Clinical trial NCT02609633: Accu-Chek® CONNECT at School (CATS) Pediatric Study
Official title: Accu-Chek® CONNECT at School (CATS) Pediatric Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 1
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2015-11-20
Enrollment: 196
Sex: ALL
Minimum age (years): 7
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: Baseline, Month 6
Secondary outcomes:
measure: Change From Baseline in Diabetes-Related Distress Among Parents/Caregivers According to the PAID C&T Child Questionnaire Score at Month 3
timeFrame: Baseline, Month 3
measure: 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
timeFrame: Baseline, Months 3 and 6
measure: 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
timeFrame: Baseline, Months 3 and 6
measure: 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
timeFrame: Baseline, Months 3 and 6
measure: Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) Among School-Age Children With Diabetes at Months 3 and 6
timeFrame: Baseline, Months 3 and 6
measure: Change From Baseline in Percentage of Blood Glucose (BG) Measurements Among School-Age Children With Diabetes at Months 3 and 6 Within Glucose Target Range
timeFrame: Baseline, Months 3 and 6
measure: Change From Baseline Blood Glucose Variability Among School-Age Children With Diabetes at Months 3 and 6
timeFrame: Baseline, Months 3 and 6
measure: Change From Baseline in Percentage of Hypoglycemic BG Measurements Among School-Age Children With Diabetes at Months 3 and 6
timeFrame: Baseline, Months 3 and 6
measure: Percentage of Participants Who Frequently Used Accu-Chek® CONNECT Diabetes Management System According to a Questionnaire About Usability
timeFrame: Month 6
measure: Percentage of Participants With Participants Preference for Accu-Chek® CONNECT Diabetes Management System With Previous Technology/Process
timeFrame: Month 6
measure: Percentage of Participants With Overall Treatment Satisfaction With the Use of Accu-Chek® CONNECT Diabetes Management System According to a Questionnaire
timeFrame: Month 6
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Pediatric Endocrinology of Phoenix
state: Arizona
city: Sacramento
country: United States
facility: Center of Excellence in Diabetes and Endocrinology
state: California
city: Aurora
country: United States
facility: Barbara Davis Center for Childhood Diabetes
state: Colorado
city: Pensacola
country: United States
facility: Nemours Childrens Hospital
state: Florida
city: Tallahassee
country: United States
facility: Tallahassee Memorial Hospital
state: Florida
city: Tampa
country: United States
facility: University of South Florida College of Medicine
state: Florida
city: Atlanta
country: United States
facility: Pediatric Endocrine Associates
state: Georgia
city: Idaho Falls
country: United States
facility: Rocky Mountain Diabetes & Osteoporosis Center
state: Idaho
city: Oak Lawn
country: United States
facility: Advocate Center for Pediatric Research
state: Illinois
city: Carmel
country: United States
facility: Indiana University Riley
state: Indiana
city: Saint Paul
country: United States
facility: Childrens Hospital and Clinics of Minnesota
state: Minnesota
city: Buffalo
country: United States
facility: Women and Children's Hospital of Buffalo
state: New York
city: Greenville
country: United States
facility: East Caroline University - Pediatric specialty Care
state: North Carolina
Study officials:
affiliation: Roche Diabetes Care
name: Lena Borsa
role: STUDY_DIRECTOR
References: