CClinicalTrials.gg
Status unknownNCT01475422Updated Nov 21, 2011

Effectiveness of the Self Monitoring of Capillary Blood Glucose at Home

An interventional study of Conversation Maps Diabetes Education and Usual Care in Diabetes Mellitus, sponsored by University of Sao Paulo. Status unknown at 1 site in Brazil. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2011-11-21.

Sponsored by University of Sao Paulo · Not applicable, Interventional, and Supportive care

The sponsor has not verified this record recently (last verified Nov 2011), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
91
Allocation
Randomized
Ages
18 Years to 90 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Diabetes Mellitus

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03

In context

Diabetes Mellitus

10,923 studies on the registry are indexed under Diabetes Mellitus; 1,318 are open to participants now.

This study's planned enrollment of 91 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

University of Sao Paulo is the lead sponsor of 1,005 studies on the registry; 90 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
91 participants (estimated)

Study arms

  • Experimental
    Conversation Maps Diabetes Education

    Behavioral: Conversation Maps Diabetes Education

  • Active comparator
    Usual Care

    Behavioral: Usual Care

Interventions

  • BehavioralConversation 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.

  • BehavioralUsual 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.

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What researchers measure

Primary outcomes

  1. HbA1c

    Change from baseline in HbA1c at 6 months to less than 7%

    Time frame: baseline, 3 and 6 months post intervention

Secondary outcomes

  1. Diabetes Knowledge Questionnaire - DKN-A

    Change from baseline in DKN-A at six months

    Time frame: baseline, 3 and 6 months post intervention

  2. Diabetes Attitude Questionnaire - ATT-19

    Change from baseline in ATT-19 at six months

    Time frame: baseline, 3 and 6 months post intervention

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Study locations

1 of 1 sites recruiting
  • University of São Paulo
    Ribeirão Preto, São Paulo, Brazil
    • Vívian Saraiva Veras, Principal Investigator · Contact · vivianveras@hotmail.com · 55 16 88074113
    • Vívian Saraiva Veras · Principal investigator
    • Maria Lúcia Zanetti, Study Chair · Sub investigator
    Recruiting
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 21, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01475422
Lead sponsor
University of Sao Paulo
Responsible party
Vívian Saraiva Veras (PhD Student, University of Sao Paulo) — Principal investigator
First posted
Nov 21, 2011
Start date
Sep 2011
Primary completion
Dec 2011 (estimated)
Completion
Mar 2012 (estimated)
Last update
Nov 21, 2011

Study contacts

Vívian Saraiva Veras, Principal Investigator
Contact
vivianveras@hotmail.com
55 16 88074113

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2011. You cannot join it, but the record below documents what was studied.

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