Accu-Chek Combo in Young Patients

Type 1 Diabetes Clinical Trial

Official title:

Evaluation of the Use of the Accu-Chek Combo System in Young Patients With Type 1 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01657630
• Other study ID #: Accu-Chek Combo
• Status: Completed
• Phase: N/A
• First received: August 2, 2012
• Last updated: March 11, 2015
• Start date: September 2012
• Est. completion date: December 2014

Study information

• Verified date: March 2015
• Source: Rabin Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 6 Years

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Device:
• Accu-Chek Combo System
12 weeks using the Accu Chek Combo System, which is an insulin pump system that offers a remote control integrating a bolus calculator, a blood glucose meter, data storage and analysis function.

Locations

Country	Name	City	State
Israel	Schneider Children's Medical Center	Petah-Tikva

Sponsors (2)

Lead Sponsor	Collaborator
Rabin Medical Center	Hoffmann-La Roche

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diabetes Treatment Satisfaction	we will assess patient's treatment satisfaction using Treatment Satisfaction Questionnaires	after 12 weeks	No
Primary	Study device acceptance	We will assess study device acceptance using a distinct Acceptance Questionnaire	after 12 weeks	No
Secondary	Mean Blood Glucose level	we will compare mean blood glucose level at baseline and after 12 weeks	after 12 weeks	No
Secondary	Number of Hypoglycemia Events	we will compare the number of hypoglycemia events at baseline and after 12 weeks	after 12 weeks	Yes
Secondary	Number of Hyperglycemia Events	We will compare the number of hyperglycemia events at baseline and after 12 weeks	after 12 weeks	Yes
Secondary	HbA1c	We will compare HbA1c level at baseline and after 12 weeks	after 12 weeks	No
Secondary	postprandial SMBG (self monitoring blood glucose)	We will compare between postprandial SMBG at baseline and after 12 weeks	after 12 weeks	No
Secondary	Overall number of BG (Blood glucose) measurements	We will compare between number of BG measurements at baseline and after 12 weeks	after 12 weeks	No
Secondary	Number of ketosis events	We will compare number of ketosis events (without documented acidosis with home/hospital management)at baseline and after 12 weeks	after 12 weeks	Yes
Secondary	Number of Diabetic Ketoacidosis (DKA) events	We will compare number of Diabetic ketoacidosis events at baseline and after 12 weeks	after 12 weeks	Yes
Secondary	preprandial SMBG (self monitoring blood glucose)	We will compare between preprandial SMBG at baseline and after 12 weeks	after 12 weeks	No