Effectiveness of the Self Monitoring of Capillary Blood Glucose at Home

Not Applicable

• Conditions: Diabetes Mellitus
• Interventions: Behavioral: Usual Care; Behavioral: Conversation Maps Diabetes Education

• Registration Number: NCT01475422
• Lead Sponsor: University of Sao Paulo

Brief Summary

The self-monitoring of capillary blood glucose is part of the package of interventions in diabetes mellitus and an effective therapeutic strategy for the adequate control of the disease; and the continuing education of people with DM is recognized as one of the goals to delay the complications arising from chronic disease and alleviate the symptoms of hypoglycemia and hyperglycemia.

Detailed Description

This study aims to evaluate the effects of educational intervention on self-monitoring of capillary blood glucose in metabolic control, knowledge and attitude in two groups of patients with diabetes mellitus: a group of diabetic patients who participate in the Self-Monitoring of Capillary Blood Glucose at Home Program and receive educational interventions (Intervention Group - G1) and a group of diabetic patients who participle in the Self-Monitoring of Capillary Blood Glucose at Home Program and receive conventional treatment (Control Group - G2). As an educational tool in diabetes will be used Conversation Maps which is considered an interactive program of diabetes education.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2011-09
• Status Verified: 2011-11
• Study First Submitted: 2011-11-10
• Study First Submitted QC: 2011-11-16
• Last Update Submitted: 2011-11-16
• Study First Posted: 2011-11-21
• Last Update Posted: 2011-11-21
• Primary Completion: 2011-12
• Study Completion: 2012-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 91

Inclusion Criteria

• Ages 18 Years and older;
• Diagnosis of type 1 and 2 diabetes mellitus;
• In follow-up in the Self-Monitoring of Capillary Blood Glucose at Home Program;
• Have cognitive conditions that enable participation (minimum ability of users to understand issues of data collection instruments, observation of the researcher and/or of the caregivers).

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Exclusion Criteria

• Patients with gestational DM;
• Patients with DM who are not located;
• Those who die in the proposed period for the research;
• Those who dropout the Self-Monitoring of Capillary Blood Glucose at Home Program;
• Those who report difficulties to participate of the study due to work and those with amaurosis;
• Used Conversation Maps as an educational tool.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual Care	Usual Care	-
Conversation Maps Diabetes Education	Conversation Maps Diabetes Education	-

Primary Outcome Measures

Name	Time	Method
HbA1c	baseline, 3 and 6 months post intervention	Change from baseline in HbA1c at 6 months to less than 7%

Secondary Outcome Measures

Name	Time	Method
Diabetes Knowledge Questionnaire - DKN-A	baseline, 3 and 6 months post intervention	Change from baseline in DKN-A at six months
Diabetes Attitude Questionnaire - ATT-19	baseline, 3 and 6 months post intervention	Change from baseline in ATT-19 at six months

Trial Locations

Locations (1)

University of São Paulo; 🇧🇷 Ribeirão Preto, São Paulo, Brazil