Overview

This trial is active, not recruiting.

Condition diabetes
Treatments accu-chek(r) connect dms, dms
Sponsor Hoffmann-La Roche
Collaborator Roche Diabetes Care GmbH
Start date December 2015
End date August 2016
Trial size 200 participants
Trial identifier NCT02609633, RD002489

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(R) Connect diabetes management system (DMS) or usual care/continued use of current DMS devices.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose diagnostic
Arm
(Active Comparator)
Participants and/or a parent/caregiver will perform 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 T1D regimen as needed.
dms
SMBG will be performed during the 6-month study according to usual care, using the participant's current DMS (other than Accu-Chek(R) Connect DMS).
(Experimental)
Participants and/or a parent/caregiver will receive training on Day 1 with the Accu-Chek(R) Connect 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.
accu-chek(r) connect dms
SMBG will be performed during the 6-month study using the Accu-Chek(R) Aviva Connect monitoring device, and corresponding Smartphone app and online tracking tool.

Primary Outcomes

Measure
Change in diabetes-related distress according to the Problem Areas in Diabetes (PAID) Child and Teen (C&T) parent questionnaire score
time frame: From Baseline to Month 6

Secondary Outcomes

Measure
Change in diabetes-related distress according to the PAID C&T child questionnaire score
time frame: From Baseline to Months 3 and 6
Change in perceived family conflict according to Diabetes Family Conflict Scale (DFCS) parent questionnaire score
time frame: From Baseline to Months 3 and 6
Change in perceived family conflict according to DFCS youth questionnaire score
time frame: From Baseline to Months 3 and 6
Change in affect towards glucose monitoring according to Blood Glucose Monitoring Communication (BGMC) parent questionnaire score
time frame: From Baseline to Months 3 and 6
Change in affect towards glucose monitoring according to BGMC youth questionnaire score
time frame: From Baseline to Months 3 and 6
Absolute change in hemoglobin A1c (HbA1c)
time frame: From Baseline to Months 3 and 6
Percentage of participants within glucose target range
time frame: Months 3 and 6
Change in glycemic variability
time frame: From Baseline to Months 3 and 6
Percentage of participants with hypoglycemia
time frame: Months 3 and 6
Percentage of participants with Accu-Chek(R) system satisfaction according to questionnaire score about use, preference, and satisfaction
time frame: Month 6
Change in diabetes-related distress according to the PAID C&T parent questionnaire score
time frame: From Baseline to Month 3

Eligibility Criteria

Male or female participants from 7 years up to 18 years old.

Inclusion Criteria: - Children or adolescents, aged 6 to 18 years - Diagnosis of T1D for at least 3 months - Currently managed with insulin MDI therapy - Attending full-day school schedule in Grade K through 12 - Parent/caregiver and adolescents 18 years of age to provide written informed consent - Children 7 to 17 years to provide age-appropriate child assent - Parent/caregiver currently using a Smartphone with ability to download/use the Accu-Chek(R) Connect System app - 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 during the study - Pregnancy - Clinically significant medical condition(s) such as 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(R) 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

Additional Information

Official title Accu-Chek Connect at School (CATS) Pediatric Study
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Hoffmann-La Roche.