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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01176149

Acronym

ROSES

Enrollment

Registered

2010-08-05

Start date

2007-03-31

Completion date

2010-04-30

Last updated

2010-08-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes

Keywords

Diabetes, Self monitoring blood glucose

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.

Interventions

BEHAVIORALSMBG plus intensive education

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

45 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026