Accu-Chek® CONNECT at School (CATS) Pediatric Study
Completed · Not applicable
Conditions studied: Diabetes Mellitus, Type 1
In brief
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.
Key facts
- Study ID
- NCT02609633
- Run by
- Hoffmann-La Roche
- People needed
- 196
- Starts
- 2015-12-28
- Expected to finish
- 2017-01-20
- Last updated by the study team
- 2018-05-18
Who can join
Age: 7 and older, up to 18. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Pediatric Endocrinology of Phoenix — Phoenix, Arizona, United States
- Center of Excellence in Diabetes and Endocrinology — Sacramento, California, United States
- Barbara Davis Center for Childhood Diabetes — Aurora, Colorado, United States
- Nemours Childrens Hospital — Pensacola, Florida, United States
- Tallahassee Memorial Hospital — Tallahassee, Florida, United States
- University of South Florida College of Medicine — Tampa, Florida, United States
- Pediatric Endocrine Associates — Atlanta, Georgia, United States
- Rocky Mountain Diabetes & Osteoporosis Center — Idaho Falls, Idaho, United States
- Advocate Center for Pediatric Research — Oak Lawn, Illinois, United States
- Indiana University Riley — Carmel, Indiana, United States
- Childrens Hospital and Clinics of Minnesota — Saint Paul, Minnesota, United States
- Women and Children's Hospital of Buffalo — Buffalo, New York, United States
- East Caroline University - Pediatric specialty Care — Greenville, North Carolina, United States
Full record on ClinicalTrials.gov
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