Status:
COMPLETED
Role Of Self-monitoring of Blood Glucose and Intensive Education in Patients With Type 2 Diabetes Not Receiving Insulin
Lead Sponsor:
Consorzio Mario Negri Sud
Collaborating Sponsors:
LifeScan
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
45-75 years
Phase:
PHASE3
Brief Summary
The aim of this pilot study is to evaluate the validity and feasibility of an educational approach involving nurses, combined with SMBG, aimed at lifestyle modification and timely changes in therapy, ...
Eligibility Criteria
Inclusion
- Patients with Type 2 diabetes (known diabetes or new diagnosis) seen for the first time in the diabetes outpatient clinic;
- Patients on treatment with OHA monotherapy (i.e. metformin alone or sulphonylureas alone or 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 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
- Patients incapable to perform SMBG
- Patients needing insulin or multiple OHA association therapy
- Patients needing a regular use of SMBG (e.g. frequent hypoglycemic episodes)
- Diabetes care not exclusively managed by diabetic clinics
- Patients with serious underlying medical or psychiatric condition
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT01176149
Start Date
March 1 2007
End Date
April 1 2010
Last Update
August 6 2010
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Consorzio Mario Negri Sud
Santa Maria Imbaro, Chieti, Italy, 66030