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

Study Overview
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Brief Summary
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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.

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

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Behavioral: SMBG plus intensive education


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SMBG + intensive education<br>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. | Behavioral: SMBG plus intensive education<br> <br> |
| No Intervention: Usual Care<br>Usual Care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in prandial Blood Glucose excursions |  |  | 
| Percentage of patients needing therapy modifications |  |  | 
| Percentage of patients reaching target HbA1c (i.e. <7.0%) |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes, Self monitoring blood glucose