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

NCT ID: NCT02609633

Last Updated: 2018-05-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 196 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-28
• Study Completion Date: 2017-01-20

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.

Conditions

Diabetes Mellitus, Type 1

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Control: Usual Care - Current Diabetes Management System (DMS)

Participants 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.

Group Type: ACTIVE_COMPARATOR

DMS

Intervention Type: DEVICE

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).

Interventional: Accu-Chek® CONNECT DMS

Participants 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.

Group Type: EXPERIMENTAL

Accu-Chek® CONNECT DMS

Intervention Type: DEVICE

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.

Interventions

Accu-Chek® CONNECT DMS

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.

Intervention Type: DEVICE

DMS

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).

Intervention Type: DEVICE

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

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lena Borsa

Role: STUDY_DIRECTOR

Roche Diabetes Care

Locations

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

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

RD002489

Identifier Type: -

Identifier Source: org_study_id