Accu-Chek Combo in Young Patients

Completed

• Conditions: Type 1 Diabetes
• Interventions: Device: Accu-Chek Combo System

• Registration Number: NCT01657630
• Lead Sponsor: Rabin Medical Center

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-08-02
• Study First Submitted QC: 2012-08-03
• Study First Posted: 2012-08-06
• Study Start: 2012-09
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-11
• Last Update Posted: 2015-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Study device acceptance	after 12 weeks	We will assess study device acceptance using a distinct Acceptance Questionnaire
Diabetes Treatment Satisfaction	after 12 weeks	we will assess patient's treatment satisfaction using Treatment Satisfaction Questionnaires

Secondary Outcome Measures

Name	Time	Method
postprandial SMBG (self monitoring blood glucose)	after 12 weeks	We will compare between postprandial SMBG at baseline and after 12 weeks
Number of Diabetic Ketoacidosis (DKA) events	after 12 weeks	We will compare number of Diabetic ketoacidosis events at baseline and after 12 weeks
Overall number of BG (Blood glucose) measurements	after 12 weeks	We will compare between number of BG measurements at baseline and after 12 weeks
Mean Blood Glucose level	after 12 weeks	we will compare mean blood glucose level at baseline and after 12 weeks
Number of Hyperglycemia Events	after 12 weeks	We will compare the number of hyperglycemia events at baseline and after 12 weeks
HbA1c	after 12 weeks	We will compare HbA1c level at baseline and after 12 weeks
Number of Hypoglycemia Events	after 12 weeks	we will compare the number of hypoglycemia events at baseline and after 12 weeks
Number of ketosis events	after 12 weeks	We will compare number of ketosis events (without documented acidosis with home/hospital management)at baseline and after 12 weeks
preprandial SMBG (self monitoring blood glucose)	after 12 weeks	We will compare between preprandial SMBG at baseline and after 12 weeks

Trial Locations

Locations (1)

Schneider Children's Medical Center; 🇮🇱 Petah-Tikva, Israel