Role Of Self-monitoring of Blood Glucose and Intensive Education in Patients With Type 2 Diabetes Not Receiving Insulin

Type 2 Diabetes Clinical Trial

— ROSES  

Official title:

Role Of Self-monitoring of Blood Glucose and Intensive Education in Patients With Type 2 Diabetes Not Receiving Insulin: a Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01176149
• Other study ID #: ROSES-01
• Status: Completed
• Phase: Phase 3
• First received: August 4, 2010
• Last updated: August 5, 2010
• Start date: March 2007
• Est. completion date: April 2010

Study information

• Verified date: August 2010
• Source: Consorzio Mario Negri Sud
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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, when needed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years to 75 Years

Eligibility

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 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 Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Behavioral:
• SMBG plus intensive education

Locations

Country	Name	City	State
Italy	Consorzio Mario Negri Sud	Santa Maria Imbaro	Chieti

Sponsors (2)

Lead Sponsor	Collaborator
Consorzio Mario Negri Sud	LifeScan

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement of metabolic control	Aim of this study is to evaluate the efficacy of Self Monitoring Blood Glucose and Intensive Education in terms of improvement of metabolic control expressed as HbA1c levels after 6 months.		No
Secondary	Reduction in prandial Blood Glucose excursions			No
Secondary	Percentage of patients needing therapy modifications			No
Secondary	Percentage of patients reaching target HbA1c (i.e. <7.0%)			No