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

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: April 2010

Interventions

  • Behavioral: SMBG plus intensive education

Arms, Groups and Cohorts

  • Experimental: SMBG + intensive education
    • 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.
  • No Intervention: Usual Care
    • Usual Care

Clinical Trial Outcome Measures

Primary Measures

  • Improvement of metabolic control

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 45 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Consorzio Mario Negri Sud
  • Collaborator
    • LifeScan
  • Provider of Information About this Clinical Study
    • Antonio Nicolucci / Scientific responsible, Consorzio Mario Negri Sud
  • Overall Official(s)
    • Antonio Nicolucci, MD, Study Director, Consorzio Mario Negri Sud

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