Accu-Chek® CONNECT at School (CATS) Pediatric Study

Status:	Completed
Conditions:	Diabetes, Diabetes
Therapuetic Areas:	Endocrinology
Healthy:	No
Age Range:	7 - 18
Updated:	5/20/2018
Start Date:	December 28, 2015
End Date:	January 20, 2017

This interventional, 6-month post-marketing study is designed to evaluate the change in
diabetes-related distress among parents/caregivers of school-age children and adolescents
with type 1 diabetes (T1D) who are receiving multiple daily injections (MDI) therapy.
Investigational sites will be assigned using cluster randomization, with approximately 10 to
20 children at each site. In order to maintain a true control group for comparison, the
investigational sites will be randomly assigned to the Accu-Chek® CONNECT Diabetes Management
System (DMS) or usual care/continued use of current DMS devices.

Inclusion Criteria:

- Children or adolescents, aged 6 to 18 years

- Diagnosis of T1D for at least 3 months

- Currently managed with insulin Multiple Daily Injection (MDI) therapy

- Attending full-day school schedule in Grade K through 12

- Able to provide SMBG data minimum of one month prior to study start

- Currently using a compatible Smartphone with ability to download the Accu-Chek®
CONNECT System App accordingly OR ability to utilize Smartphone and Accu-Chek® CONNECT
System App as provided for use in study

- Adolescents (18 years) with diabetes provide written informed consent

- Children 7 to 17 years to provide age-appropriate child assent

- Parent/caregiver currently using a compatible Smartphone with ability to receive Short
Message Service/Multimedia Messaging Service (SMS/MMS) messages

- Able to read/write in English and comply with study procedures, including provision of
self-monitoring blood glucose (SMBG) data at least 1 month prior to the study

Exclusion Criteria:

- Current or planned use of continuous subcutaneous insulin infusions during the study
period

- Use of continuous glucose monitoring or a remote data-sharing system/device (i.e.
NightScout, DexCom Share, Medtronic Connect) during the study

- Pregnancy

- Clinically significant medical condition(s) such as anemia, major organ system
disease, infection, psychosis, or cognitive impairment

- Requirement for chronic steroids, immunomodulatory medication, or chemotherapy in
adrenal suppressive doses

- Visual impairment preventing use of the Accu-Chek® CONNECT system

- Parent/caregiver is an investigator, general practitioner, practice staff, pharmacist,
research assistant, or other staff or relative of those directly involved in the study

We found this trial at

sites

University of South Florida College of Medicine

Tampa, Florida 33613

from

Tampa, FL