostics S.p.A.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00643474
Other Study ID Numbers:
  • RD000577
  • RD0107
First Posted:
Mar 26, 2008
Last Update Posted:
Mar 3, 2016
Last Verified:
May 1, 2010
Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Mar 3, 2016