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Trial registered on ANZCTR


Registration number
ACTRN12608000389303
Ethics application status
Approved
Date submitted
1/07/2008
Date registered
4/08/2008
Date last updated
4/08/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
Efficacy of blood glucose self-monitoring and intensive education in patients with type 2 diabetes not receiving insulin: a pilot study
Scientific title
Efficacy of blood glucose self-monitoring and intensive education in patients with type 2 diabetes not receiving insulin: a pilot study
Universal Trial Number (UTN)
Trial acronym
ROSES
Linked study record

Health condition
Health condition(s) or problem(s) studied:
non insulin dependent diabetes 3355 0
Condition category
Condition code
Metabolic and Endocrine 3511 3511 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
self monitoring of blood glucose (SMBG) plus intensive education.
SMBG: patients will receive specific educational interventions to teach them how to perform SMBG, how to modify diet and level of physical activity according to blood glucose levels, and the actions to be undertaken in case of abnormal values (hypoglycemia, particularly elevated glucose levels). Patients will be provided a glucometer and all the material necessary for SMBG. There will be 2 SMBG educational sessions, the first one will be at randomization (150 minutes in duration), and the second session after 1 week (20 minutes in duration).
Intensive education: patients will be also instructed to modify their lifestyle habits (diet, physical activity) in order to reach specific goals: weight reduction >=5%, reduction in fat consumption (<30% of daily caloric intake), reduction in saturated fat intake (<10% of daily caloric intake), increase in fiber intake (>=15 gr/1000 Kcal), regular physical activity (>=30 min/daily; >=4 hours/week). The intensive educational sessions will be at the randomization (60 minutes), and after 3 months (60 minutes).
The subjects in the intervention group receive both the SMBG and intensive education and standard care too.

The educational approach will be standardized and provided by specialist nurses after specific training.
Intervention code [1] 3090 0
Other interventions
Comparator / control treatment
standard care: all the patients will receive information about diabetes and its complications, the importance of metabolic control, diabetes self-care, diabetes treatment, and the importance of diet and physical activity. The patients will receive standard care during all the trial (6 months from the randomization)
Control group
Active

Outcomes
Primary outcome [1] 4413 0
improvement of metabolic control expressed as HbA1c
Timepoint [1] 4413 0
at 6 months after randomization
Secondary outcome [1] 7447 0
percentage of patients needing therapy modifications. The protocol describes an algorithm (based on pre prandial glucose levels) that suggests to the investigators when the patient needs therapy modifications.
Timepoint [1] 7447 0
at six months after randomization
Secondary outcome [2] 7448 0
percentage of patients reaching target HbA1c (i.e. <7%)
Timepoint [2] 7448 0
at six months after randomization
Secondary outcome [3] 7449 0
reduction in prandial blood glucose excursion
Timepoint [3] 7449 0
at six months after randomization

Eligibility
Key inclusion criteria
Patients with Type 2 diabetes (known diabetes or new diagnosis) seen for the first time in the diabetes outpatient clinic;
Patients on treatment with oral hypoglycaemic agents (OHA) monotherapy (i.e. metformin alone or sulphonyloureas alone or thiazolidinediones (TZDs) alone);
No need for insulin treatment;
Male and female patients, aged between 45-75 years;
Hba1c values between 7% and 9% included (considering a value of 6.0% as the upper limit of normal value)
No experience of self monitoring of blood glucose (SMBG) in the previous 12 months (SMBG performed with a frequency of < 1 times/week)
Ability and willingness to comply with all study requirements
Signature of consent form
Minimum age
45 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
insulin therapy or more than one oral hypoglycaemic agents (OHA);
need of self monitoring of blood glucose (SMBG);
concomitant serious illnesses causing a reduction of life expectancy;
physical or mental problems preventing the self monitoring of blood glucose (SMBG);
patient management shared with general practitioner (GP).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by phone
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
24/10/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment outside Australia
Country [1] 1010 0
Italy
State/province [1] 1010 0

Funding & Sponsors
Funding source category [1] 3547 0
Commercial sector/Industry
Name [1] 3547 0
LifeScan, Scotland Ltd
Country [1] 3547 0
United Kingdom
Primary sponsor type
Other
Name
Consorzio Mario Negri Sud
Address
Via Nazionale, 8/a
66030 Santa Maria Imbaro (CH)
Country
Italy
Secondary sponsor category [1] 3185 0
None
Name [1] 3185 0
Address [1] 3185 0
Country [1] 3185 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5585 0
Comitato Etico dell'Azienda Ospedaliera Sant'Anna di Como
Ethics committee address [1] 5585 0
Ethics committee country [1] 5585 0
Italy
Date submitted for ethics approval [1] 5585 0
Approval date [1] 5585 0
22/03/2007
Ethics approval number [1] 5585 0
Ethics committee name [2] 5586 0
Comitato Etico Sperimentazione Clinica Medicinali della Ausl 8 di Arezzo
Ethics committee address [2] 5586 0
Ethics committee country [2] 5586 0
Italy
Date submitted for ethics approval [2] 5586 0
Approval date [2] 5586 0
16/03/2007
Ethics approval number [2] 5586 0
Ethics committee name [3] 5587 0
Comitato Etico per la Sperimentazione Clinica della provincia di Padova
Ethics committee address [3] 5587 0
Ethics committee country [3] 5587 0
Italy
Date submitted for ethics approval [3] 5587 0
Approval date [3] 5587 0
15/03/2007
Ethics approval number [3] 5587 0
Ethics committee name [4] 5588 0
Comitato Etico per la Sperimentazione Clinica dei Farmaci della AUSL di Pescara
Ethics committee address [4] 5588 0
Ethics committee country [4] 5588 0
Italy
Date submitted for ethics approval [4] 5588 0
Approval date [4] 5588 0
22/03/2007
Ethics approval number [4] 5588 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28720 0
Address 28720 0
Country 28720 0
Phone 28720 0
Fax 28720 0
Email 28720 0
Contact person for public queries
Name 11877 0
Miriam Valentini
Address 11877 0
Clinical research management and monitoring
Dept. Clinical Pharmacology and Epidemiology
Consorzio Mario Negri Sud
Via Nazionale, 8/a
66030 S. Maria Imbaro (CH)
Country 11877 0
Italy
Phone 11877 0
+39 0872 570311
Fax 11877 0
+39 0872 570316
Email 11877 0
valentini@negrisud.it
Contact person for scientific queries
Name 2805 0
Monica Franciosi
Address 2805 0
Dept. Clinical Pharmacology and Epidemiology
Consorzio Mario Negri Sud
Via Nazionale, 8/a
66030 S. Maria Imbaro (CH)
Country 2805 0
Italy
Phone 2805 0
+39 0872 570264
Fax 2805 0
+39 0872 570263
Email 2805 0
franciosi@negrisud.it

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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