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

Diabetes Mellitus, Type 1 Clinical Trial

— CATS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02609633
• Other study ID #: RD002489
• Status: Completed
• Phase: N/A
• Start date: December 28, 2015
• Est. completion date: January 20, 2017

Study information

• Verified date: April 2018
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 196
• Est. completion date: January 20, 2017
• Est. primary completion date: January 20, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Device:
• 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.
• 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).

Locations

Country	Name	City	State
United States	Pediatric Endocrine Associates	Atlanta	Georgia
United States	Barbara Davis Center for Childhood Diabetes	Aurora	Colorado
United States	Women and Children's Hospital of Buffalo	Buffalo	New York
United States	Indiana University Riley	Carmel	Indiana
United States	East Caroline University - Pediatric specialty Care	Greenville	North Carolina
United States	Rocky Mountain Diabetes & Osteoporosis Center	Idaho Falls	Idaho
United States	Advocate Center for Pediatric Research	Oak Lawn	Illinois
United States	Nemours Childrens Hospital	Pensacola	Florida
United States	Pediatric Endocrinology of Phoenix	Phoenix	Arizona
United States	Center of Excellence in Diabetes and Endocrinology	Sacramento	California
United States	Childrens Hospital and Clinics of Minnesota	Saint Paul	Minnesota
United States	Tallahassee Memorial Hospital	Tallahassee	Florida
United States	University of South Florida College of Medicine	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change From Baseline in Diabetes-Related Distress Among Parents/Caregivers According to the PAID C&T Child Questionnaire Score at Month 3	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 3
Secondary	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	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, Months 3 and 6
Secondary	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	The DFCS Questionnaire has 19 questions, each question ranges in response values between 1 ("Almost Never") and 3 ("Almost Always"). The derived total score (19 questions) ranges between 19 and 57, where higher score indicates worsened condition. This questionnaire was answered by Children/adolescents and Parents.	Baseline, Months 3 and 6
Secondary	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	The BGMC Questionnaire has 8 questions, each question ranges in response values from 1 ("Almost Never") to 3 ("Almost Always"). The derived total score ranges between 8 and 24, where higher score indicates worsened condition.	Baseline, Months 3 and 6
Secondary	Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) Among School-Age Children With Diabetes at Months 3 and 6	Assessment of HbA1c is an indicator of long-term control of diabetes.	Baseline, Months 3 and 6
Secondary	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	The percentage of target range measurements was defined as the number of within target range readings in the interval divided by the total number of BG checks in the interval.	Baseline, Months 3 and 6
Secondary	Change From Baseline Blood Glucose Variability Among School-Age Children With Diabetes at Months 3 and 6	Glycemic variability, expressed as mean of all blood glucose(BG) readings per subject within the interval. BG variability was defined as standard deviation (SD) of all glucose readings over the interval.	Baseline, Months 3 and 6
Secondary	Change From Baseline in Percentage of Hypoglycemic BG Measurements Among School-Age Children With Diabetes at Months 3 and 6	A measurement was defined as hypoglycemic if the glucose value was below 70 mg/dl or below 60 mg/dl or below 50 mg/dl.	Baseline, Months 3 and 6
Secondary	Percentage of Participants Who Frequently Used Accu-Chek® CONNECT Diabetes Management System According to a Questionnaire About Usability	Percentage of participants who frequently used Accu-Chek® CONNECT Diabetes Management System (blood sugar meter [BSM], phone application [PA] and web portal [WP]) according to the questionnaire about usability answered by children/adolescents and Parent were reported. Here, in parent post questionnaire for usability the sum of percentages are not equal to 100%, because percentage is based on n=44.	Month 6
Secondary	Percentage of Participants With Participants Preference for Accu-Chek® CONNECT Diabetes Management System With Previous Technology/Process	Participants preference the Accu-Chek® CONNECT process compared with previous technology/process assessed by questionnaire including following questions; Q 1: Felt more sure of myself using the system, Q 2: Less worried about low BG than used to be, Q 3: Would rather use the system than what used before, Q 4: Felt safer managing diabetes using system than what used before, Q 5: Friends with diabetes should also use the system. Questionnaire was answered by children/adolescents and parents. Here, in children/adolescents post questionnaire for preference the percentage sum is not equal to 100%, because percentage is based on n=41.	Month 6
Secondary	Percentage of Participants With Overall Treatment Satisfaction With the Use of Accu-Chek® CONNECT Diabetes Management System According to a Questionnaire	Percentage of participants with overall treatment satisfaction with the use of Accu-Chek® CONNECT Diabetes Management system according to the questionnaire answered by children/adolescents and parents were reported.	Month 6