Effectiveness of the Self Monitoring of Capillary Blood Glucose at Home

Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01475422
• Other study ID #: 6266936
• Status: Recruiting
• Phase: N/A
• First received: November 10, 2011
• Last updated: November 16, 2011
• Start date: September 2011
• Est. completion date: March 2012

Study information

• Verified date: November 2011
• Source: University of Sao Paulo
• Contact: Vívian Saraiva Veras, Principal Investigator
• Phone: 55 16 88074113
• Email: vivianveras[@]hotmail.com
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 91
• Est. completion date: March 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

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.
• 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.

Locations

Country	Name	City	State
Brazil	University of São Paulo	Ribeirão Preto	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c	Change from baseline in HbA1c at 6 months to less than 7%	baseline, 3 and 6 months post intervention	Yes
Secondary	Diabetes Knowledge Questionnaire - DKN-A	Change from baseline in DKN-A at six months	baseline, 3 and 6 months post intervention	Yes
Secondary	Diabetes Attitude Questionnaire - ATT-19	Change from baseline in ATT-19 at six months	baseline, 3 and 6 months post intervention	Yes