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Completed

NCT Number: NCT01176149

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

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.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

45 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Consorzio Mario Negri Sud

Santa Maria Imbaro, Chieti, 66030, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SMBG plus intensive education

Behavioral

Primary outcomes

  1. 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 outcomes

  1. Reduction in prandial Blood Glucose excursions

  2. Percentage of patients needing therapy modifications

  3. Percentage of patients reaching target HbA1c (i.e. <7.0%)

Sponsors and collaborators

Lead sponsor

Consorzio Mario Negri Sud

Other

Collaborators

  • LifeScan

Registry information

Official study title

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

Acronym: ROSES

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Aug 5, 2010
Registry last updated
Aug 6, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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