NCT01580462

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2012

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

April 18, 2012

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 19, 2012

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

April 19, 2012

Status Verified

April 1, 2012

Enrollment Period

2 months

First QC Date

April 18, 2012

Last Update Submit

April 18, 2012

Conditions

Keywords

continuous subcutaneous insulin infusion (CSII)childrenadolescent

Study Arms (1)

Children and Adolescent with type 1 diabetes on CSII

Other: Observational study

Interventions

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.

Children and Adolescent with type 1 diabetes on CSII

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

  • no possibility to download data from patient's glucometer and insulin pump

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Outpatient Diabetes Clinic of the Institute of Mother and Child

Warsaw, Masovian Voivodeship, 01-211, Poland

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Observation

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Central Study Contacts

Katarzyna A Gajewska, MSc

CONTACT

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 18, 2012

First Posted

April 19, 2012

Study Start

April 1, 2012

Primary Completion

June 1, 2012

Study Completion

October 1, 2012

Last Updated

April 19, 2012

Record last verified: 2012-04

Locations