Effectiveness of the Self Monitoring of Capillary Blood Glucose at Home

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Diabetes Mellitus

Intervention / Treatment
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* Behavioral: Conversation Maps Diabetes Education
* Behavioral: Usual Care


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Conversation Maps Diabetes Education<br> | Behavioral: Conversation Maps Diabetes Education<br>* 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.<br>|
| Active Comparator: Usual Care<br> | Behavioral: Usual Care<br>* 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.<br>|

What is the study measuring?
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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 |