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

Consorzio Mario Negri Sud

Status and phase: Completed; Phase 3

Conditions: Type 2 Diabetes

Treatments: Behavioral: SMBG plus intensive education

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01176149

ROSES-01

Details and patient eligibility

About

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.

Enrollment: 62 patients

Sex: All

Ages: 45 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

62 participants in 2 patient groups

SMBG + intensive education

Experimental group

Description:

Patients will receive specific educational interventions to teach them how to perform Self monitoring Blood Glucose (SMBG), how to modify diet and level of physical activity according to blood glucose levels, and the actions to be undertaken in case of abnormal values (hypoglycemia, particularly elevated glucose levels). Patients will be instructed to modify their lifestyle habits (diet, physical activity) in order to reach specific goals (weight reduction, reduction in fat consumption intake, reduction in saturated fat intake, increase in fiber intake, regular physical activity.

Treatment:

Behavioral: SMBG plus intensive education

Usual Care

No Intervention group

Description:

Usual Care