Accu-Chek® CONNECT at School (CATS) Pediatric Study
CATS
1 other identifier
interventional
196
1 country
13
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2015
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 18, 2015
CompletedFirst Posted
Study publicly available on registry
November 20, 2015
CompletedStudy Start
First participant enrolled
December 28, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 20, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
January 20, 2017
CompletedResults Posted
Study results publicly available
May 18, 2018
CompletedMay 18, 2018
April 1, 2018
1.1 years
November 18, 2015
January 4, 2018
April 19, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Diabetes-Related Distress Among Parents/Caregivers According to the Problem Areas in Diabetes (PAID) Child and Teen (C&T) Parent Questionnaire Score at Month 6
The PAID Questionnaire encompassed 26 items. Score for each question ranges from 1-2 = "Not a Problem" to 5-6 = "Big Problem" (Child version) or 1-2 = "Not a Problem" to 5-6 = "Serious Problem" (Teen or Parent versions). The derived total score (26 questions) ranges between 26 and 156, where higher score indicates worsened condition.
Baseline, Month 6
Secondary Outcomes (11)
Change From Baseline in Diabetes-Related Distress Among Parents/Caregivers According to the PAID C&T Child Questionnaire Score at Month 3
Baseline, Month 3
Change From Baseline in Diabetes-Related Distress Among School-age Children/Adolescents and Adolescents According to the PAID C&T Child Questionnaire Score at Month 3 and 6
Baseline, Months 3 and 6
Change From Baseline in Perceived Family Conflict Among School-Age Children With Diabetes and Parent/Caregiver According to Diabetes Family Conflict Scale (DFCS) Parent Questionnaire Score at Months 3 and 6
Baseline, Months 3 and 6
Change From Baseline in Affect Towards Blood Glucose Monitoring Among School-Age Children With Diabetes and Parent/Caregiver According to Blood Glucose Monitoring Communication (BGMC) Parent Questionnaire Score at Months 3 and 6
Baseline, Months 3 and 6
Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) Among School-Age Children With Diabetes at Months 3 and 6
Baseline, Months 3 and 6
- +6 more secondary outcomes
Study Arms (2)
Control: Usual Care - Current Diabetes Management System (DMS)
ACTIVE COMPARATORParticipants will perform self-monitoring of blood glucose (SMBG) for 6 months using the current DMS device. Follow-up office visits will be scheduled at Months 3 and 6 to review and discuss SMBG data and modify the type 1 diabetes (T1D) regimen as needed.
Interventional: Accu-Chek® CONNECT DMS
EXPERIMENTALParticipants will receive training on Day 1 with the Accu-Chek® CONNECT DMS and will thereafter perform SMBG for 6 months. Follow-up office visits will be scheduled at Months 3 and 6 to review and discuss SMBG data and modify the T1D regimen as needed.
Interventions
SMBG will be performed during the 6-month study using the Accu-Chek® Aviva CONNECT monitoring device, and corresponding Smartphone app and online tracking tool.
SMBG will be performed during the 6-month study according to usual care, using the participant's current DMS (other than Accu-Chek® CONNECT DMS).
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
Pediatric Endocrinology of Phoenix
Phoenix, Arizona, 85053, United States
Center of Excellence in Diabetes and Endocrinology
Sacramento, California, 95821, United States
Barbara Davis Center for Childhood Diabetes
Aurora, Colorado, 80045, United States
Nemours Childrens Hospital
Pensacola, Florida, 32504, United States
Tallahassee Memorial Hospital
Tallahassee, Florida, 32308, United States
University of South Florida College of Medicine
Tampa, Florida, 33612, United States
Pediatric Endocrine Associates
Atlanta, Georgia, 30342, United States
Rocky Mountain Diabetes & Osteoporosis Center
Idaho Falls, Idaho, 83404, United States
Advocate Center for Pediatric Research
Oak Lawn, Illinois, 60453, United States
Indiana University Riley
Carmel, Indiana, 46032, United States
Childrens Hospital and Clinics of Minnesota
Saint Paul, Minnesota, 55102, United States
Women and Children's Hospital of Buffalo
Buffalo, New York, 14222, United States
East Caroline University - Pediatric specialty Care
Greenville, North Carolina, 27834, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-La Roche
Study Officials
- STUDY DIRECTOR
Lena Borsa
Roche Diabetes Care
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 18, 2015
First Posted
November 20, 2015
Study Start
December 28, 2015
Primary Completion
January 20, 2017
Study Completion
January 20, 2017
Last Updated
May 18, 2018
Results First Posted
May 18, 2018
Record last verified: 2018-04