Type 1 Diabetes
Conditions
Keywords
Insulin Pump Therapy, Type 1 Diabetes, Treatment Satisfaction
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
Interventions
DEVICEAccu-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.
Sponsors
Hoffmann-La Roche
Rabin Medical Center
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
6 Months to 6 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diabetes Treatment Satisfaction | after 12 weeks | we will assess patient's treatment satisfaction using Treatment Satisfaction Questionnaires |
| Study device acceptance | after 12 weeks | We will assess study device acceptance using a distinct Acceptance Questionnaire |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Hypoglycemia Events | after 12 weeks | we will compare the number of hypoglycemia events 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 |
| preprandial SMBG (self monitoring blood glucose) | after 12 weeks | We will compare between preprandial SMBG 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 |
| 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 |
| Number of Diabetic Ketoacidosis (DKA) events | after 12 weeks | We will compare number of Diabetic ketoacidosis events at baseline and after 12 weeks |
| postprandial SMBG (self monitoring blood glucose) | after 12 weeks | We will compare between postprandial SMBG 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 |
Countries
Israel
Outcome results
None listed