Effectiveness of the Self Monitoring of Capillary Blood Glucose at Home

Effectiveness of the Self Monitoring of Capillary Blood Glucose at Home in Metabolic Control of People With Diabetes Mellitus

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.

Study Overview

• Status: Unknown
• Conditions: Diabetes Mellitus
• Intervention / Treatment: Behavioral: Conversation Maps Diabetes Education; Behavioral: Usual Care

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.

• Study Type: Interventional
• Enrollment (Anticipated): 91
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • São Paulo
    • Ribeirão Preto, São Paulo, Brazil
      • Recruiting
      • University of Sao Paulo
      • Contact: Vívian Saraiva Veras, Principal Investigator; Phone Number: 55 16 88074113; Email: vivianveras@hotmail.com
      • Principal Investigator: Vívian Saraiva Veras
      • Sub-Investigator: Maria Lúcia Zanetti, Study Chair

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Usual Care	Behavioral: Usual Care; Patients are followed in the medical appointments for evaluation and treatment of diabetes mellitus, according to service routine. Participants will be followed for an expected average of 12 weeks.
Experimental: Conversation Maps Diabetes Education	Behavioral: Conversation Maps Diabetes Education; The Conversation Maps program is a set of innovative, interactive diabetes education tools developed by the Healthy Interactions, and endorsed by the American Diabetes Association. It consists of four conversation maps covering: 1) how the body and diabetes works, 2) healthy eating and physical activity, 3) treatment with medication and monitoring blood glucose, and 4) reaching the targets with insulin (a fifth map covering gestational diabetes will not be used in this study), and a program manual to help educators successfully implement the program. Participants will be followed for an expected average of 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HbA1c	Change from baseline in HbA1c at 6 months to less than 7%	baseline, 3 and 6 months post intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diabetes Knowledge Questionnaire - DKN-A	Change from baseline in DKN-A at six months	baseline, 3 and 6 months post intervention
Diabetes Attitude Questionnaire - ATT-19	Change from baseline in ATT-19 at six months	baseline, 3 and 6 months post intervention

Collaborators and Investigators

• Sponsor: University of Sao Paulo

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Anticipated): December 1, 2011
• Study Completion (Anticipated): March 1, 2012

Study Registration Dates

• First Submitted: November 10, 2011
• First Submitted That Met QC Criteria: November 16, 2011
• First Posted (Estimate): November 21, 2011

Study Record Updates

• Last Update Posted (Estimate): November 21, 2011
• Last Update Submitted That Met QC Criteria: November 16, 2011
• Last Verified: November 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus
• Other Study ID Numbers: 6266936