The ADHERENCE Index - the Indicator of Effective Coping With the Requirements of the Disease of Children and Adolescents With Type 1 Diabetes

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by Institution of Mother and Child, Warsaw, Poland.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Institution of Mother and Child, Warsaw, Poland
ClinicalTrials.gov Identifier:
NCT01580462
First received: April 18, 2012
Last updated: NA
Last verified: April 2012
History: No changes posted
  Purpose

The aim of the research is to develop a mathematical model called ADHERENCE index, and to evaluate its effectiveness.


Condition Intervention
Type 1 Diabetes
Other: Observational study

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: The ADHERENCE Index - the Indicator of Effective Coping With the Requirements of the Disease of Children and Adolescents With Type 1 Diabetes. Prospective Study

Resource links provided by NLM:


Further study details as provided by Institution of Mother and Child, Warsaw, Poland:

Estimated Enrollment: 200
Study Start Date: April 2012
Estimated Study Completion Date: October 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Children and Adolescent with type 1 diabetes on CSII Other: Observational study

Study plan - data collecting:

Patients will attend diabetes clinic as usual, with one additional visit in the middle of the 3-months period. During those visits - V0, V1 and V2, data from glucometers and insulin pumps will be downloaded.


  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Participants will be recruited from the Outpatient Diabetes Clinic in the Institute of Mother and Child. Patient should be treated by intensive insulinotherapy using Continous Subcutaneus Infusion Set (CSII). Number of participants: 200.

Criteria

Inclusion Criteria:

  • type 1 diabetes for min. 1 year
  • CSII
  • ability to come for one additional visit in outpatient diabetes clinic
  • using glucometers

Exclusion Criteria:

  • no possibility to download data from patient's glucometer and insulin pump
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01580462

Contacts
Contact: Katarzyna A Gajewska, MSc 48223277105 katarzyna.gajewska@imid.med.pl

Locations
Poland
Outpatient Diabetes Clinic of the Institute of Mother and Child Recruiting
Warsaw, Mazowieckie, Poland, 01-211
Principal Investigator: Katarzyna A Gajewska, MSc         
Sponsors and Collaborators
Institution of Mother and Child, Warsaw, Poland
  More Information

No publications provided

Responsible Party: Institution of Mother and Child, Warsaw, Poland
ClinicalTrials.gov Identifier: NCT01580462     History of Changes
Other Study ID Numbers: OPK 510-13-55
Study First Received: April 18, 2012
Last Updated: April 18, 2012
Health Authority: Poland: Ministry of Science and Higher Education

Keywords provided by Institution of Mother and Child, Warsaw, Poland:
continuous subcutaneous insulin infusion (CSII)
children
adolescent

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on July 24, 2014