Accu-Chek Combo in Young Patients

Clalit Health Services

Status: Completed

Conditions: Type 1 Diabetes

Treatments: Device: Accu-Chek Combo System

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01657630

Accu-Chek Combo

Details and patient eligibility

About

This is an open, prospective, descriptive study aiming to evaluate the change in treatment satisfaction of primary care givers of young children who use the Accu-Chek Combo System. Patients will routinely be scheduled and start their therapy with the Accu-Chek Combo System on visit 1. Twelve weeks later the final acquisition of data will occur. Diabetes Treatment Satisfaction Questionnaires (DTSQ) will be completed at baseline and after 12 weeks, a distinct acceptance questionnaires will be completed at final visit. In addition, Diabetes related therapeutic information will be collected and data about the use of the device components will be downloaded from the Accu-Chek Combo System

Enrollment: 13 patients

Sex: All

Ages: 6 months to 6 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diabetes Mellitus type 1
• Continuous Subcutaneous Insulin Infusion(CSII)therapy(for at least 6 months)
• Age below 6 years
• Planned and scheduled change to a Accu-Chek Combo System within the next 3 weeks at least
• Signing on an Inform Consent Form

Exclusion criteria

• Patient has been diagnosed with progressive/serious diseases that in judgment of the physician preclude successful completion of the observational period
• primary care giver not skilled enough to comment in a qualitative way

Trial design

13 participants in 1 patient group

Accu-Chek Combo

Description:

15 type 1 young patients under 6 years old who begin to use the Accu-Chek Combo System

Treatment:

Device: Accu-Chek Combo System