ACTRN12608000389303
Recruiting
Phase 3
Efficacy of blood glucose self-monitoring and intensive education in patients with type 2 diabetes not receiving insulin: a pilot study
Consorzio Mario Negri Sud0 sites80 target enrollmentAugust 4, 2008
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- non insulin dependent diabetes
- Sponsor
- Consorzio Mario Negri Sud
- Enrollment
- 80
- Status
- Recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
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).
Outcomes
Primary Outcomes
Not specified
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