Accu-Chek Combo in Young Patients

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

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

Study Overview

• Status: Completed
• Conditions: Type 1 Diabetes
• Intervention / Treatment: Device: Accu-Chek Combo System

• Study Type: Observational
• Enrollment (Actual): 13

Contacts and Locations

Study Locations

• Israel
  • Petah-Tikva, Israel, 49202
    • Schneider Children's Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 6 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Young patients with type 1 Diabetes treated at the institute of Endocrinology and Diabetes, Schneider Children's Medical Center, which is a tertiary hospital

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Accu-Chek Combo; 15 type 1 young patients under 6 years old who begin to use the Accu-Chek Combo System	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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Blood Glucose level	we will compare mean blood glucose level at baseline and after 12 weeks	after 12 weeks
Number of Hypoglycemia Events	we will compare the number of hypoglycemia events at baseline and after 12 weeks	after 12 weeks
Number of Hyperglycemia Events	We will compare the number of hyperglycemia events at baseline and after 12 weeks	after 12 weeks
HbA1c	We will compare HbA1c level at baseline and after 12 weeks	after 12 weeks
postprandial SMBG (self monitoring blood glucose)	We will compare between postprandial SMBG at baseline and after 12 weeks	after 12 weeks
Overall number of BG (Blood glucose) measurements	We will compare between number of BG measurements at baseline and after 12 weeks	after 12 weeks
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
Number of Diabetic Ketoacidosis (DKA) events	We will compare number of Diabetic ketoacidosis events at baseline and after 12 weeks	after 12 weeks
preprandial SMBG (self monitoring blood glucose)	We will compare between preprandial SMBG at baseline and after 12 weeks	after 12 weeks

Collaborators and Investigators

• Sponsor: Rabin Medical Center
• Collaborators: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (ACTUAL): December 1, 2014
• Study Completion (ACTUAL): December 1, 2014

Study Registration Dates

• First Submitted: August 2, 2012
• First Submitted That Met QC Criteria: August 3, 2012
• First Posted (ESTIMATE): August 6, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): March 12, 2015
• Last Update Submitted That Met QC Criteria: March 11, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: Type 1 Diabetes; Insulin Pump Therapy; Treatment Satisfaction
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: Accu-Chek Combo