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

Phase 3

Completed

• Conditions: Type 2 Diabetes

• Registration Number: NCT01176149
• Lead Sponsor: Consorzio Mario Negri Sud

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, when needed.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-03
• Primary Completion: 2010-04
• Study Completion: 2010-04
• Status Verified: 2010-08
• Study First Submitted: 2010-08-04
• Study First Submitted QC: 2010-08-04
• Study First Posted: 2010-08-05
• Last Update Submitted: 2010-08-05
• Last Update Posted: 2010-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
Reduction in prandial Blood Glucose excursions
Percentage of patients needing therapy modifications
Percentage of patients reaching target HbA1c (i.e. <7.0%)

Trial Locations

Locations (1)

Consorzio Mario Negri Sud; 🇮🇹 Santa Maria Imbaro, Chieti, Italy