The ADHERENCE Index - the Indicator of Effective Coping With the Requirements of the Disease of Children and Adolescents With Type 1 Diabetes
This study is currently recruiting participants.
Verified April 2012 by Institution of Mother and Child, Warsaw, Poland
Sponsor:
Institution of Mother and Child, Warsaw, Poland
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
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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
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 June 17, 2013